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

Good morning, and welcome to the ANGLE Plc interim results presentation. My name is Charlie, and I'll be coordinating the call today. At the end of the presentation, we'll be holding a Q&A for analysts. [Operator Instructions] I will now hand you over to your host, Andrew Newland, Chief Executive of ANGLE Plc to begin. Andrew, please go ahead.

Good morning, everybody, and welcome to our interim webcast. And as usual, this is open to our shareholders and investors via the webcast and is being attended again in this case, virtually by the analysts who will be able to answer questions and answers. And as usual, I'm joined by Ian Griffiths, our Finance Director, who will join with me in answering some of the questions at the end. So what we've done with this presentation and by the way, as usual, both the presentation slides and the webcast will be put up on our website later. So you'll be able to pour over the slides. And in this case, there are actually a number of slides that we've introduced because we'd like to share them more widely that have come from our recent placing presentation. In particular, you'll be interested in some of the slides which scope out detail about some of the markets that we're addressing. I won't have time to present all of that, but there is quite a lot of information on the slides, which will be relevant, I think. So once again, welcome to our webcast for the interim results for 6 months to 30th of June 2021. And we've had great progress in this first half of the year as Parsortix is moving towards prime time. I think you'll be very interested to see some of the progress that's been made. So as a recap slide here, this is the Parsortix cassette show in the image here. We believe that this can enable repeat biopsy. So it's a way to access cancer cells for analysis on a repeat way, which you can't do with a tissue biopsy. And in fact, getting living cancer cells from the blood, which are spreading disease are, in fact, the best sample possible for these biopsies. And we think that this can transform the way that cancer is diagnosed and treated to allow true personalized care because it means that there's an easy, noninvasive way to get hold of cancer cells to investigate what's happening with the cancer, how is that cancer changing in the patient and what drugs and other therapies and clinical decisions would best benefit the patient. Tremendous benefits from that, benefits for the patient to avoid them having drugs which don't work, will have toxicities and to make sure that they get drugs that do work for their particular cancer at that point in time. And obviously, benefits for all of us, even those of us who don't have cancer because the cost -- economic costs of dealing with cancer are huge, and a lot of that is in fact, the majority of it is wasted because treatments only work for some patients. So that's the backdrop against which we are working. In the first half, as I said, we've had strong progress. In fact, against all of our key milestones, there's been very good progress in the first half. Our FDA submission, where we're seeking to be the first-ever FDA product clearance for a system to harvest cancer cells for subsequent analysis has progressed well. I'll go through that in a lot more detail. And that's accessing the breast cancer application first. But obviously, once we've got the FDA clearance for metastatic breast cancer, we intend to do other much more simple clearances on other cancer types because the Parsortix system works for all cancer types, all solid tumors that it's been tried with. Secondly, we set up clinical laboratories, which is the other regulatory channel in both the United Kingdom and the United States. And those clinical laboratories enable us to process clinical samples in-house at ANGLE. And that has enabled us to set up in the first half, the pharma services business. So this is a new business where we're offering pharmaceutical companies that have cancer drug trials the ability to provide their patient blood samples to our ANGLE, and we can process them and tell them what's happening in the patient's blood in relation to the cancer. And that's a new way of doing things for the pharma because we can provide longitudinal monitoring. That means we can provide them with information on what's happening to the patient before, during and after their drugs are administered. And you can't do that with tissue biopsy. And in fact, you can't do the full analysis that the pharma would want any other way because if you look at CTDNA, the fragments of DNA dead cells, you can't get the key information on protein expression, which the drugs may be targeting. So the establishment of that pharma business, it was a major milestone during the first half. Fourthly, we've been progressing our own ovarian cancer test, and we have a clinical verification study, which has progressed very well and is now in the combination phase. During the first half, the patient enrollment was completed, which puts us in a strong position. And if that wasn't enough, right at the end of the period, we progressed the placing and subsequent to the period end, we secured additional funds to expand the operation into prostate cancer. So we're now pushing ahead with plans for prostate cancer to add on to our breast cancer under ovarian cancer activities. In terms of the financial results for our business, obviously, the critical element is do we have the resources needed to deliver our plan. At the moment, we're still at the establishment revenues level, which means we haven't actually started making the substantial sales that we're looking for yet. But nevertheless, even in a constrained COVID scenario, we increased our revenue in the like period by 26%. And margins were maintained at around 74%. So every time you make sales, this product is very profitable. The cash position finished in a good position of GBP21 million at 30th of June. And on top of that, we added a placing for further GBP20 million, which was net GBP18.9 million. So we're well funded to execute the clear strategy and plan that we've adopted. In terms of the overall process that we have, we have a very coherent strategy here. It's driven by what we call leveraged research and development. And this is third-party independent cancer centers, working with our system and coming up with uses. We then use our own ANGLE development and validation processes to select and develop test based on some of the pilot work that's done by those independent centers. We now have our ANGLE clinical labs, which are being used to actually offer services using these new tests. So I've already mentioned the pharma services side, which is a research used for cancer drug trials, a very large market in its own right. In addition, we intend to be offering tests for treating patients, so-called LDTs, laboratory-developed tests. Now these are distinct from FDA product clear test in that they are cleared under the clear accreditation and equipment in Europe for these labs, which we are progressing. So these ANGLE clinical labs based in the United Kingdom and in the United States provide us with the capability of offering a global service, which we then want to get leveraged via our product strategy with contract research organizations and large-scale clinical laboratories, third parties adopting the technology and the products themselves once they've seen how well it works within our lab. So the aim here is a wide third-party adoption of our product. So what we want is every single cancer hospital and clinical laboratory in the world eventually to start using the Parsortix system. And we're doing our -- all the work necessary to make that process easy and effective for them. Now obviously, one of our massive milestones coming forward is the FDA product clearance. And just to reiterate, this would be the first-ever FDA peer product for harvesting cancer cells for subsequent analysis. So it will be an enormous milestone. It's been a tremendous challenge to get to where we are now. We're now 6 years of work to get to the stage that we're at. But we're very proud that we've made a very full submission to FDA in September last year. And during this half year period, we received a very detailed response from FDA with their questions called an additional information request. And we worked during the half year to give a robust and comprehensive response to that, which we are very pleased with and announced in early June. So since then, FDA's review has been ongoing, and we've had continued interaction with them. So we're very pleased with the progress that is being made there and we're anticipating an FDA regulatory response in the second half of this year. And to reiterate, this is the gold standard. When we get this FDA product clearance, we will be the only company with such a clearance, and we expect that users of our product will consider that to be a tremendous validation of what we've been doing. So it is a key part of our strategy. And as I've mentioned, this clearance is in relation to metastatic breast cancer. Once we have that, we intend to progress and see clearances in multiple other cancer types. And those are much less complex, much easier and quicker to achieve. So we will be progressing that very actively once we have the first clearance. So now changing tax somewhat, the clinical laboratories do not need FDA product clearance. So this is a separate -- and in fact, virtually everybody in the liquid biopsy space is progressing solely with the clinical laboratory approach because they don't have products that they can sell. We obviously do have products, and we want to get the products out. But we're now dual tracking the strategy. We have a service-led approach as well. And we've made a lot of progress in the first half with these 2 clinical apps. So they've been set up. We have quality systems in place, the laboratory information management systems all in place. We have staff. And we've already made initial submissions to the regulatory agencies in relation to those quality systems. There's quite a lot more submission still needed. We're targeting getting the completion of the regulatory clearance by the end of this year. With a lot of these things, because of third-party agencies, it's somewhat our control, but we are doing everything necessary from our side to be able to make the submissions to seek those accreditations to be allowed to run patient samples. The pharma services business, however, doesn't need the accreditation. It simply means the clinical labs. So that is already up and running. We've announced the first large-scale pharma contract, and we now have actually got 3 active customers on the pharma side, very promising. It's quite a challenge to get new customers taking on a new service like this. But the very good thing is that once those processes are in place, it's very easy for them to extend repeat contracts for other trials. We don't need very many individual pharma contracts to have a very large-scale business in that regard. So we're pleased with the strong progress on our clinical labs that have been achieved in the first half. And just to give -- this is a slide from our placing documentation, all of which, by the way, have been subject to formal legal verification. So this is strong information that we're sharing here. And what this is telling us is that in the pharma services business, now remember, this is running already in our labs, doesn't have anything constraining us in terms of building this business. Just a single subset of the pharma services market is worth potential $1.6 billion to us. So this is looking at one particular protein known as program programmed death-ligand 1, PD-L1 on the cancer cells, and that's the target for immunotherapy trials. There are over 2,400 such trials running at the moment or about to be run and we believe that there's a potential there for nearly 400,000 patients enrolled in those trials, and there can be multiple time points, multiple samples per patient. So potentially 1.3 billion samples to process. And each one of those can garner between $1,000 and $2,000 for ANGLE. Our baseline pricing is $1,000. We discounted the first couple of contracts. But our baseline price to assess with portray plus the presence and type of cancer cells in the blood sample is $1,000. And then if the customer wants to investigate those cells in more detail and look at particular proteins or do molecular analysis, that $1,000 can increase to up to around $2,000. So it's a very large market opportunity. It's adding a lot of value to the pharma because they can get an early readout on what's happening in their trial and if they use our new assay development service, which is where they identify the particular proteins that their drug is acting on and ask us to develop an assay to investigate those specific proteins on the cancer cells, then they can potentially get information to identify likely responders and gain information that they cannot currently get from any other way in terms of their trials. So we're offering a new approach to the pharmaceutical companies, which whilst it can generate a lot of revenues for us, is a very cost-effective and proportionately low level of cost compared to their overall running costs for these trials. So a very strong business opportunity, and we've made good progress in getting that set up in the first half. And here, this slide just gives a little bit more information on the individual contracts. The first large-scale contract was a Phase III study in prostate cancer, quite unusual for us to get straight into a Phase III and in fact, we joined that partway through. It shows the level of interest in this customer to bring us on board. More likely, we expect to be involved in Phase I and then Phase II progressively. And that -- we've got our first assay development contract, which is to provide a bespoke immunofluorescence assay in relation to specific proteins. So we're developing this specifically for that customer, and it's in relation to DNA damage repair. And the great news is that DNA damage repair, of course, is an area of great interest for many pharma companies. So once we've developed this assay, we own it, and it sits on our menu, we can offer it to other customers. So progressively, the assay development approach yields us with an increasing menu that we can offer to pharma becoming more and more relevant to individual pharma's requirements. So the pharmaceutical pharma services use of our clinical apps is just one use. The other one is, as I said, us offering clinical tests directly for patient management. And the first one, and that's from the so-called laboratory-developed test, LDT. The first LDT that we're developing is in ovarian cancer. So we've already run several studies in ovarian cancer, showing that a blood test analyzed by Parsortix and our downstream molecular platform called HyCEAD, is very successful in identifying the presence of ovarian cancer in women with an abnormal pelvic mass. So actually, the presence of the pelvic mass is a very common situation, between 5% and 10% of women will have an abnormal pelvic mass in their lifetime, usually when they're a little bit older. Thankfully, only a minority, quite a small minority, 10% to 11% of those women will suffer ovarian cancer. But obviously, for those who have got a pelvic mass, is a great concern as to whether or not they have ovarian cancer, and in particular, the need to make sure that their surgery is done by a competent specialist cancer surgeon if they do have ovarian cancer. So this is an important market need to be able to detect with a simple blood test ovarian cancer. And unfortunately, standard of care is very poor in this regard. There's a very high false-positive rate with standard test. But because the ANGLE Parsortix system is looking at actual living ovarian cancer cells in patient blood, that is a much more specific test with a lower level of false positives. So the good news is that during the first half, the cancer center, University of Rochester Wilmot Cancer Center completed the patient enrollment for our clinical verification study. And so we're now in the process of getting ready to analyze those samples with the prospect of headline results by the end of Q4 this year. So just coming up in the next few months. That will then, assuming we've got the accreditation through in time, as and when we have the accreditations through, and we've got strong data, we will then be able to offer the first LDT from ANGLE labs, which will be to detect the presence of ovarian cancer in women with an abnormal pelvic mass. And another slide here from the pricing pack gives you some sort of measure on the scale of the opportunity financially for ANGLE. So there are over 7 -- and this is just United States, by the way, there are over 700,000 women a year diagnosed with these pelvic masses, and over 200,000 of them have surgery for that. So there's an existing test, which I think particularly successful but that means that the reimbursement code is already in place, and that's at $897. And we've modeled it at $1,000 per test here. So what you can see is a $1.3 billion market opportunity once we have this LDT in place. And that is, in addition, of course, to anything else that we do in clinical labs in relation to pharma services. If that's not enough, we're intending to move into prostate cancer as well. And the placing that brought funding in straight after the period end was mainly motivated by a need and an interest and the commitment to move into prostate cancer. So prostate cancer, I'm afraid apologies to men on this call and women as well, but particularly men is a rather shocking picture in the right-hand side. But that's the standard of care transrectal ultrasound-guided core tissue biopsy for prostate. And that's at best a very uncomfortable procedure. Unfortunately, it also brings with it the risk of infection and other complications. So it's not actually a test that you want to have. But over 1 million of these procedures are done every year just in the United States and similar numbers per population in other countries. Despite these being prescribed because of there being some sort of symptoms, such as a high PSA level or other symptoms, which might suggest possibility of prostate cancer, the pretest before biopsy are very ineffective. And in fact, 75% of these procedures were completely unnecessary because the previous PSA test or whatever was a false positive. So 75% of the time, that procedure is expensive and painful and potential risk of infection. So not something that you would want. And on top of that, for those that are positive for prostate cancer, it's an unusual cancer in the sense of actually, maybe it's not that unusual, but it is a notable carter for the high level of indolent disease. So of those that are positive, only 40% are actually aggressive perhaps that's going to spread whereas 60% is indolent. Now patients typically will obviously want to get rid of their cancer, and they're likely to have a prostectomy surgical operations to remove the prostate gland. And that brings with it a lot of implications, including impotency and urinary incontinence, which are irreversible like changing situations for men. And yet, 60% of the time the disease is a slow burner, a so-called [indiscernible] That is not a good way of discriminating. And so many men have the surgery, which probably should have done. So we've had some good work in the past by Barts Cancer Institute and actually now a number of others who've shown that with Parsortix you can get cancer cells out in a good proportion of patients were prior to a biopsy. So what we're intending to do here is a blood test to assess the presence or likelihood of prostate cancer as a pre tissue biopsy event. And hopefully, that will reduce unnecessary tissue biopsies and also to assess the severity of the disease to potentially allow watchful waiting for men who have indolent disease rather than aggressive spreading prostate cancer. And all of that is a very large market need. So if you have a look at the schedule here on prostate cancer, what you actually see is this is the biggest market of all. There's a potential $6.7 billion market in the United States alone and per population is something similar in other countries. So there's a real need for a simple blood test. And what stimulated our placing was the fact that we started discussions, which are now progressing very well with a group of urology clinics in the United States who have a very large number of patients that they deal with, who have the risk of prostate cancer who then have tissue biopsies and then have the radical prostectomy surgeries. So they would like to implement this test. They're also a potential study site for us. So we can easily access the blood sample that we need to run clinical studies to prove out the effectiveness of this approach. So now that we've raised the capital from the most recent fundraise, we intend to find discussions with them. And we've got into a stage where we're getting detailed clinical study plans drawn together. So I expect to see some very interesting announcements about the start of relevant studies in the next few months. Another very positive development for ANGLE. And obviously, this slide here is the growing body of evidence. It's very important to us that we get the world's leading cancer researchers behind this product. We've had the recent ACTC conference in Greece, which is the leading circulating tumor cell conference. Despite there being still some COVID restrictions, we were able to get a number of our team members out there including our Head of R&D, and we had a very, very good conference there. That was announced at the beginning of the week was worked from one of the leading research groups, the Medical University of Vienna, with 3 different posters, which we thought was highly impactful, including one, which related to an ovarian cancer pharmaceutical trial, called GANET 53, where they used the Parsortix system with 135 patients with 4 time points over a 5 year period. And what they showed there, which is very convincing data was the ability to discriminate which patients are going to respond to the drug. So by looking at the Parsortix information in the blood test before the patient had the drug, they could predict which ones would respond and the Kaplan-Meier curves, which is a technical term processing survival rates, we're quite impressive in relation to that. So that's very supportive for us doing similar things for other pharmaceutical companies. But we now have, as you can see, 46 at the -- at the period end for a 46 peer-reviewed journals. So these are top-notch publications, which have been prepared by 29 independent cancer centers for 24 different types of cancer. So all of these offer the prospect for ANGLE development in the future. And what we want to do with this is enable the entire industry. So ANGLE is not trying to be a single company out in the big ocean. We want to provide the Parsortix tool for everybody to use. We want it to become the default method for getting cancer samples for analysis. So we want med tech companies that already have great medical and diagnostic procedures that work on cancer cells from tissue biopsy to be able to extend their offering to repeat with cancer cells that come from blood from noninvasive blood test. We want pharma companies to use our technology in their cancer drug trials, as I've already explained, and we want them to use the technology as a companion diagnostic to detect likely responders to their products. We want the contract research organizations to adopt Parsortix in their work for pharma. So we don't have to run all the cancer drug trials in ANGLE. We just want to demonstrate that capability so that other contract research organizations start to adopt the technology. We want the clinical laboratories, both in hospitals and independent third-party clinical laboratories to develop their own Parsortix test using the platform. And that's one of the core reasons behind the FDA product clearance strategy is that once that is a cleared platform, we want it in the hands of clinical labs and then to come up with their own laboratory developed tests and uses, not everything developed by ANGLE. We're trying to enable the industry. And even the big cancer screening companies there's been talk of, there's a large-scale NHS trial running on cancer screening at the moment with a ctDNA company. Those companies are going to have a desperate need to work with Parsortix or similar platforms as well once they're successful because detecting cancer on its own, it's not enough. You need to know, is it clinically significant, and is it going to progress. And that's the kind of question that the Parsortix system is able to address. So to wrap up, this is the final slide. The second half is shaping up to be tremendously exciting for ANGLE. We've got growth coming through now in our expanding and new pharma services business. The FDA clearance, we're expecting and anticipating a response from FDA later this year. The ovarian cancer headline results are also expected in Q4 this year. And we're working to get the lab accreditations in place as well by the end of the year. So there's a lot to play for in the second half, and it's a very exciting time. And in the meantime, the discussions with potential corporate partners has been intensified, and we're expecting to see post FDA clearance some very interesting alliances coming forward. And on top of all of that, we're beginning work on a major new opportunity in prostate cancer. So thank you very much, everybody. I'm going to hand back, and we can move to questions where Ian Griffiths, our Finance Director, is going to join me.

[Operator Instructions] Our first question comes from [ Brian White ].

Two questions actually. One on prostate cancer, one in pharma services. I noted your comments about prostate cancer. I just wondered, actually what percentage of prostate cancer patients can you isolate meaningful numbers of CTCs from, particularly those with localized prostate cancer? And how does that compare with circulating DNA, for example? And then secondly, on the pharma services business, that looks to be a well-differentiated opportunity for you. Do you think you've got the requisite business development people, resource and skills for you to capitalize on that?

Very helpful question. So the answer to the prostate cancer question, we guided by Barts Cancer Institute's work. And what they found was that in patients who are undiagnosed for prostate. So it was prior to their tissue biopsy, they could identify around 75% of those having circulated tumor cells but most interestingly, there was around 90% of the clinically significant cancers. And that's really important because it's those ones that really need to be picked out. That was using some early approaches. And we've got a number of significant developments since that work was done. We've improved our sample-to-answer solution for imaging, circulating tumor cells. And on top of that, we have developed a high seed molecular platform, which looks for prostate cancer, which is looking encouraging as well. So in terms of circulating tumor DNA, we would we would expect to outperform, I mean, identifying the aggressiveness of the cancer, which is the key question. I'm sorry, Ian, did you want to add to that?

Yes. And one of the -- you asked specifically about the ctDNA. And one of the interesting things is if you look at the last Galleri study, prostate was along with breast was one of the cancers where they were particularly low performing. And in fact, the only ctDNA with sensitivity was 11.2%, so 47 out of 420 patients. So we think ctDNA, for some reason, has a problem with prostate and with breast cancer and a number of other cancers. And so it'll be interesting to see how the results come through on that. And that's the Galleri as GRAIL is the big U.S. company behind that.

And to your second question, which was about -- essentially, do we have the business development in place for the pharma services. We've recently recruited our more business executives, specifically on pharma services, but we aim to build that out a lot more. So we're looking to build that into a strong business unit in its own right. So we've got a lot of work going on. So we're actively progressing discussions with multiple large-scale pharma companies. But we want to build that out further. So we're not -- we haven't finished yet.

[Operator Instructions] Our next question comes from Charles Weston of RBC Capital Markets.

I have 3, please. The first one is, I guess, to some extent, the science one. In terms of the interest you see from your pharmaceutical customers and those people you're in discussions with, you mentioned proteomics and building a protein assay. Just wonder what sort of interest there is in the other omics, genomics, and I guess, particularly transcriptomics and epigenomics, sort of interest from them because, obviously, your approach would be quite differentiated from the ctDNA side for those. My second question is are you having some conversations with commercial laboratories who could potentially be early wins and early adopters of your product once you get FDA approval? And then third, and building on [ Brian's ] question around the BD team, beyond, I guess, pharmaceuticals, you could potentially have a situation where you have to be marketing to pharma companies, marketing to laboratories and potentially marketing directly to doctors, which is obviously a big endeavor. So can you perhaps give us a sense of what the BD team might look like in, say, 3 to 5 years?

Yes, so let's go through those questions as you put them. So the proteomics means the focus on protein. So we've already got programs at ligand 1, which is a key project for immunotherapy that I mentioned. And there is -- and we've got a contract which is working on assay development for DNA damage repair couple of proteins there. And there is definite interest from pharma for that. You mentioned particularly genomics and transcript genomics. So the measurement of RNA and transcriptomics, I think, is a real additional level and one, particularly, we're very strong in the sense that the system can feed into RNA-seq, for example, which is the next-generation sequencing platform. And we've shown that as one of our uses for our FDA submission. But beyond that, we've got our own platform [indiscernible], which we're using for ovarian cancer and that's a targeted gene expression platform, which works extremely well for ovarian. We've got trials going on -- sort of internal work at the moment in prostate and breast. And the prostate work is looking quite promising as well. So what we anticipate is our HyCEAD molecular offering will also be in our laboratories available to pharma. We haven't pushed it hard yet because we'd like to have the published data from the Ovarian study first. But I anticipate that, that is an area of interest. So I agree with your premise of your question. The second one was -- sorry, Ian, go ahead.

And certainly, I think it's becoming increasingly recognized that looking at the genome alone means that there's a lot of information missing, and there's been a number of studies around that have shown that adding in RNA information to the transcriptome increases the performance, particularly of some of these specialists targeted immunotherapies. And also, the National Cancer Institute basically has got a number of initiatives going on ensuring that proteins are in the spot because they view them as being critically important in developing drugs and selecting treatments and predicted treatment response. And indeed, they go as far as saying the integration of proteomic information is the next step in precision oncology. So I think that's where there's a big difference because although there's been a lot of progress, particularly with the ctDNA companies and the DNA analysis, they are coming up against limits of what that can achieve. And therefore, adding the RNA and the protein information you need CTCs to do that, and that's why we think that interest will develop, and that's what pharma are interested in and we've already took on the PD-L1. And indeed, the announcement earlier in the week on the TP53 protein as well. There's a lot of protein information around.

The last part of your question was to do with access to customers, commercial labs and laboratories and doctors. The first thing to say here is that our intention is not to be engaging with pensions directly. It must be through an existing medical center. So that's one of the attractive elements of the urology clinics that I mentioned earlier in relation to prostate cancer is that they deal with the patient. They offer the test. They'll be responsible for collecting the reimbursement, and then they will outsource the sample analysis to our laboratories. And that's the way that we see those things developing. In terms of adoption by sort of large-scale hospitals, et cetera, it's actually really not possible to engage with them until we've got through the regulatory process, et cetera. That said, we specifically chose 4 of the leading US cancer centers to participate in our FDA studies. And they are obviously sort of front runners to be early adopters. But what we anticipate is that it's like all of these things, it takes a long time to change practice. We don't expect it to happen overnight. And that's why the pharma services business and the LDTs are really, really important because they can bridge us through to the widespread adoption of the product solutions in the hospitals.

I guess just as a follow-up, perhaps just in the near term, and again, following on from what [ Brian ] was asking, what size do you think is the right size for now for the BD team for the pharma services business?

I'm not sure what the question is. What -- the right size for what? I didn't quite hear it.

The right size in terms of number of people within BD for pharma services.

The BD team -- sorry, I was mishearing you. Okay. So in pharma services, I would expect we'll probably end up with about 20 people doing that eventually. But at the moment, it's much smaller than that. It's probably about half a dozen. What -- in terms of business development, I'm sorry, I'm engaging the question factor now, Charles. Do you want to understand about the business development for pharma services. So we're offering from our labs but each time we get engaged with a pharma, there is a contract research organization, a CRO that's running their trials. So we are also engaging with them and trying to persuade them that this is actually a good offering for their other customers. And ultimately, we'd like them to first off the contract search organizations become our business development team and offer to their customers the opportunity to analyze the samples and we'll do that on an outsourced basis on. So they can offer it to their customers, but we will do the work. But beyond that, once they're ready, we will help them to set up a Parsortix lab in their own facility. And then we will just become a product supplier to them. So with all of this, we are trying to have a team which can, if you like, capitalize the whole thing, but then get the existing industry to pick it up and run with it.

[Operator Instructions] Our next question comes from Franc Gregori of Trinity Delta.

Can I ask -- forgive me if this has been asked, if this has been covered, you've used the word turbocharge that the FDA approval, and in my view, arguably, when you get a laboratory-developed test for ovarian cancer, you used the word turbocharge. Can you explain what you mean by that? What would the effect be upon the rest of your business?

Thank you, Franc. The FDA product clearance, as we explained this, it would be the first ever. So FDA is not clear upon us in the space yet. They want a clear product, and there's quite a lot of pressure on them to get one, but they don't have one at the moment. So that is seen as global standard. Now obviously, it's the United States regulatory clearance, the FDA. But it's seen in Europe and the rest of the world has being the preeminent standard. Now we see that -- obviously, the heart of the FDA product clearance is to allow our product to United States based hospitals for the intended use, which is to harvest cancer cells from the blood of metastatic breast cancer patients for subsequent analysis. So that's the purpose of it. But its impact is much wider. And beyond that, we've designed the study so that they will also meet the European regulatory requirements. So we will simultaneously submit CE Mark approval as well covering Europe in the same way. And the FDA clearance is also a path of approval for others. So we anticipate, for example, that our pharma services will immediately very positively and the fact that we have an FDA clearance despite they are not actually immediate for us, using it in our cancer trial. But it can help the pharma companies very significantly because ultimately, they would like our companion diagnostic to be able to respond to their drugs which won't. And to do that, they need an FDA-cleared diagnostic. So if we give them a clear platform, then they can then follow up their companion diagnostic on it, it is much, much easier. So that will expand the pharma services side of things. We also expect the FDA clearance to expand the research side of things because the researchers would really like to standardize their research on a platform. And if we can give them an FDA-cleared platform, we anticipate that the existing translational researchers will target their work towards it. So it really has a very widespread impact. It's not a requirement for our clinical lab work, but it will boost it. And that's why we think of it as a turbocharge.

Yes. And in addition, we'd expect that the credibility of the FDA -- the labs around the world, I mean, as I said, we've got many key opinion leaders we already work, where they have their own labs who had picked these to develop their own lab-developed tests of the base Parsortix. And obviously, it will open up different geographies for us including places like China and various other large markets, again, on the back of the credibility of the FDA.

[Operator Instructions] At this current stage, we currently have no further questions. So I'll hand back to Andrew Newland and Ian Griffiths for closing.

So thank you very much, everybody. As I mentioned at the beginning, the slides and the webcast will be put up on website. Thanks for your continued support. And as I mentioned, we're looking forward to a very exciting second half. Have a good day.

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