CelLBxHealth plc (CLBX.L) Earnings Call Transcript & Summary

Hello, and welcome to the ANGLE plc Preliminary Results Conference Call. My name is Alex. I'll be coordinating the call today. [Operator Instructions] I'll now hand over to your host, Andrew Newland, Chief Executive Officer, to begin. Please go ahead.

Good morning, everybody, and welcome to ANGLE's prelims presentation in relation to our year ended 31st of December 2022. I'm delighted to be giving you an update on the company's progress. As everybody knows, we made tremendous progress during 2022 with our FDA clearance and a number of other key milestones for the company, which were achieved. And the achievements in 2022 are the foundations that we believe will build a major business to deliver major returns for all our shareholders, and at the same time, transform the cancer care for patients. Today's presentation is quite detailed, more detailed than usual. It is already on our website, so you'll be able to look at the detailed slides. Obviously, I won't have -- when you see them, you'll see that I won't have enough time to go through all of those slides in detail, but we did want to get the information out to shareholders, which describes a lot of tremendous work that's been done post FDA clearance in terms of key steps to drive value creation and to describe the process by which ANGLE is delivering value for our shareholders. And the word I'd like to have people start thinking about is content. So content means, in our sense, means ways to utilize the Parsortix system to deliver specific applications and outcomes. And that's the actual key factor in the success of the business. And I'd like to think that the Parsortix system has been a little analogous to a smartphone, for example, the iPhone. The iPhone is very useful for making various telephone calls and so on. But what's really taken off is all the applications that is available now. And that's what I mean by content. We're working on a whole series of different applications for the Parsortix system, some of which I'm going to explain in this presentation. So just by way of background, we all know that the Parsortix system is focused on recovering intact living cancer cells from patient blood. Now, the reason that is needed is that, cancer changes -- well, cancer between patients is very different, and it also changes over time. And that means that there's a need to do repeat biopsies in order to assess the current patient status and how they -- what treatment decisions should be made for those patients. Of course, you can't repeat the tissue biopsy because once the tissue has been put out, it's no longer there for a second investigation. So patients at the moment don't have the benefits of repeat biopsies of their cancer to guide their treatment. We are pioneering a new approach, which is to recover cancer cells for examination and investigation from patient blood. So it's not -- it's easily repeatable and minimally invasive procedure, just a simple blood test. The reason that is technically challenging is that, there are very few cancer cells in the blood, perhaps only 1 cancer cell in a billion blood cells. And what we have achieved with our now FDA-cleared platform is the first-ever system FDA-cleared was successfully recovering those cancer cells so that they can be analyzed. And that opens up a whole wide range of different potential uses from the early diagnosis of cancer through to treatment selection and monitoring cancer patients who are in remission. So that's the backdrop to what we've been working on. In terms of our achievements in 2022, this really truly was a breakthrough year for ANGLE, both in regulatory, clinical and commercial terms. The major step forward that we achieved with our FDA product clearance, the only product ever being cleared by FDA for harvesting cancer cells for subsequent analysis following 6.5 years of effort was achieved during the year. We followed that with outstanding ovarian cancer results, which demonstrated a real-world use of this technology, in this case, for the detection of ovarian cancer, which outperformed all current standard of care approaches to that. And thirdly, we established and built out our clinical laboratories and established our pharma services business, which is now gathering momentum with repeat business secured from existing customers and new customers being signed. So all of those things were major achievements. We also signed a prostate cancer deal with Solaris Health, the largest chain of urology clinics in the United States, which is now progressing very well with prostate cancer studies, which I will describe as we go through. So the many, many different achievements in 2022, which I think gives us the foundation to build a very substantial business for the future. In terms of the -- what's been going on since then, I think it's really important to highlight the fact that we're now making tremendous progress in 2023. So we know now that quarter 1, 2023 revenues are strongly ahead of the prior year, and I'll give some more information on that shortly. But both products and services revenue are strongly ahead of the prior year. We've succeeded in signing an additional pharma services customer, Crescendo Biologics, and we've got multiple other such customers progressing. We have signed a deal this year very recently just announced to develop a HER2 CTC assay with BioView as a collaborator, and we will talk through that. That's a highly encouraging deal for future development and generates fairly revenues for ANGLE at the same time. We have the prostate cancer pilot study on track with headline results anticipated around the year-end. We have been working on assessing third-party molecular platforms. Now, what that means is, using the molecular platforms developed by other parties to analyze the cancer cells from Parsortix, and we're getting highly encouraging results. And I will talk more about that as well. We believe that this is a -- the molecular analysis of the Parsortix harvest offers tremendous opportunity to generate significant revenues and corporate partnerships. We also have a pipeline of assays in development, adding content for both services and products. So what I would like to emphasize here is that, the management team is extremely confident in delivering strong growth in 2023, and we see a very clear path to a large-scale business opportunity for ANGLE in the future. In terms of the financial performance, this information was outlined in our business update in January. It's very much consistent with that. The revenue line at GBP 1 million was somewhat below where we'd hope to be as a number of expected sales were delayed or impacted by the wider market backdrop as previously described. However, we're very, very pleased to say that momentum is building in 2023, and we've seen some strong growth in Q1. So the quarter 1 results are strongly up on the previous year. In fact, the quarter 1 for 2023 revenues already exceed the revenues for the whole of the first half of the previous year 2022. So that's a good start to the year, and there's a lot more to be done, and we are aiming to see that momentum building still further. In terms of the cash position of the company, as described in January, our cash position was maintained at around GBP 32 million. And the key point here is that, we -- with the number of actions that we've taken, we have a cash position funded through significantly into the second half of 2024. So the company has the cash resources in place to deliver on its current plans. Right. So now this is a new slide. And what we're hoping to do here is to highlight the commercial strategy that we're adopting. So we have a very clear commercial strategy. There are 2 business areas, and there's the product business and the services business. So in simple terms, we see the services business as being a nearer-term opportunity to generate revenue and an opportunity to demonstrate the way that the system can be used. The product business is a tremendous opportunity for ANGLE because we can sell the Parsortix system and consumables to all different hospitals and research labs and clinical labs around the world. So they can adopt this, and we can -- we have a very leveraged approach to how we generate commercial revenues. What we're seeking to do is to enable the entire industry to adopt the Parsortix system and themselves to develop different uses. There are some key commercialization drivers, 5 in total, that are necessary to [ of course ] success. The first one is to get regulatory clearance. Now, clearly, we have already achieved that with our FDA and also CE Mark and U.K. MHRA in place. The second is to develop assets to provide end-to-end solutions, such as the imaging and molecular uses of the Parsortix harvested cells, which I'm now calling content, and I'll describe that in more detail. A lot of work has been done on that post FDA clearance. And thirdly is to develop various clinical studies to show in real-world conditions, the value of doing the analysis of the cancer cells. So the ovarian cancer studies are example of that. Prostate is now running, and we've got multiple other clinical students in hand. Fourthly, in order to achieve the scale of commercialization that we're targeting, we want to partner with large companies in this space and give them the opportunity to utilize Parsortix system. And in that way, we can leverage their sales channels and fund the commercialization of the system. There's multiple things going on in terms of the partnership area, the announcement earlier this week with BioView is just to start [ up the trend ]. And finally, the fifth area is reimbursement. So reimbursement means getting the various healthcare organizations in the world to agree to pay for the use of the Parsortix test. And that can be a lengthy process. We've already started work on this, and we're making a number of good steps in the right direction in that. So we've got a very clear commercialization strategy. We're clearly focused on the necessary steps to get this system widely adopted in the marketplace. So what does that actually mean? Well, it means that we are seeking to build a substantial business. I think that the numbers shown on this slide are actually quite conservative. But in the near term, we see revenue potential for ANGLE of GBP 50 million in pharma services. So that is utilizing the existing capability and capacity that we've already got in place. We're building out that pharma services business and seeing success already in that area. We're still going to be building out a services business in laboratory developed tests. That means offering clinical tests for patients from our own clinical labs, and that has a revenue potential we can see of GBP 100 million. But obviously, the big market opportunity is selling products. That's a longer-term activity. And obviously, it provides an ongoing long-term franchise for the business, and we see plenty of opportunities of building out a business into the region of GBP 500 million per annum. So the picture on the side is purely illustrative, but it shows how those different parts of the business can add together over time. As I mentioned earlier, the services business is designed to drive the products business. The products business is very high margin. We have third-party manufacturers, so we can scale without the need for further investment. The services business generates early revenues and indicates to others how they can use this system to benefit patients and obviously generate returns for themselves. In terms of -- so I'm going to discuss now the products business and also the services business, but first, the products business. So to be successful in the products business, you need regulatory clearance. We've successfully achieved that. It's worth reemphasizing the fact that, not only we're the only FDA-cleared product for harvesting cancer cells from patient blood for subsequent analysis and our clearance is in metastatic breast cancer, but a system can be used across 24 different solid tumor cancer types. So not only we're the only one that's FDA cleared, but we're not aware of anybody else who's even in process with the FDA. So that gives us, we estimate, at least a 6-year market advantage to any competition that might come through. And we've yet to see any competition with a system anywhere near as good as the Parsortix system. So we've got the regulatory clearance in place. So we now need to get key opinion leaders, KOLs, to drive recognition and adoption of this system. And that's an established process with a medical diagnostic product. You need the leaders in the field to start using it and talking about it. So we have put in place multiple different leading cancer centers. These are 4 top cancer centers from the United States who have got Parsortix systems in their labs and they're using them right now to develop evidence to support the use of our system. And that's a key part of the commercialization strategy to have key opinion leaders supporting the use of the instrument. Very new actually to ANGLE and built out substantially since the FDA clearance is the establishment of a number of distribution partners across the world. And the idea here is that, this gives us the opportunity to have a much larger sales force available to sell product in countries where obviously ANGLE does not have a footprint and does not have any local presence. So we've selected distribution partners who we've signed in numerous different countries based on their existing sales of oncology-related products and their contacts with potential customers, and also based on their ability to provide service and support to the product. So most of these distributors are not only selling products for us, but they can provide the servicing and they can provide the support to the customer to implement the product. That's very, very important to ANGLE. So this is leveraging more sales capacity for the business. And we expect to see, towards the end of this year and then heavily into next year, sales coming through from these distribution partners. In addition to this, by the way, we have substantially strengthened our commercial and sales team internally both to manage these distributors, but also to make direct sales alongside of them. We have been putting content down this distribution channel. So they're currently selling the Parsortix system and the Parsortix cassettes. But soon, they will be selling Portrait+ kits for immunofluorescence. And then after that Portrait+ PD-L1 kits, again, for immunofluorescence imaging. And then after that, we'll be providing them with Landscape+ molecular protocols on how to use the Parsortix system with established third-party molecular platforms. So the key idea here is that, these distributors are selling already for a number of very large companies their molecular PCR, digital PCR, next-generation sequencing platforms for molecular analysis of cancer cells. So we can generate protocols showing how to use those same systems with the output of Parsortix then they can sell Parsortix in alongside of these other systems. And that's a key part of our commercialization strategy for the product is to align our Parsortix sample with the existing methods of analysis that are in the market. So now moving across to the services side. We have got our clinical laboratories set up. They've got capacity to run between GBP 50 million and GBP 100 million revenues of analysis of samples and we can build that out still further quite easily if we choose to do so. We're about 2 years into the regional establishment of those laboratories. We've hired a lot of additional staff. We've got a lot of equipment, and they're in a well-positioned place to deal with the pharma services and then eventually with clinical services. We are finding that our customers are very happy with the service that is provided as illustrated by the fact that we're now getting a lot of repeat business coming from existing customers. And I believe that our laboratories are world-leading liquid biopsy laboratories and operating in a standard higher than any other labs in the world because of their ability to utilize the Parsortix system, it opens up new forms of analysis, which cannot be done in other labs. The critical point here, though, is that, we're not aiming to centralize all work in our labs, it's quite the opposite. We want these labs to be the accelerators and demonstrates, and we're seeking to encourage clinical laboratories and, of course, contract research organizations with laboratories around the world to copy this, and we will provide them with the Parsortix system, training and protocols so that they can do so. And that's the way that we can leverage these laboratories. In terms of the pharma services offering, the clinical labs have given us the opportunity to build out a highly successful pharma services business, which is uniquely differentiated and it adds value to the pharmaceutical company's drug trials because it's possible now using a Parsortix system to analyze the patient status before, during and after the time when they have the drug. That's something that's new. And a lot of the analysis that the pharma companies are interested in is looking at proteins on the cancer cells. And those proteins can be the target for their drug. And now that's very significant because you can't look at proteins without getting hold of the actual cancer cell. You can't do that from a tissue biopsy because the tissue biopsy can only be done once, and you can't do it from the alternative approach for liquid biopsy, which is fragments of dead cells because you have to have an intact cell. So we're offering them something that they genuinely can't get from other methodologies than CTC analysis. We've secured a good number of customers. We had 4 customers last year. 3 of those 4 have now signed repeat contracts with us and the fourth one is in discussions. We've added a new customer this year, and we've got multiple others in discussion to be added. So these contracts are -- can be high-margin contracts and they can be significant. So each contract can be worth over $1 million in its own right, and the margins can be in excess of 75%. And we've added to the ability that we have to analyze some samples and assay development capability. And this sets us far apart from other laboratories because we can actually develop bespoke assays for the pharmaceutical company. They can tell us which protein their drug is targeting, and we can develop that specifically for them. And that is -- and so essentially, they pay us to develop that capability, which they then use in their own clinical trials, but we get the opportunity to own that afterwards, and we can offer it to other parties. In terms of the content that we're developing, there are 2 main areas. There's Portrait and there's Landscape. So Portrait means imaging. So in -- what that means is, getting the cancer cells and putting them onto a microscope slide and staining them with antibodies to determine the presence and phenotype of cancer cell and then staining them for other proteins of interest. And that imaging work is branded by ANGLE under the term Portrait. So we've got various different assays, Portrait Flex, Portrait PD-L1 and so on. And these are all developed by ANGLE, and we put substantial efforts and resources into developing the assays that are listed on the side there. The second area is molecular. We founded that Landscape and the various different things that we can do with molecular, we can do DNA mutational analysis of the cancer cells, and we can do RNA molecular analysis, gene expression analysis of the cancer cells. So in our product business, what we're seeking to do is to develop product kits, reagents and protocols, which can then be sold by the distributors to clinical laboratory customers. So we're giving the clinical laboratory customer access to the Parsortix system to recover the cancer cells from patient blood, and then we're giving them product kits and protocols to how they analyze those cells. So that content is critical because getting the cancer cells is only the first part. It enables everything else, but they still need to know how to actually analyze those cells. And so, there has been a lot of efforts on the product kits, reagents and protocols development. In our services business, it's slightly easier because we're the ones running the test. So the productization is not needed. So what we're doing there is verifying and validating assays in our laboratories. So we're doing direct development -- we've already done direct development work in our R&D labs, we then transfer that to our clinical labs who verify their performance. And once they've done that, they can offer that to pharmaceutical and biotech customers. So the key point here is that, we've been doing a tremendous amount of work since FDA on developing the content that can be sold alongside of the Parsortix. So here you have on this slide, a representation of the different assays, which are expected to come out in the near term over the next 12 months. Now, it's important to recognize that we already have tests in our clinical lab that we are offering the pharma and biotech companies. And what we're doing here is, we've improved and we're launching new tests. So, on the imaging side, which is the Portrait ones on the top of this slide, the Portrait Flex is a method for staining in the cancer cells and identifying the phenotype of the cancer cells. And the Flex part means that we have designed this assay so that we can add additional protein markers. So if, for example, the -- as one of our major customers has done the customer requests, the measurement of a DNA Damage Repair protein such as gamma-H2AX, that's something that we can put into the Flex channel. So that's where the pharma can define what it is that they want. We've gone the next step with Portrait PD-L1 to actually use the Flex channel for programmed death-ligand 1, which is a fundamental target for immunotherapy drugs. So that has been developed by ANGLE and is going to be launched in Q3. We've also developed a DNA Damage Repair assay, which was designed for one of our customers. This is really important for PARP inhibitors. And as announced earlier, we're working on Portrait HER2, which HER2 is a key protein in breast cancer measurement. So on the molecular side, we're working on Landscape products. The first one is going to be in measuring EGFR, which is a DNA mutation with multiple different variants that need to be understood in lung cancer, particularly but in multiple other cancers as well. That's Landscape EGFR. And that and the next one, KRAS and the next one PIK3CA are specific DNA mutations where there are reagent kits available from QIAGEN, we are utilizing the QIAGEN digital PCR platform for the purposes of those assays. And then towards the end of the year, we anticipate coming out with RNA digital PCR panels, but -- and they will be tailored for our ovarian and prostate cancer samples. So I'm going to motor through some of these other slides. There's a lot of detail in here, and which can be studied at your leisure, and we'll answer questions in the future. So the Portrait Flex, I mentioned, it's designed for monitoring patients who are in cancer drug trials. It enables with the Flex capability, a bespoke development for each pharmaceutical company. And what you can see on this slide is that, it's a very high-performance assay. It leverages both our CTC capability to get hold of mesenchymal cancer cells, and those are particularly relevant for clinical significance measures. And it's something that is of real interest to all customers, the fact that we get high performance from mesenchymal CTC systems because the legacy systems failed to do that. In terms of the DDR assays, this was developed as a bespoke -- so DDR DNA Damage Repair. This was developed as a bespoke assay for one of our key pharma customers. And that customer has raised hundreds of millions of dollars to develop PARP inhibitors, and they have a large-scale collaboration with Merck. So this customer paid for the development of these assays. So we made money whilst we were developing them. But now, of course, we can offer them to other customers as well. The customers accepted these assays meet their requirements, and we're about to move into large-scale clinical trials with them, utilizing these assays. So it's measuring 2 critical proteins relating to DNA Damage Repair, which can be used to assess whether the drug is being impacting positively for the patient or not. It's a unique capability that ANGLE is now offering and it cannot be done on circulating tumor DNA, and it can't be done on tissue because that can't be repeated. And the assay performance here is very high performance. And it's been developed and validated by ANGLE, and it's now being verified by our clinical labs for wider use. So very strong performance in that asset. On the PD-L1 assay, which is also being developed, all this work has been done since FDA. We've been tremendously busy on these commercialization content activities. There's now 8 peer-reviewed publications in 373 patients showing the measurement of PD-L1 on circulating tumor cells isolated by our Parsortix system. So we've gone the next step to develop the assay for in-house use and eventually for launch as a reagent kit down our distributor channel. So as I said, the PD-L1 program [indiscernible] is a key protein for immunotherapy. Now, the thing about immunotherapy is very expensive. Average cost is $175,000 per patient, but it only works for 1 in 5 patients. So there's a massive need to determine which patients will benefit from the drug. That's not just about wasted healthcare resources, although that's incredibly expensive. But the patients are basically subject to toxicity with these drugs. So you don't want to give it to them unless it's going to be useful. And again, you can see from this information here, very high-performance assay. It's in the process of being transferred into our clinical labs for offering to customers at the present moment. The announcement that we just made of the deal with BioView in relation to HER2 is one of many such announcements. It's a very clear demonstration that third parties want to work with Parsortix. So why would BioView want to work with Parsortix? Well, they have very high-quality microscope solutions, which automate the process of looking at cancer cells to measure these proteins. And they are an FDA -- they have an FDA-cleared clearance for measuring HER2, which is a key protein in breast cancer management in tissue. So -- and they do that in conjunction with Abbott, utilizing Abbott's PathVysion FISH kits. So it makes sense to us to combine the ANGLE's Parsortix FDA clearance for harvesting cancer cells with BioView's FDA clearance for assessing them microscopically. So that's the key there. And both companies can benefit from the development of a HER2 assay kit because we can sell more Parsortix instruments and they can sell more microscopes. And jointly, we can make additional money on the HER2 assay kit, which will be sold. There's a very large market opportunity for HER2 in breast cancer. So every single patient will have a HER2 test in their tissue if they've got breast cancer. And this needs to be repeated. But at the moment, they can't access the cancer cells to do the repeat test. So we estimate that there's a $2.5 billion market opportunity for the HER2 assay kit. And that's in addition to the money that we'll make selling the Parsortix instrument and consumables. This has been -- as I mentioned, we've put a lot of effort into developing an assay development capability in ANGLE. We have scientists, researchers and product development people who have highly experienced doing assay development. As a consequence, we're leading the work that's necessary for this HER2 assay development and BioView are contributing to the costs and doing the microscope side of things. And that means that the development work, we've been able to monetize that. We will generate revenues in the region of GBP 1.2 million over the next 12 months, just in the first phase of development. Both parties, BioView and ANGLE, have agreed that we can bring other larger companies into this collaboration at the next stage, if we choose to do so. And there are many interested parties. So as well as Abbott who provide FISH probes for HER2 analysis, there are large-scale pharma companies such as AstraZeneca with their HER2 drug who have a vested interest in getting a really good HER2 assay into the market to drive adoption of their drugs. So we're very, very positive about this approach. And we want to use this approach where we secure some development revenues during the development cycle. And then we have a tremendous commercial opportunity at the other end of it and the partner to work with. And we want to do that with multiple downstream technologies. That's one of our key areas of focus for commercialization. And we've already done some proof of concept work on the HER2 assay, which we published at the AACR Cancer Conference a week ago. So we know that we can develop a successful assay here. So it's a question of productizing that and getting it in a format, it can be taken to market. So now the molecular assays. So molecular analysis is the future. We hear lots of stuff about genetic testing and national governments are getting more interested in looking at the DNA makeup of people and how best to target treatment. So the drive is for molecular. Now, the difficulty for molecular analysis is how do you get the sample. So you can get the sample from a tissue biopsy, but you can't repeat it. There are some various large-scale commercial companies, particularly in the United States, who are doing analysis for DNA of fragments of dead cancer cells known as circulating tumor DNA. And that is a very, very promising area of development, and that's why some of these companies are doing well. And the FDA has cleared multiple different therapies, as targeted therapies based on their DNA mutational status. However, it's only part of the picture. It doesn't give you any information on RNA, which is gene expression nor does it give you any information on protein expression, which is key for many of these targeted drugs such as the HER2 and the PD-L1 that we've been talking about. So there's a big opportunity to get cancer cells from blood to drive this sort of molecular analysis. Now, we believe that it's important that the Parsortix solution is complementary to what is already out there. So we have developed the ability to recover the plasma for circulating tumor DNA analysis from the blood sample prior to running the Parsortix harvest to get the cancer cells. And that means that ANGLE will, in due course, be offering the protein analysis, the RNA analysis, the ctDNA analysis and cell DNA analysis. So that means that we will provide a truly multiomics solution in the future. And you cannot do that if you can't recover cancer cells from blood. So the Parsortix is the absolute critical first step to enable all of this. As you know, last year, we took the view that made the commercial decision. The best way to approach this market is to leverage third-party systems that are already on the market. I mentioned earlier, the QIAGEN system, that is a very good digital PCR system, highly sensitive, very appropriate for working with the Parsortix harvest, and we're actively working on QIAGEN DNA solutions at the moment in EGFR, KRAS and PIK3CA. And we will be using the QIAGEN digital PCR system for RNA solutions, focusing on our prostate and ovarian cancer assays. Beyond that, we're working on Landscape DNA NGS and Landscape RNA NGS. So NGS is next-generation sequencing. So that's sequencing the entire genome or the transcriptome, depending on whether it's DNA or RNA. And we have pilots running with Illumina and with Thermo Fisher at the moment, which are very large-scale players in those sequencing markets. So the idea here is that, we can leverage the installed base. Once we show how to use the installed base of molecular platforms with the Parsortix harvest, then our distributors can sell our products into the customers for those molecular platforms. We can also, in addition to that, partner with those medtech companies and look at working together to get our products in the market because it's directly to their benefit. If they can get the Parsortix example going through their sequencing or PCR systems, then they can drive greater volume into their own installed base. I mentioned that a key part is getting clinical data to demonstrate the value of all of this. And ANGLE is funding -- has developed and is funding multiple clinical studies. We've run the ANG-006 study in ovarian cancer, and that has already announced extremely good results. And so, that's complete. We haven't really talked about it, but we've assembled a large-scale metastatic cancer study called INFORM, which is targeting the enrollment of over 1,000 patients. And that's in the U.K. and the U.S. And that is moving extremely strongly. We've had -- I can't remember the exact number, well over 100 patients through that already. And the good thing about it is, we get multiple blood [indiscernible] from each patient at multiple different time points. So we're assembling data showing how you can monitor patients at different time points and you can analyze key different factors. We're also banking the molecular lysates that come out of the Parsortix for subsequent analysis. So that means that when we had the molecular assays that I've been talking about ready to go, we will already have banked in the freezer samples from numerous different patients in prostate, in breast cancer, in ovarian and crucially in lung, which is a major area of focus. So we will have already processed those samples on the Parsortix system. We will have banked the samples in the freezer. And once we have the assays, we will be able to demonstrate their performance on those samples very quickly. So this is a -- this is ANGLE being innovative and proactive. We're getting the samples ahead of being ready to analyze and so that we could fast track the different uses to market. We're also running with ANG-012 substantial prostate cancer studies with Solaris Health, and we're on track with those to complete for the year-end. And finally, we haven't yet started, but we're planning a study called PRECISE in immunotherapy PD-L1 immune checkpoint inhibitor analysis. And that will be kicked off, I expect, by the end of this year. So that's where we're focusing on gaining clinical utility data. So I've got 2 more slides and then I'll wrap up. As I mentioned, this is longer than usual and a lot more detail than usual, but I thought it was important for shareholders and interested investors to see the extent of the work that's going on to drive commercialization to generate shareholder returns as fast and as effectively as possible. So moving on, this is summarizing the ovarian cancer results, which came through during the year. They were highly successful results. In fact, we had area under the curve of over 95%, which is by far the best-in-class ovarian cancer detection test, much better than alternative approaches. And as a read-through for ANGLE more generally, it's really important that we recognize that these real-world data. So these are women who had an abnormal pelvic mass, all of them had a condition, but it wasn't clear whether they had a benign condition or a malignant condition. And this trial demonstrated they're analyzing the cancer cells captured by Parsortix from a simple blood test could determine with a high degree of accuracy, which women had cancer and which didn't. And that makes a tremendous difference as to how they're cared for in terms of their surgery and also to do with neoadjuvant chemotherapy. So following those successful results, we've made the decision to move this assay across to a third-party molecular platform to open up a product-based solution. So as I mentioned, the QIAGEN Digital PCR approach is most likely the one we're going to use for the RNA analysis. We've got those samples waiting in the freezer. This sample is retained, so we can reanalyze them once we've got the third-party molecular platform working as we wish. And then that will open up the ability to sit to advise the market of those molecular protocols so that third parties can offer an ovarian cancer test. And we would expect to also offer it initially as a laboratory-developed test from our labs. The target is to do that in the first part of next year. And then the prostate cancer study that we've developed with Solaris Health. So this is a very good approach because we've signed up a deal with Solaris Health, the largest urology chain of clinics in the United States with over 700,000 patients annually. We've done that first. So we've got the commercial route to market set up for this test ahead of it being in place. We're also fast tracking with Solaris Health the necessary studies to assess the ability to use Parsortix to detect prostate cancer and critically assess whether it's clinically significant and needs intervention or not. We're fast tracking these studies. We expect headline results around the year-end. And if positive, these will be used to start offering a test initially from ANGLE's labs and for Solaris Health to offer to their patients on a private pay basis. And then after that, we will obviously publish the protocol so that others can do exactly the same thing. But, of course, they can only do it if they buy the Parsortix system in order to recover the cancer cells in the first place. So thank you very much for basically listening to this much longer presentation than usual. And I just want to sum up that we have multiple near-term commercial milestones. We have success in making sales to our pharmaceutical companies, such as Crescendo and we expect to see new pharma services contracts coming through in the near term. We're rolling out new assays. We've got particularly the Portrait Flex, PD-L1 and DDR assays coming through for pharma services, and that will be through shortly. We will be launching later this year a Portrait+ product kit. So this is to be sold down the distribution network so that third parties can buy this, and we'll have all the reagents optimized, lipolyzed, and in an easy-to-use format with instruction so that third parties can do exactly the same Portrait+ analysis as [indiscernible]. We anticipate the completion of the prostate cancer pilot study before the year-end and expecting some very good results from that. We're targeting completion of transfer of ovarian cancer test to a third-party molecular platform also by the end of the year. And if we can do that and repeat the results that we've already shown last year that we will have a very successful assay in ovarian cancer. And last but definitely not least, there's a major focus on getting selected third-party molecular solutions identified and notified to the market so that people can use these. And the installed -- the good thing about this approach is, we can install the molecular solutions in our lab, but at the same time, as making information available to the wider market so that they can do the same form of analysis. And again, we expect to see significant progress by the end of this year. So there's a lot of momentum behind the company, and we'd like to thank our shareholders for their support. We're very confident of delivering substantial returns in the future. So thank you very much, and I'd like to hand over now for questions from the analysts.

[Operator Instructions] Our first question for today comes from Charles Weston of RBC Capital Markets.

Andrew, I just had one question. A lot of the presentation has been around the clinical testing or clinical trial testing spaces. But near the beginning of the presentation, you highlighted some of the researchers who have been buying your system and the work they've been doing. So I just wondered if you could touch on the progress that you've been making in that sort of earlier stage research tools space.

Yes. Well, what we've got now is a -- and this is what we want to mirror in the clinical market as well. But in the research market, when we first started, it was very challenging to get our first peer-reviewed publication. But now we've got a wide number of users out in the market who are developing their own uses. And we're seeing pretty much every month, at least one peer-reviewed publication coming through. And we have, I think, at last count, 77 peer-reviewed publications from 24 different cancer centers all showing a high-performance and potential applications of this system. And maybe, Ian, you'd like to add anything to that?

Yes. I mean, we're seeing sort of an increase in inquiries. So we've got a stronger pipeline than we've had historically for the product side of the business from the translational researchers. We're seeing that the confidence is in that, there's a very, very strong interest in the ANGLE solution, partly the sort of old legacy system, one of the ones that used to be used, which had sort of a different FDA clearances, we're seeing as having superseded that. So in that sense, along with that increase in publications up to, as Andrew said, 77 now, then we've got a lot of momentum building behind that. And some of the publications that are in sort of breakthrough research areas are then leading to follow-on inquiries and sales for other of these translational researchers wanted to do similar type of work to replicate that in their lab and test out some of these results. So it's -- that sort of ecosystem is all building and reinforcing itself.

And my last question was just around cash, please. If you could just comment, you've got just over -- I think we finished at just over GBP 30 million. What's your anticipation of burn rate for the year?

Yes. So as we just reported, GBP 32 million at the year-end, another GBP 2.8 million of R&D tax credits that's coming in and then, obviously, the gross margin from sales that we closed out in the period. That takes our cash runway out to about into second half or H2 '24. We have been -- well, last year, we're burning a bit less, but we're planning on a sort of a net GBP 2 million burn a month at the moment through 2023, and that's to deliver on all the activities that we've been talking about. But we are very conscious that we need to tightly manage our cash. And obviously, as you know, we announced last October, we regrettably had to take the tough decision to close down the Canada operations partly reflecting the fact the R&D tax credits regime had changed in the U.K. costs were a lot higher. We're focusing very hard on our core activities, which meant some other programs have had to be pushed out or we'll do more in a serial fashion rather than a parallel fashion. So we're trying to make sure we right-size to progress here. You would have seen with the BioView, that's generating income, but it's also a partnership approach to get some of the product development done, which is a cost-effective use of our cash and our resources and various other activities to make sure that we are tightly managing the cash, reflecting where we are, but we are also making sure that we deliver on the milestones and the news flow that goes with that. So the shareholders, investors gave us money to deliver against those milestones and we've got to progress that. So it's a tough environment. We recognize that. And therefore, we have to be careful with how we deploy our cash in particular areas we spend our money on.

[Operator Instructions] Okay. At this time, we have no further questions. So I'll hand back to the speaker team for any further remarks.

I just want to thank the shareholders for their support, and we're looking forward to a very successful 2023. Thank you very much.