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AGM 2022

Jun 29, 2022

Operator

Good afternoon, and welcome to the ANGLE plc annual general meeting proceedings. Throughout this recorded presentation, attendees will be in listen-only mode, and questions will only be taken from those physically attending today's meeting. I'd now like to hand you over to Garth Selvey, Chairman. Good afternoon.

Garth Selvey
Non-Executive Chairman, ANGLE plc

Good 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 physically in Guildford and others joining online. My name is Garth Selvey, and I'm the chair of the company. I'm joined today by the executive, Andrew Newland and Ian Griffiths, as well as my co-non-execs, Brian Howlett and Jan Groen. Brian and I are attending online courtesy of COVID, 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. 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.

Ian Griffiths will, when I finish speaking, present the votes received for each resolution and ask for a 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
Finance Director, ANGLE plc

Great. Thanks, Garth. Obviously sorry, Brian and Garth can't be with us, but COVID is still rearing its head. 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 of the virtual, so looking forward to that dialogue and interaction, and thank you for coming. To those listening online, welcome. I propose that we take the notices read. As I said, I will go through the formalities. I will repeat the individual resolutions. We'll start off with resolution one, which was to receive the accounts.

Before I put it for a vote of the hands, just advise that the company has received votes for of 89,327,733, representing 99.31%. Third party's discretion, another 0.69% that will be added to that. And essentially a de minimis amount against 343 shares. 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 couple of non-members here. That's duly resolution one is duly carried by the necessary majority. Resolution two, to approve the directors' own remuneration report.

Just to advise, the company's received proxies as follows: for 70,541,110 for 78.51%, with a further 0.69% in favor at third party's discretion. Against, 18,689,922, representing 20.8%. Those in favor in the room? Thank you. I declare resolution two carried by the necessary majority. Resolution three, which is to reappoint PricewaterhouseCoopers. The proxy voting received for 89,077,629, representing 99.06%. Third party's discretion, another 0.69%. Those against, 220,198, representing 0.24%.

Those in favor in the room?

Speaker 7

Can I ask a question?

Ian Griffiths
Finance Director, ANGLE plc

Yeah.

Speaker 7

When was the last time you brought them up for tender?

Ian Griffiths
Finance Director, ANGLE plc

PwC were brought on board two years ago after RSM.

Speaker 7

Right. When are you doing? When is that? Two years time, three years time?

Ian Griffiths
Finance Director, ANGLE plc

Well, we'll review that at an appropriate time. We've only recently appointed PwC. Normally, unless there was a challenge of some form, you'd look at five, maybe 10 years. It would depend on where the company is in its development and how it's going forward. If we could take questions after the formalities, that'd be great. Thank you very much. Resolution three, as I said, just to remind people, to reappoint PwC as auditors. Proxy votes received, those for 89,077,629, representing 99.06%. Further, 0.69%, third party's discretion who voted for. Against, 220,198, representing 0.24%. Those in the room? Thank you very much.

I declare resolution three carried by the necessary majority. Resolution four is to appoint myself, Ian Griffiths, who's retired by rotation. We were last appointed three years ago, so retired by rotation in accordance with Article 91, which also applies to the rest of the directors who have all been appointed at the same time. The proxy votes received, those for 89,150,665, representing 99.07% of the votes. Third party's discretion, another 0.69%. Those against, 212,088, 0.24%. Those in the room. Thank you very much. I declare resolution four carried by the necessary majority. Resolution five is to reappoint Nimesh Patel, your colleague to the right, I'm sure you're familiar. Again, retiring by rotation.

Proxy votes received. Those for, 85,134,082 representing 94.64%. Third party's discretion, another 0.69%. Those against, 4,197,201 representing 4.67%. Those in the room. I declare resolution five carried by the necessary majority. Resolution six, to reappoint Brian Howlett, who you saw earlier, who's again retiring by rotation. Those for, 82,378,551 representing 91.58%. The third party's discretion, another 0.69% votes for. Those against, 6,949,202 representing 7.73%. Those in the room. Cool. Thank you very much.

I declare resolution six carried by the necessary majority. Resolution seven, to appoint Andrew, again, retiring by rotation. Those for, eighty-nine million, two hundred and nine, three hundred and sixty-eight, representing 99.18% of the vote. Third party's discretion, another 0.69%. Those against, one hundred and eighteen, three hundred and eighty-five, representing 0.13%. Those in the room. Cool. Thank you very much. Resolution seven carried by the necessary majority. Resolution eight, to reappoint Garth Selvey. Those for, seventy million, six hundred and twenty-two, four hundred and nine, representing 88.51% of the vote. Third party's discretion, another 0.78%. Those against, eight million, five hundred and forty-two, three hundred and one, for 10.71%.

Those in the room. Thank you very much. I declare resolution eight carried by the necessary majority. Resolution nine, the authority of the directors to grant unissued shares in the capital, representing about a third of the company's issued share capital. Proxy votes received. Those for, 88,736,007, representing 98.68%. Third party's discretion, another 0.69% who voted for. Then against, 561,051, representing 0.62%. Those in the room. Thank you very much. I declare resolution nine carried by the necessary majority. Only two more.

Resolution ten, the ability of the company to disapply the statutory preemption rights, representing about 10% of the issued share capital of the company. Note this is a special resolution and therefore requires a 75% majority. The proxy votes received. Those for, 88,552,147, representing 98.5% of the vote. Third party's discretion, another 0.69%. Those against, 723,462, representing 0.8%. Those in the room. Thank you very much. I declare resolution ten carried by the necessary majority. 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 party's discretion, another 0.69%, voted for. Against, 1,155,214, representing 1.28% of the vote. Those in the room. Cool. Thank you very much. I declare resolution 11 carried by the necessary majority. I've rattled through it because I know we're all here for the next part, which is the presentation Q&A. On behalf of the board, I'd like you to thank all of you for your attendance and declare this formal part of the annual general meeting closed. Thank you.

Andrew Newland
Founder and CEO, ANGLE plc

Great. Well, thank you very much, Ian. Now I'm going to do a presentation. If you could put the slides up, please. Thank you very much. Just get those on full. Great. Okay. You are now looking at the Parsortix FDA-cleared platform, which is now gonna be full screen, hopefully. Yes, there we go. Today's presentation is going to be a little bit longer than usual, for two reasons. First one is that I'm gonna try and address a number of questions which have come in, within the presentation. 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.

I'm gonna 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 frustrating that was, but I'm glad that everybody's been able to come. I'm also pleased to have the attendees online as well. You're all very welcome. As I said, this system is the first system ever cleared by FDA for harvesting cancer cells from patient blood for subsequent analysis. We believe that will have a profound impact on the lives of cancer patients in the future.

Very importantly for all of us, make ANGLE a highly successful investment for its shareholders. The backdrop to this is that the incidence of cancer is rising inexorably, unfortunately. The National Cancer Institute 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. 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 healthcare expenditure.

A great deal of money is wasted in healthcare at the moment because of a lack of understanding of the individual's cancer at a particular time and point, and they therefore get given drugs and other therapies which won't work. It'd be far better if you could personalize cancer care. That is the mission for ANGLE. 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. I should say also in Europe because we designed our studies to meet the European requirements for CE mark. We now have a product which can be used to recover cancer cells from blood for subsequent analysis. That's the background to the company.

In terms of the performance in the year in question, 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. 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. We developed a full and complete response to those questions. That involved no extra clinical samples, thank goodness, so we didn't have to start a new patient study. We did have to run another 1,000 analytical samples.

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, in that we set up two clinical laboratories. 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 set up in the United States, in Pennsylvania, in a place called Plymouth Meeting, which is quite close to Philadelphia.

Those two 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 for pharmaceutical companies in cancer drug trials. 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. We developed some plans for prostate cancer development as well.

In amongst all of that, we completed a fundraise which was well supported by existing and some new shareholders, both UK-based and in the United States, to raise GBP 20 million gross funding. That put us into a reasonably strong cash position at the year-end. At the year-end, we had GBP 32 million in cash reserves. By the way, we have no debt. There's no debt in the company. In addition to the GBP 32 million that we had at the year-end, we had a further receivable of GBP 4.5 million from UK government R&D tax credits. That gave us cash position which is reasonable for what we're seeking to achieve.

We also delivered an increase in revenue by 33% year-on-year. Now that's, 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. I'll explain a little bit later on the impacts of that. 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. This is not just United States. Every single cancer diagnostic company or hospital in the world looks at an FDA product clearance if they want to buy a medical product. It is absolutely, literally the gold standard for getting a medical device approved.

It took our company six and a half years to achieve. We processed 16,000 samples to do that, and we wrote 400 technical reports and documents in pursuit of that clearance. 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. We also know that there are no other companies who are even trying to do this. 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. The intended use is very broad. We asked FDA for a platform clearance. 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 that they can recover the cancer cells from patient blood, but that they can then decide what they want to do with those cells. That was probably the single biggest challenge that we were concerned about with FDA is whether they would accept that. Because normally they go for one specific use and clear that only. That would be, for example, looking at one protein on the cancer cell to advise on one particular drug that could be prescribed.

They accepted our argument, however, that we were seeking to provide a liquid biopsy alternative to tissue biopsy. With tissue biopsy, they cut out the cancer, 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. We've got an exactly parallel clearance. 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. We believe that's the best way to get a broad adoption of the technology. In terms of the impact that this has had, I was sort of noting that we'd 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 and increased interaction from commercial companies about this. We've had several large-scale medical diagnostic companies have now spoken to us, and we're about to start conversations with them.

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. 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. 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. Clinical users are beginning to sit up and look at this platform, whereas before they wouldn't. In addition to inbound, we've had an increased level of outbound.

We have a marketing team who are involved in directly spreading in information about the system to potential users. We also upping our game in terms of attending major clinical conferences. There's a big one coming up later this month, which I will be at together with several of my colleagues. That's a sort of change because up until the FDA clearance, we didn't have a clinical product. 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. We want the whole healthcare 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. That's very, very good for the patient because cancer changes over time. They can get now with our system, they'll be able to get real-time information on what's happening for the individual patient, and that will improve their healthcare and also reduce costs. 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 hold of a fragment of dead cells. Centrifuge the blood. By centrifugal force, the blood cells go in one portion and the liquid is separated, remove the liquid with a pipette 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 small part of the picture. You want to look at RNA, you want to look at protein expression.

For example, most drugs target proteins. They don't target DNA. There's a major benefit if you can actually look at the cells, morphologically and look at the way that they're structured. 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. Whereas circulating tumor DNA by definition is dead cells, you don't know why it died. Did it die because the 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? It's clearly a retrospective analyte. That said, we see the two analytes as being complementary, the circulating tumor DNA and the CTCs.

They both can come from the same tube of blood. We're seeking to work with the very large-scale clinical services labs that are in ctDNA. If they buy a Parsortix as a customer, they can do both analytes from the same blood sample. We've shown the waste product of ctDNA can be put through Parsortix, recover the cancer cells, and you can get more information. 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. Med tech companies can benefit 'cause 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 and in diagnostics. 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 a tissue biopsy, you can do with a blood test now that you've got Parsortix. That clearly opens up a very large market, over $100 billion in the United States market alone. Exactly the same across other parts of the world as well.

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. While 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. That's available in 63 peer-reviewed publications on Angle's website. 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. This is where it comes to how we're going to do that. It's quite complex, so I'm gonna 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 are we really able to start putting our foot on the accelerator to deliver it. It's a carefully developed strategy intended to leverage the entire industry. Stage one is providing the system and selling it into researchers. 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 Aceto 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 lab's been working with Parsortix for four years now. They've been in Nature three times. 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. It's very important to us to design a commercialization strategy which can deliver substantial revenue in the relatively near term, and that's gonna come out of our pharma services business.

The reason I say that is because we have a known customer base, which is the pharmaceutical companies and the biopharma who are developing new drugs, and they are in a position to pay for this test right now, and they want it. I'll explain why on a later slide. We're also building out in our own clinical laboratories what's called lab-developed tests. LDTs, as they're named, are tests offered by an accredited laboratory for patient management. That process is a much quicker process and less involved process than getting an FDA clearance. We've established these labs to be accelerators and demonstrators for new uses. We've got two LDTs which are developing, one in prostate and one in ovarian. Can you stop here?

Operator

Okay.

Andrew Newland
Founder and CEO, ANGLE plc

All right. Finally, the fourth stage is the IVD CDx. What I mean by that is, that is the very large-scale use in treating patients. There are three 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. 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. They will develop their own uses of the cancer cells, which they can start to deploy with their patients. We want to use them as essentially the opinion leaders to drive the marketplace.

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. We've talked about the interaction with Abbott. 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 a 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. If plans go ahead as expected, we will do a deal with Abbott or one of their competitors to combine HER2 testing that already exists with Parsortix. 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. 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.

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 analyses and techniques to work with the cancer cells, and they will drive that adoption. That's one major method of getting into the clinical market. The other one is the pharmaceutical companies. I'm gonna 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. The regulators are saying, "Well, we're not gonna approve this drug unless you tell us who should have it.

We can't just blanket give it to everybody 'cause it's too expensive, it's got side effects, and it doesn't work for everybody." Those pharma companies need companion diagnostics, and we believe that Parsortix is an excellent platform to give them those companion diagnostics. 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. Again, it's about harnessing the industry. We're essentially trying to be a catalyst to get all of these things moving ahead. That's how the commercialization strategy looks in overview. Now I'm going to talk about some of the details on the different elements. The first one is about the pharma services offering. First off, why do pharma companies want this?

The answer is that in the way that cancer drug trials are run at the moment, the pharma company or the hospitals working for them will recruit a cohort of patients to try out a drug, and then they will recruit a matched cohort to be given the placebo. Standard drug trial, one lot has the drug, other lot has the placebo, and then they look to see who does better. Essentially, what they're measuring is overall survival and progression-free survival. 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.

Also, it can take quite a long time, because you might have to wait several years to distinguish the two groups in terms of their outcome. 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. 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 and what were they made up of.

That gives a set of baseline information as to the current status in the patient. They can repeat the blood test when the patient is having the drug and look at the difference. If the drug is having an impact, it should be reducing the number of cancer cells and the type of cancer cells that are present. They can repeat that again after they've had the drug to see if any response is continued or whether it dissipates. They may want to do that several times. Actually, we've got one customer who's looking at seven 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.

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. 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 stain the individual cells, cancer cells, to say, "Is that present or is that not present?" Now we're giving them all the information about the cancer cells, but we're also indicating whether their target for their drug is present or not, and if so, how much. That has been very well received. Bear in mind, I'm talking about proteins here.

You 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. From a standing start, we've built out now four customers, and one of them is we announced as being a large-scale contract, so it was a $1.3 million contract. They jumped us 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 one of their studies, different drug altogether, for $1.2 million.

What we've learned from that is what we were anticipating, but it's now been born out in practice, is that it takes a significant effort to sign up a new customer. Some of these contracts are taking us nine 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 sign 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. Over time, we're selling now things that we're doing work in three, four, five years' time.

That's great because we're gonna get visibility on growing revenues, so it means we can plan out the capacity of our labs to address that. In terms of the assay development, we've got two customers who've taken that on already. Both of the assay developments are going really well. We get paid for the assay development, by the way, somewhere between $100,000 and $200,000 for each one, depending on how difficult the work is. We provide them with a quote, they accept that. At the end of that process, we jump straight into their clinical study. We know that it'll be follow-on revenues.

That's what we expect with every one of these contracts, is they start with a phase 1A, then a phase 1B, then a phase II, then a phase III, et cetera. Getting more and more patients each time. They're scaling out. We really only need a handful of customers in order to make a very significant impact. 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 two 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.

There's a tremendous opportunity just in those two 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 four different cancer types. They just happen to be four that we're very active in. The same thing applies across all the 24 cancers that I mentioned. It highlights that we've got multiple peer review publications by independent cancer centers showing that Parsortix works in these cancers. Then the critical point is that on ClinicalTrials.gov, there are a lot of different studies that we can address.

In just breast cancer, there are 950 clinical trials that might be appropriate for this that are logged on that system, including 247,000 patients. If a pharma company signed us up, each one of those patients would have at least three blood samples and maybe five or even seven. There's a very large scale opportunity. Just in these four cancers, we think the opportunity is up to $2 billion of revenue per annum. This is where we're building out our near-term commercial revenue. Now I'm changing tack to talk about the first of our two lab-developed tests that we intend to offer from ANGLE Labs.

Now, just to repeat, we're gonna 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, "Well, you know what? We want that. So you've got an ovarian cancer test. Right, we'll take it on from you." That way 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. This is our first one, ovarian cancer.

We've done two clinical trials already. Both of them were successful. The last one was 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 got a pelvic growth. But you can't tell from symptoms whether they've got a 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. Those patients will typically be a six-hour operation, and they'll end up in intensive care afterwards. Not knowing who's who at before you start the work is very dangerous. In this country, we don't have a good discrimination.

Many women who have ovarian cancer don't get appropriate surgery. 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. Within the next month or so, we will be able to get the headline results of that study coming through. 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 into 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's 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.

We're getting, in the UK 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. 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. 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.

There's far too much invasive procedures going on from a very bad blood test, and it would be much better to have a more specific blood test which had a lower level of false positivity, and that's what we're seeking to achieve. The second half is even more impactful, which is that a diagnosis of prostate cancer almost inevitably leads to a decision to have surgery to cut the prostate gland out. Obvious reaction. We've got cancer, let's cut it out. Unfortunately, the radical prostatectomy surgery has lifelong impact in terms of impotence and urinary incontinence. When you know that the statistics are that 60% of men who have prostate cancer have a slow burn cancer that's not gonna impact them, unfortunately, that's not a good way to go forward.

It'd be far better to have a blood test to assess whether or not the cancer is aggressive. 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 three months' time, just check 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, you know, unchangeable decision to take action. That's what we're targeting with this.

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 the ability to assess with a hazard ratio of over 10 times serious aggressive prostate cancer versus indolent cancer. We looked into some statistics about men who had died, not from cancer, and autopsies show that over the age of 70, up to 50% of men have prostate cancer. They didn't know they had cancer. It was undiagnosed. They had no symptoms that really affected their life. 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.

We're hopeful that our test will be able to achieve that. It has a secret advantage over 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, and they don't have cancer. That doesn't happen with living cancer cells in the blood. We have the secret advantage that we're working with the actual cancer cells that spread the disease. I said it was gonna be a bit longer than usual.

I hope it's not too long. In terms of the IVD market, post 510(k)-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 a 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. You're sure you're not another Theranos?" Well, the answer is Theranos never had a single peer-reviewed publication. We have 63 peer-reviewed publications. They're on our website. Anyone can read them. 31 world-leading cancer centers have all attested to the performance of this system. We've got in place a very clear strategy for commercialization. Over the next 12-18 months, there's some immediate priorities. 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. Corporate deals. Now that we've got the FDA clearance, we're re-energizing conversations that we'd already started, and we're starting new conversations with big corporates about working alongside of Parsortix on the basis that that can help them extend their tests and do multiple repeats. The two laboratories that we've got, which are now trading under the brand OncAdapt, are in process for accreditation, and we're hopeful that that accreditation will come actually possibly a bit quicker than H1, calendar 2023. They're dependent on us having a clinical test to 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 laboratory-developed tests in both those areas. 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, but some very important immune cells which are attacking themselves, those cancer cells. I already mentioned Aceto once, but we'll mention them again. They're looking at clusters and seeing white blood cells embedded in those clusters. There's 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 gonna be ANGLE scientists coming up with the next breakthrough. It's gonna be these other people using our system. We're gonna 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. Just in summary, 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. 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. It's very, very difficult for us to be challenged by another CTC company. All the other companies in this space we want to work with and enable them. 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, very, very good news, and we're looking to expand that into other cancer types. Overall, we've got multiple potential catalysts over the next 12-18 months. That concludes the presentation.

Thank you very much. We're gonna move to questions and answers. If colleagues would like to put their videos back on, and we can expand that out, that would be great. Ian, you-

Ian Griffiths
Finance Director, ANGLE plc

As Garth mentioned at the start, we'll start off with some of the questions that have been received, which have been pre-approved, but then we'd like to go out to the present here. I can start off with the first question to Garth to answer. The question is a potential NASDAQ listing still being considered? If so, when is it likely to happen, and what conditions would be required?

Garth Selvey
Non-Executive Chairman, ANGLE plc

A very frequently asked question. All options are open is the answer. The NASDAQ one equally remains open. Our present focus is very much on the commercialization process and the development of revenue opportunities. You would be able to very clearly see the intensity of that process from Andrew's presentation. 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've 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 advisors already in place and the systems in place that we would need to implement such a move. That in a nutshell is a maybe, but we will have choices.

Ian Griffiths
Finance Director, ANGLE plc

Thank you, Garth. I'd probably add to it on giving Bruce's point as we're going through the formalities. You know, for NASDAQ, there is only a choice of one of the Big Four auditors to take us through. Realistically, the only two very strong ones for listing NASDAQ are PwC and Ernst & Young. That's as Garth said about lining up our resources to take us forward. I'm sure there's another different view that you may come back on later, but there are reasons why we work with some of the organizations to put the company in as strong a position as possible. Second question, which I'll ask to myself in this case is what is the current cash position. What is the route to profitability with further funding required. Which I'm sure plenty of.

There was quite a few questions along those lines. What I would say is that, we don't give out the current cash position. Obviously, the last reported cash position was GBP 32 million at the 31st of December, along with another GBP 4.5 million R&D tax credits that was 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, so we can push it out a bit further with some of the discretionary spend. We're deploying the capital that we raised, for the activities that we have talked about.

That includes, for example, obviously the newer areas here, such as 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. We're in good shape financially, no immediate requirements. In terms of the route to profitability, Andrew's 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. That's where the nearer term revenue is available. We do have to focus on specific areas and activities, and so we can't just get out into all areas. We've got a very tightly focused plan. Following that tightly focused plan does affect when we get out to profitability or not.

Obviously, keep on the tightly focused plan. We can get to profitability much earlier. That'd be estimated about 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 earlier, obviously we're increasing the spend, which would push out the breakeven, but actually gives us more of an opportunity to do a land grab. We need additional capital to get there. The question is what is the source of that capital? Obviously we're progressing key corporate partnerships with the potential for some upfront milestone payments. Of course, historically we've raised money from the capital markets.

We're in good shape, but we also have to keep to a 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 nine months?

Andrew Newland
Founder and CEO, ANGLE plc

The onboarding of pharma customers is a significant effort. 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. They want to review our quality systems, and we have to agree with them which centers are doing their studies, how the bloods will be processed, et cetera. There's a lot of different elements involved. 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 timescales. 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. The part of us going out and finding the customers and getting them to engage in the first place, that is getting quicker already. 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 dead 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. Once it's in place, just adding an additional contract to it is very easy.

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. In terms of brand new ones, I think it will continue to be a significant process that has to be followed.

Ian Griffiths
Finance Director, ANGLE plc

Thanks, Andrew. Next question was on clinical labs. In fact, there's three questions here, which again, I'll put to you, Andrew. I'll read the three questions out first. Can you provide guidance on the likely timing of clinical accreditations in both the U.K. and U.S. and explain the processes involved? What LDTs will be offered by the clinical laboratories once credited, 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 Newland
Founder and CEO, ANGLE plc

Well, the first two I think probably were addressed to an extent in the presentation. In terms of the timing of 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. The U.S. center, for example, is already registered. It's not fully accredited, but it is registered. To get the full accreditation, we have to, in each of the categories, there are two main categories that we're interested in. One is imaging cells, and the other one is doing molecular analysis of cells. In each of those two categories, the first test that we're going to offer for patient management has to be submitted and approved by the regulatory agency.

It's a little bit of a chicken and egg situation. For example, the first on the molecular is gonna be the ovarian test. We have to finish the ovarian studies first, be satisfied that those are all in place, and then submit that data for clearance. Similarly with imaging, we're validating an imaging assay, and when we submit that will be part of the accreditation. I would say the best guidance on that is somewhere around the end of the year. To an extent, it is 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. That's that one. In terms of the LDTs, the first two are expected to be ovarian cancer and then, prostate cancer. We're considering a number of other things, but at the moment, those are the first two. 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.

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've got prostate conditions, and they order the tests from us, draw the blood from the patient, send it to us, and then we get paid for the test and send them results back. We never talk to the actual patient, nor would we even know the patient's identity. In terms of having a website, 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. That will be business to business, not business to consumer.

Ian Griffiths
Finance Director, ANGLE plc

Thank you. Got two questions on FDA here, but the first one's 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 Newland
Founder and CEO, ANGLE plc

Yes. That's the point about what are we allowed to do and the intended use. What that is is that we, our Parsortix system is intended to harvest cancer cells from the blood of metastatic breast cancer patients for subsequent analysis. 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 tests that 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, you know, what they're gonna look at in the cells and what do they want to do as a result of that, not ANGLE.

Ian Griffiths
Finance Director, ANGLE plc

Thank you. Jan, a question for you is: What other FDA clearances are likely? Will you be seeking clearance for the ovarian cancer and prostate test? If so, how long would that take?

Jan Groen
Independent Non-Executive Director, ANGLE plc

Yes. I think during the presentation where you stated that the initial focus of ANGLE will be on the laboratory developed test. Of course, we'll be engaging with the FDA regarding the processes for clearance, and it should go faster now we have cleared a platform. As already presented, we will focus predominantly on breast cancer, ovarian, and prostate cancer, and we expect actually that the process will go faster since we have a cleared instrument.

Ian Griffiths
Finance Director, ANGLE plc

Thanks. Brian, I don't know if you can put your microphone on. Hopefully it will work. Broader question for you. Is recruitment of qualified personnel proving to be an ongoing challenge?

Brian Howlett
Senior Independent Director, ANGLE plc

Yeah, that's a great question because ultimately a med tech company depends on the quality of its workforce. 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 this company has successfully attracted a talented, internationally based, diverse team that has marked up very, very significant achievements in its preliminary stages of commercialization, as you heard from Andrew, i.e., demonstrating clinical utility of Parsortix publications, highly relevant pioneer or establishment revenues, as Andrew called them. They're all the building blocks that has built a very, very solid foundation of the company.

Last but not least, of course, this team has managed to achieve something very unusual indeed, which is an FDA clearance. That plus all the steps that I know that the company takes to make sure that ANGLE is a great place to work will ensure that we'll have the wherewithal to attract in the necessary additional skills and talent that we need to achieve the full financial potential of Parsortix. 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.

I have great confidence in the company's HR approach to recruitment and retention of staff.

Ian Griffiths
Finance Director, ANGLE plc

Well, thank you, Brian. I'm conscious of the time, so I'm gonna 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 just to make sure it does go through.

Andrew Newland
Founder and CEO, ANGLE plc

We've been specifically asked to do that.

Ian Griffiths
Finance Director, ANGLE plc

Yeah. Hi, Bruce.

Speaker 8

Andrew, thanks for a wonderful presentation. Very good. Can you just say what are your major obstacles to growth?

Ian Griffiths
Finance Director, ANGLE plc

The question is, what are ANGLE's major obstacles to growth?

Andrew Newland
Founder and CEO, ANGLE plc

That's always a very difficult question because we're in an extremely strong position. I would say the obstacles to growth revolve 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. We will become a very large company ourselves, or we will have partnered with multiple very large companies, which is the preferred strategy, or we'll have been acquired by a very large company. The only other alternative is we will fail to meet the objectives that we set out.

Speaker 9

Yeah. On that point then, you delivered Parsortix with great vision. I've been here 10 years. I'm sure I can find most people.

In pharma terms, on a shoestring budget, really. How do you protect yourselves from people who can see your vision, and see what's cheap, if you know?

Andrew Newland
Founder and CEO, ANGLE plc

That's probably one of the biggest risks. Do you want to comment on that, Ian?

Ian Griffiths
Finance Director, ANGLE plc

Well, I was gonna-

Andrew Newland
Founder and CEO, ANGLE plc

Oh, you better repeat the question.

Ian Griffiths
Finance Director, ANGLE plc

Yeah. The question is, you know, we put in a lot of effort over a lot of time on a shoestring. With the overall market cap, 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, 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 who will long-term buy into what we're trying to achieve, the value we're trying to build, and would say, "No, that is a lowball offer." That, in particular, is why we've been trying to bring in some of the U.S. investors.

They see, you know, liquid biopsy, it's coming, it's gonna happen, it's gonna change the market, right? There's gonna be multiple winners in this space. It's a massive market opportunity. Andrew already talked about the slide. We are incredibly strong, strongly differentiated. He's already explained ctDNA players are a commodity to bigger players. So yes, we will be attractive to some of the companies, but we've also got that unique value proposition that we can create a massive value out of it. If we've got the right backing and the right shareholders, they see that, a lowball offer is not of interest to them. What they're gonna see is that what we can do. It's platform technology. It works with every cancer. It works across every part of the patient pathway.

You know, if we can deploy it, you know, we will be, as Andrew said, a major company. We don't want to see one of the American companies just coming in and buying us cheap. You know, 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 on board who understand the potential value we create and therefore wouldn't accept such an offer.

Speaker 10

You mentioned during the presentation that the total addressable market for liquid biopsy was somewhere north of GBP 100 billion, I think. Later on, you looked at subsets of ovarian, prostate, and breast cancer. Those totals come to, I think, it looks like GBP 14 or 15 billion. Could you explain the gap between those? Where is

Ian Griffiths
Finance Director, ANGLE plc

Yeah.

Speaker 10

The remaining-

Ian Griffiths
Finance Director, ANGLE plc

That's fine. Yeah. That's quite easy. The question is about the TAM we presented at greater than $100 billion for the U.S. market alone. ANGLE's individual bottom-up TAMs in this case that we've described for breast cancer, prostate cancer, and ovarian cancer. The main gap on the TAMs, if you look at how that $100 billion is made up, is around $50 billion is allocated towards early screening. ANGLE is not involved in early screening. That is the biggest part of our bottom-up, our addressable 'cause that's our real addressable market that we've described, okay? Doesn't mean we won't get into early screening at some point, but we don't have plans. We'd like to support somebody else to do it.

If you look at the other parts of the patient pathway, we talked about high risk, we talked about the therapeutic decision-making, the remission monitoring, and residual disease, which is associated with the remission monitoring. Obviously, we're only looking at breast and prostate, two of the major cancers, hence the TAMs are much larger. Ovarian is one of the smaller. But look at all the other cancers that are there. Lung cancer, colorectal cancer, all these other cancers, they all make up a constituent part of that addressable market. That accounts for the rest of that difference.

we, as Andrew explained, you know, we have an advantage over all of the other companies in the space because CTCs are very specific. We have a specific analyte. We think that will play out also in the remission monitoring 'cause if you find a cell, and they're rare, you shouldn't find that the person is probably 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. We think we'll have a very, you know, strong role to play there, because of the nature of the analyte that we have.

Speaker 10

Okay.

Speaker 8

We talked previously about reimbursement codes. I think you mentioned in the past that possibly you might be able to go in under existing codes at a lower value. Perhaps you could just remind us of the situation on that and what work needs to be done to get future reimbursement codes for the top value that possibly this deserves.

Ian Griffiths
Finance Director, ANGLE plc

Yeah. The question is, will we be able to leverage existing reimbursement codes, remember in the process of securing the higher value codes that we think would be appropriate for our tests?

Andrew Newland
Founder and CEO, ANGLE plc

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 pay us. The way that system works is, you effectively accept the patient, and then you apply against the reimbursement code, and then they will reject you and then you appeal.

Unfortunately, it's a bit of a dysfunctional system, but that's how the approach works. The current ovarian test has approximately four false positives for each true positive, i.e., its positive predictive value is low 'cause 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're increasingly giving neoadjuvant chemotherapy prior to surgery. That means that the patient is given the cancer drug before they're going to surgery to try and reduce down the ovarian cancer. That is in itself a medical challenge because they don't know which chemotherapy will be most effective for the patient.

It happens that 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 that there was cancer present. It looks like that information in its own right is gonna be valuable for choosing chemotherapy. We may be best off 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 'cause we've got a better test and it gives more information, and we want more money." All of that work is extremely challenging. Getting reimbursement codes is not for the faint-hearted.

It's not quite as bad as getting an FDA clearance, but it's the same sort of idea. It can take a year or maybe even a couple of years of effort. Well, 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 paths, but we strongly want to do that kind of work with big companies who. For example, if we're successful with the deal with Abbott, they already have a reimbursement code for PathVysion. They already have a huge team of people who work on reimbursement, who are already engaged with the necessary insurance companies. Clearly that's easier to use their 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 code, it's two different things. They are focused on providing codes for specific tests end to end, and Parsotix is not a specific test end to end. It is the first part of a test, which is then gonna be added to another test that already exists. What we're going to do is to see if we can engage with MolDX in the exact same way we did with FDA to persuade them that actually maybe they should think about a code for Parsotix.

If we could get that would be a breakthrough because then you wouldn't need to get a lot of extra codes 'cause you've already got one for Parsotix, you got one for imaging, you got one for molecular already. You just add the two 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
Finance Director, ANGLE plc

Any further questions?

Speaker 8

Sorry, just one more. Maybe just a bit, and probably getting a little bit ahead of ourselves, but obviously in the resolutions, one of them was the potential to be able to buy back shares, which obviously with the capital position I'm sure is not on the short-term horizon. Just in conceptual terms, do you have any thoughts of where the priority would be, potentially if funds become available, to buy back shares or provide a dividend? Is any-

Ian Griffiths
Finance Director, ANGLE plc

Yeah. The question is about sort of capital distribution policy at a point in the future. I mean, what we've seen obviously with quite a few of the larger sort of cash-rich companies is they're going down a dual route these days. You'll have some investors who prefer a dividend payback and then obviously we see a lot who prefer a share buyback. That's the whole thing is, you know, if you've got you know certain of your people who've got it in a tax wrapper, they're probably happy with the dividend approach, but share buyback, you know, if it's outside off-market offer routes as well because of, you know, the annual allowance. Just varies.

I mean, we will obviously, you know, we're focused on deploying the capital raised and creating larger value from it. When we're at that point, we'll consider the distribution policy in more detail.

Andrew Newland
Founder and CEO, ANGLE plc

Thank 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. 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. 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.

Ian Griffiths
Finance Director, ANGLE plc

Thanks.

Operator

Thank 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 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.

Andrew Newland
Founder and CEO, ANGLE plc

Thank you.

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