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

Good morning, ladies and gentlemen. Thank you very much for joining ANGLE's Interim Results Webcast Call. We're doing this, obviously, virtually because of the COVID-19 situation. And COVID-19, of course, had quite a significant impact in the 6 months to 30th of June as it hit towards the end of March. It did cause some disruption within ANGLE, but I'm pleased that we managed to regroup. And during that 6-month period, we had a strong half year and set up the position for the FDA submission, which followed in the following period, as you know. We're addressing a large-scale market opportunity for liquid biopsy. ANGLE's Parsortix system can play a key role in transforming cancer care for the better. As you know, the whole point here is to have personalized cancer care. The idea of this is to improve the patient outcome by making sure that they get care, which is targeting their cancer at that particular time and simultaneously reducing health care costs. And we do that by utilizing the Parsortix cassette and microphonic system shown in this slide. As a Parsortix cassette, to separate cancer cells from blood and thereby enabling a regular routine analysis of cancer cells to work out how best to treat the patient. And the highlights for the period was that we continued to have a sustained focus on our established four-pronged strategy which is now delivering, and there are 4 different aspects to that: clinical studies, regulatory approval, published evidence and partnerships. And the critical elements that have been achieved are the FDA submission, which, of course, was made after the end of the 6-month period, but a major amount of work took place during this half year. And we're delighted that our FDA submission has been subjected to the administrative review, which is a formal process that the FDA goes through over 15 days to ensure that all the relevant documentation is available and they've accepted our submission and is now under substantive review. That's obviously a major step for the company. Also during the period, Ovarian cancer clinical verification study has been enrolling and the body of published evidence, which is third-party independent cancer centers utilizing the Parsortix system and polishing on it has continued to be strengthened. And of course, we were delighted earlier this week that we completed a further fundraising of GBP 19.6 million from a conditional share price placing, which was announced earlier this week. In terms of the financial results for the 6 months to 30th of June, the revenue, unfortunately fell as a consequence of the COVID-19 impact. The research use customers that utilize the Parsortix system, broadly speaking, shop their facilities. And as a consequence, the revenue for the 6 months is down 40% compared to the prior period. I'm pleased that most of those centers are beginning to -- are already back up and running, so that the revenues, to a great extent, have been deferred rather than lost. The gross margin of that activity was maintained at the 75% level or above. So we continue to make good returns on the sales level. And the expenditure was primarily in relation to product development and clinical studies, and that was as planned. And consequently, we had a level of loss for the period consistent with the prior period of around GBP 4.8 million. We finished the period with cash position of GBP 13.8 million. And on top of that, there was an R&D tax credit recoverable of GBP 2.6 million, of which GBP 1.6 million has already been received post the period end. The conditional fundraise announced this week strengthens that cash position and adds a further GBP 18.5 million. So those 2 elements, the existing cash balance and the conditional fundraise together, put the company in a strong position to execute its plan. We are funding well into 2022. And in addition to that, we have funding for a number of discretionary programs relating to clinical utility studies, product development and other aspects all designed to accelerate the commercialization of our system. A major area of focus for our business over the last 5 years, has been to seek FDA clearance. And the reason we're doing that, the Food and Drug Administration in the United States is the global standard for regulatory approval for medical devices. We've put it in -- As I mentioned, over 5 years, we've put it in an enormous amount of effort to develop that submission, which was made post period end, and as I've already mentioned, was accepted by FDA for a substantive review. This gives us a prospect of being the first ever FDA-cleared platform for harvesting cancer cells for subsequent analysis. And the term subsequent analysis is critical because it's only by analyzing the cancer cells that you can make a determination how to improve the treatment decisions for those patients. The FDA process leading to submission has been extremely challenging, both technically and in terms of the amount of resources required. We process over 15,000 samples as to Parsortix to gather the necessary information to make the submission. And the submission itself consisted of over 400 reports and technical documents. Whilst that, as I mentioned, has been extremely challenging in terms of not just the workload, but the technical difficulty in doing a large number of the studies involving ANGLE's having to develop new intellectual property and know-how. We perceive that this is a barrier for other want-to-be competitors in the CTC space. If they want to get an FDA clearance, they will have to go through something similar themselves. We undertook a Q-Submission process. And during the half year, we had the most recent meeting with FDA in January to discuss the detailed information we've submitted in the Q-Submission, and to ask a number of questions. And that was designed to de-risk the process. We've been seeking throughout the dialogue with FDA. And we've had, by the way, the same executive responsible for our submission throughout the 5 years and the same divisional director. So we've developed a rapport with them, and they have got an ongoing understanding of our submission and the background to Parsortix. So we've sought wherever we could to identify questions that they needed answering, so that we could address them in our submission. The -- as mentioned, the FDA clearance is recognized as the gold standard globally. We believe that the earliest likely time when we might secure that clearance is second quarter, Q2 next year. So we're within touching distance of a potential clearance. Obviously, as this is a De Novo, nobody else has ever made such a submission for those systems to harvest cancer cells to the subsequent analysis that's being cleared. There's an inherent uncertainty over the timing of the process and the ultimate -- and its ultimate success. But as I mentioned, we've used a process of ongoing dialogue and extensive work to, kind of, minimize the risk of any problems. In terms of the implications of the FDA clearance, post an FDA clearance, multiple commercial pathways open up for our business. We expect to see the existing transactional research use sales increasing very significantly as researchers want to use an FDA-cleared platform. We're going to build on that with work that we're doing on samples to answer solutions to make it easy for them to utilize the cancer cells once they've been harvested by Parsortix. We've got a big focus on expanding our business into pharma services. So this means the use of the Parsortix system in cancer drug trials. That is a very large-scale market opportunity, and we particularly believe that in the space of PD-L1, programmed death-ligand 1 for immunotherapy. There is a large-scale opportunity for ANGLE to sell the use of the Parsortix system to pharmaceutical companies. A big effort within ANGLE on that for the future. The product-led strategy for clinical sales of Parsortix will be enabled post FDA clearance for metastatic breast cancer in the United States and also in Europe because we designed the studies for the FDA clearance to meet the requirements for European CE mark. So on acceptance by the United States Authorities, we will simultaneously file for a European CE mark so that we can make sales to European hospitals. And the product-led strategy will also stimulate ongoing deals and potential collaborations with corporate partners, which I'll touch on a bit later on. The final area that we're developing and putting a lot of resources into from the placing that we've just announced, is the clinical laboratory background, and I've got more information on that, but this will be acting as an accelerator and a demonstrated to show how Parsortix can be used to benefit patients in a variety of different ways. The ANGLE benefits with the Parsortix system of having a proprietary. So it's backed by granted patents worldwide, the proprietary product-based solution for harvesting cancer cells from blood. And that enables us to be both a diagnostic test provider in our own right but also an equipment supplier to others. So our aim is to capitalize the entire industry adopting the Parsortix system for harvesting cancer cells and then doing a variety of different things with them. As I mentioned, during the 6 months, there was significant work done on the ovarian cancer side of things. And whilst the University of Rochester, unfortunately, ceased patient enrollment with the onset of the COVID-19 lockdown, they subsequently have restarted that. We are now enrolling patients. The -- and this is for the clinical verification study for our ovarian cancer detection assay. The rate of patient enrollment is slightly slower than it was previously. And that combined with the period where we didn't get any enrollment means that we have a revised completion date for patient enrollment of Q2 next year. And the idea is that this ovarian cancer trial will verify the results that we previously obtained showing an area under the curve of 95% accuracy in the detection of ovarian cancer. And ovarian cancer is a particularly difficult cancer to detect. So we believe that a successful result from this clinical verification study will achieve 2 very important outcomes for ANGLE: One, it will enable us to offer a test from our own clinical laboratories for the detection of ovarian cancer, and that will open up a substantial market opportunity for the business. But two, it will also act as an example of how sensitive and effective the Parsortix system is in harvesting cancer cells. And we hope that, that data will act as the stimulus for multiple other companies to wish to use Parsortix for the detection of other cancer types, not just ovarian. We have a declared strategy to try to grow the body of evidence. What we mean by that is to get third-party independent cancer centers to work with Parsortix and then publish their results in peer-reviewed publications. And this is critically important because the medical market only adopt systems, which are fully proven and you need as much third-party evidence as possible. The good news is, you can see from the chart that the number of peer-reviewed publications is now rapidly growing, and in fact, is up to 36 peer-reviewed publications. All freely available on ANGLE's website for review. And they demonstrate that this system works without modification in 24 different cancer types. And we've had, in fact, the same number of independent cancer centers who use this system and published showing that it works for their particular application. And there have been 7 separate studies published comparing the Parsortix system with the legacy CTC system cell search. And in each case, the Parsortix system has been shown to have key advantages. And this work has led to a further 9 peer-reviewed publications this calendar year-to-date. Now that's -- in terms of quantum, it's amazing because it took us several years to get the first peer-review publication. And now they're coming through at the rate of roughly 1 per month. And what you can see from this slide, and it's written up in the interim results in more detail, is there's a wide range of different cancers, which this -- have been published on in this period. And there's a number of very specific uses which have come out, which stand out. So University of Hamburg-Eppendorf, which is a leading cancer German research center -- cancer research center has shown that you can do single cell analysis in breast cancer so you can take an individual circulating tumor cell and analyze it when it comes from Parsortix. The same group has shown that you can assess the status of brain metastasis in lung cancer. That's incredibly important because obviously, you wouldn't want to cut into the patient's brain simply to do a biopsy. So this may offer a blood-based alternative process. The Santiago in Spain demonstrated the analysis of MET alterations on CTCs. MET alterations are another key target for drug companies, new drugs. So that helps with our pharma services business. The University of Southern California showed that the information from a Parsortix liquid biopsy was by comparison to the tissue biopsy of a metastatic site in breast cancer, you could get the same and in fact, somewhat more information from a Parsortix blood-based liquid biopsy as compared to the metastatic liquid bio -- sorry, metastatic tissue biopsy in breast cancer. And that's very important because it ties into our FDA submission, which is in metastatic breast cancer. And then finally, and possibly with the greatest impact, the Laboratory of Translational Oncology at University of Crete, did breakthrough research showing the ability to use Parsortix to measure programmed death-ligand 1 protein on circulating tumor cells. And not only that, but to use that information for the first time, to evaluate in advance where the patient might respond to immunotherapy. And we believe that, that is a massive market opportunity assessed at over $1 billion per annum, opportunity in pharma cancer drug trials. So the significance is you can't detect whether a patient is going to respond to immunotherapies, PD-L1 immune checkpoint inhibitors with existing tissue biopsies because they tend to be out of date and you can't use circulating tumor DNA, which is fragments of dead cancer cells because you cannot measure proteins from ctDNA. So to be able to do it with a blood test using CTC's is a potential massive step forward. And it's an area that ANGLE is currently working on in its own lab to develop a PD-L1 assay, which we intend to offer to pharma services in the first instance. But obviously, later, it can be a major opportunity for use with patients. Partnership potential to enable the entire industry. So we have a big advantage with Parsortix because we have an enabling platform. And this platform means that we can be a benefit to all of the large-scale players in the health care sector. We don't need to compete with these organizations. Instead, we can offer them ways to expand their business opportunities. So the existing medtech companies who already provide medical diagnostic solutions based on tissue biopsy, we can offer them the opportunity to extend their revenues into blood. So as an example, we utilized Abbott's [indiscernible] for HER2 in our FDA clinical trial for breast cancer. So what we did was we ran the patient's blood through Parsortix, recovers the patient's circulating tumor cells and then show that the existing tissue biopsy test could be used on those cells. So that opens up a growth in revenue opportunity for Abbott and in HER2 testing in breast cancer. And that's a particular area of negotiation at present. It also opens up numerous other large-scale opportunities where there are tissue biopsy analysis that could also be done on CTC's. For pharma companies, we're offering them the opportunity to enable new precision medicines. So some of these new immunotherapies are getting rejected from regulatory clearance because they don't work for a sufficient number of patients. So if you could have a companion diagnostic utilizing Parsortix CTCs, you could then expand the pharma services revenue into new cancer types. It also has the potential to reduce the cost and time for pharmaceutical cancer drug trials. So pharma companies can benefit from using Parsortix. There's a lot of noise at the moment, rightfully so in the United States regarding clinical laboratories that are offering liquid biopsy solutions in ctDNA. This is the [indiscernible] of dead cancer cells. The likes of [indiscernible], Exact Sciences moving into that space. Grail and numerous other companies are using the fragments of dead cells. Now that's limited to analysis of DNA. They've shown that you can use the same blood tube, same blood sample for CTC analysis. So as well as the fragmented dead cells, you can get the intact living cancer cells out. And that means that those organizations could extend their revenues by not only offering ctDNA but also offering CTC analysis from the same blood sample. And what that does is enables the user to have information on RNA and protein expression, which provides extra key clinical data beyond what you can get with DNA. So it's additional to them. And similarly, the screening companies where there's been a lot of -- particularly in the United States, a lot of interest in the detection of cancer early for cancer screening. Those companies will all have a big question to answer once they do detect the presence of ctDNA. And that question will be, is this a clinically significant cancer which requires interventional treatment? Now that is, we believe that the assessment of the presence of CTCs using Parsortix offers the potential to answer that question. So in time, we expect to be able to partner with the large-scale cancer screening companies to give them extra specificity as to whether or not a patient needs intervention and treatment. The funding that we've just announced this week is going to be primarily addressing the items on this slide, the establishment of accredited clinical laboratories in the United States and the U.K. So this means that ANGLE will own its own clinical lab, which will be authorized to run patient samples. Now we want to do that in order to accelerate the commercialization of Parsortix. We're going to use it in order to be able to develop assays, i.e., tests that can be used for patients in-house, which third parties can then take on at a later point. So it accelerates the commercialization also enables us to -- once we've got such tests, to engage with the payers, the insurance companies that pay for patient diagnostics and get the necessary reimbursement date. The first revenues coming out of those labs will be focused on pharma services and the big cancer drug trials, for pharma companies who want to run those samples in clinically accretive laboratories and that's what we'll be able to offer there. And that, as I mentioned, it opens up a large-scale opportunity working with pharma companies on cancer drug trials. The first test that we're intending to offer are the ones listed in that slide, epithelial EMT-ing, mesenchymal CTCs and clusters. So this is the identification of the presence a number of these types of cells. This is both the epithelial ones, which legacy systems look up, but also the mesenchymal ones, which have changed phenotype and are clinically significant. And of course, a major focus on clusters where Parsortix is uniquely placed to identify large-scale circulating tumor cell clusters. We're going to expand that with the breast cancer offering in ER/PR and HER2, which is a specific phenotyping for breast cancer, which is an identified immediate medical need. And we're going to expand that, as mentioned, into program death-ligand 1, which is the measurement of a protein to assess the likely response to immunotherapy drugs. And finally, the ovarian cancer test that we're developing will be installed in these clinical laborites in the first instance. So a lot of efforts from ANGLE to develop the accelerator and demonstrator for the use of Parsortix. This is all designed to get this widely used within the industry for treating patients and for pharmaceutical services. And what that does then -- this is the last slide, so we'll be moving to questions. The ANGLE is already in a leading position in the liquid biopsy market. We've developed a highly differentiated solution, and it's addressing a multibillion dollar market. The most recent U.S. investment bank report from Cowen suggested that this market is worth over $130 billion per year in the United States market alone. So it's a very big market. We have a highly differentiated product-based solution, which has been demonstrated by numerous parties independent to ANGLE adapted to be highly effective. We have the prospect of getting the first ever FDA period, which is the global gold standard and we're targeting Q2 next year for that. We have an ovarian cancer detection clinical verification study in progress expected to complete enrollment in the same time frame with the prospect of potentially being offered at the end of next year. We've got growth plans to build on this with some to answer solutions, pharma services and a clinical service laboratory. And let's not forget, we've got an expanding partnership program with a wide range of large-scale companies where we're seeking to offer them solutions which can expand their revenue opportunities for the future. And all of this is backed up by a substantial body of peer-reviewed customer studies, which showcase the breadth of utility of this system. So with that in mind, I'll hand back to our organizers and perhaps I can raise some questions, which I'll be sharing the answering with Ian Griffiths, our CFO.

[Operator Instructions] We have a question from [ Brian White ].

It's [ Brian White ] from [indiscernible]. I got couple of broad questions, which I was wondering if you could answer for me. Just in terms of -- we tend to think of harvesting CTC's versus circulating tumor DNA has been in competing areas. Is that fair? Is that relevant? Or should we see them as being complementary as well? I guess what I'm asking is that your biggest competition out there? And then separately, just in terms of thinking from a regulatory perspective, this may not be relevant to your own submission, but just in general, given the low frequency of CTCs and the circulation, I just wondered how relevant are the concerns from a regulatory perspective, we've got a small sample, how relevant that is to the whole or the heterogeneity of the whole tumor?

I'll start with that. And if Ian wants to add that will be fine. That's a very good question. Yes, we see the 2 analytes as being complementary. So the circulation tumor DNA, as you mentioned, is the fragments of dead cancer cells. So either the immune system or the therapy has killed the cell or its guide at the end of a [ natural line ]. And analyzing the fragments of dead cells can give some information on the DNA of the cancer. Circulating tumor cells are complementary to that because as well as the DNA, they can provide information on RNA and printing expression. So we've actually spent part of the time in ANGLE working on a program we call [ Bio-detect ], where we take a single tube of blood from the patient and centrifuge it and remove the plasma liquid in which the ctDNA is present. And we do that according to the same processes used by the big ctDNA lab. And then the waste [Audio Gap] the white blood cells [ inside the ] circulating tumor cells. And we've shown that we can resuspend that in a saline liquid and flow that through our Parsortix and get the CTC. So we do see the 2 things as complementary. We believe that it's possible that ctDNA may be better for some applications. And certainly, CTC will be better for other applications and possibly during the 2 together will be the best for other applications. Do we have another question?

I think, Andrew, there was the second question on the regulatory side about the low frequency as well.

Okay. So I didn't really follow that question. So...

Brian, can you just repeat the question on the low frequency inquiry you had?

The small proportion of CTCs in the circulation of [indiscernible] be aware of the whole tumor given how heterogeneous tumor mass is?

Right. Okay. Sorry, yes, I did get the question. Okay. So cancer is heterogeneous. So there are lots of different elements to it. The circulating tumor cells have an advantage in the sense that they're the ones that are clinically significant in the sense that they are spreading the metastatic spread of the disease. And over 90% of cancer patients who actually die of their disease die from the metastatic spread. So we believe that the CTC analysis has a particular relevance. Some of the work that we've done during this period showed that it is possible to take the individual CTCs and look at them separately. And that can give some information on the heterogeneity of the cancer. But at this point in time, I don't think that the science has really caught up with the breadth of information that could be available. I would say that ctDNA on the other hand, does suffer from a specific disadvantage in the sense that you know that those cancer cells are dead, but you don't know why they died. So they could have died because the therapy has been successful and killed them or the immune system kills them, in which case, both of those outcomes are sort of, in a sense, good for the patient. Alternatively, they might not have died for that reason. There might have been the remaining tumor which wasn't killed by either of those processes and just die a natural death. So there is a conundrum when starting ctDNA, which needs to be taken into account and it's not present with CTCs. And Ian, did you want to add to that?

Yes. And so a couple of points as well. So obviously, one of the challenges with existing tissue biopsies is that you normally have the primary biopsy once. And then when you're in the metastatic side, you'd have that biopsied again. Now when they do a solid tissue biopsy, it's only biopsying that particular site and therefore, may not reflect the tumor heterogeneity. With CTCs, these are shared from all of the metastatic sites, so you can get a full representation of the tumor. Yes, they may be low frequency, but if you get them, you get information. But equally, the tissue biopsy has its problems as well. So for example, with the metastatic breast cancer patients, it's recommended in the guidelines that they have a metastatic biopsy, and that's often problematic with up to half of those patients not actually having a successful biopsy either because they're too ill for surgery, the tumor is inaccessible and that's often the case where it's metastasized to the brain, or there's insufficient tissue. So what that means is that, sort of, half of those patients are being -- having treatment based on out-of-date information. That is the beauty of a [ liquid biopsy ] because we can repeat it regularly, it's noninvasive, we can get the information, we can get a feel for the overall tumor heterogeneity. And in terms of what we'd be targeting, that is the low-hanging fruit in terms of those patients who currently don't get a successful tissue biopsy. And there's a significant medical need and liquid biopsy can provide a solution to that.

[Operator Instructions] We have a question from Mark from finnCap.

I wanted to just ask a question in terms of the service labs, could you just outline your intentions in terms of sales and marketing effort to drive awareness of those labs in terms -- both in terms of time and the sort of investment that you want to put into that.

So the first intention is to focus on pharma services. So this is the engagement with pharmaceutical companies for cancer drug trials. The interesting thing about that market opportunity is that there is actually not that many large companies that we need to deal with. So any one [indiscernible] pharma will have numerous different cancer drug trials. So there are multiple different aspects that we're doing. One of them is that we have a proactive program of webinars where we're actually bringing in experts to produce webinars about different aspects that are relevant to cancer drug trials. And we're inviting obviously the representative of pharmas to join into that. Another is that we can go on to clinicaltrials.gov, and we can assess -- we can identify registered cancer drug trials, which are focused on areas of interest. So for example, PD-L1 is obviously a critical area of focus for us. And we found that there are 1,373 registered trials on clinicaltrials.gov, which is targeting PD-L1 in cancer. So each one of those trials identifies contacts and -- for those trials, and so we can essentially proactively reach out to those individuals. The critical elements that are needed in order to grow this business are we do need the clinically accredited clinical lab, and that's what we're working on. And we do need to have an assay, which is robust to measure the PD-L1 on the CTCs. And we're developing that at the present. The last, as I mentioned, it's a question of engaging with pharma and doing a great job. And one of the aspects that we've pursued to enable us to do this is that we have hired a clinical laboratories Director, Madeline Repollet. And she was for 12 years the Clinical Laboratory Director of the CTC labs for cell search. And so she has had an extensive experience of not only setting up and getting these lives accredited, but running them and engaging with pharma to execute CTC drug trial. So we believe we've got a good team of people and we're putting a lot of effort into building this aspect.

But we are also adding to that team specifically with regard to certain sales and marketing resources. So there's plans to recruit a new Head of Pharma Services sales to go out proactively knock on the door of these organizations and engage them. And that's part of the use of funds of the fund raise announced earlier this year -- sorry, earlier this week.

You also mentioned, Andrew, that with regards the HER2 FISH probe that you're in discussions with Abbott. Is there anything that you can -- any further detail that you can provide, or would like to provide with regard to those discussions, again, both in terms of time line and when you or Abbott or both would have such a test?

So -- And the discussions with Abbott are ongoing. They're not the only player, by the way, there's also [ Dako Ventana ], who focus on the same market. So there are several players who are interested in getting this opportunity to expand the HER2 products into blood. And there are various particular advantages. Obviously, the opportunity for repeat sales for the same patients because a regular repeat HER2 test would enable an assessment of the current space of HER2. And secondly, there's the opportunity to actually seek a much increased reimbursement code in other words, be paid for a lot more for a HER2 test because it would obviate the need for -- the only way you can repeat HER2 test at the moment is to wait until the best cancer patient has a metastatic secondary cancer site. And then do a surgical tissue biopsy and analyze that. And as Ian mentioned in his earlier answer, that is part of the natural cancer guidelines in the United States. So that should happen. And the cost of that surgery is circa $16,000 per patient on average. And so you save the $16,000 by doing a blood test, and therefore, Abbott have a view that we could secure a significantly higher reimbursement code. In terms of the actual process, we don't really expect that to move forward significantly until post FDA clearance. I think what it will involve is Abbott making a significant investment in clinical utility studies and demonstrating this process. And to do that, they want to make sure that we've got the FDA clearance is what we're anticipating.

[Operator Instructions] And I have a question from Lala from Trinity Delta.

I have a sort of overarching question in relation to, I guess, the bigger picture with COVID. Now that the second wave is in progress. How do you feel positioned. Once you learned earlier this year and what would be operationally different this time around to mitigate any impact? I'd be quite interested in both your views on [indiscernible] clients and also your own activities given that it's coming into quite a critical time for you?

Thank you for the question. I'll start and then I'll ask Ian to pick that up. So as I mentioned in the presentation, when the lockdown came in March, we're broadly speaking, had to shutdown of operations in ANGLE's labs and offices whilst we assess the situation. We were able to bring our Toronto facility back on stream pretty quickly because the Canadians are deemed biomedical research to be an essential activity. That was never the case in the U.K. It was never a clear determination. So it was somewhat unclear. We -- obviously, we had as many people as we could working from home, but a core part of our activity involves scientists and technicians and engineers and others who can only work from our facility, they cannot actually do their work from home. And on top of that, we had key studies going which needed access to blood. There's both the patient blood -- luckily the patient blood for the FDA study had already been completed. But patient blood for the ovarian cancer studies was no longer accessible until those studies stopped. And we needed a healthy volunteer blood in our Guildford facility on the Surrey Research Park in order to run the analytical study in order to complete the final FDA requirements and that's stopped. So we have to make a number of changes. We initially removed to a double shift situation so the [indiscernible] people work from 6 a.m. to 2 p.m. and then from a second shift 2:30 p.m. to 10:30 p.m. at night. And by doing that and by getting the office, commercial-type people working from home, we were able to do social distancing and get them back in. The starting -- the blood donations again was more difficult. But eventually, the government allowed various covid activities, which would be acceptable for the donors, blood donors who up until that point, have been coming to our facility and coming into a phlebotomy room inside ANGLE's laboratories. We had to repurpose a separate building so that we basically converted a separability to be the phlebotomy room. So that was kept completely separate from ANGLE. And then once we've done that and the phlebotomists were in full PPE, with stringent cleaning and also with time gaps between blood donors in order to clean all the surfaces, et cetera. We were able to reinstitute the blood donations. And since then, we've refined a number of those processes. But -- and the University of Rochester Wilmot Cancer Center in New York restarted its own procedures and therefore, was able to take blood from patients for that study. Since we've done all of those things, we're now essentially back to normal, and we have a working process that, unless something very untoward happens, we believe it can continue with our operations without any further damage. Ian, do you want to take over and add some more details to it?

Yes. I mean there are some bits that in a total lockdown still presents a challenge. So we've seen with Steve Rochester on the patient enrollment for ovarian cancer, they are getting fewer surgeries coming through. Now that's partly a capacity constraint because there's a backlog of surgeries from -- during the lockdown that they're catching up. So -- and the facilities are being used by other surgeons and teams. So that element is slower. If that stops again, then obviously, that has an impact on the recruitment. But I think there's enough headlines around saying, look, you really must proceed with your cancer diagnostics and treatment. So I think that was even a headline today on the mail or something about sort of 50,000 and diagnosed cancer cases in the U.K. alone. And from this screening and diagnostic procedures. In terms of the lab, as Andrew said, we've made amendments there. But again, if there's a total lockdown and no blood, then that can impact work. However, we've also got multiple programs that are around that can work without patient blood so that the staff are gainfully engaged. So there's multiple product development and engineering type experiments. We've also got a number of blood sources outside of the U.K. that we can import blood through. It costs more money. It's less convenient. But it does allow us to carry on with essential experiments. So we've been trying to sort of plan for and deal with multiple situations depending on different extents of lockdown on COVID-19. So that's a challenge. What we did see earlier in the year was obviously the advantages of having a strong balance sheet so that you're not forced into doing anything in a an accelerated fashion. And obviously, we've got coming up both the winter period, and we're not quite sure what's going to happen with COVID-19. And obviously, we've got Brexit towards the end of the year. So we try to do as much preparation and planning and mitigation as we can. But clearly, if there's a total lockdown, that can have a bit of an impact, but we've got other programs in place that we can deliver on.

I'd add one further comment, which is -- well, 2 actually. One is that we've developed some of our techniques for remote installation of instrumentation and also for remote maintenance. So we're trying to become more responsive without having to physically travel the engineers quite as much as they were previously. And that has a knock-on benefit of potentially expanding the international reach of the business. In other words, we don't necessarily up our engineers in the country if we can do things remotely. And secondly, the whole COVID-19 lockdown issues. And as Ian was mentioning about undiagnosed cancer and also cancer patients not having procedures like tissue biopsies, et cetera, which they do need, shows -- puts in the stock contrast the need for liquid biopsy because you can send the phlebotomist to the patient's home in full PPE, and that avoids the patient who may have a compromised immune system having the risk of going to hospital and a lot of patients are nervous to do that, or the facilities not available for them in the hospital. So it makes a perfect sense to have a blood-based alternative to the invasive procedures, and they just reemphasizes that.

And we currently have now any further questions.

Okay. Well, we'd like to thank everybody for participating in the webcast. And we're continuing to move the business forward fast. And I think there's going to be some exciting things in the coming period. Thank you very much indeed. Have a good day.