Q3 2021 VolitionRX Ltd Earnings Call
[music].
Good morning, ladies and gentlemen, thank you for standing by welcome to Volition Rx Limited's third quarter 2021 earnings Conference call.
During todays presentation, all parties will be in a listen only mode.
Following the presentation. The conference call will be opened for your questions. If you have a question. Please press the star key followed by the number one on your Touchtone phone. If you would like to withdraw your question. Please press. The star can you followed by the number two if you are using speaker equipment. Please lift the handset before making your.
Selections.
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.
Welcome everyone to todays earnings conference call for Bullshit Rx limited.
This call will cover Volitions 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 Terex Hughes, our Chief Financial Officer.
Dr. Tom would be Terra Chief Executive officer of Volition Veterinary diagnostics development L. L C.
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.
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.
Uh huh.
Thank you everyone for joining Volitions conference call today.
I know I always say it but we especially appreciate your time given how busy you all are doing earnings call season.
Whilst we usually kickoff with Terry and our financial report.
Where we have continued to keep our cash burn rate low this quarter given the anticipated surrounding updates on listen best we will start our presentation with Dr. Tom Butera, Chief Executive about veterinary subsidiary.
Tom over to you.
Thanks, a lot Cameron and thanks, everyone for joining the call today.
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 a term sheet for a first licensing distribution deal for our new COO vet cancer screening test.
I'm delighted to say that we are in advanced term sheet discussions with three top global veterinary companies and anticipate signing a term sheet with one of those parties before the end of 2021.
We have been and continued extensive and wide ranging negotiations with each of these three large multinationals on launching our test product worldwide.
The reference labs, and point of care tests, and on bulk and exclusive and nonexclusive basis.
Okay.
A 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 our low cost companion animal cancer screening tests, so they obviously need to be sure.
Im excited to say that I believe each of these potential partners either have completed or near completion of their extensive due diligence process of all aspects of the product.
The due diligence process in all three companies us included.
Not been limited to our intellectual property validating the test in their own labs.
Any learnings from our beta launch in Texas, and determining the potential total addressable market and platform development. It.
It is very apparent to me from this process to date that all three companies share our vision for the new cubic cancer screening test to be a simple low cost easy to use test available to veterinarians and pet owners around the world.
<unk> has probably been our biggest learnings from the beta launch and so does company to note that all three company 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 and 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 tests for cancer and have the desire to build out their blood based oncology diagnostic franchises.
They've also expressed a 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 new COO that 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 our requires patients they were 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, Gail for Terror, and Cheyenne crews are senior business administrator for their fantastic focus and organizational management.
From a personal perspective, I want to reassure you that finalizing one or more of these licensee 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 Volitions 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 am so excited at the first data was published in relation to what we will likely be our second new gene that 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 their clinical decision, making process for both the veterinarian and pet owner.
Not to get too technical here, but the data demonstrates the new Covid 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 <unk> is a simple blood test that could be an incredibly useful tool in the clinic and in a general practitioner veterinarians office being able to use the new few test anomalies 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 her mission will meet a real unmet need in the market.
Really great first data and I know that Dr. <unk> and the whole team are excited to finish. This study of over 100 dogs to published 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 new to capture.
Coalitions enrichment tool to better understand the types of circulating nuclear zones and their genome patterns in the plasma of dogs with lymphoma.
It was exciting to see that once again the animal data showed similar findings to human studies in that canine lymphoma patients have circulating nuclear zones lacking linker DNA that is shorter nuclear zones that are not detected in plasma from healthy canines, and then nuclear capture is capable of enriching.
Canine cancer associated nuclear zones, and plaza of lymphoma patients. This is truly cutting edge research and a really exciting set of findings for us. So please watch this space as we look forward to expanding our research in this area.
And lastly, as I appreciate are taking 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. Seuss at injure a K a doctor Sue cancer vet presenting on future of cancer diagnostics at the New York Vet show last.
Weak and this week, we will presenting at the prestigious London Vet show.
As the World opens up however, slowly I am very much looking forward to hearing the continued thoughts about new convert from our veterinary colleagues across the globe. All findings to date point to need 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 2020 to be a very exciting year on the <unk> side with the planned commercialization of our products and with that I'll pass it back to the camera.
Cam.
Thanks, very much Tom for that comprehensive update.
Thanks to all of the veterinary team for their hard work this quarter.
He is an exciting fast moving part of our business with significant potential for not only helping man's best friend, but also in generating significant revenues to the company.
I look forward to our first deals signed and the launch of a second product in cancer treatment monitoring expected in 2022.
From one exciting part of our business to the other EQ nits the choices.
I'm delighted that our team is involved in such cutting edge research with several internationally renowned institutions. As a reminder, we believe our new units.
Have wide applicability for monitoring diseases with a niche component.
Such as Covid, 19, influenza sepsis auto immune disease, and even cancer and.
Lee the risk stratify patients for treatment selection during this quarter, a new product manager Remy River joined the team and is spearheading the new <unk> 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 nuclear nets products across multiple platforms, including Elisa.
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 wins.
We intend to register a new niche products with a broad almost C. P style claim for the detection and evaluation of infection tissue injury.
Climates readers orders and disease associated with the Texas.
We believe that not only is this broad claim achievable. It also gives us the largest possible market opportunity.
By way of example, CRP 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.
More details of this will be announced in the coming months.
Other than Texas related activities. This quarter included the publication of data as an international Congress by two collaborators from leading UK hospitals, using the new assays in COVID-19 studies.
These places included early stage data showing that results with Newquay nips tests on admission could predict future COVID-19 disease severity.
And that cereal results correlated with disease progression.
A fantastic result.
And Greg 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 any of the peer reviewed papers or conferences. However.
However, it does mean a lag in time from study results for 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 finding and I'm delighted to say we have further large studies completed in COVID-19, and sepsis, which are now awaiting the finalization of data analysis and publication.
As well as studies in other diseases in progress with results expected in the coming quarters.
So to summarize.
We are in what I think is an extremely exciting new area about use of our proprietary <unk> 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 our very experienced industry professional to help us with this process. We anticipate our first the mark products in the summer of 2022 across several platforms.
And you outlined the full strategy for an FDA approval of <unk> products in the next few months moving.
Moving on from new units to our work in human cancer.
As I've stated on previous calls Unfortunately, given the pandemic something but thanks for 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 night 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, but I used symptomatic and asymptomatic populations and have submitted these findings for presentation at a conference in early 2022.
We are excited to have just completed a preliminary analysis of the lung cancer study and also look forward to reviewing with professor Chen and his team ahead of publication either through clinical paper or Congress abstract.
As previously reported collection for the U S E D. R. In study we initiated enrollment in June of this year.
The latest update is the enrollment has been slow but steady.
E D, Iran have devoted some efforts to drive recruitment and as announced during the last earning 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 future 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 that we are not in a position to publish data yet and so collection continues.
We look forward to analyzing a more complete data set in 2022.
Given the pandemic delays in the larger NHL study of over 1000 subjects we.
We have taken the opportunity to ultra the study protocol and are in the process of upgrading the platform to a high throughput platform, which will help facilitate an FDA compliant products.
Consequently, we now expect the study to initiate recruitment in the first quarter 2022.
The study completion anticipated in 2023.
Something that became more apparent during the pandemic and in particular in relation to the US Studies is that we have been under Resourced in the U S from a personnel perspective.
So now we are really shifting gears to expand our U S operation.
The delays have been primarily due to lockdowns. However, we're using the time to greatly strengthened our U S team and operations to be robust enough to handle multiple FDA studies.
Human because advertisers and we out outsourcing NFPA compliant U S production facility for a range of products.
Dr. <unk> Michel our Chief operating Officer has recently relocated to the U S and they started building out the team with ROE is expected to be filled in the quality regulatory and manufacturing functions. He is bringing up right up having built the Belgian volition came up from 10 people to about 50 and commissioning both are.
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 accrete team members for our innovation hub in San Diego.
Many of whom are concentrating on our next pillar to discuss you capture.
As I've said on previous calls we believe the nuclear capture technology will be transformational as a DNA enrichment technology, which could potentially eye diagnosis treatment selection and both treatment and disease monitoring when using combination with either secreting <unk> assays.
We have made great progress this quarter and then you could 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 as Tom mentioned earlier on the call. We have recently published a place there with the best Cancer Society Amazing using our new COO capture technology in dogs with you and find out.
It is exciting to see our pillar of nuclear capture branching out in terms of research for humans to veterinary uses.
Well.
We feel this extremely cutting edge use of our new 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 gear shift for sure.
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.
The challenges of the pandemic.
To wrap up the call I will now pass over to our Chief Financial Officer Terry.
So the all important financial report.
Eric.
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 32021.
We closed out the third quarter of 'twenty, 'twenty, one with cash and cash equivalents of approximately $22 9 million compared.
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 spending 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 new Cuvette screening test have remained stable quarter on quarter as expected given the nature of our beta launch.
We also anticipate new COO 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 this 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 a clear priorities and good visibility over the resources required further strengthening our financial controls 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 backed 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.
Uh huh.
Thank you at this time well be conducting a question and answer session.
You'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question you.
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Our first question comes from the line of Bruce <unk>.
MS Jackson with the benchmark company. Please proceed with your question.
Hi, good morning, and thank you for taking my questions.
So Ricky.
With the does that product, obviously, you're contemplating some menu expansion with additional tests in terms of the negotiations with the vet companies, how how do those term sheets.
Contemplate that the new test is it something that can get fold then automatically or do you have to renegotiate.
Renegotiate for every new tests.
Yeah. Thanks for the question.
A couple of things on that so H H agreements a little bit different obviously, each company has its own worldwide reach.
Some are more lab based some are very very focused some are quite point of care focused so each one's a bit different.
I think how these negotiations typically go is they tend to try to roll everything in the start and we tried to kind of break it out to the weekend continued kind of get value for each one as we add on.
So it could easily be either of those two are rolled in.
It depends on the company and what they are after but it is up to the same Kansas. So it does kind of naturally fit with the first test.
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 try for even more so to monitor.
So in some discussions it is part of it and some discussions in separate.
But obviously, there's a lot of potential products beyond these two as well and 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 say there is 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 prefer to keep relationship with them and work through that with them as kind of a cancer franchise, but we're working with different companies on different different discussions and so each one to be different but it.
It would be probably be working with the same company or companies on both of those products.
Okay got it.
And then moving over to the human data from National Taiwan University is that going to be can you tell us.
Which meeting it could be presented at or.
Which just generally as it can be a regional meeting or an international meeting.
And international meeting in Asia in it as well.
Because that moves around and say, yes. This the pandemic things start and thoughtfully move around it.
<unk> for Q1.
And then submitted it and that'll be hopefully early early in Q1.
And a big International meeting Thats why they are waiting for.
They're at the half year with the data presented at the conference.
Okay got it alright, thank you very much.
Thank you Bruce take him.
Thank you, ladies and gentlemen, as a reminder, it is star one to ask a question, we'll pause a moment to allow for more questions.
Okay.
Thank you. Our next question comes from the line of Steven Ralston with Zacks. Please proceed with your question.
Good morning, and thank you for taking my questions.
Good morning, David.
Good morning could you go into our the progress at silver, one and bringing up the revenue base there.
Hum.
Hugh.
Got some approvals.
Mentioned that.
So you had some inquiries last quarter and how is that panning out.
Yes, so very well.
Silver one has been a fantastic.
Approach for US is facility, where we can manufacture the key components for ourselves at the key components, most notably being the antibodies the controls and as you as you rightly point out nuclear 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 but there's been a lot of interest we have a handful of contracts in negotiation now for a range of different uses.
From from actually from a quite a wide range of companies and processes. So this is kind of the maximum we can handle 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 for a.
A number of those will reach completion and there has been a lot of interest.
So.
So I still have a one will be producing the key components of what we do worldwide the antibodies the controls.
Just on the format 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 restaurant production as well. So we're looking to outsource FDA compliant production of the place and also the key components on the platform.
Debate.
As soon as we can so that we're really get things produced the silver line itself will be producing Mackay components.
The two gigabyte at the antibodies and controls and we're also looking to expand I guess you could tell from Nicole the point of care, we've been working on a lateral flow. So that we produced 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 where the figure was very very high in sepsis in Covid.
Bring a fourth platform to what we do from the place the magnetic bead platforms, a large auto analyzes our point of care and now hopefully if everything goes well and mix few months, we'll have a.
Very high throughput capacity machine as well so and so.
Silver one the facility mentioned has been really key part of our strategy to control what we do not only from the intellectual property front from having the trials to launch the first products and shows 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 <unk>.
Human to vet, the cash had been the ptosis and also on the capture side, obviously, the antibodies and debates for can you 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 the continued strongly for next year.
You also received another tranche of grant money from.
The local government there in Belgium.
One another at least 400000, so thats over $800000 in the last two quarters are there any contingency of where that money is targeted or is that a free flow and you can designate it where ever you want.
It is targeted the region you're right. So we raised money a few different ways in the region and Belgian has been incredibly generous.
Therefore for that reason also extremely good qualified staff that have really built out our facilities.
These are very very cheap.
Just a few million dollars and we've got two very very outstanding facilities now.
It's a bit of <unk>. So the targeted two particular projects, but they can be used in developing antibodies or up I mean, there's a lot of different ones, which we go through separately.
Katanga and go through there.
They are usually for projects, but they can help lift a lot of different boats as well.
The genius I think with the <unk> 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 that can also be used in the human space and decided to replace invades and everything so they are.
Targeted to an area, but we design them. So that they can help us in many areas as possible and I would like to thank again the regions in Belgium have been tremendously helpful in giving us many millions I'm, sorry, Jack remember $6 million to $7 million, though it's been a 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 high people are very.
Cost place to have great facilities, and they've been extremely helpful. In there.
Our non dilutive funding as well.
Thank you for answering my questions.
Thank you David.
Thank you once again as a reminder, if you'd like to join the question queue. Please press star one on your telephone keypad. Our next question comes from the line of Jason Mccarthy with Maxim Group. Please proceed with your question.
Hey, guys. This is Michael <unk> on the line for Jason Thanks for taking my question.
Thank you.
The camera, obviously, the pandemic plays a bit of pressure on timelines across biotech. So I'd like to see if you could walk us through the expected timing for some of the nearer term potential human commercial assets and which data sets you need to obtain for those for the different regular.
Tori environments.
So human commercial I guess what was that.
Around the world move across so starting in Asia.
Which is where I guess, the pandemic has caused us to lease problems.
We're working with a group in China, a very large group, who have 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 two.
<unk> successfully depth of their platform they've got some great results.
In colorectal cancer, and they're looking to licensing from US license it from us so thats going to be a next year story.
<unk> University has as you know the lung and colorectal we're going.
We have got the data readout and obviously, it's good enough to publish which they're doing it.
The conference, which will be happening in Q1, and then will describe what that looks like for product hopefully in Taiwan. Their focus was on using ours is for early detection and even adenomas.
In conjunction with the current screening so that's something we will have better visibility when we can talk about publicly after after the conference but were hopeful from that.
Also hopeful from the lung cancer work in Taiwan that will be coming out.
That finished it so they're reviewing analysis, it's something we'll have to either assume.
Assuming it's good enough to published like the colorectal will be sometime in the first half of next year.
On the human side.
I'll just go through I guess, we're through the rest of the human cancers.
In the U S.
The monitoring study Unfortunately, it was encouraging but clicking a lot of time points from one person during the pandemic proven to be a very difficult thing to do.
So the data has been what we're expect to hoping to see.
But pretty.
Pretty much every one of the fab with had some missing data points Tom 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 best cancer and also in the ptosis in a wide range of diseases. So we're very hopeful for that.
Edr in.
[laughter] Lucy.
They were they get there, but it's been like everybody group that had real problems collecting during the pandemic.
They last update we heard from them. They are expected still the same updated last time, so that has not changed on the colorectal front. The finished collection at the end of next year.
We will say they've had a very no one quite knows what's going to happen in the next couple of quarters coming was but.
They are trying to stick to the schedule of into next year. So as of last quarter as the timing, we gave last quarter that still so on schedule.
I'm not sure if you've really followed the <unk> 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.
A couple of fronts. The gentlemen, we hired Remy in the US is X a roche and he's worked on although it is still this allows us and at inflammation like what we're doing in the past.
He has come to conclusion that.
We have a potential for a very broad applicability in the doses of <unk>.
Our platform 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 and July over the summer.
Which is possible because we've got the <unk> developed and is very well developed on the on the on the order of analyses.
And he is also trying to adapt with our team to a very high throughput high J H.
Machine, which would bring it down from down just a few minutes to run an even lower custom RF, which is possible because the signal is extremely extremely high in in Covid and sepsis phenotypes. So you can use.
And even simpler platform than the one room, so I would expect too.
Have all of that a big amount of news in the first remarks as I said about the summit, but not just in one platform, but we're trying to get to.
To really reach all the different areas of the market have different platform is approved and then obviously launches like we havent event spaces 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.
A lot going on in front of the U S. At the same time for the choices as all the other things going on with probably a bridge too far so we're going to stop 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 other one I forgot what was the non Hodgkin's lymphoma study.
As its been delayed it's been very we didn't want to start collection and stop and start like Edr and had to do some rewriting for Clearwater ahead of US if you will.
But.
Well that's been going on we really wanted to I guess.
Our platform has moved on from.
Place, which was which was at the format we started with.
It's all kind of thought a year ago, but now that we've got working on quite high throughput platforms.
We've upgraded the that trial to be a high throughput with a high throughput platform throughput platform and so we're.
Assuming that goes the way, it's looking now will start collection in Q1.
And hopefully finish it all in 2023 for a non Hodgkin lymphoma human trials in the blood cancers in the U S, but as I said on the call we have.
It's very much realized we didn't have very many personnel at all in the us so by moving Dr. Michelle over there.
Our best operator.
To really kick start things, we're looking to make some big hires and the regulatory <unk>.
And also get some very good arrangements, where we can manufacture the product in the U S directly a compliant so it would be a lot of news in the next year from U S work as well I think I've covered everything today.
That's the human side.
Alright, yes. Thank you very much I appreciate it and then so on.
On that larger NHL study.
Could you just give us a bit on the practical advantage for immuno regulatory commercial spector to upgrading to the high throughput assay format does that just give you data with a more commercial ready product.
Yes, so that platform, we've been using obviously, because we're a small company and the lies at the plate format. We've been working on bids for long time, its not working incredibly well.
Base gives you a lot of advantages play it's a great fit for starting a lot of tests and the right products and working great on plates.
But if you are going to be a mass market product millions of tests per year. It gets a bit tiresome running place debates magnetic beads and large order analyzed machines.
Time wise.
If you're looking for.
It's reasonably quick on place that can be done the same day in the next six hours, but six hours if you're in a critical situation or if it turned around is obviously not ideal.
The bids and the larger order analyses run it in under an hour and the new high throughput midstream. We're looking at can do it in a matter of minutes. So that it gives you several advantages.
Debates 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't just do five or six in the diagram on our plate you do batches of 40, so which is 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 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 saw.
Even even 45 minutes might be too long. If you. If you are an emergency ward with during an operation or in the process. So we've been working very heavily on point of care by collateral flow, which will give you an almost infinite result, and also when these high throughput machines, which are usually fixed base and it can be done in.
You can virtually turnaround in under 10 minutes and it's very very high throughput.
So I think we.
We are incredibly happy with our platform. We think it's absolutely revolutionary in 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 wanted to provide a lot of solutions, whether it be place, which have their advantages and disadvantages beige, which have the advantage of the 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 widely as we can to really broaden out what we do well.
Uh huh.
I mean.
It looked housing prices and I think coming out of it we're going to be much stronger having done all the work we have.
Alright, Thank you very much I appreciate the long.
The long answered Karen.
Thank you thank you Michael.
Thank you ladies and gentlemen. This concludes our question and answer session I will 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 evolution.
We've managed to really pivot towards what we can do during the pandemic on the veterinary space on the doses, 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 in the next few quarters are going to be very exciting. So please keep it close.
I look forward to updating 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.