VolitionRx Limited (VNRX) Q3 2021 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited's Third Quarter 2021 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. [Operator Instructions] This conference call is being recorded today, November 11, 2021. I'd now like to turn the conference over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, and welcome, everyone to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the third quarter of 2021, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer; Mr. Terig Hughes, our Chief Financial Officer; and Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development, LLC. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any of these forward-looking statements made during the course of this call. I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thank you, everyone, for joining Volition's conference call today. I know I always say it, but we especially appreciate your time given how busy you all are during the earnings call season. Whilst we usually kick off with Terig and our financial report, where we have continued to keep our cash burn rate low, this quarter, given the anticipated surrounding updates on Volition Vets, we will start our presentation with Dr. Tom Butera, Chief Executive of our veterinary subsidiary. Tom, over to you.

Thanks a lot, Cameron, and thanks, everyone, for joining the call today. While it's been quite a ride since I joined the team in May, to use an American football analogy for all the sports fans out there, I believe we are on the 10-yard line with respect to executing the term sheet for our first licensing distribution deal for our Nu.Q Vet Cancer Screening Test. I'm delighted to say that we are on advanced term sheet discussions with three top global veterinary companies and anticipate signing the terms sheet with one of those parties before the end of 2021. We have been in continued extensive and wide-ranging negotiations with each of these three large multinationals on launching our test product worldwide, both via reference labs and point-of-care test, and on both an exclusive and nonexclusive basis. Large multinational organizations and, indeed, deals of this nature require extensive due diligence, but especially before launching a revolutionary test like ours. After all, this would be the first launch of a low-cost companion animal cancer screening test, so they obviously need to be sure. I'm excited to say that I believe each of these potential partners either have completed or are near completion of their extensive due diligence process of all aspects of the product. The due diligence process in all three companies has included but not been limited to our intellectual property, validating the test in their own labs, understanding learnings from our beta launch in Texas and determining the potential total addressable market and platform development. It's very apparent to me from this process to date that all three companies share our vision for the Nu.Q Vet Cancer Screening Test to be a simple, low-cost, easy-to-use test available to veterinarians and pet owners around the world. Pricing has probably been our biggest learning from the beta launch, and so it is comforting to note that all three companies shared the desire for a sub-$75 price point and possibly even as low as $50 to the pet owner. We feel at this price point, our test can very much be a mass market product, especially in the hands of these large multinational sales teams. It's even more comforting to note that all three potential counterparties identified the significant unmet need in the market for a simple screening test for cancer and have desire to build out their blood-based oncology diagnostic franchises. They have also expressed the belief that the potential total addressable market runs into the millions of tests each year, which at a $50 to $75 price point would result in very substantial revenue for everyone involved. Indeed, our potential partners have expressed a general belief that our Nu.Q Vet Cancer Screening Test could eventually be one of the most popular diagnostic tests utilized by the veterinary community in the future, certainly a great target that we feel the same enthusiasm for. So whilst it requires patience, that we are not quite there yet, I think we are close. And while we don't want to overemphasize the football analogy too much, this has truly been a great team effort with every member of the squad playing their part. So I'd like to publicly thank the entire team for all their hard work to date. Let's keep up the great momentum we have. In particular, I'd like to thank Chief Commercial Officer, Gael Forterre; and Cheyenne Kruse, our Senior Business Administrator for the fantastic focus and organizational management. From a personal perspective, I want to reassure you that finalizing one or more of these licensing distribution deals is our absolute priority at Volition Vet, and I promise that we will stay focused on our goal of getting the first term sheet signed by the end of 2021. But before I hand the call back to Cameron, I wanted to take a couple of minutes to briefly discuss some of our other fantastic work our colleagues at the Texas A&M Veterinary School Oncology Department and Volition's R&D team have been jointly working on, which includes the recent presentations at the Veterinary Cancer Society Annual Conference, which was held virtually last week. I'm so excited that the first data was published in relation to what will likely be our second Nu.Q Vet product, on track for a planned launch in 2022. We believe this additional test has significant potential to help improve the treatment and the quality of life for dogs by providing valuable additional information to inform the clinical decision-making process for both the veterinarian and pet owner. Not to get too technical here, but the data demonstrates that Nu.Q Vet may serve as a more sensitive measurement of both minimal residual disease and remission, and could be a very useful monitoring test for dogs with cancer. Given Nu.Q is a simple blood test, this could be an incredibly useful tool in the clinic and in a general practitioner veterinarian's office. Being able to use the Nu.Q test will not only screen for cancer as part of our current product, helping identify disease earlier, but also to then be able to help monitor the disease progression as an early indication that a dog is coming out of remission will meet a real unmet need in the market. Really great first data, and I know that Dr. Robles and the whole team are excited to finish this study of over 100 dogs to publish findings early in 2022 and progress the product to an expected launch in 2022. The second poster presented at the conference reports our first study using Nu.Q Capture, Volition's enrichment tool to better understand the types of circulating nucleosomes and their genome patterns in the plasma of dogs with lymphoma. It was exciting to see that, once again, the animal data shows similar findings to human studies in that canine lymphoma patients have circulating nucleosomes lacking linker DNA, that is shorter nucleosomes, that are not detected in plasma from healthy canines, and that Nu.Q Capture is capable of enriching canine cancer-associated nucleosomes in plasma of lymphoma patients. This is truly cutting-edge research and a really exciting set of findings for us, so please watch the space as we look forward to expanding our research in this area. And lastly, as I appreciate I've taken quite a bit of time today with the veterinary update, but in addition to our commercialization and R&D product development efforts, we are also continuing our education campaign for veterinarians with Dr. Sue Ettinger, aka Dr. Sue Cancer Vet, presenting on the future of cancer diagnostics at the New York Vet Show last week, and this week, will be presenting at the prestigious London Vet Show. As the world opens up, however slowly, I'm very much looking forward to hearing the continued thoughts about Nu.Q Vet from our veterinary colleagues across the globe. All findings to date point to me for a low-cost, easy-to-use blood test to be ubiquitous. And on the positive note, I'll say please stay tuned for veterinary updates. We expect that 2022 will be a very exciting year on the Nu.Q Vet side with the planned commercialization of our products. And with that, I'll pass it back to Cameron. Cam?

Thanks very much, Tom, for that comprehensive update, and thanks to all the veterinary team for their hard work this quarter. It's an exciting, fast-moving part of our business, with significant potential for not only helping man's best friend, but also in generating significant revenue for the company. I look forward to our first deal signed and the launch of our second product in the cancer treatment monitoring expected in 2022. And from one exciting part of our business to the other, Nu.Q NETs, NETosis. I'm delighted that our team is involved in such cutting-edge research with several internationally renowned institutions. As a reminder, we believe our Nu.Q NETs assays have wide applicability for monitoring diseases with a NETs component such as COVID-19, influenza, sepsis, autoimmune disease and even cancer, and potentially to risk stratify patients for treatment selection. During this quarter, our new product manager, [Remy Rebus], joined the team and is spearheading the NETosis product development and has immediately focused on defining the intended use of the product and our regulatory strategy. I am delighted to announce that we expect to register CE marks on our first Nu.Q NETs product across multiple platforms, including ELISA plate, automated beads, and a proof of concept on very high throughput platform by the summer of 2022. These are ambitious but achievable targets, given the huge amount of background work we have done on our platform. We intend to register our Nu.Q NETs product with a broad, almost C.R.P. tyle claim for the detection and evaluation of infection, tissue injury, inflammatory disorders and disease associated with NETosis. We believe that not only is this broad claim achievable, it also gives us the largest possible market opportunity. By way of example, C.R.P., C-reactive protein, is used extensively around the world with approximately 85 million tests each year. We are also in process of developing our U.S. clinical study plan, which is likely to start with a pilot study in the second half of 2022, using the CE mark product as a base. But more details of this will be announced in the coming months. Other NETosis-related activities this quarter included the publication of data at an International Congress by two collaborators from leading U.K. hospitals using the Nu.Q NETs assays in COVID-19 studies. These posters included early safe data, showing that the results for the Nu.Q NETs test on admission could predict future COVID-19 disease severity and that serial results correlated with disease progression, a fantastic result and great for the data to be reported at such a prestigious congress. We are pleased to be making progress in our more rigorous approach to present data where we can in either peer-reviewed papers or at conferences. However, it does mean a lag in time from study results to publication. By way of example, the data from these studies was finalized in February-March, however, only released at the end of July. That said, these studies resulted in strong findings, and I'm delighted to say we have further large studies completed in COVID-19 in sepsis, which are now awaiting the finalization of data analysis and publication, as well as studies in other diseases in progress with the results expected in the coming quarters. So to summarize where we are in what I think is an extremely exciting new area of our use of our proprietary Nu.Q platform. We have had excellent results to date with a range of different world-class collaborators, with more results to be published, and we are now shifting gears to focus on the regulatory registration to transform these results into a range of products worldwide starting in Europe. Given the broad use claim that we have identified to date and our expectation for further identified uses, we have already expanded the team to include a very experienced industry professional to help us with this process. We anticipate our first CE Mark NETs product in the summer of 2022 across several platforms, and to outline the full strategy for an FDA approval of NETs products in the next few months. Moving on from Nu.Q NETs to our work in human cancer. As I have said on previous calls, unfortunately, given the pandemic, some, but thankfully not all, of our studies have been affected due to the very difficult collection and enrollment environment, and we have pivoted to those areas we can still make progress during lockdowns. The brightest note in this pillar during the pandemic is Asia, where we have reached our target patient cohorts for both colorectal and lung cancer, all collected in conjunction with the National Taiwan University, a fantastic effort by the team there. We are excited to have completed preliminary analysis of the colorectal cancer study, both asymptomatic and symptomatic populations, and have submitted these findings for presentation at a conference in early 2022. We are excited to have just completed preliminary analysis of the lung cancer study and also look forward to reviewing with Professor Chen and his team ahead of publication either through a clinical paper or a conference abstract. As previously reported, collection for the U.S. EDRN study reinitiated enrollment in June of this year. The latest update is that enrollment has been slow but steady. The EDRN have diverted some efforts to drive recruitment. And as announced during the last earnings call, we anticipate study completion in the fourth quarter of 2022. Our two U.S. blood cancer studies have also been impacted to varying degrees by the pandemic due to collection and protocol issues. The smaller proof-of-concept monitoring study is ongoing, and interim analysis of a small subset is promising so far. However, due to missing samples, we are not in a position to publish data yet and so the collection continues. And we look forward to analyzing a more complete data set in 2022. Given the pandemic delays in the larger NHL study of over 1,000 subjects, we have taken the opportunity to alter the study protocol and are in the process of upgrading the platform through a high throughput platform, which will help facilitate an FDA-compliant product. Consequently, we now expect the study to initiate recruitment in the first quarter of 2022, with the study completion anticipated in 2023. Something that became more apparent during the pandemic and in particular in relation to the U.S. studies is that we have been under-resourced in the U.S. from a personnel perspective. And so now we are really shifting gears to expand our U.S. operations. The delays have been primarily due to lockdowns. However, we are using the time to greatly strengthen our U.S. team and operations to be robust enough to handle multiple FDA studies in both human cancer and NETosis, and we are outsourcing an FDA-compliant U.S. production facility for a range of products. Dr. Gaetan Michel, our Chief Operating Officer, has recently relocated to the U.S. and have started building out the team with roles expected to be filled in the quality, regulatory and manufacturing functions. He is a brilliant operator, having built the Belgian Volition team up from 10 people to about 50 and commissioning both our R&D and production facilities in Belgium. Now he has been tasked with upgrading our U.S. operations. Dr. Terry Kelly has also continued to recruit team members for our innovation hub in San Diego, many of whom are concentrating on our next pillar to discuss Nu.Q Capture. As I've said on previous calls, we believe the Nu.Q Capture technology will be transformational as a DNA enrichment technology, which could potentially aid diagnosis, treatment selection and both treatment and disease monitoring and used in combination with either sequencing and/or our Nu.Q assays. We have made great progress this quarter in the Nu.Q Capture program, having now identified multiple methods for enrichment and have continued to conduct experiments in studies utilizing different applications such as mass spectrometry, and Tom mentioned earlier on the call, we have recently published a poster with the Vet Cancer Society meeting using our Nu.Q Capture technology in dogs with lymphoma. It is exciting to see our pillar of Nu.Q Capture branching out in terms of research from humans to veterinary users as well. We feel this extremely cutting-edge use of our Nu.Q platform will be a key part of the product development from next year on. And lastly, to reiterate, as part of the U.S. team expansion, we've added a number of hires to our early research innovation team based in California State University in San Diego, another gearshift for sure, and so I look forward to sharing publications and data on that front in the coming quarters. We have made significant amount of progress on many of our pillars this year. It really is shaping up to be quite an amazing year for us despite the challenges of the pandemic. To wrap up the call, I will now pass over to our Chief Financial Officer, Terig, for the all-important financial report. Terig?

Thanks, Cameron, and thank you, everyone, for joining our earnings call today. I will now provide a summary of the key financial results for the quarter ended September 30, 2021. We closed out the third quarter of 2021 with cash and cash equivalents of approximately $22.9 million compared with $19.4 million at the end of last year. The cash burn rate this quarter averaged approximately $1.7 million per month, a little lower than in the prior quarter and our previous guidance, mainly reflecting our ongoing efforts to tightly manage costs and improve cash management. Nevertheless, we continue to expect a gradual increase in the monthly cash burn rate to around $2 million a month by year-end, excluding the impact of any receipts from a licensing deal or deals, if any. The main reasons for the expected increase in spend is due to increased human resources costs as we build out the organization, including the U.S. team, as Cameron just mentioned. From a revenue perspective, the sales of our Nu.Q Vet Screening Tests have remained stable quarter-on-quarter, as expected, given the nature of our beta launch. We also anticipate Nu.Q Discover to add to the revenue this year with several contracts in process. The net loss this quarter was $7.2 million versus $5.6 million in the prior quarter, with its increase primarily due to noncash items. From an operational perspective, the finance team, along with senior management, has been working with managers across the business on a detailed planning exercise for 2022 and beyond. This ensures we have clear priorities and good visibility over the resources required, further strengthening our financial control over the business. So to summarize, the company continues to be in a healthy financial position, with sufficient runway to achieve our near-term commercial milestones. Cameron, Tom and I, along with the rest of the Board and indeed, the whole company, very much look forward to sharing Volition Vet licensing news and the results of key studies and publications over the coming months and quarters. Thank you for joining the call today. We very much appreciate it, given the busy earnings call season. We're happy to take your questions. Operator?

[Operator Instructions] Our first question comes from the line of Bruce Jackson with The Benchmark Company.

So with the vet product, obviously, you're contemplating some menu expansion with additional tests. In terms of the negotiations with the vet companies, how do those term sheets contemplate the new test? Is it something that can get folded in automatically? Or do you have to renegotiate for every new test?

Thanks for the question. A couple of things on that. So each agreement is a little bit different. Obviously, each company has its own worldwide reach. Some are more lab based, some are very vet focused, some are quite point of care focused. So each one is a bit different. And I think how these negotiations typically go is they tend to try to roll everything in at the start, and we try to kind of break it out so that we can continue to kind of get value for each one as we add on. So it could easily be either of those two rolled in -- it depends on the company and what they're after. But it is for the same cancer, so it does kind of naturally fit with the first test. It's a different market. And the monitoring could easily be millions of tests per year as well because there are 6 million dogs with cancer, and you may need it three or four or five times for every animal to trace or even more to monitor. So in some discussions, it is part of it and some discussions, it's separate. But obviously, there's a lot of potential products beyond these two as well, as you can tell just from the Capture side, but also from other animals, also a range of other cancers and other things. So we would see there's strong potential for a handful of products in the vet space at least. And -- but having said that, I think once we work with a partner or partners, we'd probably -- if everything is equal, everything is going well, we'd prefer to keep relationship with them and work through with them as kind of a cancer franchise. But we're working with different companies on different discussions. And so each one is a bit different. But it would be probably working with the same company or companies on both of those products.

Okay, got it. And then moving over to the human data for National Taiwan University. Is that going to be -- can you tell us which meeting it could be presented at, or which -- just generally, is it going to be a regional meeting or an international meeting?

An international meeting in Asia, and it's about -- we just don't say it because they've moved around the pandemic, things start [tossing] me around. It's due for Q1, and they've submitted it. And that will be, hopefully, early in Q1. And a big international meeting, that's what they're waiting for. They're acting with the data, so they want to present at a big conference.

[Operator Instructions] Our next question comes from the line of Steven Ralston with Zacks.

Could you go into the progress at Silver One and bringing up the revenue base there. You've gotten some approvals. You mentioned that you had some inquiries in the last quarter. And how is that panning out?

Yes. So very well. So Silver One has been a fantastic approach for us. It's a facility where we can manufacture the key components for ourselves. The key components, most notably being the antibodies, the controls. And as you rightly point out, Nu.Q Discover, which is where we're offering our services and what we do to a range of different companies. And yes, as we said before, there's been a lot of interest. We have a handful of contracts in negotiation now for a range of different uses from -- actually, from a wide range of companies and processes. So this is kind of the maximum we can handle at the time to negotiate. And we're working through that, and we expect one or more to be signed this year. And I think there's a good chance a fair number of those will reach completion, and there has been a lot of interest. Also, so Silver One will be producing the key components of what we do worldwide. The antibodies, the controls are both on the formats of the plates, which are manufactured currently there, but also in the U.S. Dr. Michel has moved to the U.S. to really make sure we can get a strong start in the U.S. on production as well. So we're looking to outsource FDA-compliant productions of the plates and also the key components on the other platforms, like the beads as soon as we can, so that we'll really get things produced. But the Silver One itself will be producing the key components for the two key components, the antibodies and the controls. And we're also looking to expand, I guess, you could tell from the call, the point of care. We've been working on a lateral flow. So that, we produce externally as well, but again, with our controls and our antibodies. And also, we're looking to do a very high throughput platform, particularly for the -- it's where the signal was very, very high in sepsis and COVID. So we'd bring a fourth platform to what we do from the plates, the magnetic bead platforms, the large order analyzers, our point of care. And now, hopefully, if everything goes well in the next few months, we'll have a very high throughput capacity machine as well. So -- and that Silver One, the facility mentioned, has been really a key part of our strategy to control what we do, not only from the intellectual property front, from having the own trials to launch the first products and show that they work, but also to controlling all those aspects and launching on many platforms. And those platforms can be used in everything we do from the human, the vet, the cancer, the NETosis. And also on the capture side, obviously, the antibodies and the beads for Nu.Q Capture as well. So yes, it's been a really good decision that we took last year to develop that facility and produce our own, and we expect the first revenue from that this year and to continue strongly through next year.

You also received another tranche of grant money from the local government there in Belgium, so another -- at least $400,000. So that's over $800,000 in the last two quarters. Are there any contingency of where that money is targeted? Or is that free flowing, and you can designate it wherever you want?

It is targeted. So the region -- you're right. So we raised money a few different ways, and the region in Belgium has been incredibly generous. We went there for that reason, also extremely good qualified staff that have really built out our facilities. The facilities are very, very cheap, just a few million dollars, and we've got two very, very outstanding facilities now. It's a bit of both those. So they're targeted to particular projects, but they can be used in developing antibodies or -- I mean, there's a lot of different ones, which we can go through separately or Gaetan can go through. But they're usually for projects, but they can help lift a lot of different boats as well. The genius, I think, with the Nu.Q platform is, what helps us in one area can help us in many other areas. So as we talked about, if you develop a point of care for the vet space, it can also be used in the human space, and same with plates and beads and everything. So they are targeted to an area, but we designed them so that they can help us in as many areas as possible. And I'd like to thank again the regions in Belgium who've been tremendously helpful in giving us many millions. I can't exactly remember, $6 million or $7 million now. It's been a very big help for us. So not only is it a great place to work, it's a great place to hire people, a very low-cost place to have great facilities, and they've been extremely helpful in their nondilutive funding as well.

[Operator Instructions] Our next question comes from the line of Jason McCarthy with Maxim Group.

This is Michael Okunewitch on the line for Jason. Cameron, obviously, the pandemic has placed a bit of pressure on timelines across biotechs. So I'd like to see if you could walk us through the expected timing for some of the near-term potential human commercial assets and which data sets you need to obtain for those for the different regulatory environments.

So human commercial, I guess, will start around the world and move across. So starting in Asia, which is where, I guess, the pandemic has caused us the least problems. The -- we're working with a group in China, a very large group, who've been adapting our platform to their machines. And we're hoping to have the first licensing work underway with them in the next quarter or 2. They've successfully [developed] their platform. They've got some great results in colorectal cancer, and they're looking to licensing it from us -- license it from us, so that's going to be a next year story. National Taiwan University has, as you know, their lung and colorectal were going. We have got the data readout. And obviously, it's good enough to publish, which they're doing at -- present at a conference, which will be happening in Q1. And then we'll describe what that looks like for products, hopefully, in Taiwan. Their focus was on using ours for early detection and even in adenomas, in conjunction with the current screening. So that's something we'll have a better visibility, whether we can talk about it public after the conference, but we're hopeful from that. We're also hopeful for the lung cancer work in Taiwan. That will be coming out. They've finished it, so they're reviewing it now. So it's something we'll have to either -- assuming it's good enough to publish like the colorectal, will be sometime in the first half of next year. On the human side, I'd guess go through -- well, I guess, work with the rest of the human cancers. In the U.S., the monitoring study. Unfortunately, it was encouraging, but collecting a lot of time points from one person during the pandemic has proven to be a very difficult thing to do. So the data has been what we're hoping to see. But pretty much every one of the samples had some missing data points, time points, so we didn't want to publish until we had a very complete kind of set, which we're working on. So we'd expect to have that next year as well. But I have to say, every monitoring work we've had with our products has actually worked out very well, whether it's in human cancer, vet cancer, as you can see from the papers and the second product in the vet cancer and also in NETosis, wide range of diseases, so we're very hopeful for that. EDRN, we'll see where they get to, but it's been -- like every group, they've had real problems collecting during the pandemic. They -- last update we had from them, they are expecting still the same update as last time, so that has not changed on the colorectal front, to finish collection at the end of next year. We'll see. They've had a very -- no one quite knows what's going to happen in the next couple of quarters timing-wise, but they're trying to stick to the schedule at the end of next year. So as of last -- as of the time we gave last quarter, that's still on schedule. I'm not sure if you've really followed the NETosis side, but that was a big part of what we've done, and we've actually really managed to move that ball forward this last quarter on a couple of fronts. The gentleman we hired, [Remy] in the U.S. is ex-Roche and he's worked on a lot of [indiscernible] and information like what we're doing in the past. He's come to conclusion that we have a potential for a very broad applicability in NETosis of our platform if for the first CE Mark approvals. And as I said on the call, we're looking to get several of those approved by May or June or July, so over the summer, which is possible because we've got the plates very well developed, and it's very well developed on the auto analyzers. And he's also trying to adapt it with our team to a very high throughput [HAA] machine, which would bring down from -- down just a few minutes to run and even lower cost than where we're at, which is possible because the signal is extremely, extremely high in COVID and sepsis for NETosis. So you can use an even simpler platform than the one we're on. So we'd expect to have all of that, a big amount of news and the first CE mark, as I said, by the summer, but not just in one platform. We're trying to get to really break through in all the different areas of the market, have different platforms approved and then, obviously, launch like we have in the vet pace, and license it as far as we can. We've decided to go off the back of that to start the work in the U.S. We've got a lot going on from the U.S. at the same time for NETosis, as all the other things going on was probably a bridge too far. So we're going to start the U.S. work off the back of the CE marks next summer. So that would be end of next year, 2023, kind of story for the U.S. studies for the sepsis side. And on the -- the one I forgot was the Non-Hodgkin's Lymphoma study. As it's been delayed, it's been very -- we didn't want to start collection and stop and start like EDRNs had to do, so we've been waiting for clear water ahead of us, if you will. But while that's been going on, we really wanted -- I guess, our platform has moved on from plates, which was the format we started with, I mean, when this all kind of started a year ago. But now that we've got a working on quite high throughput platforms, we've upgraded the -- that trial to be a high throughput -- a high throughput platform. And so we're -- assuming that goes the way it's looking now, we'll start collection in Q1 and hope we finish it all in 2023 for a Non-Hodgkin's Lymphoma human trial in the blood cancers in the U.S. But as I said on the call, we have very much realized we didn't have very many personnel at all in the U.S. So by moving Dr. Michel over there, who is definitely our best operator, to really kick-start things, we're looking to make some big hires in the regulatory and also get some very good arrangements where we can mass manufacture the products in the U.S. that are FDA-compliant. So there will be a lot of news in the next year from U.S. work as well. I think I've covered everything, didn't I? That's the human side.

Yes. Appreciate it. And then so on that larger NHL study, could you just touch a bit on the practical advantage from a regulatory commercial perspective to upgrade into the high-throughput assay format. Does that just give you data with a more commercial-ready product?

Yes. So the platform we've been using, obviously, because we're a small company in the ELISA is a plate format. We've been working on beads a long time. It's now working incredibly well. Our beads give you a lot of advantages. Plates are great for starting a lot of tests, and the vet products have been working greater on plates. But if you are going to be a mass market product, millions of tests per year, it gets a bit tight in running in plates. I mean the beads -- the magnetic beads and large order analyzer machines. Timewise, if you're looking for -- it's reasonably quick on plates. It can be done the same day in like six hours. But six hours to be in a critical situation or if it turned around is obviously not ideal. The beads and the large order analyzers run it in under an hour. And the new high throughput machines we're looking at can do it in a matter of minutes. So that -- it gives you several advantages. The beads, you can -- you do it one by one. You can run 10 or 20 or 50 or -- usually, the machines run up to about 500 a day. But you can just do five or six in a day, where in plates, you do batches of 40, so -- which is -- works fine, but if you want really high throughput and sort of plug-and-play, the next platform is definitely where you want to be. So because it's -- the delays are taken with the lockdowns, we thought we might as well -- we've moved on and keep improving. So we're upgrading that platform, but it gives you a lot of advantages. And actually, if you continue on with that, if you look in the sepsis space or even 45 minutes might be too long if you're in an emergency ward with -- during an operation or in a process. So we've been working very heavily on point of care like a lateral flow, which will give you an almost instant result and also on these high throughput HAA machines which use latex beads and can be done in -- you can virtually turn it around in under 10 minutes, and it's very, very high throughput. So I think we are incredibly happy with our platform. We think it's absolutely revolutionary and what we're doing is really special. And I think to really address all the different markets and the different needs from different people, we want to provide a lot of solutions, whether it be plates, which have their advantages and disadvantages; beads, which have their advantages; large auto analyzer machines; point of care; as well as very high throughput machines. And I think by doing that, we've become an incredibly successful company. So we've used the time as wisely as we can to really broaden out what we do while the worlds have been in lockdowns in the process. And I think coming out of it, we're going to be much stronger, having done all the work we have.

Ladies and gentlemen, this concludes our question-and-answer session. I'll turn the floor back to Mr. Reynolds for any final comments.

Well, I'd just like to say, thank you, everyone. I know, as I said, everyone is extremely busy. It's an incredibly exciting time at Volition. We've managed to really pivot towards what we can do during the pandemic on the veterinary space, on NETosis, while really keeping our platform development and broadening the team and what we do on the platforms, and also keeping as much going as we can on the human cancer side as well. So I think the next few months and the next few quarters are going to be very exciting. So please keep a close eye on us. I look forward to updating you as things continue to go forward. Thank you for your time.

Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.