Avacta Group Plc (AVCT) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and welcome to the Avacta Plc interim results investor presentation. [Operator Instructions] Due to the significant number of investors on the call today, the company will not be in a position to answer every question it receives during the meeting itself. However, the company review all questions submitted today and publish responses where it's appropriate to do so. These will be available via our Investor Meet Company dashboard. I'd also like to remind you that this presentation is being recorded. Before we begin, I'd like to submit the following poll. I'd now like to hand over to Alastair Smith, CEO; Tony Gardiner, CFO; Neil Bell, Chief Development Officer of Avacta. Good morning.

Good morning. Thanks very much, Hadid, and thanks, everyone, for making the time to listen to the presentation. I'll push straight on with it, so we don't lose time for questions. So for those of you who are new to the company, I suspect many of you will know this, but let me give a quick introduction for those who are new to the company. So we have 2 divisions, 1 based in Cambridge, U.K. just focused around the therapeutic developments based on the Affimer platform and the pre|CISION platform. We'll have some time today to talk about the first of those pre|CISION programs, AVA6000, that we're pushing into the clinic early next year. And the Diagnostics division, which is based in Wetherby in Yorkshire. And of course, we will be talking in some detail around the lateral flow antigen test we are developing with Cytiva and the test we're developing with Adeptrix as well, give you an update on that, too. Okay. So brief introductions, myself, Alastair Smith, for those of you who don't know, Chief Executive. I have a scientific background but have been out of scientific work for many years now. And Tony, would you like to say a quick word?

Yes. Good morning. I joined Avacta back in 2016 as CFO. I've worked across several different businesses as CFO over the last 20 years, particularly businesses where we've got lots of intellectual property to handle. Thank you.

And Neil?

Thanks. Yes, I've just recently joined Avacta Life Sciences as Chief Development Officer in August of this year, and I'm delighted to be here. So I'm responsible for late-stage preclinical and clinical development for the therapeutics pipeline, including the pre|CISION pro-drugs and Affimer immunotherapies. My drug development career spanned over 30 years across various leadership roles, working for successful mid- to large pharma companies as well as biotech at the global level. And I think it's worth actually highlighting that my drug development experience extends across small molecules, biologics and more recently, cell and gene therapies, where I've taken actually CAR T cells successfully into the clinic. So I've got extensive early and late development experience covering preclinical, Phase I, II and III. And in addition to the technical side of my drug development experience, I've got significant experience in building new organizations from the ground up. So I hope that gives you a useful insight into my expertise. Thanks.

Thanks, Neil. I'd just like to say publicly, welcome aboard, Neil, to Avacta. And thank you for the impact -- the positive impact you've already had on the company. So really looking forward to Neil's contribution over the coming years. Okay. So let's go through the results, and then we'll look at the business update. I'm not going to read through all of the operational and financial highlights because those are sort of historical RNSs that you should all be familiar with. So let me push through to the numbers and let Tony just take you through those.

Thanks, Alastair. So this is our first reporting period to the end of June, having changed the year-end to December back in December '19. So reporting the 6 months to June 2020 compared to June 2019. So revenues have increased across the period, primarily from the customer projects in our diagnostics sector increasing, but also the development projects with our partners, such as LG Chem and Daewoong where we've got funded income coming through on those projects, which has pushed revenue up in the period. You'll notice there's a line where R&D and amortization costs have increased over the period as we start to build towards taking our first program into clinical trials, and we obviously expect those to continue to increase given the cost of that program. The taxation positive numbers there reflect the R&D tax credits, which we receive as part of the process we go through on our tax returns every year. Now retained loss for the period was just shy of GBP 7 million compared to GBP 5.7 million in comparative period. But loss per share has reduced slightly, given the increase in the average number of shares in issue over the reporting period. Moving on to the cash on balance sheet. We -- there was a net inflow of cash of just over GBP 45 million within the 6 months. Obviously, that was driven by the proceeds from the 2 placings but also from the purchase of shares by staff from the employee share option schemes that they've exercised. So there was a net GBP 51 million that came into the business in that period. That left us with just over GBP 54 million of cash at the end of June. Now that will be used to fund the expansion of the therapeutic pipeline and also the expansion in the diagnostics side of the business, and that should provide us a cash runway through into 2023. We finished the 6 months with net assets of GBP 71 million. So we're in a strong position as we head forward. Thank you.

Okay. Thanks, Tony. So again, I'm not going to read through the post-period highlights. Obviously, we're going to cover a lot of this during the presentation and the forward look as well. So going on to the business update. The first thing I thought I would do is set out some near-term milestones over the next 3 and 6 months. And I put those broadly speaking into 3 buckets. So the first relates to AVA6000, which we'll talk about more in a moment. So that is the pro-drug form of doxorubicin, the pre|CISION form of doxorubicin. And we are aiming for a regulatory filing before the end of the year. We're dosing first patients late in Q1 next year. We should see the initial PK and safety data around the middle of the year. Neil will take us through that in a little bit more detail in a moment. That's a really significant set of milestones for the group because not only does that move the AVA6000 into the clinic and transition Avacta into a clinical-stage biotech. But most importantly, I think is -- should deliver proof of concept for the pre|CISION platform in human. And of course, that can be more broadly applied to a wide range of chemotherapies. And again, Neil will talk a little bit about that in a moment. And then the second area, which is obviously of huge importance and very great interest to everyone at the moment, is the rapid antigen test, a saliva-based SARS-CoV-2 spike protein test. We are -- and we'll talk through this more. We're aiming for clinical validation in the fourth quarter of this year. I'll talk to you about how we can more precisely nail that down in terms of timing. I'll talk to you about the product strategy in a little bit more detail than we've done in the past around professional use and consumer self-testing. And I'll say a little bit about the additional opportunities that the Affimers we've raised against SARS-CoV-2 spike protein have generated. Then the third bucket as it were is around the core business. The continued progress of the Diagnostic business towards licensing deals for non-COVID applications, which is absolutely key to the progress of that business towards validation of the Affimer platform in this sector and profitability, notwithstanding, obviously, the huge COVID-19 opportunity that there is. And of course, in therapeutics, where we continue to carry out the business development to deliver further substantial licensing deals for the group. Okay. So let me ask Neil, if he would take us through the next few slides around AVA6000, the first of these pre|CISION pro-drug chemotherapies and they're taking that into the clinic. Thanks, Neil.

Great. Thanks, Alastair. So I'm going to talk about the AVA6000 early clinical development. And I think it's important and Alastair has already indicated this that AVA6000 will be Avacta's first entry into the clinic. It will be a first-in-man study, and it will take Avacta through a really important milestone to become a clinical-stage company. So this morning, I've got a few slides to cover 4 key areas. The first is what is the pre|CISION platform and how does it work. The second is what is pro-doxorubicin also known as AVA6000. The third is the overview of the time line and design of the AVA6000 clinical study. And finally, the potential for the pre|CISION platform to be used across other chemotherapeutic agents. So if we go into Slide 15 -- sorry, that was Slide 15, yes. Okay. So fibroblast activation protein-alpha, also known as FAP, is an enzyme known to be highly expressed in most solid tumors compared to normal healthy tissues. So the pre|CISION platform is based on using the overexpression of FAP-alpha to cleave or to break a link substrate, which is attached to the drug and thereby, switch the drug into its activated form, and that's why we call this a pro-drug. So the graph at the top right-hand of the slide highlights the high level of expression of FAP across different tumor types compared to the matching serum. And what this actually means is that the FAP expression is actually localized in the macro environment of the tumor itself in the stroma. So pre|CISION is a simple peptide substrate, which is chemically linked to a drug of choice. And in our case for AVA6000 is doxorubicin. The linked drug is actually prevented or limited from entering cells and it, therefore, renders the chemotherapy agent inactive once it's infused into the body prior to reaching the tumor microenvironment, where it's activated by high levels of FAP, cleaving the linker to the cytotoxic. And as we know, the substrate is exclusively licensed from Tufts University in the U.S. So going on to Slide 16. So while doxorubicin is an effective antitumor agent, it does cause what we call cumulative and dose-dependent cardio-toxicity. So it ranges from hidden changes in the heart structure and function to severe cardiomyopathy and congestive heart failure. And these are 2 serious pathologies, and they may result in even a heart transplant or death. So despite doxorubicin being considered an important standard of care treatment for many cancers, which it is, its use in patients is limited by its cumulative toxicity. And what that means is that physicians are limited by the additive dose of doxorubicin by the total dose that they can give to patients. Normally, they're limited up to 400 mg per meter squared. So what we have with AVA6000 is we have the potential to address these key cardiac safety concerns for doxorubicin by limiting doxorubicin getting into cardiac cells, to cardiomyocytes as they're called, and actually damaging the heart. So we know that data from mouse models has demonstrated that AVA6000 compared to doxorubicin, a significant increase in penetration in the tumor tissue compared to the cardiac tissue. And this means potentially that higher doses of AVA6000 can be tolerated systemically in the body without risking cardiac toxicity. So this is an important market opportunity for AVA6000 and is significant across a number of tumor types, including soft tissue sarcoma, breast and ovarian. So in terms of our planned Phase I clinical study, these are the time lines that we're looking at, at the moment. We're aiming to file a clinical trial application to the MHRA by the end of fourth quarter 2020. And our team are actively putting all the relevant documentation together to actually compile the CTA now. So our anticipated dosing of first patient in the current planned study is by first quarter of 2021, followed by initial safety and pharmacokinetic data from our first dose, first cohort, expected around about mid-2021. So the Phase I clinical study has been designed in 2 parts, Part A and Part B. Part A is the dose escalation stage, where the main objective of the study is to assess safety and tolerability of AVA6000. And the next objective is to determine the maximum tolerated dose that the patient can tolerate and that might well be the recommended dose or maybe a dose below. So we anticipate Part A will recruit approximately 15 to 20 patients through approximately 4 dose levels, depending on dose-limiting toxicities that we'll see in the study. Patients will be recruited across a range of cancers, but they'll include soft tissue sarcoma, breast and ovarian, as we said earlier. Once we've decided on the recommended dose to move into Part B, part B is the dose expansion stage, where the main objective of the study, again, is to assess the safety and tolerability of AVA6000, but in a larger cohort of patients in possibly 1 tumor or maybe 2 tumor types depending on the data that we see from Part A. Now I think it's important to say that, unfortunately, we'll be starting the study in hospitals in the U.K., where at the time of COVID-19 pandemic and where many clinical trials, particularly oncology trials, have been severely affected in the lockdown. We'll monitor the situation and we'll take mitigation actions where necessary to actively move AVA6000 into patient recruitment, and we are looking at the planning of an IND as well in the U.S. So in terms of a little more detail around the Part A, we actually are going to follow a classical 3-plus-3 design for Part A. Three patients will be dosed. And if no dose-limiting toxicities are observed, we'll then escalate to the next dose until we reach the maximum tolerated dose. If we do see any dose-limiting toxicities, then we'll need to expand that particular cohort by adding further patients. So we are aiming to dose patients up to 6 cycles of AVA6000 every 3 weeks, which should take normally 18 weeks. So what's the wider pre|CISION pro-drug opportunity? Well, the wider opportunity and the rationale for pre|CISION platform, I think, is compelling. Many chemotherapies have dose-limiting toxicities, which restrict their use in patients. Yet despite these toxicities, these chemotherapies retain significant market share and continue to increase their share annually due to better cancer detection rates. As an example, Takeda's Velcade is a protease inhibitor and its antitumor potential has never really fulfilled -- been fulfilled in the market due to dose-limiting toxicities and is only a market -- only has market approval for multiple myeloma and mantle cell lymphoma. If we look at another example, taxanes such as paclitaxel also has significant sales potential through to 2025, but its market share is constrained due to significant toxicities such as myelosuppression and peripheral neuropathy. So we can see that AVA6000 will help us to demonstrate the value and the potential of the pre|CISION platform. We're at a very exciting junction with pre|CISION, and we need to continue to drive towards the milestones that have been laid out in the development plan. So I'll stop there and hand back to Alastair.

That's great. Thank you, Neil. Okay. So pushing on because I'm very sort of aware of time and wanting to make sure that we have time for plenty of questions. So the first thing I wanted to do was talk to you about the performance of the Affimer reagents that Avacta has developed against the SARS-CoV-2 virus spike protein. So these are Affimers that are in the lateral flow antigen test and in the Adeptrix test and potentially can be licensed to other third parties for their tests as well. So the point that I want to get across is that we now have a fully validated, what's called an ELISA test, which is a laboratory test. We will be launching this as a research laboratory test as soon as possible. But the point I wanted to get across is the performance of the Affimers is really excellent. This is, as far as I can find certainly on the Internet, the best-performing ELISA test that we can see, both in terms of sensitivity in simple systems like buffer, which is effectively just water as well as in saliva. We've not been able to see any saliva performance data for the ELISA test on the Internet, but also in terms of specificity. So very briefly, because I appreciate that not everyone has a technical background, but let me try and put this in context. The sensitivity we can talk about in terms of the lower limit of quantitation, so that's a term used to describe the lowest amount of spike protein that can be properly quantitated in a sample. And that is down at a few picograms per ml. So to put that in context for you, that is very good for any ELISA. It's certainly much better than other SARS-CoV-2 spike ELISAs on the market. And I'll give you one there just for reference. You can go to the website. You can see the performance of that test and make the comparison yourself. But also to put that in context, that level of detection, that level of quantitation is right down at the lowest levels of viral infection. And the work we did with Liverpool School of Tropical Medicine to confirm that shows that this ELISA test will detect down to just a few thousand copies of the virus per ml of saliva. And you see there the saliva performance in the graph in the table as well. So from a sensitivity perspective, this gives us huge confidence in terms of the performance of the lateral flow test and the Adeptrix test that -- and the others, the Affimer reagents work really well. Specificity is absolutely key as we'll see in a moment, and you see there without going into a lot of the detail, no cross-reactivity against common coronaviruses and less common ones like SARS-CoV-1, which is just not around too much anymore. So no cross-reactivity, very good specificity as well. So that's the performance of the basic Affimer reagents. Let me touch on now the BAMS assay. So this is a mass spectrometer assay, and I've done a very simplified cartoon of how this works. So the sample -- introduced into the sample are beads coated with the Affimer. So those will capture the spike protein and virus from the sample and then you can use a magnet, obviously, to hold those whilst you wash off all the other stuff that will be in that sample. And then those beads can be introduced into the mass spectrometer in a very simple way. And one of the beauties of the way in which Adeptrix has developed this test is that there's a very simple yes-no answer that can be generated from what is quite a complex mass charge spectrum you'll see in a second on the next slide. So that's fundamentally how the test works. And in this way, each machine can do 1,000 samples or upwards of 1,000 samples per day. And of course, the installed base of these machines is quite considerable across the U.K. and elsewhere in clinical microbiology labs and hospitals. So that's the opportunity for us to deliver. And we haven't been able to show much data so far, primarily because of commercial confidentiality with Adeptrix, but -- and I obviously don't plan to talk through this mass spectrum. But for those of you who've never seen these things before, that gives you an idea of, let's call it, the fingerprint that this test delivers. There's 2 points to make. So first of all, this is the mass spectrum from one bead, a single bead. So in terms of sensitivity of this test, it's excellent. And then in terms of specificity, you are combining the Affimer reagent specificity to the SARS-CoV-2 spike protein with this fingerprint that is literally a fingerprint of the protein. So you get exquisite sensitivity. And just an extra bit of detail, this spectrum gives you information about things like mutations of the viruses as well potentially. So not only a diagnostic, but a really important tool. So what we are all, literally all of us, are trying to get to is the clinical validation data. And without going into a lot of detail, it has been a frustrating process, getting through the U.K. health system's CONDOR system to get that clinical data. We are making progress, but it's been slow. However, what is a real positive is the level of commercial interest we've now got for this test. And it's clearly critical that we have a significant partner who is most likely a mass spectrometer manufacturer, who can take these BAMS assays to market, both the research use and as an IVD, and get those into the installed base at scale to generate the commercial opportunity for us. And I'm very pleased to say we've made solid progress in securing that commercial partnership, which I hope over the next weeks and months, we'll be able to talk about publicly. Okay. So that's a quick update on the BAMS assay. We are getting on with the clinical evaluation now, but it's still slow. So as soon as I have some clinical data to talk about, I will do, but we're obviously relying on third parties for that. So then getting on to the lateral flow antigen test. I've shown this slide before, so I won't dwell on it for too long, but it's the -- for those of you who don't -- haven't seen this slide, it's really understanding the difference between an antigen test, which tells you whether you have the infection currently, or an antibody test, which really tells you -- and we'll see on the next slide the detail, but really tells you whether you've had the infection in the past or not. Two different functions, two different uses. But what we're really focused on and what's sort of the U.K. and worldwide governments are focused on is identifying infectious individuals. And this next slide really gives you a bit more insight into that. So this is a figure taken from Nature. And what it shows you is the sort of relative utilities of PCR, antigen testing and antibody testing. And you can see that the PCR and antigen testing have the best likelihood of getting an accurate result early on in the infection, when there's a large amount of material to detect. And it takes probably 7 to 10 days post-symptom onset for the antibodies to be generated. So the benefit of antigen testing compared with PCR is that you don't get that long residual positive results, long after the patient has recovered. And antigen testing is most effective in that period of couple of days, 2 to 3 days before symptom onset and up to a sort of week or so after symptom onset, when the patient is -- has the highest viral load and is most infectious. I'm going to touch on that again on this slide because it is so important for the intended use of these tests. So again, I'll put some references here, which if you have time, you can go and have a look at a little bit more around the detail. But the presence of the virus, the infectious material, is highest in the first couple of days, sort of 5 days or so after you get infected, the first couple of days before symptoms are seen. And then the next sort of 7 to 10 days after symptoms appear. So there's a window there which is when the antigen tests work particularly well. And of course, it's that period when individuals are infectious. So there's a very short period when you get infected, but are not necessarily infectious because there's not enough viral load. There's not a virus in your upper respiratory tract to be shedding it everywhere and infecting other people. And so the purpose of these tests is to identify those people who are infectious, not necessarily all people who are infected. And just an interesting point to note that the -- that presymptomatic period of 2 or 3 days before symptoms appear is thought to account for around 50% of the infection. So that is why this is so important to be able to identify infectious people who are presymptomatic. And sometimes, those people are referred to as asymptomatic incorrectly actually. The number of people who are truly asymptomatic throughout the infection is it's actually difficult to determine because obviously, they are asymptomatic, and there's a lot less data around that. But certainly, presymptomatic transition is a major issue that antigen tests can address. Okay. So then again, just making the final point on -- and I've been asked a lot -- I mean, a huge amount about sensitivity and what are you aiming for. And I want to just sort of dig into the detail just a little bit for 2 minutes. So what you see with the graph here is -- I mean, it's just a made up distribution of patients with different degrees of infectivity, different degrees of viral loads. So on the left, those people who have very high viral load and that may go from just a few virus particles per ml up to maybe 10^9, 1 billion virus particles per ml of saliva. So there's a very broad range. And you are infectious probably from around 1,000 or a few thousand viral particles per ml and upwards. So that's that group on the left there that I've shown that the red line shows the difference between not being infectious and being infectious, and every one to the left of that black line is infectious and it's absolutely essential to be able to identify those people quickly. So the purpose is frequent testing, frequent testing with a very specific test. You need a very specific test because otherwise, you're going to create a large number of false positives, and that will overload the already stretched testing, centralized testing. But this is exactly what the governments around the world are now trying to achieve, frequent testing on a weekly or even more often, a weekly basis. And the sensitivity within that group has to be very good. You need to be able to identify all of those infectious people. Unfortunately, they're the ones with the highest viral load, so that is more straightforward. If you were then to look at the sensitivity across the entire group, clearly, it would be lower. But that's the subtlety and the way in which different companies present these results. And obviously, we will be very clear how we do the clinical validation and exactly what we're measuring and how we express that in terms of sensitivity. But that's the question of infectious versus infected individuals. And the use cases, therefore, look somewhat like this. So the product strategy is to CE mark for professional use first, because that is quicker and more straightforward sales certification process, as many of you know. The process to achieve consumer self-testing is a little bit more involved and involves what's called a notified body that has to audit your technical files, so that takes a little bit longer. The professional use case -- I mean just to take hospitals from it, immediately, that suggests hospitals and GP surgery. Actually, I think the hospital use of lateral flow test is not likely to be that high because the PCR is on site. It's relatively rapidly accessed. It's far more likely to be professional use around workplace testing, and that involves having a trained technician or health care worker on-site, which many companies are planning to do to be able to do this sort of testing in the workplace. With the professional use-only test, testing stations, GP surgeries, potentially as well, triaging individuals to reduce the burden on the current testing capacity, centralized testing capacity. And then the use case for consumer self-testing is obvious, of course. It's individuals at home as well as individuals in the workplace. But predominantly, it will be testing at home. And then we've talked quite a little bit about the product profile, saliva, because of the ease of use compared to NP swabs, visual readout is very important, and we are confident of being able to deliver a visual readout test, which means it doesn't need a specialist reader, which, of course, if it did, would limit the deployment of the test. So visual readout is very important. And another area that we've been doing a lot of work on is with our partners is around a smartphone app to read the results, which provides objectivity, which is very important because, of course, this test will limit or prevent certain activities. So objectivity is very important, plus the data connectivity into the health care system data systems and ultimately provide a record of positive or negative results. So all of this is going on at the moment, somewhat behind the scenes, but we can update on that as we progress. Okay. So let's just talk through what we -- I mean we've learned a -- we, Avacta, have learned a huge amount about the market and the demand and the use cases that we've talked about. And what I can tell you is that within the U.K. alone, in order to have effective disease control, i.e., get this R value well below 1, you need frequent testing with these types of tests. You need to be able to catch the infectious people ideally as soon as they're infectious. So let's say, weekly testing -- and ideally, it would be more often, but let's say, weekly testing. So that even if you tested half the population weekly, that implies 120 million tests per month. And that's U.K. only. So that does not obviously include any U.S. opportunity or elsewhere. So clearly, the commercial opportunity for Avacta is determined right now by supply capacity and not by demand. There is lots of room in the market. And again, people ask me very often about other tests that are coming through. There will be other tests. There is more than enough room for many tests, many antigen tests across not just the U.K. but the rest of the world. So that competition, if you like, doesn't bother me in the least. The demand is really significant as we're now very clear about. So the supply capacity is what we need to worry about, and we have been for the last 6 weeks or so, really working very intensively on this. So there are several factors: raw material, so the nitrocellulose strip made by Cytiva and the Affimer reagents, we'll talk about that in a moment; the lateral flow strip manufacture and assembly into cassettes; the plastic ware, so the saliva collection plastic and the -- what's called the transfer pipette to move the sample on to the lateral flow test; and then assembling the full kit, so that's putting all of these elements in a box with the instructions for use and so on and shipping those. So I'll talk about that in a moment. The other area in which we have been working to add capacity and increase the commercial opportunity for Avacta is looking at OEM deals. So this is providing the Affimer reagents to third parties who may develop other types of testing modality. And obviously, that doesn't impinge at all upon our own capacity, but it's a good way to expand that opportunity. And we have several ongoing conversations with potential OEM partners to add to that commercial opportunity for Avacta. Okay. So let's look at those individual elements that determine capacity. So first of all, we are putting in place, and in fact, we would have finished putting in place by November, the increased production facilities within Avacta. So we will be able to manufacture at reasonable scale ourselves in-house and have control over that, but we're also putting in place very large-scale contract manufacturing partners. And we will -- I'm pretty sure it will be a U.K.-based manufacturing partner that will allow us to scale that up to very large volumes, which if we get to that 120 million per month or even higher numbers by accessing other markets around the world that will require some third-party contract manufacturing. So the Affimer supply, we do not believe, is going to be a bottleneck, a limiting factor and nor will the nitrocellulose strip. So we've partnered with BBI Solutions and Abingdon Health, to date, as you know, and they can manufacture several millions of lateral flow test strips per month. So clearly, there is a significant upscaling that needs to be done within the U.K. to be able to meet the demand. And that, I'm sure, we certainly are supporting our partners to do that at scale. But I think what it speaks to is the requirement to put in some capacity overseas as well to be able to meet that demand. I mean we will put through all the manufacturing we possibly can in the U.K., but we are very actively in discussion with manufacturers overseas, mainly Asia, Southeast Asia, to be able to put in place increased capacity. And that, of course, just means doing the job properly and making sure that we do our due diligence properly and getting quality product manufactured. The kit assembly, whilst you might sort of think that's straightforward, it is a reasonable challenge out of these sorts of volumes. If you do a quick calculation of how many kits per second, 120 million a month represents, it's a significant number. So we've already identified U.K. partners. And again, we'll be putting in place further resource overseas to be able to not only meet the demand but hopefully look at other markets around the world in addition to the U.K. So we now have detailed discussions ongoing on with governments and regulatory authorities, health care providers and so on. But those are strictly confidential at this stage, and I can't talk in any more detail about those. Okay. So as I'm sure you all know, we are in the process of technology transfer, Cytiva and BBI. So our partners are working together to carry out that technology transfer. And what that involves is the development of the scaled up process to produce the test strips that will perform adequately for the -- what we know as the clinical performance targets. And just to be clear, that is not a simple tick box exercise. That is a process, a development process, which takes some time. And as soon as we have good visibility on that pilot batch of around 10,000 units, which we intend to use for the clinical validation, as soon as we have visibility on that, I will be able to give you all a much clearer and a much more precise timing of the clinical validation, CE marking and product launch. I think it's important to stress that this process of manufacturing scale of the tech transfer, it is absolutely essential that we do that properly. Rushing that simply pushes risk down the line to the clinical validation. I'm not prepared to do that. So we are working with really excellent partners to get that process nailed so that we have a scaled up process that is robust and reliable and that takes out a huge amount of technical risk from the process. So then the clinical validation and lay user studies, which is the study required for the additional study for the consumer self-test CE marking, those are being designed with Liverpool School of Tropical Medicine. That's a relatively straightforward process. We get patient sample access through LSTM and also through the CONDOR system. And we will complete the verification of validation and that will allow us to self-certify for professional users we talked about. We'll run the lay user study in parallel as much as we possibly can with that process and then go into the audit by the notified body of the technical file, and we're looking at how we can streamline this process but keep it robust so that we end up with a product that is competitive globally at identifying infectious people in the society. So as I said, just to summarize that slide, the manufacturing scale-up process is a development phase. We are going to do it properly, and we are going to take risk out at this stage rather than pushing it down the line. And when we have completed that and got the pilot batch, which won't be too long, then we will obviously be able to give a much more precise picture of the path through to product launch, which is what we all want to see. Okay. So just to summarize and give ourselves some time for questions. I'll hit the main bullet points here rather than go through them all. So on the therapeutic side of the business, the effect of COVID actually on both sides of the business has been really on the laboratory operations because, of course, we've had to maintain social distancing within the laboratories. And that has meant we've effectively been working at half staff to get that sort of half staffing levels to get that social distancing. We are putting more space in place, both in Cambridge and in Wetherby, because we see this issue lasting for a considerable length of time from now. So we've actually taken on more space, so we can get everyone back into the laboratories. We're fitting those out now to be able to get that back up to full capacity, as I expect this issue of social distancing to remain for some considerable amount of time through next year and potentially even into '22. So the progress on the therapeutic side has been very good. We focused on partner programs to ensure that those kept moving forward. So I would like to say that it's a good opportunity to thank the teams publicly for the really positive attitude and commitment that they've shown, despite the challenges of traveling and the risk that, that has presented. The attitude and the commitment of both teams in Cambridge and Wetherby has been outstanding to keep -- not only keep progress going but to grow the company and to create these opportunities under these sorts of pressures. And on the diagnostics side, good progress in getting this COVID-19 lateral flow test to market. We talked about the next key milestone is the pilot batch, and then I'll really be able to set out the launch date with more certainty. But also remembering that there are multiple additional COVID testing opportunities, not least through the mass spec test with Adeptrix but also a lot of other potential partnering opportunities for those SARS-CoV-2 spike Affimers. So then finally, obviously, during the summer, we raised a significant amount of capital, and that puts us in a very strong balance sheet position to be able to deliver on the opportunities we've talked about, drive multiple programs into the clinic and add huge value there in support of core businesses. So I'll leave it there and give ourselves some opportunity for some questions out of what's been a very, very large number of questions.

[Operator Instructions] For investors on the call, particularly for those that came in perhaps or registering on the platform slightly after the event had started, that a recording of this presentation, along with a copy of the slides and the published Q&A will be available via your Investor Meet Company dashboard. I'd also like to remind you that your feedback is important to the company. Immediately after the presentation has ended, you'll be redirected for the opportunity to provide feedback in order that the company can better understand your views and expectations. Alastair, thank you very much for dropping on the chat. I got the selection of the questions from investors that have come in today and obviously a selection of those that were pre-submitted. And I think just given the number of questions that have come in on the platform, along with a number of investors on the call today, that for any question that doesn't get answered, the company will be reviewing all the questions submitted today, and we will, as I said, publish responses where that is appropriate to do so. So the first question, Alastair, I think you selected this. Could you please give an explanation of Cytiva's role in the manufacture of the rapid antigen test? It was initially indicated that they would manufacture, but this hasn't been mentioned in subsequent news regarding BBI [ stroke ] Abingdon. If so, will they manufacture for the U.S. market only?

Yes. Thank you. So that's a good question. It allows me to sort of clarify. So Cytiva are a materials company. So they manufacture the materials to make the strip. And so we probably could have been clearer on that. So they supply the nitrocellulose strip, not the finished IVD. So the manufacturers who make the finished IVD are the likes of BBI Solutions and Abingdon Health, who we've already partnered with. There's a couple more potential partners in the U.K., and as I said, many more around the world that we can access as well. So it's really a process of raw materials from Cytiva and Avacta's. So we manufacture those raw materials. We have partners then who do the strip manufacturing and then partners who do what's called the kitting, putting the kits together, and then obviously, the logistics of shipping those out.

Follow-on question. What is the maximum number of LFT antigen tests that can currently be produced per month? And what would be the maximum capacity in 6 months? Can you give a ballpark figure for the potential worldwide manufacturing capacity for Avacta's rapid antigen test?

Yes. So I touched on this in the presentation. But in the U.K., so what -- I mean, we are partnered with BBI and Abingdon to access their available capacity because, of course, they are doing other things, and we will look to partner with others in the U.K. as well to get as much of the available capacity in the U.K. as possible. I suspect, without giving away anything that's commercially sensitive, I suspect that is 5 million to 10 million tests per month as we sit here today. So that can be scaled. And that depends on investment by partners and others to support that expansion, which clearly is in everybody's interest. And it's difficult to put a precise number on that, but I do believe that, that could be many tens of millions of tests per month. We've talked about requiring in the U.K. alone, even just for weekly testing of half the population, 120 million tests per month. So that, I think, does still indicate some capacity overseas. The total capacity overseas is difficult to sort of know with certainty. We've done a lot of work in Asia Pacific to understand what the opportunities are there. And then there is, without doubt, in my mind, the capacity to meet those hundreds of millions of tests per month, although as I said, doing the due diligence on any third-party overseas manufacturer has to be done properly. Otherwise, it's a whole world of pain that you have to deal with later.

And what you see as the potential for the 2 therapeutic platforms and their combination?

Sorry, I didn't catch that. But I think -- can you say that again?

Yes, of course. Can you talk about what you see as the potential for the 2 therapeutic platforms and their combination?

Yes, it's a great question. So these 2 platforms, pre|CISION and Affimer, actually are really interesting in their own right. But in combination, they're very interesting as well. So the pre|CISION, as I've already said, the wider opportunity and the rationale for the pre|CISION platform, as I indicated, is actually very compelling. Conventional chemotherapy is designed to eliminate that fast-growing tumor cell. But obviously, it's also harmful to normal tissues as well. So the pre|CISION platform will actually help create a much more targeted therapy. Then you look at the Affimer platform, and this actually brings really interesting alternative to antibodies because it's derived from a small human protein. It's approximately 10x smaller than antibodies. So that offers potentially significant advantages in terms of tissue penetration into solid tumors. And there's a huge amount of work going on at the moment to actually develop drugs that will get into the tumor microenvironment and be more specific. In addition, the Affimer proteins can be actually genetically fused together to form what we call multi-specific. And at the moment, there's a huge amount of interest and development activity in actually developing bi-specific monoclonal antibodies. And so again, the Affimer approach with its small size, it can actually -- we can design approaches like checkpoint inhibitors. So these are pathways that are set up to actually -- for the tumor to defend itself because the tumors are very clever when they actually are growing in the body, and they start to actually work out ways to defend themselves. So when you combine these 2 platforms, combining Affimers with the chemotherapy agents and using a linker that is designed only to release that chemotherapy agent into the tumor microenvironment, then this actually enables an extremely potent chemotherapy to be combined with an Affimer immune checkpoint therapy. So I think there's a lot of work going on at the moment with antibody drug conjugates. It's a very exciting area, and I think these 2 platforms being combined actually helps us to get into that area very seriously.