Q2 2020 VolitionRX Ltd Earnings Call
[music].
What are 2020 <unk> earnings conference call.
During today's presentation, all parties, albeit not listen only mode.
Following the presentation. The conference call will be open for questions. If you have a question. Please press the star <unk>, followed by the number one and your Touchtone phone.
So it's all your question. Please press the Star <unk>, followed by the number two.
If you are using speaker equipment. Please flip the handset before making their selections. This conference call is being recorded August 14, 2020, I'd now like turn the conference over to Scott <unk> Executive Vice President Investor Relations. Please go ahead.
Thank you and welcome everyone to today's earnings conference call for Volitionrx Limited.
This call will cover Volitions financial and operating results for the second quarter of 2020.
Along with the discussion about recent activities and key upcoming milestones.
Following our prepared remarks, well open the conference call to a question answer session.
Also on our call today are Mr., Kevin Reynolds, President and Chief Executive Officer, Mr., David <unk>, Chief Financial Officer.
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 views based upon information currently available.
But to us.
Because these statements reflect our current views concerning future events. These statements involve risks uncertainties assumptions actual future results may vary significantly based on a number of factors that may cause actual results or events to be materially different from future results performance or achievements.
Expressed or implied by these state.
We have identified various risk factors.
Associated with our operations and our most recent annual report on form 10-K quarterly reports on form 10-Q.
The other filings with the Securities and exchange commercial.
We do not undertake an obligation to update any forward looking statements made during this call.
I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds Kevin.
Thank you everyone for joining Politians conference call today.
Especially appreciate it given the busy earnings calls season, and the ongoing pandemic [laughter] speaking to rich, let's first start with an update on how the cobot 19 pandemic has affected operations for but this is Bob.
I would love to reach right, how proud I am with the way that our team has adapted to the different well, we find ourselves in and kept working at fees paid during this whole time.
They're fantastic efforts have put us in excellent position as we move towards the launch Abbas first products expected later this year.
During the first quarter of Twentytwenty, we implemented contingency planning to protect the health and wellbeing of our employees.
With most employees working remotely where possible.
However, in addition to our remote habits are lapping Belgium has remained opened up up with the tenants about dedicated lab technicians socially distancing observing other safety protocols, you know logic 20000 square foot facility.
As a pandemic continued into the second quarter.
And indeed looks like it could continue for the Indeterminant future.
We focused on two key areas to try to mitigate yep.
I've been locked down.
Allow us to keep moving towards our first product utilizing a cutting edge you Q platform, Firstly and very importantly, we significantly strengthened our balance sheet.
True both an underwritten public offering about common stock and through the style of shares of common stock pursuant to our existing at the markets offering program.
Sure we have sufficient capital to work on our many programs concurrently and not to products were still possible during the pending.
More at a much strengthen cost position and our product launch strategy later.
Secondly, we have increased the flexibility about supply chain through the addition of a second supply of key materials for our products and we look into the future in manufacturing those materials ourselves by bringing all key component in house to this end I'm very happy to announce today, we have just submitted an offer to purchase a neighbor.
Facility in Belgium, known as silly, but one.
We expect that this would be the production hobbled, all about product and components to by securing supply at a lower cost.
And to drive reagent revenue building on our purchase of Optima early this year more missed later as well.
I'm sorry.
I'll start with the all important strengthen financials.
We closed out the second quarter with 21.3 million in cash and cash equivalents.
Pad with 12 million at the end of glass quotes on the mouse quota.
In addition to this during the second quarter of Twentytwenty, we raised 15.8 million Greg crises.
In an underwritten public offering which was especially pleasing given the challenges posed by the pandemic and the volatile stock market.
During the quarter, we also periodically sell jazzed about common stock pursuant to a previously disclosed at the market equity offering program well idea.
Under our existing registration statement, along with the Irene tend to be five one plan [laughter] through the end of the second quarter of Twentytwenty. We had raised approximately 1.6 million in gross price even under the ATM and subsequent to the courts and throughout August seven we raised an additional approximately 4.7 million.
Even gross proceeds through the ATM [laughter]. The ATM has been in place since late 2018, I provide full the off and sale of our common stock having an aggregate offering price of up to 10 million from time to time through Oppenheimer and company acting as our agent and all principle.
We decided to use the ATM now to further strengthen our balance sheet during the uncertain times and fueled by the pen Debbie.
Support our goal of launching several products over the next few quarters.
I'd like to yet again to thank our investors for this strong support.
Our underwritten public offering.
That we completed in May was oversubscribed, and we welcome some new investors as well as many existing ones.
[laughter]. We're also delighted in gene to be added to the Russell 3000, and Russell Microcap indexes.
Great step forward for a company.
I think it's fair to say oldest activity significantly strengthened our cash position.
Providing a great runway to achieve our many milestones and give us flexibility during the continued pandemic.
[laughter], we continue to manage our expenditures very Kathleen and as we approach commercialization I burn rate has ticked up to approximately 1.6 to 1.7 million per month.
Which we expect to continue as we make additional investments towards product launches.
The increase is mainly due to the acceleration of our assay development.
The purchase of Cmstwo samples for clinical evaluation about assays and securing resources in both people in facilities to launch multiple products worldwide.
And so to some of our achievements this quarter.
[laughter] I'm incredibly proud the work we've done today.
Indeed much of it within the June quarter regarding the development of a potential cobot 19 tree odd prognostic test.
If we succeed in launching this debt.
Spec that it could not only be very helpful. In the fight against type of 19, but could also prove useful for many years to come in a wide range of <unk> respiratory viral outbreaks, including influenza and ammonia since our test matches. The body's immune response robin targeting the actual bar itself.
It was only just a few months ago in April when we announced that we had followed a novel Patton at a proof of concept studies Dawson and yet by July we had reported results from two clinical studies.
Just to recap.
The preliminary study results reported in my demonstrated the area under the could for single I say that accuracy of 98.7, PCR positive breast is control subjects with 100% sensitivity at 94% specificity.
The second you asked I also showed promising results when accuracy are you, saying, 86.2%.
To date, we have now test the two independent cohorts of covered 19 positive patients with quantum Duke NUKEM same immuno your assays and found the numerous times are highly elevated in plasma of severe kobin patients relative to healthy control subjects and more importantly that both he started 3.1 bearings and fits nicely.
Yes, I'm increased with disease severity.
[noise] given that the highest level of nuclear savings were found in patients requiring artificial ventilation.
Extra hope real oxygenation, we believe the nuclear times could serve as a guiding biomarker studies disease severity in cobot 19 positive patients.
These does it imply that you could have strong prognostic potential and so we have now focused on the completion of larger longitudinal studies that would needed to be support the potential closer to 19 product launch.
[laughter] our collaborators have submitted the dollar for peer review and we look forward with publication.
Earlier, this indication and tragic a patient tested positive for quite a bit 19 through the most likely to theory I need critical care, what enabled by improved outcomes for patients and a more efficient use of critical care resources for health care providers.
We believe this is still very much an unmet need worldwide in fighting impact independently. Our goal is to develop I prognostic test would need to same as they biomarker right, earning in thought into which could have been 19 positive patients require high levels of monitoring, including hospitalizations and critical care results as best as those who are less.
Lucky develop serious symptoms [laughter] I would like to make it extremely clear.
While cancer remained our core disease, because these results demonstrate the best utility of an ERP platform and the range of application for which these products can be leveraged to help increase diagnostic power.
I'm hopeful that our new Q epigenetics, two books might have potential to help doctors and patients independently. I believe you may also be hopeful that other respiratory ball outbreak, including influence and pneumonia, particularly given that the current cabin jets specific to strain or disease, which I knew you chess are not.
It appears very lucky that hyper inflammatory response to the virus involving massive injection of NIS made up of nucleosomes into the blood by white blood cells that damage the lung and kill so many patients also do in influenza every year. Consequently, we believe that if a test works well for quite a bit it should.
Also worked for influenza and pneumonia.
And ongoing and massive potential worldwide Mako I'm also pleased that you test kits used by the teams in the Asia Muni performed extremely well independently on their own lab equipment.
This bodes very well for use of the kids in any future lab setting and yet again is testament to the robustness and rebid Richard we stability of and you keep platform. Our team has spent many years optimizing.
As many of you know the health care vote, pharmaceutical diagnostic et cetera moved fairly slowly and so I'm, particularly grateful to our team and most importantly, our collaborators.
So quickly and so diligently on these studies and indeed in prepared undergraduate longitudinal studies you to get underway this quarter.
In terms of launching a cobot 19 product in the U.S.. We're currently in discussions with a major U.S. contract research organization to conduct a large perspective prognostic opened 19 study.
The study will be intended to satisfy all requirements to apply for an FDIC emergency use authorization you buy you why is no longer adoption. Upon study completion EBITDA onto also satisfy all requirements to submit a traditional FDIC five 10-K Denovo application.
In addition to the regulatory approvals the study will be designed to maximize likelihood of receiving funding awards from the biomedical advanced research and development Authority BARDA operation Wolfspeed RWS and all the coalition for epigenetic preparedness innovations CPR.
These programs what funding tick accelerate development manufacturing and distribution of covered 19 products.
If this study where to proceed and positive results received then a product receiving E. You I can only be ordered cobot 19 patients. However longer term I product commercialized via E. U I emergency use authorization can be used in a post market 510 case studies to expand.
For many other clinical uses.
For example, a subsequent five 10-K could be followed for use in cobot 19, plus influenza.
More broadly intended use five 10-K claims could also be something we'd be ball for example, well use infectious diseases and hyperimmune reactions with associated devices. So this study would represent a great first step.
I look forward to announcing further details of this study as soon as we can.
So happy to announce soon further details of other Cobrand 19 longitudinal studies currently being planned in Europe for European CE Mark approval.
If we continue to see positive results in these long digital studies, we aim to have a CE mark product available on multiple platforms. Beginning at the ended this year and we look to launch a low cost product that could be used in any laboratory worldwide.
As soon as possible thereafter, and we're also looking to launch in Asia soon after your.
In addition to all of a hard work on the carbon 19, Treehouse product development I'm glad to decide that we have continued to make strong progress in our other programs again, despite a lot of new hurdles that we are facing during the pandemic.
From an assay development point of view.
We have now 13 assays developed as of June 30.
And this may I talked with a 12 assays by June 30.
And I've been tested clinical research programs.
We plan to reach a total of 20 essays by the end of this year.
This is yet another milestone we have reached.
This is a huge step for us and we have kept this key milestones despite the pandemic conditions.
These assets can now be used in our key maki cancer diagnostic programs, our best studies and acquired what discussed earlier.
We have also manufactured our first Recompeted nuclease I'm in house with a plan for further for to be completed by the end of this month and three in September.
These new good times will be used in our assay development program in house and May also be sold his research use only two biotech and pharma companies to be used as readout for the therapy monitoring and personalized medicines for example.
We've also made great progress with our point of care platform.
Something which could be particularly useful in both the veterinary market and for the code retreat.
From the large cancer clinical trial perspective, our Maki trials I.
I think it's fair to say that the various ways that we have now been affected by the continued pandemic either by flow of course collection or a host of other supply chain or travel and communication issues.
We believe we have successfully manage those areas under our direct control such as the Dare I say development and running samples both on track with our milestones, but many issues obviously beyond our control the easier in study in the U.S. has been impacted the most by the pandemic further throughout last update remotes.
At home or upside contending has been I'd be approved and is expected to begin the smell.
This approach limits potential exposure to cobot, 19, and will help enhance enrollment, but we do not expect that will match the standard system numbers.
[laughter] most institutions participating the study reopening, but with various degrees the restrictions and barriers and you start in Australia was open and was initially enrolling at full capacity, but now Stripy has recently re implemented locked down restrictions.
Pdrs, it's currently seeking to add additional side outside of the west in regions with fewer restrictions.
Today, none of these thought I collecting.
So in summary, the easier and expect lower collections in 2020 than originally planned and we expect that this trial may be extended.
As always I will update with further details once available.
The collection of both large discount studies at the National Town University continues with the aim to complete collection by Middle of next year.
With regard to those studies, we've now completed assays on the subset of both of the two National Tony University study CRC in London, and we're working with our collaborators on data and analysis.
We expect over this coming quarter to run additional number of assays.
As far more rigorous process for processing data, where we can you need to peer reviewed papers or a conferences. The plan submitted abstracts to two upcoming conferences.
CW in December the colorectal cancer result, and the I guess LC lung cancer results now plans to be held in January.
And finally from a clinical study perspective, we're at the final stages. The planning some additional clinical study, including non Hodgkin's lymphoma, as well as colorectal cancer and loan.
Right.
We're generates a lot of data in our new capture program. This quarter with the aim of submitting a clinical paper without findings by the end of the third quarter, but just once the paradigm.
<unk> mass spectrometry, we have made fantastic progress, but edifying and then developing and you keep biomarker from scratch. So I can now be used in one of our clinical programs.
This was simply our best quarter ever for from a publications point of view as well.
We had three abstracts published at SK, The American Society for clinical oncology and then we have also just received acceptance of oral presentations for two abstracts at the now virtual written recast Society meeting in October of this year.
As I alluded to earlier abstract are underway for both colorectal cancer lung cancer, well, the APW and I SLC, respectively.
Clinical paper Wise and you bet paper regarding pre analytics has been submitted for peer review and accepted for publication.
Three papers have been submitted by collaborators lung disease for communications during pregnancy, and because of 19, using our technology, yet again, showing the wide adaptability of our platform.
We have three more pipe is in process a pre analytic paper for humans do you for submission over the summer month and two papers from need to capture program on mass spectrometry and also if the sequencing.
Now that we are very coupled with our IP and our about cyber platform. We are aggressively moving to publish all our and our collaborators very wide ranging where please continue.
Yeah.
And so to the future firstly I'm delighted to announce on the goal today that we have an accepted offer to purchase so well one a 10000 square foot facility on the same size box as our lab in Belgium, which will be our manufacturing hub and service lab.
So for has been accepted and both parties and now completing the necessary type work.
Facility comes at a cost of under a million euros, including a whole new fit out showing our commitment to buckets, keeping costs down and moving to the product phase of development.
We anticipate that as with our previous real estate transaction at least some of these costs will be supported through non dilutive crowd.
And all loans from the number regions.
We expect that the fit that will take place over the next few months and we hope it will be operationally in October and produced several key components right away with full ISO certification next year. Our plan is to produce at large scale raw materials, such as recovered a nuclear times, which acts as the caliber.
Thank you and you add side. In addition to antibodies that are key elements to our branded products and indeed, who manufacture our whole diagnostic kits. Once finalized we expect to up all elements for both commercial style and for clinical trial purposes, and see my products for sale in Europe and beyond.
We also intend to install a service lab in the new facility, which would undertake sample processing for external parties such as the pregnancy samples processed as a service phonemes as mentioned on an Oracle.
The opening of this new facility would not only bring manufacturing a key component in house, thereby securing our supply chain. It would also significantly reduce the cost of production of any of these elements and intent would reduce the cost of assay development. It's an exciting time and I could not be happier that we could find a suitable side.
So closely situated truck aren't lab.
It's another great step forward in our right to a diverse revenue stream to that end, we're encouraging I sales and business development manager to help drive revenue through research use only kids through service proposition and three CE Mark products.
I look forward to announcing an appointment say.
More broadly as we approach commercialization of our product be that Tobin daunting trash test or one of the castle lung brought our colorectal cancer Treehouse products. We have commenced licensing discussions with a range of companies and platform providers to ensure we can supply the market quickly and cost effectively.
First triage CE Mark is due to be completed the next few weeks being delayed from Nigeria as our supplies facility was halted Judy several key members being put on cobot not important thing.
Given our new enhanced capabilities, giving us greater flexibility. We have now brought the funnel work in house and under our direct control. This yet again shows the benefit of our focus on diversity of supply and having an in house production option product wise, we remain on track to launch our first nuke you bet product later this year we.
Field that market is one where we have the best chance of launching products during the pandemic threats vet products due to be launched at the end of this year, a lucky to be for blood and lymphoma remission monitoring and we then aim to talk additional uses permission monitoring for other cancers and for diagnosis. So in 2021.
The Texas bed team has made great strides forward despite depending.
Said earlier, two abstracts have been accepted for presentation at the Bcf meeting, where we expect further you bet data to be presented.
Inline with our product focus Nate Jews very firmly positioned Betsy.
We'll shift is focused purely to commercialization and services listen bit Chief commercialization officer.
We have made fantastic progress on the vet part of the business and this is truly an area of the business to watch closely.
I could not be proud of how hot the whole team has continued to work throughout this difficult time, my thanks to them and their families as I quickly adjusting to the new normal.
Thanks also to our collaborators and supplier throughout the world the impact to the pandemic has been felt everywhere and so we are grateful for their can do attitude.
I think also should go out to the fans community and our investors.
We have greatly appreciate your support and so did add have significantly strengthened our balance sheet in order to deliver our future milestones and outburst products.
Looking to the future I'd like to reiterate our vision and what makes us so excited with our progress and Downspace volition isn't epigenetics company focused on advancing the size of epigenetics and exploiting these advances in human and animal health.
This has been I mentioned since our founding and it's coming to fruition without you can keep platform at the very hot epigenetics.
So we say the epigenetics is as if not more important than the genetics DNA in short it's not DNA is the food crime is then we believe the last decade of work at religion.
Our ever expanding team empathetic puts us in an extremely strong position with our expansive IP portfolio to base. It if it can play in this key field overall on so many fronts without ever growing team and our intellectual property I'm delighted with the progress, we're making and I'm excited by the momentum we have developed in the epigenetics field.
Indeed, our whole team is incredibly excited by the company's future opportunities. We aim to report throughout this year and beyond several key milestones, including usability detect a range of Kansas in both human and animal. In addition to clinical data on then you capture and Dr. relating to the Cobot 19 triage test in development.
We will also focused on driving revenue in the coming quarters, where possible during the pandemic enough four key areas.
Lastly.
Our for potential Treehouse tests.
Secondly, vet products.
Thirdly, using our new production facility to drive reagent sales and revenue.
And for the licensing of our technology for others to commercialize.
Hi, along with the rest of the board and indeed, the whole company look forward to sharing the results of our case studies over the coming month and yet with our optimize the platform. Despite the pandemic, we expect 2020 to be I'm, most exciting year yet.
Thanks for joining the call today I very much appreciate it given the busy in cold season, we are now happy to take your questions.
Operator.
Thank you.
Ask your question. Please press star one and your telephone keypad.
Ladies and gentlemen.
My question.
Prestart.
Some of your question.
For participants using speaker equipment.
Sorry.
Before pricing.
Our first question is from Jason Mccarthy.
Please proceed.
Hey, guys. Thanks for taking the questions Michael.
Okay.
Thank you.
So.
First I'd like.
More detail.
Upcoming CE Mark instead of.
I think you said, so which tree that Martin is it just for a single asset.
Yes, it is a tree our product it's the blood cancer.
As actually blood counts between humans and in the sites have been actually best results or anything.
So as we announced alcove it has excellent tighter so we bought at the very good way of thought even see my process.
To help on products and that's actually that the ice report what ethic, which also works well in a lot of other thing. So it gets it all starts.
And just enjoying good obviously, one about the glides had some major cobot issue. So we bought back in house. So it appears very soon to be finished in the next few weeks sorry, let's say September.
And that will really start the process. So once we haven't seen my product, we can work with that in the blood cancers, but also where that they use one other areas. It makes it much easier to.
C market for other purposes, and yes. It's also the ethane which was also very valuable in private so it gives the huge has started a range of different areas.
The country, our product itself, we doing some pretty analytics work.
[laughter] is being done in Australia, which obviously is going back and looked down sorry, we haven't updated exactly when we start marketing the product, but we will have the same Oxford quite soon and that gives us a really good building block.
For a lot of other products. So it's a great stop.
All right and then separately relating to the blood cancer product, how many how many assays would you need to get us CE Mark before you have an actual product to bring to market.
I'm sorry, the onest, they actually works quite well as well as the frontline Eritrea indoors as an adjunct I've been looking the results presented at ASCO.
Your last they actually within the 80 to 90 or you see why.
So I think it's getting quite close so.
We're doing a lot more work only on the blood cancer.
It actually I actually can probably tell it caught by surprise, how I would have been how how.
Worked in a range of different species. So quickly. So we're doing a lot of work now on what the product would look like.
So obviously the CE Mark was CAD to healthy, which is incredibly impressive, but we need to make.
Better trials to make what a CE Mark allowed you to do with pellet commercial it doesn't mean people are going to Rochelle, and and bought but by CE, marking the product. The white is when you run it in trial I guess its product ready immediately so.
3.1 by itself had incredibly good results in the blood cancers and once we finished the freight analytics whenever that is given the current what we're doing up because the pandemic.
We will see if that's a good enough assets the tree out by itself. Its good enough for theme occupancy so what the take up is commercially.
The results as you can see from the Alaska work and I can say them again offline, we're incredibly impressive but that one asked a by itself in the blood cancers.
As healthy so it's a good first step, but we haven't talked about along the goal because we're not exactly sure or the process, we're putting all the pieces together now.
As regards to products in different areas, but.
Yes, I would say bucket because the results actually fantastic as as presented to Alaska for that one ethane, but obviously the more asset you put together the more accurate typically so we're working out now but it seemed like a very good step forward. Given this is in that segment music and a lot different areas to make sure that its product ready.
Hi, Thanks, Cameron and then just more on the Colgate 19.
Right exactly this would be.
Slide impact you mentioned that will be largely focused on the.
Hi risk groups, but what's the need out there for prognostic indicator and then and then what do you want to physicians do with the information.
Yes, very good question, so people I've got prognostic and diagnostics, a little confusing among clinicians.
Got it tells me you haven't prognostic tells you will attempt to tell you whether you're going to be badly off you probably familiar.
A lot of people had very low or no symptoms.
And unfortunately, some people get extremely bad symptoms Natalie symptoms you get are actually the body's immune response not the virus itself at all it's immune response, which is the near Texas, which is something we've been looking up from one time because it.
It's.
It's lower than trials of victory times, which the body stories out to try and track the virus.
Which is what's called a net I guess, that's one where that came with the equity back which I guess starting to focus on net so what we measure is promising long change the parameters. So a very simple product for us and potentially because it's very low cost easy to use something maybe use very widely.
We used clinically so if unfortunately, Mike you weren't hospital with perfect you've already feeling a bit tick.
It's very hard to tell now whether you're going to spiral down in intensive care quickly or what you stay fit for a while we get the can recover or you recover and come back again.
So what lacking is the prognostic market actually stay where you are in that cycle. So what we looked at it's a three type process one of the third stage now and the first two extremely successful could be measured covert from helping it covered positive otherwise there's no point, having any test and it was extremely I mean way beyond our expectations of almost 99.
Then accuracy.
Then is it worth it higher in very sick people.
And for the for the second time and samples collected we took property. So those in intensive care, we seem to the most sick which makes.
Those who had cobot in a normal award at medium and those who had quite a bit but didn't know us where autistic tested positive but weren't really sick. So following comes in and I think that will make that exempt and in the paper we can see soon.
The people with in intensive care, we're absolutely off the scale high and particularly those who were on the path to death or ventilation. Unfortunately.
And the people who will take about moderately stick in normal awards and those so it was that's what that's what it means when it has progressed with disease progression. So and these numbers. We've never seen accounts is I mean, just off the scale high.
Lastly, if your drowning in total switches the tragic.
Cause of death of so many people from global view you have a massive sticking their nuclear times, which is understandable. So it's two things. So the next level of trial is in the same people what does the curve looks like from when you come in feeling okay for either getting better or worse.
But also doctors need something to quantify.
To put it very simply it.
So people, Mike I'm not sure Michael Mueller traces also who Terry one of you might come in and think I'm dying I'm dying and very pick and actually be okay, and one of you might be thank him like high but actually it very thick.
The doctors always what's coming to quantify where they are limited to switch there really isn't at the moment. So we think if it can be proven its incredibly important to have a prognostic also if it ever any therapy.
For coated it is the choices, which killed not the virus. So knowing if you're getting better you need a prognostic as well to see it is a market going down with treatment.
So and don't forget that means is not taken one taken time and time and time and time and time again. So if it is one that has 3.1 again, that's one where thematic border the.
Blood cancer now of course.
You're not going to be screen for cats, and while giving hospitals that total starting today and a completely different thinking.
What.
It'll it'll put together very well so you need a lot of them. If it's only one ethane it's going to cost is very little to manufacture with any facility now that were.
In the prices manufacture all that so we can bring down by about 90, 95% the cost of that when I say all the fitful nation also worked very well I won't go to that too much in depth, it's quite technical but that usefulness and having to markets for different reasons in different measures of information, but it looks like it could work just with one perhaps to now the one if it is this.
One it's something.
We can launch extremely quickly because it but.
We certainly expect to be already thima for different purpose, which is one of the reasons, we would pertain to see market quickly for the other purpose total fits together and I think it's showing the.
Several things. These trials, we are we refer intellectual property, we got it out there with the information we had we rushed kits to independent sentence that ran the kit that we tried to 15 years ago other collaborators and the kids really didnt have the robustness needed at this time I'm extremely proud to say that they were incredibly reproducible reliable they measured exact.
People they should be measuring.
Standard curve to protect the.
They worked exactly the white independently in separate hospitals and of course, because the private equity traveler and find anyone it just shows that the bumped annualize the people can run get tighter on quickly and launch so I was extremely happy to hold other reasons.
Just shows the rising taught about platform lifts all boats, it's reproducible reliable.
Incredibly impressive for all the work we've done so yes sort of using that prognostic test and were working on trial in Europe, which can be retrospective. Therefore, we can get data quite quickly we're hoping to run the first to them in September which is coming up quickly now.
And then the U.S. trial I mentioned, obviously, we'll give full these out we've decided in the us.
Given its potential uses for years and needs to come in influenza into my needs to go for proper see arbitron try to kind of rush samples here in terms. There. So will it will give some informational medicines, we havent, but.
We're very pains to do a proper CRM FDIC study for this in the U.S. and we'll update on that so expect to see data on products for the European market and we're hearing about same not to see once we have that so are you most quickly.
And as I said it can be done on plate on paid and the.
Point of care products, we're working very heavily toward cancelling also just a drop of blood on on the screen and it could also be used also tantalizingly with a quite a test if you put the curve except on the point of care you can have a diagnostic kind of prognostic on the same centerpoint. So all this very exciting and we're working very hard.
Alright, Thank you Karen.
Progress.
Thank you it's been a busy time thank you.
Our next question is from Mark Breidenbach.
And company. Please proceed.
Hey, guys good morning, and thanks for taking the question.
Hi, Kevin I guess, we're used to getting update on the progress we're converting your assays to commercial grade formats, and I guess I'm still trying to understand why.
Adding when key assays.
It is a meaningful milestone given.
Most of your products would likely.
The one or two or three new kids on a panel.
Why do we need 20 and.
What's what's really the rate limiting step now.
Since you have so many commercial grade assay is ready to go what's really the rate loan except for moving.
Ignostic camels forward. Thank you.
Very good question. So yes, the simple panels, the one two or three one other the treehouse panels. So that's why we're very came to loan product. Since we can I mean, you met results to be an amazing in the best fits with one or two at any covert just with one or two so that's why I think through independent bank, we can launch them. The way. They are so we did.
Good.
We always had target to launch more uptake on the place than it just took a lot of work I guess when the TV.
Good as they could be were up 10 or 15% the down to repeat the same now doing that at curve is an older work committed hundreds and hundreds experiments per appetite to make sure it's completely robot.
Now don't forget we're getting too is that an office that we can run it someone we know relevant but anyone can run it anywhere, which I think shown to be incredibly true now in facilities in Europe, where we run so we now.
So having a wide range of assays to run in the trials works because each one I mean as you know they were up 1000 structures on the next season or more.
Including really very things like it's done modifications methylation said license Foster license you pick relations.
And.
This huge but I wouldn't get durable and I don't know them off the modified.
It's huge and we've never really managed to get a reliable test now don't forget the important rebates from flight.
We had some working on place which worked.
Okay, but the issue in serum wasn't there was a lot of background signal. So the actual signal in plasma is very very pure and it's a much better signal to noise, but we really needed to be on beat to get there. So we took on.
Especially on the based platform in the audio platform on the hammered has done an amazing job and you get another fantastic team member is really pull their wife tremendously during the pandemic.
So the different business I think it's probably the most important step in your question. So too. So January February we can say, perhaps things closing up so we bought.
Smaller quantities of the antibodies to do the work to adapting to the platform you need 345 mixed depending on what you want to do that Reiterations to make sure you get that added curves in the process.
I think we have a team of five doing nothing else that I'd platform development. This minutes a huge amount of work that hundreds of experiments, perhaps I forget it really really really level it should be but to run the trial for example.
If you are and some of the assays.
Typically what happens is the rains in them worked quite well in a few very well in some Monroe, but do you want to Ron.
Lot of them through a bigger population because just the ones that worked very well done it sort of work on entitlements because that correlate with the other ones. So typically you want to run not just those a couple of.
As you know we have not pick the panel yet so there's still.
Good idle 10 candidates reached the cast is to see what's best for the panel is not just the ones that worked best it's what works best in a panel, including competing conditions everything else, but for example for Taiwan.
The amount of anybody you need for Canada them times 5000 samples is actually quite large which normally would be trivial I mean getting antibodies.
Typically it's tough but over the last three or four months everyone's really thought manufacturing new antibodies. So we've stopped through we thought during all this let's stick to things we can definitely produce.
In large quantities things like high 3.1 situation, where we have good access to everything.
Launch the products, where it's very easy to to run again coated the tree out products with data has been excellent on just a couple of outside.
So in the meantime, we're developing as many assets is we can to give us totally many bullets and began to make sure. We get a good of handle is we can.
And it's just the right into the Mylan media Ren studies, Paul several different when they're going to be restarted you can probably tell me a bit of yours live in the site when when things going to get back to normal I would roll up maybe month or two ago, we'd be heading back to know melting and it's not so it's very hard to give exact timeline. When study is going to be finished on viasat, because it's all kind of up in yet.
Just practical things with Taiwan, we haven't they left right now so a lot of trio product. For example, you have to a lot of co analysis. It's not just the athleta is in conjunction with a low dose they taste Ken and.
But there's a lot of difference.
Variable so we've had to deal with all that so but I think.
The team has done incredibly well controlling what we can which is that they development and launching the products that are you really do take a small under wraps, which we can control.
And and we'll just be ready for the call reconciled to since it will listen I'm going to list will have a huge range of ethane.
And a lot of than we expect to be able to manufacture at large volumes of the antibodies and control vessels.
And so it's all overly don't you.
[laughter].
Short answer okay. Thank you [laughter].
[laughter], it's a complicated time clinical trial.
Our next question is from Bruce Jackson with the Benchmark company. Please proceed.
Hi, Thanks for taking my question.
Well the Copeland 19 launched net you Didnt know studies, if I could get some.
Additional details so I take it there are theres a study in Europe, and then there's going to be a study in the United States and the study in Europe Sinclaire from the press release, whether you had launched an internal data or not or whether you're about to start the study or it's in process should give us like the status.
The European study and then how many months of launch need to know data are you trying to get.
And then with the U.S. study when do you think you might start that study in how long do you think it might take.
Good question. So initially.
The short answer is all of that so we have some longer term a lighter which was encouraging.
Im pleased to go from low to medium to high there is the curve between them.
We caught up instead of what that looks like and do you have quite a few of them. So.
You'd need quite a few people and we're working on the numbers now.
To make sure we're going to 50 or 100 to really trying to be short of what the curve looks like in between the different groups. The definitely the curve, we just going to see what that looks like so we have run run some long internal data, we've got working with what institutions that we already have who have collected.
Appears to be an up for a trial and the CE marked with positive.
Add but like everything you have to go through NESCOE process, and ethics process and running them. It's not massive longitudinal data typically cobot actually kind of victory I conclusion, while the other in a week quarter. So they already have been collected so it I mean, the actual the samples collected running them.
Thanks, very much time, but as you've seen from this lot paper when you're working with real for institutions. It takes months just to kind of all package it up and everyone agree and this last night, but there are 12 volt isn't for institutions. So there'll be I love. The deiter, noting that is getting everyone to the degree of what should we said how it should be publishing and we're trying to publish everything that obviously so.
And it takes some time so the short answer is the long tailed study directionally, we quoted per person. So it's not falling to present for months.
Typically the first thing Mike launch.
There are enough that which we think I mean, that's determined but to six branches out work, but it looks to be good from what we have I'm looking for a few different sources in Europe. The on what we have so we'll have updates on that on the west side, We've got a lot of work.
Trying to do a study now of course, you can try to kind of do small studies in sneak it through where you can do it at Big front door study with a big CRR Dr. Trail, Jason who I think you know quite well as doing a lot of work for us on that.
And we'll see I think we're getting close to what we want to do.
That does take time I don't have the final timelines when talk but it would be something in the.
At least six to 12 months in the U.S. I mean, it doesn't take download to collect for when you read everything up it takes on it just out but we're very comfortable spending that because I don't think anyone certain that the bottleneck the epidemic will be over.
Pandemic will be over and also anything we do I think is extremely hopeful going forward.
In regards to undermine your influenza, which fueled millions of people every year and things like diabetes. So it's not a global product to the touches product. So we took the decision.
In Europe to apply to see Moccasins began and I think it's close we'll Miss you have the product in the Sema Globalstars probable.
And in the West we decided to do I proper CRM study.
Ill the timeline things will do as quickly as we can move again. This is why we strengthened our balance sheet to make sure we had money to do it properly and get it done by purposely error and so it would apply to you I invite 10-K as well.
Well, obviously work that we bought or an operation what spacing.
Things as well, so I think Europe will be much quicker, but the U.S. study will be.
Gold plated as we can make short so I, probably done FDIC product that we can really hang our head on.
Okay, and then turning over to the National Taiwan University Studies on you mentioned that on these completed eight of the the new Cume markers.
The plan to do.
The plan to do all 20 as they become available.
And yes.
Just just off the cuff.
Continues now go ahead.
So yes, so we have subset of the tourism. So we're not I said as our assortment to.
Okay, given supplies and this is all of that type we have limited quantities. We can run running 5007, the hasn't actually a lot of work. It I'd ask Dave normally would be more trivial because you have complete supply chains. When everything there were six months now everything starting to drop a bit again, it's why we are doing a lot of already work now to guarantee all of that in large volume.
So I guess, we run Ida absolutely, we're going to run all 20, because we have a lot volume of sample there. They're currently good collaborators and elected again thank them for their continued on reflecting during this time period. So we will be ready win win win win win remedy that will be ready and when the pandemics over I mean neglecting very.
They've actually started their schedules, which was amazing so we will split off sub debt to running subsets of RFS and need we went public subsets of subjects. We will publish when we have a big package, but not sample we've got enough.
Hi, there as you said as soon as we can which is probably one of the complexes, but also the conference of the moving timing, how we're going virtual and everything is kind of moving around so I.
I would like that they're working incredibly hard selecting and we're working incredibly hard getting after is ready and I'll be put together and be very happy to have released results as soon as it's all going to put together.
Okay. That's it from me thank you very much.
Thank you have a great idea.
Our next question is from.
Capital. Please proceed.
Hi, Good morning, Chairman and the Burleson team. So thanks for taking my questions.
I guess on the veterinary help side, if you don't mind, if you need to share for some more what's exciting to you about that market just seeing us on the commercialization front. It seems like it could be more in the near term and also what was like a plan for comers commercialization look like in that market.
Thank you that's an adequate to focus on the vet as well as the everything else. So what we love about the vet market actually a few things during the pandemic.
Only a couple of assays have got very good results in very important, though Kansas Star tick, we can launch product on a reasonably simple.
Given the current supply chain.
You really need to do hundreds or few hundreds of Doug samples to get a product out there. So tick the might look we don't have to run 10000 trial when no one can travel in the supply chain rolled it messed up and the market itself is absolutely phenomenally Big I mean, there's two and a half times more don't diagnoses every every cancer than humans.
Given that short Lifecycles, and it's something which we take it very good care about four legged friends. So we've been charged the great similar price.
To add the human diagnostics also the collaborators, Texas dynamic I mean, what a remarkable if it they've done during the pandemic to continue on with the work Dr. Bruce and revenues has been an absolute star in keeping things going and and intellectual curiosity to accept what we do understand it and adapted to the debt market, they're one of the bodes very.
Thats a bit schools. So we're incredibly lucky to be working with them. It's not something we wouldn't that unless we had a great partner because we're not that people at all so that continued on.
The data has been good enough pick the comfortable but I think I can launch product with you and it's something which you continue to slow to normal products, because there's a range of vet cancel the range of animals and the market is controlled by few different companies in the west so tremendous licensing opportunities as well as low generic product. So I think it couldn't.
We better for US right at the moment simple product is small numbers of that was getting more product. Its a massive need is a great partner and certainly something we can do during a pandemic. So.
Let's take Thats something closer to the University closes.
I mean, it's on track and I couldn't be happier with the work they've been doing.
Great. Thank you guys I appreciate the appreciate that insight.
Thank you.
Our next question is from Steven Roth.
Please proceed.
Good morning, good afternoon.
Good afternoon.
If we could get a little more granular on your two lead products that are closest to commercialization.
Oh, you mentioned.
Thanks to Bruce's question that.
You're looking at doing these studies in Europe.
The size of the sample you mentioned in the 50 to 100 range of subjects.
He is that's sufficient for the CE Mark.
Yes, sorry that subjects, but I forget the theater with ample so you'd have.
Five or 10 samples from each person ask you would add to that we've done up the hundreds another populations as well, okay, but healthy and sorry, you typically don't have thousands of serum samples because what you have thousands of samples, but from any 100 people longer generally I will add to that other samples that we have to be so I was talking.
50 to 100, where you followed individual person destroy the curve, but to show that actually works in different groups. In the protest is also very good background work. So I'd expect to be in the in a lot more than that and again that's up to out we haven't seen knocking thing now that understand what's required in the process, which we have in house, but it would be hundreds and hundreds and hundreds of samples from hundreds of.
Different people and again it just comes out we intend to abuse and whats available one and then you could add a lot more healthy to what to get better specificity I was talking about the declared that sort of it but you'd add probably quite a few hundred other healthy people. So you'd be looking at least four or 500 samples I think as a minimum to wade want to be but that's a question for our.
Im not a female specialist.
We have a lot of people in that but but it has been loosen the picture and part of it because obviously every once in a hurry to get product out there, but we're very confident with what we're looking at we would Argentina that would be enough to get a CE mark and not just given the market something which people would be interested in buying given the numbers we have.
You mentioned you were going to use some of the same data from the second proof of concept.
Study.
How many.
Subjects were in that study.
And that we had 42.
And then how many how much of that data can be used in the oh.
Longer term data that will be part of the product.
Listen the pipeline the actual papers themselves the products have been driven by acquisitions.
I'm not actually obviously, you know from the Piper or the prices.
We have strong theme mocking team internally and as you can probably but as you've got a tolling. The pipe is public this a dozen different obviously conditions on the during the work for us. So we're getting extremely good advice and what emanated from all those areas.
For that the final numbers, which were working on them but.
That will be I'm looking to do it obviously that's enough to satisfy all the requirements, but I need to get it FEMA, but also to be marketable.
And we're confident.
We want to make sure most incentives as well so.
Yes, so my specialty, but we do have very good people doing that so I'm very confident when we go ahead it would be on a very solid base.
Moving over to the.
New cues that.
Yeah. That's currently in the hands of Texas, and M. College of Veterinary medicine and from what I understand there's a study either ongoing are going to be started.
That you just mentioned, we're going to have a few hundred subjects, where exactly in that process are you.
So that selected arrangement samples that bottom by banks, obviously, the collecting has gone slowed a bit from dumps coming in from other reasons.
They've gone to quite a few other big buybacks. So.
As far as I'm aware, and I'm pretty where they have enough in what's happening there to do the products which are.
For the first product, which is the monitoring for lymphoma and the blood cancers.
So what they have currently is enough to launch the best products the talking about which is why the company doing this year, but they're also expanding is what is possible we buyback samples as well as many large samples as they can.
So that's going to be the bidding a lot of papers now on the pre analytics so that all the work.
The the Athleta stable metabolism side with the for analytics, that's I think been except now so that should be very soon and if there's any a lot more data at the conference in October which would be on supporting all over the work we're doing so lets them bostwick the through very confident of meeting the timeline I mean that can change if there's an outbreak of covered where they are I think this write down but I'd.
Sometimes they are on target for that they have samples that has been good.
For the products and they're presenting the data in pipe isn't it comes is now so.
At the moment so it's all systems go on target.
And last question you closed in the acquisition Voc tumor in January and looking at their website.
If some pretty hefty price point I'm wondering one the sale their sales will start flowing through your income statement.
Yes.
The right. So we obviously that hit right poker did when we were so what the aim it's always been to absorb that same into the Belgian Jay.
So it's now, but it's in Germany from Optima and yet potentially this is why we're very keen on reagent sales being one of the four key areas to drive revenue because mucositis you can tell for a few million the Graham so obviously that could be not to do so brands.
That's not a prediction that's just what I go for that people do smaller amount and then get up to it. So we focused in the March April may sort of timeframe in developing already capabilities and as I mentioned in the script. We can now manufacturer quite a few of the DPCMS ourselves.
But it was pretty obvious to try to do all that in same facility is the development and wasn't going to be what we needed which is why we have been intend. It looks like we are purchasing so the one with a 10000 square foot I will make some team members in there so given all the problems and supply chain for focused not on external thousand last few months, we focused on doing what we need for Uh huh.
3.1 launch.
For the CE Mark for that part of it for the vet thought.
And the phase, which we've been developing that recombinant for so thats, one very well and now that we're moving in and we expect and B.
But maybe the facility in October looks at our attention much more to not just doing stuff for ourselves and secured on supply chain, but as you said there was some.
Optimization reconcile if ever comedy news items and other things an optimist.
So we will in the private now of hiring but but also we're not really a thousand came from that area where in the price of injury.
He has managed to manage the prices of the antibodies to controls the kids and I think is also a strong market for contract research organization, which will be the same facility the ability to improve our lead times is useful for lot of other people and no. One else has ability to do it. So it people shipping samples, which is what we did with names which is the revenue reported last year.
I think thats got potential legs as well so short answer it.
Obviously affected by carbon so we focused on a bill last few months to make sure our programs, where we are valid and now we're focusing on new facility. So then we can I guess like walking through government sometime within 90 days I'm for ourselves as well I'll start selling them. So I'd expect would really thought aggressively doing that in the neighborhood.
Today, we can you sales manager.
Later, this year and I'd expect to see since else picking up all the way through next year because being at the heart of epigenetic we make fantastic components, we think and I think as can be obviously one of them as well so expect to see that one of the for revenue streams coming through next year as well.
Thank you.
Thank you.
A question and answer session.
The conference back.
Thanks.
Thank you everyone I know, it's a very busy time I really appreciate your interest and listened and I look forward to updating throughout this quarter as we have a lot of milestones coming up and on the next Q in November Thank Lucky time Goodbye.
Thank you everyone for joining us today for volition.
Second quarter.
Conference call. We appreciate your interest.
And look forward to speak.
Yeah.
Okay.
Thank you thanks Sharon.
Thank you. Thank you.
Thanks.
The is it the same number we sound.
I don't believe.
Thank you.
Yes.