Good morning, everybody, and welcome to ANGLE's preliminary presentation for 2024. I'm pleased to see a very good turnout, considering it's half term in the FTI offices, and a warm welcome to those of you who are participating virtually. It's been a year of substantial progress for ANGLE in a market that is moving towards us, and I'm looking forward to telling you about the progress that has been made. Our large pharma strategy is now in place. We announced that in the middle of last year. It's firmly in place, and it's moving forward well. This is all about using Parsortix to select and monitor patients in trials for pharmaceutical drug development, and that can progress all the way through to companion diagnostics, where the Parsortix system could be used to select patients for each drug.
This approach is critical to the new way that drugs are being developed for precision medicine. The new cancer drugs only work for some patients, and it's critical to work out which patients. These kinds of new drugs, such as antibody drug conjugates, DDR inhibitors, and immunotherapies, fundamentally require an understanding of what's happening in the patient's cancer. However, the cancer changes over time with clonal evolution, so the current standard of care, which is to examine the tissue biopsy to guide these drug selections, is insufficient, especially in later stage cancer. It does take time to educate the market and the pharmaceutical companies about the opportunity that comes with the Parsortix CTCs, but we're now making a lot of progress with that, and the pipeline is steadily growing in the right direction.
In terms of the year of 2024, we had two major areas of development, which were the large pharma strategy and the DNA dual analysis, and then four other significant achievements. In terms of the large pharma, we established and secured three large pharma contracts and one large biopharma contract, and I'm pleased to say that the three large pharma contracts, which I'll discuss in more detail later in the presentation, have all progressed very well indeed and successfully concluded. We also have a variety of other large pharma names under discussion to bring in Parsortix into their trials, and we have discussions with the existing large pharma in relation to the next stage of development. The second major area is the DNA dual analysis.
Now, from a standing start, we've developed a new way to measure DNA mutations in cancer, and that new way involves looking at the living cancer cells, the circulating tumor cells that can be obtained with our Parsortix system, in addition to looking at the fragments of dead cells, which is the circulating tumor DNA. It is dual analysis, and we're the only company that's able to offer that potential to evaluate both aspects. We'll explain in more detail how that works and what the impact of it is, but suffice it to say, we had breakthrough results during 2024 showing the importance of analyzing the intact living cells in addition to what the industry already is beginning to do, the fragments of dead cells.
We moved swiftly to position ourselves strongly with that new market opportunity by securing an exclusive deal for the next-generation sequencing DNA panel that we'd used for that work, covering 6,500 mutations in 61 clinically relevant genes. Post-year-end in this space, we were pleased to complete some similar work with an end-to-end Illumina solution, which was developed by ANGLE and was showcased at Illumina's EACR conference webinar. EACR is a very large European cancer research conference, and Illumina had a webinar there, which they allocated entirely to ANGLE to present the results of our DNA dual analysis. In terms of the other areas where we've made progress during the year, we have developed a new approach to getting cancer cells, or indeed any cells, of small numbers down onto a microscope slide without cell loss.
We developed a new technique, it's actually more than a technique, it's a physical structure called the CellKeep Slide, which reduces that endemic cell loss to virtually zero. This is really important when you're working with rare cells, and there are a number of uses outside of our own internal use for the CellKeep Slide, which is now being offered and sold to our customers. We have European and U.S. patents now granted on the CellKeep. Another aspect where ANGLE is proactively innovating to address key issues in the marketplace to improve the adoption of liquid biopsy. We also reached a milestone during the year of the 100th peer-reviewed publication by independent cancer centers showing how well the Parsortix system works. We also completed a placing in adverse markets, raising GBP 9.3 million gross in June 2024.
Beyond that, we've opened up a new line of attack, which is to engage with the large medtech companies as well as large pharma. We're now working with large medtech companies with a view to giving them the opportunity for repeat testing of their existing tests. I will say a bit more about that shortly. In terms of the financial results for the year, despite there being a very adverse market with FDA regulation of laboratory developed tests and actually problems with research grants post-COVID funding, we have achieved a 31% growth in revenues in 2024 compared to 2023. We also secured an ongoing gross margin of around 62%, and that was even after we had given a number of introductory offers to new customers to get them started with our technology.
We've been bearing down on costs, and we reduced our operating expenditure by a further 21%, and we continue to bear down on costs. That, in conjunction with the increase in revenues, led to a reduction in our loss by 29%. The business is now streamlined. We have an improved cash runway of GBP 11.6 million, including R&D tax credits at the year-end, and that lasts through into Q1 of 2026, even on very conservative assumptions in terms of growth rates. We're actively now driving our milestones and projects forward. In terms of our pharma services revenues, the initial contracts that we've had, the three large pharma, one with Eisai and two with AstraZeneca, are actually the starting point for a pipeline of opportunities with those companies.
As you can see from this slide, the moment we get into phase two trials, we could be looking at between GBP 1 million and GBP 4 million of revenue for each one of those trials, and phase three is a major step up, more like GBP 15 million-GBP 45 million. If just one of these particular projects progresses all the way through, there is a very substantial revenue opportunity for ANGLE. We have currently three such areas, and we are in discussions about multiple others. Obviously, the ultimate aim is to get to the bottom of that box, which is a companion diagnostic.
The idea of a companion diagnostic is that the doctors will do a blood test on the patient, will use Parsortix to look for a particular target, and that target is linked to the drug, and then the patient would be prescribed the drug if that target is present. That means that the pharma is likely to become a very, very large global customer for ANGLE, and it plays directly from our services business into our products business, where we can sell the Parsortix instruments and consumables worldwide to support a companion diagnostic program. As shown in that slide, a conservative level of revenue on an annualized basis would be in the GBP 20 million range for a particular companion diagnostic, and it could be very much larger than that.
The reason that pharma is keen to do all this stuff is that their trials cost a lot of money. A pharma phase II trial might cost $180,000. Spending a bit of money on ANGLE to make sure you select the right patients and you monitor them properly is not very much, and hence we can charge up to GBP 3,000 for each sample that we process in our laboratory. Overall, the cost of developing a cancer medicine is as much as $4.4 billion. It is critical with these new precision drugs that they have a way of identifying which patients can be given the drug in order to get good clinical study results and get regulatory clearance and have doctors want to actually prescribe the drug. This is not a nice-to-have for pharma.
In the future, this is going to be absolutely essential to their future success. A bit more detail on each of the contracts. The first contract with Eisai, the large Japanese pharmaceutical company, is in relation to the measurement of HER2 in breast cancer because they have an antibody drug conjugate. The way an antibody drug conjugate works is the drug attaches to the cancer cell via a protein on the cancer cell, and then it puts its treatment into that particular cancer cell. The idea of antibody drug conjugates is that they're much more specific. Instead of causing toxic side effects all around the patient, it's much more targeted to the individual cancer. However, the antibody drug conjugate will only work if the protein that it is targeting is present on the cancer cell.
In this case, the protein is HER2, which is a very, very important target in breast cancer. There are HER2 targeted therapies in first-line treatment, so trastuzumab, for example, and then there are HER2 treatments in later stage cancer, such as Enhertu. As an example, Enhertu, which is an AstraZeneca and Daiichi Sankyo drug, has a current revenue line of circa $5 billion per year. Now, remember, this only works if HER2 is present. HER2 is only present in a minority of patients, and it changes over time. At the present moment, all those decisions are made on the tissue biopsy, which is cut out at the time of primary diagnosis. Yet, Enhertu is often prescribed three, five, or even longer years later. By that time, the patient's condition may have changed.
If it's changed, that means that the drug will be not effective for that patient. The other way of looking at it is up to 60% of patients are HER2 negative at tissue biopsy, and they never get offered that particular drug. What I'm pleased to report is that our HER2 study, which was a subset of Eisai's phase II trial, was very successful. We successfully managed to get consistent results between two blood tubes taken at the same time point, both in terms of the numbers of circulating tumor cells present and in terms of their expression of HER2. We've got a good, reliable, consistent test based on blood tests to tell you what is the status of the patient's HER2.
We also showed, and this is the key point, that in the two time points, which were before and after the patient had the therapy, there were significant changes. Consistency between two tubes at the same time, but very significant differences between two time points. In some patients, the number of CTCs reduced significantly, HER2 expression reduced. In others, it was unchanged, and in a few cases, it increased. This is likely to be a guide as to whether or not the patient is responding to the drug. Very importantly, what it shows is that RSA is fit for purpose to measure on a longitudinal basis changes in HER2 status in the patient condition, which is critical to the prescription of this drug in the future. Now, Eisai have actually decided not to progress BB-1701 and have turned it back to Bliss Bio.
They've made a $2 billion commitment to this, and I guess in some of their internal financing structures, they decided that they did not want to go down that route. The good news is that ANGLE is now in discussions with Bliss Bio about the next stages of this, and we're looking forward to presenting to them the results that we have in relation to the first trials. That was very successful. Bear in mind that HER2 targeted therapies, there are many companies interested in that with products. I've already mentioned AstraZeneca's product, which is already on the market. If AstraZeneca used our assay on the HER2 negative by tissue patients and they had done the necessary clinical studies and secured an extension of the label to cover HER2 positive patients by CTCs, they could add at least $2 billion per year in revenue to their drug.
It means a lot. Antibody drug conjugates, by the way, there's many different antibody drug conjugates being developed for other areas, not just HER2. Our technology works well for all of those. The next one is AstraZeneca's first contract, the DNA damage response contract, which is assessing, again, proteins on the cancer cells. You can't look at proteins, by the way, with ctDNA, and the timeframe is not when the tissue biopsy is there. This is the only way you can get an update on what's happening with DNA damage response in the cancer cells. There are specific DDR inhibitor drugs which target that, try and stop the cancer cells repairing themselves after they've been dosed with chemotherapy as example use. AstraZeneca paid ANGLE to develop the ability to look at Phospho-KAP-1, a key protein, and to measure micronuclei, CTC micronuclei.
We've done that development work, and we've had sign-off from AstraZeneca that we meet their requirements. Now we're waiting for AstraZeneca to tell us which clinical trials they want to use it in and how large those trials are and when they want to start. The second AstraZeneca contract is in relation to prostate cancer. A bit like HER2 is the leading protein for breast cancer, a leading protein for prostate cancer is androgen receptor. There are drugs that target androgen receptor, androgen receptor inhibitors. We were initially contracted by AstraZeneca to develop a means of looking at androgen receptor on the cancer cells. We didn't have that, so they agreed a contract to pay us to develop that for them. The initial contract was $550,000. During the year, they extended that and increased it to $670,000. Now we've successfully completed that.
We've been able to demonstrate our ability to measure androgen receptor reliably and meeting their requirements. Actually, AstraZeneca have put us through our paces, testing our quality control system and the way that our clinical labs operate in order that they can be certain that we meet their requirements for large-scale clinical trials. We are currently waiting on the next steps in relation to that. We expect that they will want to deploy it in time on multiple different programs, and we are looking forward to hearing how we can help them with those programs. We've got during the year a large biopharma customer called Recursion. Recursion is involved in using next-generation sequencing and artificial intelligence to identify drug targets. At the moment, it's an initial pilot study to show how CTCs might be of assistance to them.
It's very interesting, actually, because the costs of next-generation sequencing and also the sensitivity are going faster than Moore's law in terms of their reduction. Moore's law is that one where computers get cheaper and more powerful progressively. This is even faster. Make it fast and look for patterns, et cetera. The costs are coming down from artificial intelligence and the performance is going up. However, there is a limiting factor, and the limiting factor is the sample. If you're looking at the wrong sample, it doesn't matter how deeply you sequence or how hard you look with artificial intelligence, you won't find the right answer. It's a standard garbage in equals garbage out. It's critical to have a good sample.
We believe that, and so does the industry now, that the circulating tumor cells, intact, living cancer cells gives you the best possible window on what is happening in the patient development. You can't just do it with fragments of dead cells. Again, the market is coming towards us. CTCs do make a big difference. We've got other biopharma customers which are developing nicely. Particularly, Immatics is moving forward, has got Parsortix systems in their laboratories, and these other ones are also making progress. Artios helped us a lot in the early days for the development of our DNA damage response assays. By the way, our strategy for developing new assays is, despite customer paying for it, we own it at the end, and it goes on our menu, and we can offer it to all our other customers. That's a key part of our development strategy.
Onto the second major development area during the year, which is the DNA dual analysis. Now, this has been developed by ANGLE and proven by ANGLE. It's a very interesting area because the industry felt that they had DNA mutations analysis sorted with circulating tumor DNA. Angle felt, well, we're going to investigate, actually, is there any difference between the living cancer cells and the dead cancer cells? We already know that the advantage of the living cells is that you can do RNA analysis, and you can do protein analysis, you can do cell morphology, you can look at clusters. None of those things can be touched with ctDNA. The industry felt that the DNA part at least was covered by ctDNA. That is why the American companies have had multiple billions of dollars invested in them to develop assays.
For the first time, we've been able to show from the same tube of blood the analysis of living cancer cells recovered with Parsortix with a specific DNA sequencing panel compared directly with the ctDNA coming from the same tube of blood using identical sequencing. The answer is that we find a lot of extra information from the living cancer cells. This is critical information. This is information about how the cancer is changing over time. This is what is evading the immune system. This is what the drug is not killing. It's not dead. Therefore, it is not being killed by the immune system, and it's not being killed by the drugs. Whereas the ctDNA is a different analyte from that perspective because it is dead. We now have evidence that shows that you can get extra information from looking at CTCs.
Critically, which is part of our commercial positioning, you can combine it with ctDNA to get the maximum amount of information. That is the pitch to all of the large companies who have already established methods of analyzing ctDNA. Those are all good. You can add to that analysis with the same approach of the circulating tumor cells. Following success with that, we moved quickly to secure a deal over the panel that we use for that analysis. This is a very high sensitivity panel. It is very good for looking at DNA mutations in amongst a lot of background. It is a pan-cancer panel. It covers 6,500 DNA mutations in 61 clinically relevant genes. ANGLE has now signed. Whoops, what has happened to the computer? Looks like we have lost our power, maybe. I do not know why that is.
I'll keep talking on the basis that we've got. That's the first time that's ever happened in quite a number of these. Hopefully, that's back up now. I think that's all right. We moved quickly to get exclusive rights over this panel. We're the only ones who are allowed to use it for circulating tumor cells. We're the only ones allowed to use it for a combination dual analysis of circulating tumor cells and ctDNA. It's now being made available to our pharma customers for use in our lab. Eventually, we'll be selling kits as a product to others as well. All of this information needs to be backed up by solid third-party evidence. In this industry, nobody takes much notice of what a company says. They want to see what independent cancer researchers have published under peer-reviewed processes.
We now have over 100 peer-reviewed publications from over 40 independent cancer centers. They all say exactly the same thing, that we can get information from the living cancer cells harvested by the Parsortix system that we cannot otherwise access. That information is absolutely critical to the future decisions about patient management. They have published now in 24 cancer types. This system works without modification right across the piece. The market is moving towards us. In terms of our revenue build, going forward, ANGLE is extremely well positioned with both. Something funny is going on with the computer. ANGLE is extremely well positioned with—we have got a system update going on. Cancel. You are going to do it for me. Right, I am being helped with the computer. I do not know why it has been problematic today.
In terms of our revenue build, we have a products and a service business. Under the service business, our research laboratory is able to develop tests that can be run on CTCs for our paying customers, which is the assay development, and then they get added to our menu. Our clinical laboratory is staffed up with experts who have Parsortix systems and a variety of downstream analysis techniques so that we can run blood samples for our patients in the pharma customers' pharma trials. The key thing is we also have a products business currently selling products to research use customers who are generating the evidence that I was just describing. We are extremely well placed to help our pharma with the companion diagnostic rollout. For that, you need products.
Most people in this, most other companies in this industry have a service-based clinical lab, but they have no product. We have the product which can be used worldwide across all the different cancer types. Here is our last slide. In terms of the outlook, we have multiple large opportunities under discussion. They are binary in nature. We either get them or we do not get them. Their timing is uncertain. As a consequence of that, we are confident of modest growth in revenues. We expect revenues to increase in 2025 compared to 2024. Dependent on the large opportunities under discussion, this may be exceeded. Following the successful completion of the existing large pharma contracts, we are awaiting follow-on contracts which are expected to be substantially larger in revenue levels. We are also in discussions with prospective additional new large pharma customers.
We've decided to move that same approach into the large medtech companies. Those companies are now looking at how they could work with Parsortix CTCs to extend repeat testing of their existing tests. We had a very successful webinar on the Illumina EACR slot progressing our DNA Dual Analysis, and that is gaining traction and a lot of interest. There have also been, and as was announced, there were two announcements in January of this year. There have also been some very significant therapeutic developments using Parsortix with the potential for drugs which could block the spread of cancer in the future, to contain cancer. The pipeline is very encouraging. I just give you a couple of examples about why I think the market is moving towards us. I mean, a very, very interesting and poignant one is the development of the HER2 testing.
I explained we've had a contract with Eisai. That went very well. There are multiple HER2 targeted therapies out there which could benefit by increasing their revenues if they also tested patients who were HER2 negative by tissue biopsy and become HER2 positive by their CTCs. A poignant comment is that in our INFORMED study, which is targeting the recruitment of 1,000 patients from six NHS trusts, and we're making very good progress with that, we have already had three breast cancer patients who were put onto palliative care, told there was nothing more that could be done for them, who were HER2 negative according to their tissue biopsy, and therefore were not given HER2 targeted therapy. Those three patients, we proved beyond a shadow of a doubt that they were HER2 positive in their circulating tumor cells.
You need to do a clinical trial to prove this, but you could expect that they might respond to a HER2 targeted therapy if they've got HER2 positive cancer cells. What happened? Nothing at all. All three patients died within six months. That is what we're addressing here, an opportunity to radically improve cancer treatment. That message is what we're getting out to the market. We're beginning to educate the market. There are lots of elements to it. I've just stressed, obviously, the benefit to patients. There is opportunity for patients to have a much better outcome than they currently have. On top of that, there's an opportunity for the pharma to make a lot more money because if they extend their label to these patients who are HER2 negative, then they will get paid for those drugs.
The final leg to the stool is that the healthcare systems are spending an enormous amount of money on drugs which are ineffective because they keep prescribing based on historic information, which may be three to five years out of date, when right in front of them is a solution which can give them the information they need to do that properly. Thank you very much. We're happy to take some questions from the floor.
Morning, it's Sam England from Berenberg. I've got three questions, but I'll maybe do them in turn. Firstly, can you just give us a sense for how the early discussions with the potential med tech partners that you're speaking to are going, and how big you see the opportunity in med tech being relative to the opportunity you have in pharma?
How do you see those deals with med tech partners developing, particularly in terms of the financial structure of the partnerships? I'll do the other two afterwards.
Okay. I'll dive into that one. The difference between med tech and pharma is that pharma have a defined process for clinical trials, which they spend a lot of money on. I was indicating in the presentation they spend up to $180,000 for each patient who is enrolled. It is sort of more straightforward for them to have a biomarker put into those trials. We've got the right clinical lab to be able to process the sample. That fits into a sort of understood process. In addition, there are thousands of potential trials that we could be in. That's an existing market that we're breaking into. Obviously, we're having to educate the market.
They do not all necessarily believe this stuff until they see data. It is fitting into an existing structure. The med tech, there are smaller numbers of opportunities, but they can be very, very large. The reason that the med tech can be interested is that at the moment, their tests can only be used once. If you are a large med tech company that has a diagnostic test for breast cancer, let us say, that will be deployed when the patient has a biopsy and you have got source material. That is a one-time revenue opportunity for that company. If they are willing to engage and run the same test on cancer cells that come from blood and run the necessary clinical trials to show that the patient responds in the expected way, then they could measure the patient every six months or even every three months, or certainly on progression.
That's what we're seeing with our NHS informed study is the massive gap is that doctors are trying to make decisions on late-stage patients who are progressing without any new information. If you've got the same old information, how do you make a different decision? The truth of the matter is it's done by, to an extent, guesswork and seeing whether the patient does or doesn't respond. The way we can engage with the large medtech, and we've started doing this, is provide them with some of our Parsortix samples and look to see whether they can actually analyze those samples with their existing approach. If they can, then we could engage with them in a similar way to the pharma to help them do clinical trials to prove it out.
Then ultimately, they would want to sell the Parsortix system or use it themselves in their business. We would make money out of every single test. If you look at the cost of tissue biopsy in metastatic breast cancer, it's averaging at $16,000. If a solution came through at $2,000 or $3,000 for the sample prep using Parsortix, it's much, much cheaper. It obviously makes a lot of money.
I think what I'd probably add to that as well is that the key thing is that the tissue biopsy is the standard of care. It'll take time to change that. You add in the CTC analysis at time point one at the same time. The key thing here is that you can do the repeat testing and the longitudinal monitoring. That's going to pick up the status change in patients and so forth.
That is the immediate time expander because they have already got the tissue biopsy diagnostic test. It is now expanding it to tissue plus liquid. That is the time expander for them.
Great. Thanks. The second one is just around the uncertainty that you are seeing. I suppose, have you actually seen evidence so far of projects getting cancelled or sort of major delays that have affected the business? Do you think these are really just temporary delays that are going to affect 2025? The longer-term opportunity is pretty much unchanged. It will just maybe shift back a bit as a result of the research funding challenges and tariffs this year.
One of the examples was the Eisai. They have handed back their project to Bliss Bio, and we have seen a few others that are passing those assets back.
Now, obviously, that creates a bit of uncertainty on our side because we had a pathway through with Eisai. Now we're back to sort of discussion with Bliss Bio. They appear interested in progressing, still progressing the asset. We've got good data, as Andrew said, but the original path was with Eisai. What we're seeing is even with some of the larger companies such as Eisai, we'd already seen it before with the smaller biopharma because of the funding environment. There is a bit of a tightening, and that we think is sort of delaying some of the decisions. We just have to sort of recognize that that's one of the indications in the market.
Yeah, I mean, the pipeline's building. What's happening is that some of the decisions are being slipping, which is disappointing, but it doesn't mean that there's not interest. There's just delays.
In terms of some of the other on some of the product side of things directly in the U.S., the sort of uncertainty and cutbacks in NIH funding, again, is sort of pausing some of the buying decisions. We are not seeing them go away, but we are seeing them sit on them and sort of waiting for some clarity for that to come through. In Europe, to a lesser extent, we have seen a little bit of that as well, but also an increased emphasis on people trying to go through a procurement process. They want to choose us, but they said for financial reasons, they have to go through a procurement process, even though we are the only ones who can effectively do this to the level that the researcher wants. It still then delays the process.
We are seeing a few more delays in that fashion.
Great. Thanks. The last one's just around the cost piece. You called out that you've got sufficient cash through to Q1 2026. Does that assume any further cost reductions to come this year, or are you really where you need to be now on the cost side?
We continue to try and take some of the costs out of the business, but there's a bit of a balance there because we have been investing in the clinical lab as well. The reason for that is, of course, that we've got to make sure we've got the capability and the capacity to deliver for the AstraZenecas and so forth. They do test our quality systems. They make sure that we've got everything in place to meet their criteria that we're a selected vendor.
We have gone for that process with them. There are various initiatives such as SOC 2 and everything, but we have to do a bit of investment to make sure we are fit for purpose. That has an upfront cost, but it is a one-off. In general, we are trying to keep that cost base fairly tight and be as efficient as we can.
Great. Thanks.
Yeah, hi. It is Chris Cavendish. Just adding on your last bullet point there on the outlook slide in terms of pipeline. I assume there is a bit of commercial pipeline in there, but also I was just wondering in terms of product development, is there also a Parsortix pipeline that you are working on and bringing through? If you can provide a bit of detail around what that might be and what that looks like going forward.
Thanks. Yeah, thanks, Chris.
I mean, we're primarily focused on development of the uses of the cancer cells rather than developing the actual instrumentation. The Parsortix system and the Parsortix cassette, they're stable. We're not developing them further because they're best in class already. We have done development work, as I mentioned, on the CellKeep Slide to get the slides down onto the microscope slide, but that's all completed and is also stable. Where we're doing development work is on methods to analyze the cancer cells. We've done a lot of work on next-generation sequencing of DNA, and we're also working on RNA. We've done paid for by customers mainly. We've done a lot of work on proteins, like I mentioned, the HER2 and the DDR. That's where the product development is coming through. It's in the uses of the cells. It's non-trivial to do that.
You have to have a sort of lockdown process, and then you have to test it and make sure it's analytically valid, and you get consistent results and so forth. That's what we're working on. Our focus on the large pharma strategy enables us to get that funded in the main by them.
Hi, Edward from Singers. Just two questions, if I may. I think with the first one, you might have touched upon this already, but just those large pharma opportunities under discussion, you say they're binary in nature. I just want to kind of understand, is that more to do with reservations about the CTC technology, or is it more to do with competition in terms of ctDNA or cfDNA?
What I was trying to refer to is the need to educate the pharma.
When we engage with pharma, there may be people who do not know much about CTCs at all, in which case we need to explain what they are, how they work, etc. There may be some people that use the legacy system, CellSearch, maybe 10 years before and did not get as good results as they want. In that case, we need to explain what is different about Parsortix, the fact that it gets all the cancer cells, it does not damage them, it gets them easily out, etc. The sort of education process is really driven by data. For example, with one large pharma, we are engaging with them specifically in relation to glioblastoma, which is a brain cancer. It is a very major market need because 40% of brain cancer patients do not have a biopsy. They do not have surgery. They do not have biopsy.
We have recruited a number of patients ourselves in-house to get a base data that we can show to that pharma, "Listen, you may think that you can't get so ctDNA does not work in glioblastoma. There's just not enough fragments of dead cells at all. Let alone being limited, it doesn't work at all." There's an expectation that CTCs don't work to the extent that some of the leading researchers in the world are working on trying to get cells out of the spinal column fluid instead of a simple blood test. What we've done is some pilot studies ourselves. We're soon going to be having that data that we can then take to these pharma and say, "We told you about this, and you've seen it in a publication, and here's our data." That's what we mean by education.
Yeah, that's very helpful. Just my second question, just more about the kind of the assays that have been added to AstraZeneca's many validated assays. I just want to kind of understand the visibility you have in terms of the potential contracts you might win or potentially be asked to kind of use your assays on. Are they primarily going to be sort of earlier stage, so phase I, phase II, or do you think there's the prospect of even going on to phase III?
I don't think there's much prospect. It's not impossible. I don't think there's much prospect that we would go straight to a phase III. I think it's more likely there'll be a phase II and then a phase III. In terms of the two areas that we've done so far with AstraZeneca is the androgen receptor in prostate.
We know it's publicly available. You can look on their website. They've got multiple prostate cancer drugs being developed which target androgen receptor. Even if they do not target androgen receptor, it would still be an important thing to measure as the patients are progressing in their trials. We know that there are several different applications there. In DNA damage response, it is one of the six key areas of AstraZeneca's investment. There is a whole separate part of their website about that. Again, we are offering them an assay. They cannot get it, they requested it, paid for it. We have developed it. They cannot get that assay from anybody else. It makes sense to use it with all of their DDR inhibitor trials. In terms of the specifics of which trial, when, and how big, we do not have visibility on that.
That's not something they would discuss with us until they're ready, unfortunately.
Thanks.
Can I go back to the commercial question that was asked right at the start? You're not the only company to face headwinds, but I'd like to get a feel for what your impact is. Can we start? Tariffs. Are you affected directly, or is it your clients who would be affected?
Sorry, I'll add that. Tariffs in the U.S., we're just passing the cost straight on. We have a unique offering. We can't absorb those costs ourselves. The customer base seems to accept that's just a consequence of dealing with us. We just pass the tariff straight on.
The next one is going to be a bit more visibility.
Obviously, we've got uncertainty on funding on basic research.
That's a very small individual order from each client, but a large number of clients. Do you have visibility on when that will open up again? Will it be like a floodgate that everything comes through, or will it be more staggered? And roughly the timing on that?
No, we don't know what Trump's going to do, I'm afraid, and how the entities are going to respond. What we anticipate is that as they get and the plan is obviously to slash back the budget significantly on the public research side. If he follows through with that, they are going to have less funds available for their projects. That would directly affect us. We don't have the visibility, obviously, because we don't know whether he will fully follow through on that.
The other thing is that many of the organizations will try and secure funds from other sources. Some of the ones that are funded from philanthropic resources will not be affected. You will see some of the bigger institutions, they will replace the funds from other areas. The government institutions, they will struggle, and they will have to focus on priority areas. It will be a bit of a mixed bag.
Thanks, Ian. The next question then is on big pharma. Obviously, they are less susceptible to funding crises than the smaller ones. Following on from what Ed was saying about the binary outcomes, do you have any visibility when the likes of AstraZeneca will press the button and say yes?
No. No. That is one of the challenges and sort of feedback on those.
What we know is, as we said in the prelims, it has been a slower start. What we can see is some of the uncertainty in the environment and that we just have to reflect that and be more cautious in what we think is going to happen. If we look at the sort of pipeline of opportunities, there are quite a few biggies in there. If one of those comes through, it starts to give us that visibility and certainty. Until we have that signed up and inked with the customer and we have agreed the work programs and the profiling and all of that, there are challenges on assessing the timing. There is getting the sale, and then there is getting the revenue recognition. Even with the sale, your revenue is going to be spread.
Thank you, Ian.
Okay, that concludes the questions.
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