Hello everyone, and welcome to the ANGLE plc FDA approval call. My name is Melissa and I'll be your operator today. If you would like to ask a question, you can do so by pressing star followed by one on your telephone keypad. I now have the pleasure of handing over to CEO Andrew Newland and CFO Ian Griffiths to begin.
Well, good afternoon, everybody. It's good morning where we are because we're in the United States at the moment. We are absolutely delighted to be joining you to give the fabulous news that we've secured the FDA product clearance that we've been working towards for over six years now of sustained work. The aim here is that we're going to give an initial update. I'm gonna speak for a couple of minutes, or maybe 10, 15 minutes. Then we've got a series of the company's industry analysts on the call, and they will ask questions live. We don't know which questions are coming, so we'll do our best to answer those, as frankly and clearly as we possibly can.
As I said, this has been over six and a half years of sustained work for ANGLE to have achieved a world first, which is a breakthrough FDA clearance for our Parsortix system. We've been granted the first ever FDA product clearance to harvest cancer cells from blood for subsequent analysis, as our Parsortix system has been cleared by the FDA for use in the intended use in metastatic breast cancer. FDA, of course, is the United States Food and Drug Administration, and they're responsible for approving new medical devices for use in the United States. They are also seen as the global gold standard for medical device approval.
Indeed, we had designed all of our studies and necessary work in order that we can also achieve a CE mark. We have submitted and we also have a CE mark. Now this clearance means that the Parsortix system can be sold to United States hospitals and clinics for its intended use in metastatic breast cancer, and it can similarly be sold in Europe for the same intended use. We believe that the Parsortix system now has the potential to become the de facto standard, enabling the entire industry to move forward with non-invasive repeat testing of cancer patients to tailor treatments, improving patient outcomes, and at the same time reducing healthcare costs. It's a big moment for ANGLE. Not just for ANGLE, it's a big moment for the entire medical industry and most importantly of all, for every cancer patient.
Our system is now FDA cleared for harvesting intact cancer cells for analysis. Other liquid biopsy companies, and it is a very important area, there are many other big companies, but these companies are limited to working with circulating tumor DNA, which is fragments of dead cells. We are the first company in the world ever to have achieved an FDA product clearance for harvesting intact cancer cells for analysis. We believe this is heralds the start of a completely new era in personalized cancer care. For the first time, it allows the opportunity for patients to have repeat non-invasive biopsies to assess the status of their cancer and how best to treat it. The reason that is incredibly important is cancer is a very diverse disease.
Every patient's cancer is different from every other patient's cancer, and hence they respond differently to different therapies. Furthermore, the cancer changes over time, and this is the critical point. The cancer changes and the legacy information which comes from the initial tissue biopsy on original diagnosis, that becomes out of date, and hence doctors are literally flying blind in treatment of patients later on because they cannot repeat the original tissue biopsy, because the tissue's been cut out and it's, there's nowhere to go and secure the tissue. It's incredibly important because most drugs only work for approximately 20% of patients. 80% of the time patients are given toxic drugs which do not actually benefit them. Furthermore, not only that, it wastes a lot of healthcare expenditure.
Indeed the importance of assessing the patient's current status of their cancer is so important that the National Cancer Guidelines in the United States recommend a tissue biopsy of the secondary site in breast cancer. What that means, if the breast cancer primary has spread, and then the patient now has a metastatic secondary cancer, this cancer, by the way, in breast cancer could be in the bones or the brain or the liver or the lungs as common sites. The National Cancer Guidelines recommend a tissue biopsy of those secondary sites because of the crucial need to get medical information on the current status of that patient's cancer. The problem is, that's very invasive, involves surgical procedures to cut out part of the liver or part of the patient's lungs.
If it's the brain, then obviously they can't access it at all. Unfortunately, many patients by this time are too sick to withstand such an invasive procedure. Remember, we're talking about patients who are quite ill. 50% of patients do not receive any biopsy at all of their secondary sites in accordance with the National Cancer Guidelines. This FDA clearance, which is clearing Parsortix system for harvesting circulating tumor cells from the blood of metastatic breast cancer patients, opens up for the first time the opportunity of those patients who can't have that secondary cancer biopsy to have a blood test instead. From that blood, our system has been shown to reliably recover cancer cells which are involved in the spreading of the disease in the patient's blood circulation.
All the patient has to have is a simple blood draw, normal peripheral blood draw. That can give the doctors access to up-to-date information on what the cancer is doing, how it's evading the immune system, how it's growing, et cetera. This knowledge is crucial in ensuring that patients can be offered drugs and other therapy decisions which are likely to benefit them. Incidentally, this process is also saving money because the average cost of a metastatic tissue biopsy is $16,000, and that assumes there are no serious side effects and adverse events, which quite often there are. At $16,000, it's actually a lot cheaper to use a blood test approach with the Parsortix system.
The other point is that virtually zero patients have more than one tissue biopsy of metastatic site, despite the fact it being known that the different metastatic sites can be different and that the status of the cancer continues to change throughout the whole course of the disease. Now the patient can have repeat biopsies based on a blood draw as often as the doctors think it is appropriate. This can save an enormous amount of money on the prescription of drugs. Many drugs cost in the hundreds of thousands of dollars per patient, and yet they don't work for the patient in 80% of the cases. In those cases, that money is completely lost to the healthcare system, and the patient will experience various toxicity and side effects from the drug, but have no benefit whatsoever.
Indeed, they will have a further disbenefit in that any drugs that could have worked for them will be delayed in their administration. This approach, this new approach that the Parsortix system is heralding, in cancer treatment is good for patients, and it reduces costs. The FDA clearance is a gold standard regulatory clearance, and it gives ANGLE a massive head start in a huge emerging market. It's a stamp of approval on the Parsortix system and a clear demonstration that it does what it says on the tin. Now that we have a platform FDA-cleared for metastatic breast cancer, other cancer types and specific clinical applications can be added for numerous different uses of the cells.
This gives ANGLE the platform to work with a wide range of large companies to develop a wide range of clinical uses of the technology for specific uses. Intact living cancer cells recovered by the Parsortix system are, quite simply, the best sample for analysis of the patient's cancer. Large medtech companies can now work with us to extend their existing tissue-based tests, to do repeat testing on blood samples. They can extend their markets by marrying their existing technologies and tests with the Parsortix system to secure the cancer cells for analysis. Large pharmaceutical companies can work with ANGLE to develop companion diagnostics to support the identification of patients likely to respond to their drugs .
Our clearance is absolutely critical in that regard because now that we have a cleared platform, it is massively easier to add specific clinical applications to that cleared platform. No other competitor has this capability, and if they wanted to secure it, they would have to go through a similar rigorous approach to that ANGLE has undertaken. It would take them many years and millions of dollars. We took over six years, and we had to develop 400 technical documents and reports, and we processed 16,000 samples in order to meet the FDA's requirements. We now have a clear first-mover advantage in a multi-billion-dollar market that is increasing in size very, very fast.
To conclude, I would like to express my gratitude on behalf of ANGLE to over 300 metastatic breast cancer patients and several thousand healthy volunteer donors who all donated blood to us to allow us to achieve this major breakthrough in the adoption of liquid biopsy as a potential new standard in the care of cancer patients. We would also like to thank our investors and shareholders for providing the considerable financial support and patience that has allowed us to undertake such a substantial exercise. We've now got the opportunity to build out a substantial business as the leading company in the field for harvesting intact cancer cells for analysis. By making the Parsortix system widely available, we intend to support the entire industry in its adoption of liquid biopsy solutions for repeat non-invasive diagnostics for true personalized cancer care.
Large pharmaceutical and med tech companies now do have an FDA-cleared platform on which to develop new medical solutions. As well as growing our existing pharma services business, we expect to work with other large companies to develop specific uses of Parsortix in terms of cancer detection in high-risk groups, drug selection by identifying which drugs will be effective at different times, and monitoring patients for residual disease, and advanced warning of potential relapse. I would also like to thank the whole senior team at ANGLE, the staff, now and actually a number of our retired staff, for tremendous efforts in achieving this fabulous outcome. We are delighted that many years of hard work have paid off, and we're excited about ushering in a new era of improved cancer care for cancer patients. It is a world first, and it is a British technology company that is leading the way.
Thank you very much. We're pleased to take questions, and as I mentioned, Ian Griffiths will join me with the questions.
Thank you. If you would like to ask a question, please ensure that you are dialed in on the phone line and press star followed by one on your telephone keypad. If you do change your mind or feel that your question has already been answered, you can press star followed by two to withdraw your question. Please note that only questions from analysts will be accepted. That is star followed by one to register a question. We have our first question from Lucy Codrington of Jefferies. Lucy, over to you.
Hi there. Thanks for taking my questions. Just, you mentioned about the kind of indirect effect of this in terms of driving, business through your pharma services, offering and also potential collaborations with medtech and pharma companies. Can you remind us how you can directly monetize this clearance? Is that primarily through sales to hospitals and specialist cancer centers? Do they then need to develop their own assays to use with the harvested cells? Secondly, what learnings have you taken from this process, to influence your subsequent 510(k)s? Finally, what could be the potential cadence for subsequent 510(k)s, by the FDA as opposed to the LDT route? Thank you.
Well, thank you very much, Lucy, for an excellent question with a number of different parts to it. We're very pleased that the pharma services business that we set up last year, so it's just about a year old, has started to gain some significant traction already, and we expect to see this new FDA clearance to actually catalyze and turbocharge that activity. We've already secured five independent customers for that business. What they like about it is the ability to do multiple blood draws on a patient, so they can longitudinally monitor the patients during trials. They can assess the patient's status prior to having the drug, then assess it while they're having the drug, and then assess it multiple time points afterwards, looking to see whether any response is sustained.
That's something they cannot do with tissue biopsy because you can't repeat it. Most of these customers are specifically interested in looking at target proteins, and you cannot do that with ctDNA. That is a business area that's already established in ANGLE. We've got two clinical labs, one in the U.S. and one in the U.K., delivering that. It takes quite a significant amount of time to onboard a new customer. Once you've got them, they can sign up repeat business very easily. That is beginning to come through. The pharma companies who might be considering working with ANGLE will be very much reassured by the credibility of the FDA product clearance.
Secondly, those that in the longer term might wish to get involved in companion diagnostics now have a clear platform on which to add an application. It's very challenging to get an FDA clearance for a companion diagnostic while simultaneously getting a drug clearance. It's much easier if the companion diagnostic platform is cleared in its own right, and then you're adding an application. That's why we see that accelerating. In terms of monetization, the primary monetization is likely, for the short term at least, to come through on that pharma services business, because it obviously takes time to get adoption in the new clinical market.
However, we are in discussions with a number of large medtech companies and, we're hopeful that some of those will be spurred on by our clearance to actually seek to move to commercial arrangements with us. Those, I would say, are the key areas of monetization. Ian.
Yeah. Just to elaborate on that a little bit more, as Andrew said, the pharma is the near term, along with the credibility that we have with the existing translational researchers. We've seen that in the past that they like to work with the FDA-cleared product. The reason it will take a little bit longer to work into the other areas, in MedTech, in particular in the metastatic breast cancer setting, is that we've got to go through a process of getting the system deployed with some of the leading cancer centers. They're gonna have to develop specific assays. We'll obviously develop our own for putting into our own labs as well, which we're in the process of getting accredited.
There are existing codes around the biomarkers that could be used, but we'll have to go through a process to get our own reimbursement code, and that just takes time. That's gonna take, you know, one to two years to get a specific reimbursement code. That's when we can start to see that part of the revenues coming through specifically on the metastatic breast cancer.
You asked about the regulatory side and specifically mentioned 510(k)s. One of the reasons that it's been very challenging to get the FDA product clearance for Parsortix is that it's seen as a de novo, and that means that nobody else has got a clearance in this space. It required us therefore to have a new medical device classification set up by FDA specifically for us. There was a lot of work involved, but you're quite right that now we have this clearance, we can do 510(k) comparative clearances for other applications against our own clearance, and that makes the thing, the whole process, very much more rapid. You also referred to LDTs.
LDTs are Laboratory Developed Tests offered by a clinically accredited laboratory. The two clinical labs that we've established are going through a process of securing accreditation, and we are seeking to offer Parsortix-based tests from our own labs as lab-developed tests in the relatively near future. I'm hopeful that by the end of the year or the beginning of next year, we'll have the first one that we can start offering. Also as a reminder, we have an ovarian cancer trial going on, which is due to report in the mid-year. There's a lot of different elements coming together. The laboratory developed tests where we offer a service from our labs is as an accelerator and demonstrator. We wish other labs to take on those tests and develop their own tests.
We're trying to prove out the market and accelerate commercialization in developing LDTs ourselves. Hopefully, that answers most of your questions there, Lucy.
Thank you.
Thank you, Lucy. Our next question today comes from Mike Mitchell with Panmure Gordon. Mike, the floor is yours.
Thanks. Hi, Andrew. Hi, thanks for taking my question. I'm just looking back to the prelims presentation and also the wording in today's statement. You know, you've used the word turbocharged in terms of the sort of pathway to commercialization on account of the FDA clearance. Now, you said that because pharma companies would now see the credibility of the platform and because of the opportunity in companion diagnostics. Just looking at the first one there, I think you've got, what, five companies with contracts signed for the services offering. I'm just wondering how you see that progressing through the rest of this year and through 2023.
I'd be grateful also if you could tell me how long the sales process has been for the recent contracts and how or if you expect that to change in light of today's announcement?
Oh, that's a very good set of questions there, Mike. I'll start, and then Ian can add if he wants to. The credibility factor is important. If you imagine that you're sort of middle or senior manager in a pharma company, and you're responsible for running some cancer drug trials which are costing potentially hundreds of millions of dollars. You may have a little bit of reservation about trying a new approach which you haven't done before. First thing to note on that is that the customers that we currently have are using the Parsortix system for exploratory objectives, which means that they're not absolutely critical to the cancer trial.
What we anticipate is that in future, the customers will actually move to using them as critical objectives of the trial and feed that back into companion diagnostic areas. In terms of the sales process, there's a lot of work involved in not only gaining their sort of belief that the approach is sensible by providing a lot of data and answering questions, but also demonstrating the quality systems that we're using, the strength of our teams, the processes we're using, the reporting structures, and a whole variety of other things to gain their confidence that they should, in fact, direct the cancer hospitals, which is quite often all over the world, to send samples to ANGLE's labs.
We've got some contracts where there's, you know, several thousand samples involved, and sometimes over many years. Understandably, there's a number of checks and balances that they want to run through before committing to that. We have already seen that a sales process which can take around nine months from initial discussions can turn into sort of nine hours for the repeat contract. Some of the customers that we've got already are billion-dollar revenue pharmas, and they have numerous other contracts they could offer us. We don't need all that many customers to have a very substantial business. We're building out our clinical labs to have capacity between $50 million and $100 million of revenues capability on an annualized basis.
They can be expanded very significantly beyond that if we chose to do so. More likely, other people's clinical labs would undertake pharma services work using our system and pay us for the product side of things rather than services. Yes, there are multiple other pharma that we're talking to, and I would expect that tomorrow morning or if not already this afternoon, our sales team will have been reaching out to them to share the information about the clearance and so forth. We view that very positively for the future.
Got it. In terms of that sort of substantial size of the business, I mean presumably that will sort of that builds over time. It's a kind of layered or cascading sort of set of revenues that you're expecting to build. It's more over the sort of medium to long term that grows.
Yes, correct. There's layers of revenue. Obviously there's the market we're currently in in terms of research use-only sales where we've been selling to the translational researchers. We expect that to increase on the back of the FDA clearance, the credibility with that. There's the Pharma Services which we started business last year. As Andrew mentioned, these are multi-year contracts. As we added more, we're building up that visibility of the pipeline. That is the nearer term. We move into the clinical use sales, where there's the two regulatory pathways. There's the lab-developed tests. As we've explained, we've got our labs that are currently going through accreditation that we set up last year. There's the IVD FDA-cleared product, which is the ultimate goal here.
Now, the lab-developed tests are critical in this because that's what, when we refer to the sort of accelerator and the demonstrator, the accelerator is this whole element where we've got to go and secure reimbursement codes and then get payer coverage. It just takes some time to put those things in place. As we open the market in that, then that allows those parts of the revenue streams to start flowing in. That takes sort of a couple of years to line all those things up and start them getting in. There is an earlier route to revenues before that, which is the private pay market, but we're assuming that is modest revenues as we build up until you know we've got those other elements in place.
Fantastic. Thank you. Just a final one from me. Realistically, if I'm thinking about time frames for a companion diagnostics approval, what sort of length of time should I be thinking about that?
Yeah. I can comment on that. I mean, in general terms, the idea about the companion diagnostic is that it is something that is entirely funded and developed by pharma. Because of the need for very, you know, specific clinical studies to prove that companion diagnostic works, that will take probably, I would say at least three years before we get the first one. However, the beauty of this is we will be paid all the way through the process. We'll be paid to do exploratory work first with the pharma, then we'll be paid to do all the clinical studies, and then we'll probably be paid milestones and licensing deals for the companion diagnostic.
Every single time they use a companion diagnostic, they'll have to pay for the Parsortix element of that. That's exactly the same thing, by the way, with the MedTech. What we want to do is deals with large-scale medtech companies who've got product already used on cancer cells and tissue biopsy, and they will pay us a series of milestones to help them develop the same thing, but running on blood. We can do extremely well during the process of getting those things cleared.
Right. Thank you.
Thank you, Mike. Before we do move on to our next question, I'd like to remind everyone, in order to register a question, please press star followed by one on your telephone keypad. Our next question comes from Franc Gregori of Trinity Delta. Franc, over to you.
Thank you. Firstly, can I say congratulations? I know it's been a hard slog, but you finally got there. Andrew, in your presentation, you mentioned that the reason it was such a hard slog was because it was a de novo, and you had to do all the groundwork yourself. When answering Lucy's question, you said future tests would be much quicker, presumably because you'd use the predicate device pathway. Can I ask, what's to stop other people with similar technologies, which are still CTCs, from using you as a predicate device and having a shortcut to approval?
Well, Franc, thank you very much for the kind comments at the beginning there, Franc. You're quite right, and we both know there's been a lot of effort to achieve this. I'm actually not concerned about the risk of other people being able to do it quicker, because if they want to do a 510(k) on our system, they will have to use a very similar methodology for capturing the cancer cells. Of course, they're challenged for that because we own the technology for Parsortix with multiple granted patents, so they can't copy it. They'd have to have an alternative approach.
If they have an alternative approach, then they, you know, will probably not be able to do a 510(k). However, if they did manage to do a 510(k), which is not inconceivable, they will still have to run all of the very detailed studies. The good thing is that soon FDA will be putting details on their website about their decision notice. Within that, there's a lot of detail about the sort of challenges that we had to meet in order to be approved. Different things about interference and reliability of the system and so on, which anybody wanting to do a 510(k) would have to more than meet all of those criteria.
Some of those things were technically so difficult that we had to invent new ways and new know-how of how to conduct the test. I'll give you a particular example. We had to do tests on lipids to show that if a patient was obese, our system still worked. That meant we had to work out how to get fats, dissolve them, and put them into healthy volunteer bloods, and then run studies to see the impact of that. Let's do the same thing with a whole variety of prescription drugs, some of which were not in a form that could be dissolved into a liquid. We had to solve the technical problem of how on earth do we turn this solid substance into a liquid that can be added to blood. All of that know-how is proprietary to ANGLE.
Even things like how can you accurately spike in cells and count out cells, there's so many challenges that we had to face, that is in-house knowledge and will never be shared with the outside world.
Very clear. Thank you, Andrew.
Thank you, Franc.
Thank you.
We don't have any further questions registered at this time, so I would like to hand back to Andrew and Ian for any closing remarks.
Thank you very much indeed. I'd like to just thank everybody who has supported our company through this process, and a special mention for our staff, and all of our loyal shareholders. Thank you very much indeed. We look forward to the future with great excitement.
Thank you. Thank you everyone for joining. This concludes the call today. You may now disconnect your line.