Q2 2021 VolitionRX Ltd Earnings and Business Update Call

[music].

Hello, and welcome to Volition Rx limited second quarter, 'twenty 'twenty, one financial results and business update conference call and webcast. At this time all participants are in a listen only mode.

I didn't want you require operator assistance. Please press star zero on your telephone keypad.

Question and answer session will follow the formal presentation. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Scott Powell Executive Vice President Investor Relations. Please go ahead.

Thank you.

And welcome everyone to todays earnings conference call for Volition Rx limited.

This call will cover Volitions financial and operating results for the second 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.

Mr Cameron Reynolds, President and Chief Executive Officer.

Mr. Terry Qs, our Chief Financial Officer.

And Dr. Tom You Tara 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 reports on form 10-Q.

And other filings with the Securities and Exchange Commission.

We do not undertake any obligation to update any forward looking statements made during the course of this call.

I would now like to turn the call over to our President and Chief Executive Officer Mrs.

Mr Cameron Reynolds.

Men.

Thank you everyone for joining Volitions conference call today.

Specially appreciated given how busy you all are during the earnings call season.

And speaking of busy our whole team has worked very hard during the pandemic towards our goal of becoming a commercial enterprise.

As you might remember from our last call. We have had quite a start to the year and made excellent progress in developing a range of products based on our proprietary <unk> platform. In addition to making significant progress in negotiations over a number of potential licensing arrangements.

I expect that we will have a lot of news throughout the remainder of this year on progress with our numerous commercialization efforts.

We'll be updating you today on our patents publications products people and most importantly progress within our four key pillars.

Q <unk> <unk> units and you could capture and I'm delighted that Dr. Thomas <unk>, Chief Executive Officer of our veterinary subsidiary is joining us to update on the fantastic progress and upcoming plans when you view bench.

To start off however, I'll quickly hand over to Terri for the financial report.

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 June 30th 2021.

During the second quarter of 2021, we reported a net loss of $5.6 million compared to a net loss of $5 million in the same period last year.

These results reflected research and development expenditure of $3.6 million up slightly compared to approximately $3.5 million in the prior year period.

General and administrative expenses of $1.8 million.

Some of the $300000 higher than the prior year period.

And sales and marketing expenditures, which more than doubled to $459000, primarily driven by our ongoing transition to a commercial organization.

Grant income earned in the quarter was approximately $400000.300000 higher than the same period last year.

During the second quarter of 2021, we also received approximately $857000 of net proceeds through our.

At the market or ATM equity distribution program.

And so we closed out the second quarter of 2021 with cash and cash equivalents of approximately $27.9 million compared with approximately $19.4 million at the end of 2020.

We expect the cash burn rate going forward to average around $2 million per month, excluding the impact of income from a licensing deal or deals if any.

So the company continues to be in a strong cash position, providing us significant runway towards achieving our commercial milestones.

From a revenue perspective, we recorded $25000 in product revenues for the second quarter of 2021, mainly from the beta launch of <unk>.

This was steady with the first quarter of 2021 as expected given the nature of the beta launch.

I don't want to steal Tom's Thunder, but given the interest we're seeing in the new Q vet products from a licensing perspective, we anticipate significant future revenue opportunities to come from licensing arrangements, including potential upfront payments and commercial milestones rather than just directly book sales.

Last but not least our new commercial team continues building a solid pipeline of sales opportunities with interest developing <unk> discover our sample processing service for external parties, such as pharmaceutical companies biotech companies and academic researchers.

We believe that this opportunity should also translate into some solid revenue this year.

And with that I will pass back to Cameron for further operational and product updates.

Thanks, Terry I'm delighted to have such a strong cash position.

It's still a consistently low burn rate, providing us significant runway towards achieving our commercial milestones.

So to patents a core element of our competitive advantage.

We have a broad intellectual property portfolio, which covers both human and animal applications and we continue to strengthen our protection or widen that Mike so to speak.

Our research and development team is both highly innovative and prolific.

And we work hard to ensure their inventions are protected to the fullest extent of the laws. So that we might gain commercial advantage.

The first half of 2021 was extremely busy from a patent filing point of view and so I expect our patent portfolio to continue to grow in the quarters and years ahead.

As of June 32021.

Our portfolio includes 27 patents and families.

Plus III in licensed families 10 granted patents in the U S 14 in Europe.

Further 47 patents granted worldwide.

We also have 89 patents pending.

Our next P publications.

Given our comfort with both our IP position.

And the stability and robustness of our <unk> platform publications and abstracts remain one of our key objectives and our list of publications and abstracts continues to grow.

Starting with our veterinary team.

Our second clinical paper was published in respected BMC veterinary research at the end of the quarter.

With a third clinical paper accepted and imminent publication now.

Our first fiber will be submitted later this month detailing new clinical data for our new qubit cancer screening test broadening its application to seven of the most common canine Kansas.

Also on the veterinary side, we've had two abstracts accepted for the veterinary cancer Society meeting due to be held in October.

We will showcase a lot of new data firstly, using a new Q assays to monitor both disease progression and treatment response in dogs with cancer and secondly, our first ever data using our patented <unk> capture technology in Dolby cinema.

And absolutely fantastic effort on the R&D side from the veterinary team and the researches at Texas A&M University.

Well done to all.

Also published this quarter in nature scientific reports was a fundamental research project led by Professor Stefan holding radar with some volition team members as co authors.

The paper was entitled Cereal profiling of cell free DNA and nucleoside histone modifications in cell cultures.

Summarizing a better understanding of the cell free DNA, and so free DNA biology by measuring and comparing in three different cell lines.

So free DNA fragment sizes, and epigenetic profiles of nuclear.

And the aim to develop comprehensive clinical assay.

I am delighted that our team is involved in such cutting edge research and that their efforts are leading to published papers.

More recently data has been presented at an international Congress by two collaborators from leading UK hospitals using unique units assay in Covid 19 studies.

These posters included early stage data showing that results within Youku nets tests on admission could predict future Covid 19 disease severity.

And that's similar results correlate with disease progression.

A fantastic results and great for the data to be reported as such in International you were now in Congress and to be working with such great colleagues.

We are pleased to be making progress in a rigorous approach to present data, where we can neither peer reviewed papers or at conferences.

However, it does mean a lag time for study results for publication.

The way of example, the data from these two studies was finalized in February March However, released only at the end of July.

All in all 2021 has been our strongest ever year to date with publications and we expect more papers posters and abstracts in the second half of this year.

And sorry to our product updates.

First our new units.

As a reminder, we believe our new units assay will have wide applicability for monitoring diseases with a niche component such as Covid 19, influenza sepsis autoimmune diseases and cancer quite a list and potentially to risk stratify patients for treatment selection.

We have previously reported preliminary results demonstrating that our unique units ethane correlated well with current Covid 19 disease severity.

The recently published prices showed that early stage data with the same assay demonstrated that results on admission could predict future Covid 19 disease severity.

Zero results correlate with disease progression.

The lead author of the first poster Dr. Catherine Maria said, the nuclear nets biomarker results taken non hospital admission in this study correlated with Covid 19 disease severity and were predictive of where the patients required in a general award organ support and intensive care Award.

The study results also indicated that elevated values, you Q3, 0.1 could predict poor outcomes in patients admitted to intensive care.

Including in Association with 28 day mortality.

And maybe a value and risk stratify patients for treatment such as therapeutic anti coagulation as well as in monitoring patient response to treatment and quote.

Dr Sofia Stanford lead scientist and also of the second study commented quite whilst this was a small exploratory study the <unk> net $3 one biomarker values closely tracks the clinical course of Covid 19 patients.

Directly to intensive care.

It had been into a general ward.

<unk> admitted to a General award and then transferred to intensive care during the hospital stay.

These findings suggest that the new Q3, 0.1 assay may be able to risk stratify Covid 19 patients on admission and monitor disease progression in individual patients and quake.

Strong findings from these studies and I'm delighted to say we have further large studies in progress in Covid 19, sepsis and other diseases due to be completed soon with the publication of further data expected in the coming months.

During the second quarter, we hosted our first key opinion leader workshop on the ptosis and are delighted with the level of openness and collaboration across the team.

We have our next session in the coming weeks I look forward to continuing this positive dialogue.

Lastly, with regards to notices are people update I'm delighted to say that we have a seasoned product manager joining us in August.

With a strong track record working in sales and marketing for Roche diagnostics for over 20 years.

Fantastic addition to the team I'm sure, it's something we're aiming to help us develop the first products.

To summarize where we are in what I think is an extremely exciting new area for a proprietary new platform.

We have an excellent results to date with a range of different world class collaborators.

With more results to come and.

And we are now looking to transform these results into a range of <unk> products worldwide.

The numerous potential commercial uses that we have identified to date.

And our expectation for further identified uses.

We have also expanded the team to include a very experienced industry professionals to help us with this process.

We aim to launch our first commercial <unk> remarks next product in 2022 and to outline the strategy for an FDA approval of nets product this year.

And that leads me to another fantastic vision to our team as I hand over to Dr. Tom Butera, Chief Executive Officer about veterinary subsidiary.

You May remember, Tom originally joined volition team.

As an independent director on our board.

But we would then delighted when he agreed to come onboard full time as CEO of the vet business, Tom a seasoned veterinary executive with a fantastic track record.

Joining us directly from the veterinary centers of America Pcie.

Out of the Mars Veterinary group, where he served as business development director.

We are thrilled to have someone of <unk> caliber and experience join us whilst he only joined US at the beginning of May He has truly hit the ground running and has some fantastic updates to share.

Over to you.

Thanks, very much Cameron and thanks to everyone, who has joined the call today Wow, a busy first three months in my new role, but tremendously enjoyable and rewarding.

I'd like to start off by complementing the volition team and the researches at Texas A&M University.

Hey by the incredible Dr. Heather Wilson roadways.

Great work they have done in developing a simple easy to use blood test to address a huge unmet need in the veterinary market.

It has certainly made my job much easier.

Cancer screening is not yet as contemplation of animal health as it is in human health, but.

I believe blood tests like the new to that cancer screening test could significantly help transform.

Any range manage cancer Kenyan animals.

Early diagnosis of cancer has the potential to help improve the treatment and quality of life.

As well as providing valuable additional information to inform the clinical decision making process.

I've had the opportunity in these first few months to really dig deeper into our ongoing research and extremely excited about the clinical work being done by our veterinary team to date.

There are numerous.

Relevant concepts, we have for future programs and I believe that we were really are only at the very beginning with the new platform the veterinary world.

Yeah.

So where are we today.

The recent clinical papers published on the 20th June authored by Dr. Wilson brokerage reported that the new to that cancer screening test almost 82%.

Angiosarcoma cases at a very high specificity of 97%.

The test detects all stages of the disease with unsurprisingly nucleosome concentration levels, increasing with disease severity.

A second paper co authored by Dr. Wilson Roberts has been accepted and as Cameron mentioned earlier is expected to be published any day now.

This paper shows the data from Youtube and detecting a very high proportion of lymphoma patients again at the same specificity <unk>.

The clinical team has also completed the analysis of over 600 canine subjects 500 for cancer patients and 134 healthy control dogs. Unfortunately, I cannot say too much on the call today.

This data will be submitted for publication and a widely read peer reviewed veterinary journal.

But I am happy to say that nuclear zoom levels were evaluated in plasma samples from patients with seven of the most common keen on cancers.

So we do expect to broaden our marketing claims in the coming months. So please watch this space for further updates on this multi cancer topic.

Dr. Wilson Road Rage also presented new data is an invited speaker at the <unk>.

<unk> in June.

This is a closed meeting so the proceedings are not reported however in an abstract regarding the use of <unk> debt in monitoring disease progression and treatment response has been accepted by the veterinary Cancer Society Conference in October.

So we anticipate more clinical moves that.

These studies papers and conference publications, while time consuming for helping to build our profile and credibility with Kols oncology specialists, and GP doctors, which I firmly believe will position us any formidable leadership position long term.

There is also significant progress being made to help expand the clinical utility of the current <unk> that cancer screening tests. In addition to fueling new product development for the monitoring test.

We are continuing our work with several veterinary University teaching hospitals to collect samples from additional cancers as well as other non cancerous conditions, such as inflammatory conditions benign splenic masses, and endocrinology et cetera.

To determine how they may affect the plasma lubrizol compartment.

This data may help us better differentiate between cancer and other diseases and help provide further very relevant products in future.

Clinically I couldnt be happier with our new to that product. So let's go tell these folks about it.

This quarter I had the pleasure of attending the 2021 BMX conference in Orlando, Florida.

While the physical meeting attendance was smaller than usual due to the pandemic. There was also a virtual format available and we have great interest in our new Q screening tests.

We were delighted to be featuring Dr. Su Ettinger's HCA, Dr. Su cancer deaths presentation entitled What's new in cancer in 2021.

So it was just a great speaker and a great advocate for us and we believe we will be still need some of our new cube Tasty studies soon.

We have a busy program planned through late summer and the fall too.

We'll be presenting and hosting a booth at the upcoming Western Veterinary conference in Las Vegas in September and then if the vet show in both new Europe in London.

I said earlier, we hope to have poster sessions at the veterinary Cancer Society Conference in October.

These conferences are helpful not only in raising our profile awareness and credibility, but also we're engaging important dialogue with numerous veterinary colleagues.

These invaluable conversations help us to truly understand some of the unmet needs to provide improved diagnostic cancer screening and monitoring test for their pet owner base, which served to fuel our future product development.

While we are certainly confident in our current knowledge base, we are always listening and open to new ideas, which we are sure to get that are busy conference boots.

And so to a more commercial update in terms of the commercial opportunity in the addressable market cancer in dogs is widespread.

It is a leading cause of death the doors over the age of 10 and there are over 6 million new cancer diagnosis in the U S alone each year.

And as I said earlier.

Screening is simply not commonplace currently in the animal health market, but the need is there the potential to help veterinarians pets and their owners sits there.

The new to that cancer screening test is positioned for use during the annual preventive care wellness test for over seven years and older and for dogs from four years in order of the at risk breeds such as builder Retrievers.

Approximately 80% of dogs visit the veterinarian each year and according to the AVMA in 2016 and was 77 million dogs in the U S alone.

Number which has grown significantly during the pandemic. So the addressable market is simply huge.

But how long we accessing the opportunity.

Our beta launch has achieved everything we wanted from it and we have.

And extremely valuable insight into all aspects of discrete first Youtube product.

Interesting, though I think likely the most valuable contribution from the beta launch has been a high level of interest and has garnered from some of the worlds biggest veterinary companies.

This is not totally surprising give me we're the only company with the outstanding through Q platform.

And there are multiple large potential licensees distributors very interested in our veterinary products, which puts us in a solid negotiating position.

Clearly I am new to the volition team, but I believe it is no secret that volition does not currently have the ambition to assemble its own large scale sales and marketing teams, but rather to focus our skill set and know how on scientific breakthroughs and intellectual property development and to drive the revenue by licensing our patented technologies to large company.

He's already placed within the relevant marketplace.

Yeah.

And so a great deal of my time, together with our Chief commercial officer, Gail for Terror and other talented members of volition team has been spent identifying vetting working with and negotiating with several potential licensing partners around the world.

We are not at the finish line, just yet and I clearly cannot disclose too much given the very active negotiations, but we have a lot of good folks around the table and are certainly at the business end of negotiation with a number of prospective partners.

We hope and I know all of the prospective licenses. So that terms can be finalized in the coming months and we aim to have a very meaningful deal signed in 2021.

On behalf of the whole team I'll be delighted to share that news with you just as soon as we can.

In summary, a fantastic start to my time with the company.

Appreciate the warm welcome from my colleagues, but more importantly have been incredibly impressed with the policy of the work completed to date and the exciting plans we share.

With that I'll hand, it back over to Cameron.

Thanks, a lot Tom great to have you onboard.

We do appreciate all your hard work and the experience you bring to the team.

I'm conscious of time, so I'll briefly provide a quick update on a couple of other items.

I think it happened just as the March quarter closed so as a reminder, from our new capture perspective, we published a clinical paper in nature scientific reports, which details our novel <unk> approach to epigenetic profiling of sake of adding new <unk> in the blood of cancer patients.

We believe the NICU capture technology will be useful not only when using combination with mass spectrometry to discover new biomarkers as part of this paper.

But also as a DNA enrichment technology, which could I diagnosis.

Treatment selection and both treatment and disease monitoring when using combination with either sequencing and <unk> assays.

The nature of scientific reports clinical paper was a great first paper on our nuclear capture with further human studies expected to be submitted in the coming quarters.

And as I mentioned earlier on the call. We have submitted an abstract to the veterinary cancer Society meeting using and you could capture technology in dogs, which you can find them.

It is exciting to see our third pillar of nuclear capture branching out in terms of research from humans to revert uses as well.

And so to our oldest and fourth pillar <unk> in human cancers.

Unfortunately, given the pandemic, some but thankfully not all of our studies have been affected due to a very difficult collection and enrollment environment and we have pivoted to those areas, where we can still make progress during lockdowns.

The brightest note in this pillar during the pandemic is in Asia, where I am delighted to announce we have reached our target patient cohorts for both colorectal cancer studies in lung cancer study.

All collected in conjunction with the National Taiwan University.

A fantastic effort by the team there.

We're excited to have just completed preliminary analysis of the lung cancer study and look forward to reviewing with professor Chen and his team ahead of publication either through clinical paper All conference abstract.

We're also running the assays and finalizing the analysis for the CRC study and anticipate these findings will be presented at a conference in 2022.

As previously reported collection for the U S E D RN and colorectal study has been paused.

And what is hopefully a good sign I am happy to announce today that offer 15th month pause.

Iran re initiated enrollment in June and aims to be enrolling at full capacity in September.

Given all this they expect to study completion date has been extended by E. D. R. N to the fourth quarter of 2022 regarding our two U S. Blood cancer studies. These timings to have now been impacted by the pandemic due to collection and political issues.

The 1500 subject NHL diagnostic study all preliminary protocol development and study preparation has been completed.

Given the experience we've had with EDI, Iran. We're closely monitoring the ability of clinical sites to performance study as covid restrictions dissipate, while ensuring our pre analytical and logistical procedures aligned with routine clinical workflow.

We now aim to begin collection light this year protocols and pandemic permitting and submit the first data to the FDA like in 2022.

Covid restrictions have also made sequential therapy matched specimen collections exceptionally difficult in the D. L. Bcl treatment monitoring study, we now aim to issue interim analysis results later this year.

We also have ongoing negotiations with a major player in Asia on our first human cancer launch in China.

We will of course keep the market updated on any successful transaction being closed.

As discussed on previous calls following the opening of silver one.

We have installed a service lab in the new facility, which will undertake sample processing for external parties, such as pharmaceutical companies biotech companies and academic researchers.

We have branded this service you can discover and have already generated much interest.

We have commercial interest from and quite send to multiple pharma and biotech companies and anticipate revenue from this activity this year and continuing to grow in the future.

Thus far the projects we are handling through <unk> discover service involve exploring the use of our new assays to monitor the efficacy of our customers' therapeutics in development for cancer, the ptosis and other serious and chronic diseases.

Both pre regulatory and regulatory trials.

These projects initiated and indeed, if the outcome is positive.

Could lead to more significant revenues for volition, if our assets are proven as companion diagnostics to our customers' therapeutics.

And so to the future.

I'd like to reiterate our vision and what makes us so excited with the progress and our space.

Volition is an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health.

This has been our mission since our founding and it's coming to fruition with our new <unk> platform at the very heart of epigenetics.

We believe the lost decade of work evolution with our ever expanding payment epigenetics puts us in an extremely strong position with our expansive IP portfolio to be a significant player in this key field overall.

Overall on so many fronts with our ever growing team and IP I'm delighted with the progress we are making and I'm excited by the momentum we have developed in the epigenetics failed.

Indeed, our whole team is incredibly excited about the company's future opportunities.

We aim to report throughout 2021 and beyond numerous key milestones now that we are in full swing in turning our platform into a range of products worldwide.

We will focus on driving revenue in the coming quarters in the following key areas.

<unk> licensing of our technology with a particular, but not exclusive focus on <unk> with the aim of signing the first deal or deals this year.

Two nuclear discover processing samples that silver one using a new discovery assays.

And three disease monitoring tests, such as Covid 19 and sepsis.

We also aim to publish data on multiple fronts across our four pillars.

Along with the rest of the board and indeed, the hold company look forward to sharing the results of key studies over the coming months and year with our optimized platform.

Thanks for joining the call today I very much appreciate it given this earnings call season.

We're happy to take questions now.

Operator.

Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question Hugh you.

You May press star two if he'd like to remove your question from the queue for participants using speaker equipment may be necessary to pick up your handset before pressing star one one moment. Please while we poll for questions.

Our first question today is coming from Bruce Jackson from Benchmark Company. Your line is now live.

Hi, Yes, good morning, and thanks for taking my questions.

Thanks Bruce.

So.

If we could just talk a little bit about the <unk> capture.

Product line.

The paper in nature of course is a major milestone for you lots of potential applications here have you gotten any like inbound interest from people who want to work with you on this either in their own labs or with silver one.

Yes. Good question Bruce. So then you could capture program, we've been making progress I guess on the two fronts. So it's split into the sequencing and mass spectrometry. So as you I'm sure read the paper that the papers on the mass spectrometry side. So we are starting to generate some interest on that side.

And it's such been encouraging the sequencing side.

We hired I think you remember and you've met Dr. Terry Kelly.

California.

He has been building a team to fully optimize.

And that process as well so it's too early on the mass spec side, because it's like RSA as we've had to spend a lot of time.

Making sure, it's very robust and reproducible and very good.

Good enough to be to be a product.

On the mass spectrometry side given.

Given the paper and the work we have we are seeing interest.

But the commercialization and focus.

Given capture it's still very much a work in progress has been less of an effort than in the vets in the nets and the human cancer side.

Because I agree with everything else, we want to make sure it's fully.

Fully optimized and then quite a.

Reproducible before we really start marketing it aggressively but there has been some interest on the mass spec side as incoming interest but.

I Wouldnt expect for us to put a lot of effort into the capture side.

Amortization until it's fully optimized so hopefully sometime in the next 12 months, but I guess, we'll see how the optimization guys.

Okay, Great and then.

Moving over to the nets.

You outlined.

The FDA regulatory strategy really quickly I was hoping you could just go through that again.

I didn't quite catch if it was you can have the strategy by the end of this year, if there's going to be.

Ready to submit by the end of the year. If you could just run through that one more time I appreciate it.

Absolutely, yes, no it's not submit by the end of the year, it's get the strategy. So I think on the nuclear net side, we've been very happy with the data and our fantastic collaborators we've had.

And it all lines up incredibly well our team and our collaborators are exceptionally happy now we're in the process of working out I think to put it in one way we're shipping from Avaya uses of opportunities. So.

We're following a little what we've done on the vet side, we've strengthened the bench within industry professional restart soon we've had great data with collaborators.

Our strategy will be a very similar one in the sense, we will launch our own product, but also look to use it in a wide range of areas with other industry players of our collaborators.

So the outline.

We're talking with several parties in the U S about potential uses of it in areas like sepsis.

Jason has been doing a lot of work with our CRO on working around 500, 10-K study alone and we've also been talking to partners about using it in conjunction with other things to currently used.

In Covid and sepsis so.

Aim is to sort of get all of that ready.

So the FDA work and outline our strategy this year.

And on top of that we're looking of course on a European strategy, which our new higher ex Roche.

<unk> is helping us with as well.

Does that answer your question Bruce.

It does and thank you so much I'll hop back in the queue.

Thank you Bruce have a great day.

As a reminder, that star one to be placed in the question queue. Our next question is coming from Nathan Weinstein from Aegis capital. Your line is now live.

Good morning, and thanks for taking my question. So, perhaps we could start with <unk> and just would appreciate sort of a general view into the beta launch how that's going any reception.

Reorder rate or anything you could say to kind of help us understand how that is proceeding would be great.

Yeah, absolutely. Thanks, Nathan So I think as Tom very well put it its done everything we wanted it to do it was done to make sure. We're all the aspects we're ready for our own launch which was the focus of the last call.

Since then as you probably gathered our focus has been on.

Partnerships on the launching with the very major players.

Their interest has been very very large.

Strong interest from the large players.

Tom has been spending a lot of its time.

Making sure that the negotiations are going as well as they can and as quickly as they can.

A strong focus now is to license through one of the big collaborators as he said.

So the beta launch I think showed us a few things.

The interest from the Vets, who has been very high I think we've worked at all.

The issues, we had to do with shipping and packaging all those kind of things. So that we certainly can launch ourselves.

Think the best way to make sure you get a good deal is to be able to do it yourself.

Under no circumstances, when we sign a what's not.

A good deal with event company, because we can launch ourselves and we've shown that now but the interest has been very large as I said it from the best companies and why wouldn't it be it.

Instead, it is a fantastic platform, it's a mass market easily we think it's easily several million tests per year, which is potentially hundreds of millions of dollars in revenue. So even for the one of the big vet companies that moves the needle.

So yes so.

You did everything we wanted to do.

We're really focusing on getting a very meaningful deal with one of the big players and we will keep the market updated on that but I think overall.

The big launch with everything we wanted to Dominion was a very good success and sales as you say the steady which I think we're also happy with because we have not done a relaunch we do not have the sales team will have no. One on the sales side. So it's been ticking over at a very steady pace, but the focus really is on a big deal, which I think would be quite transformational for the company.

<unk> as well as for the <unk> subsidiary.

Great Thanks, Cameron and.

Turning to clinical cancer, it's great news that our end.

It looks like it's proceeding again and actually just thinking about NHL diagnostic study in particular, we have this timeline around submitting first data to the FDA in late 2022, I'm can you just help us think about what our expectations should be for that and would that data may be sufficient to drive clearance in that indication.

Yes.

Jason can go through with you there are many sub types of NHL.

And I'll, let him go through all of those with you.

The biggest ones, we can be potentially done in that timescale next year, and then submit to the FDA, which would be a product launch in 2023.

And I think once the trials in full swing and collections going obviously, you're not going to take a huge amount of time.

The delay has just been very understandable and pandemic, it's tough getting protocols.

And collections, obviously difficult and particularly in the longitudinal studies, well, where you're trying to get fixed.

The same person to come in six times during Lockdowns and Pandemics and they can be very problematic, but I think.

So end of next year I think is very achievable.

That's our target date and that would be enough for the first FDA product if it was successful.

In 2023 and.

As you can tell on the vet side, the human blood, Kansas are very similar to the <unk> to the animal Kansas. The data has been very very good on the vet side. The product is being received extremely well and the data is very similar what we have now and the human side and the need is also very strong in humans. It's about.

Oh, combined about 5% of human cancers.

It's a very.

It's a cancer, which is if we could be very helpful. And it's also one where there is absolutely no really good current to way to directly towards the biopsy. So I think it could be a very good product as well.

We will keep you informed but our U S team.

Led by Dr. <unk> has been working on this a lot to really push it through.

Great. Thanks, Cameron Thanks for taking my questions much appreciated thanks, Michael.

Take care. Thank you.

Thank you next question is coming from Steven Ralston from Zacks. Your line is now live.

Yes.

Good morning, or good afternoon, whatever the case may be.

Yes.

To drill down to the.

<unk>.

You have it seems like you've established a steady base on.

The revenue side there as you proceed to.

Get into them a partnership arrangement.

In your in house sales effort, which youre not going to build on but exists.

It seems as if your customer base was primarily in Texas and I'm wondering if there's going to be some just natural geographic expansion there with all the.

And new information that youre pushing into the veterinary field abstracts the papers attending these conferences.

And whether you would have.

Veterinarian to outside that small geographical area.

Contacting you.

To utilize your product.

Yes, so yes all of the answers. So yes. The interest has been good yes, it's been focused on Texas, because that's where the beta launch was we have not spent much time or effort and have no salespeople.

Pushing the product this was.

The teachings that we can do a national launch, but I think.

That you can try and grow organically like that but I think given in our opinion and I think as well backed up and this is potentially a very big mass market products in the millions of tests per year, which in for the entire product would be hundreds of millions in revenue per year to be shared around by a few parties, but.

But it's the first product I'll focus really is on getting a partnership because I won't mention names. We're obviously in very serious discussions, but all the obvious candidates are very keen and.

Some of them have getting close to a 1000 salespeople worldwide.

And many different countries there.

Their interest.

Often be exclusive.

We give them that Jo Malone it depends I guess on how aggressive you're going to be in and what they can pay us.

Each one is has better.

<unk> focus on need to point of care or vets themselves zorba borrowed trees.

So at each partner comes with benefits and.

In different areas and Tom Bain in the industry's entire life, obviously knows the move very well and knows the chief executives of all the companies we're talking to.

So I think I wouldn't necessarily see it as an organic growth coming out of Texas now I think.

Hopefully I mean, no deal has been fun. So I mean, we're.

We are hopeful and it's looking very good but we don't have to find a deal. If we did not want to we can launch ourselves as you said and grow organically, but I think the potential to grow very quickly is much higher when you are with that.

A company that could be what 60 or $70 billion.

Some of them are and even one of the smaller companies with point of care specialists with several billion dollars just for this one product area. So.

We'd look at it much more as getting a deal.

Hopefully signed as Tom said this year and then really launching quickly now if that doesn't happen for whatever reason and that's certainly possible.

We will continue to grow we will hire the first sales group and push out on our own launches.

Thank you.

Best quickest easiest way to get this is a mass market product and so we can also focus on all the other things we're doing in the nets and the human Kansas.

And put all of effort into that would be a licensing deal and as I said, they are going very well in those discussions so.

Keep in Europe for the rest of the year, but something we're hopeful about.

And thank you and looking forward to that.

The other potential revenues in the second half of 2021.

Hu <unk> discovery.

You mentioned that you've provided multiple quotes to.

Several pharmaceutical and biotechnology companies.

That's correct.

Generally what is the timing.

Timing on them, considering these quotes and going through and deciding to go forward with them.

That's a good question actually and that's actually something Terry is going to have to work through.

On the revenue recognition side.

But we do have a handful of quite some of them quite chunky and in aggregate of it certainly in the hundreds of thousands of dollars now how many of them actually come through how many can be booked this year. If it's a year program. Obviously have to book the revenue every year or two all those things will have to reported in your accounts.

And as I mentioned on the call quite often with these things they can start in the tens of thousands and if it all goes well and if you use that could be in the millions if it continues through but.

For for where our revenues at the moment.

Hundreds of thousands in quotes with a very real companies. It is a good start.

If we convert a fair percentage of them it will be a reasonable amount of revenue over the next 12.18 months or two years and hopefully growing.

Because I think as I discussed before I think we have something very special.

Epigenetics is really taking off our platform now is very very stable.

Have over dozen assay. So we can run on an auto analyzing now.

Tech different six inch signatures on the nuclear <unk> as well as potentially revenue coming from.

Domestic pulmonary and capture side as well as running samples as well as selling nuclear times.

So I think that could get quite interesting, but I think this year.

And depending on how many quotes converted.

As with many things they speed up and slow down and but when you have quite a few of them going at the same time, we're quite confident we can book some revenue this year.

<unk> showed strong growth through next year.

And thank you for taking my questions.

Thank you Stephen take care.

Thank you. Our next question today is coming from Jason Mccarthy from Maxim Group. Your line is now live.

Yeah.

Hey, this is Michael <unk> on the line for Jason Thanks for taking my question.

Thank you.

Yeah.

So I'd like to ask just in Europe.

In your press release over here you do mentioned later this year and the ptosis Youre expecting a few readouts from some larger trials coming in the coming months, but let's see if you could give us a bit more color on what data points, we could expect from those studies.

Yes.

As an example of what how long they know that.

<unk> released results typically through a publication appeared publication of our conference sometimes there's a lag time. So for example, the great data that came out from <unk>.

<unk>.

And Pseudomonas is London was ready in February but not represented the conference in July just the way conferences work and I can't talk too much about them, because theyre not public yet, but obviously.

There's a lot of work going on in the last few months, which are in the process of being published and will be published later this year.

There's a very wide range I think mitosis.

Is really quite spectacular in its opportunity I say that because.

If you look at the conditions, where <unk> is a main or a big driver.

Sepsis.

Influenza covid it looks to be a primary driver in the metastasized cancer heart attacks strokes I mean, it's just quite amazing.

How many things that RSA is could be useful and as you can see.

If im not sure if you had the chance, but if you haven't I would strongly recommend read the abstracts that were from July it's quite remarkable.

The potential uses that our assets could have and again. This is only the start. This is just the first one is that we have ready there's a lot of epigenetic signals.

The net themselves and related to all this but.

It's something which if you have a high level of knits. It's not good for you in for example in sepsis and Covid it could be hundreds of times a healthy person's normal level. If you are in intensive care.

It's not good news, so I think it's something which a lot of people that want to buy a lot of hospitals, who want to know what the niche live a lot of everybody in the hospital because sepsis can kill you. If it comes on stream quickly and it's not really seen so all of our trials and we're working on a range of different areas.

We did a lot of work on Covid for obvious reasons.

But finding a trial for products being a little problematic because when the hospital was a very busy but very very busy amendment, it's getting them to collect samples.

A trial is problematic.

Unfortunately, it is in every hospital every day, so collecting large numbers of samples is obviously not as challenging and its not seasonal or a variant related like covid spikes tend to be so.

I was doing a lot of work on that.

And also a broadening into the other areas, where <unk> is known to be quite strong as I mentioned.

Including cancer and as you probably remember we also have a relationship with centers in the monitoring.

Of and treatment of <unk>.

This ah using blood plasma apheresis to remove nits, so I expect to see some data on that V series will and potentially.

If it goes through what would be a fantastic publication.

Using our assays to monitor they can show that they can remove nits that's been doing it in pigs and now they've had the first human.

Humans.

Treated.

So there'll be a lot of data we expect on the the bits of the Covid sepsis and all the other conditions through the rest of the year.

You too much more because they're obviously being run now and in the process of being either prepared republished but.

It's definitely picking up space picking up speed in the space and there'll be a lot more data.

We're also focused we don't just want to keep producing more and more fantastic data, we're very mindful, we're a product company now.

We're looking at all the different ways, we can make products. So expect some news on that as well.

Okay.

Alright. Thank you very much and then I'd just like to touch briefly on.

On lung cancer, specifically you have the N <unk> data coming later this year and that's a pretty large dataset. So I'd like to ask what would be the next steps after the NTT data for getting the first human lung cancer product to market.

That's a good question, Michael and something we're looking to do obviously that partially depends on the data as you probably remember the initial data was encouraging are quite encouraging.

And it was looking at low doses demography as well as the general tests.

Quarter remarkable study that was close to 1000 lung cancer samples and there.

She is as you know is huge for us.

For study.

That's something we're working through it.

Somebody would have an ethical today will process. The data so that finished collection, which is fantastic and quite an accomplishment during the pandemic as you know.

A lot of places don't manage to do that but Taiwan has.

And also what they are doing now this trial is 200 samples in this 7000 on the colorectal side. So at the moment, they're collecting the clinical data, which when you're looking at thousands of different patients can take some time, but we're analyzing the sample data now once we've seen that data.

See what questions have been answered, but and then make a decision on how we commercialize but as I said before we're hopeful because the early data was very encouraging.

While we do not have a current clinical path for that product like we do for the other ones, we'll wait to see the data and make some decisions.

Alright, Thank you very much Kevin.

Thank you Michael.

Thank you we reached end of our question and answer session I would like to turn the floor back over to management for any further or closing comments.

Thank you everyone.

In an exciting start to the year I think it should be an even more exciting end of the year.

We've got a very strong commercial focus now and I'm very hopeful to have some very good news.

On a range of different areas, including commercialization in the coming months and I look forward to updating you as they happen. Thanks.

Thanks for your time.

Thank you that does conclude today's teleconference. Webinar you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.

Okay.

Okay.