Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited's Third Quarter 2022 Earnings Conference Call. [Operator Instructions] This conference is being recorded today, November 15, 2022. I'd now like to turn the conference over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, operator and welcome, everyone, to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the third quarter of 2022, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer; Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary subsidiary; and Mr. Terig Hughes, 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 used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions, actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements, we have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this conference call. I'd now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thanks Scott. And thank you everyone for joining Volition’s third quarter 2022 earnings call today. We especially appreciate as always, your time given the busy earnings call season. We will commence the call with Dr. Tom Butera, Chief Executive Officer of Volition Vet to discuss the rollout of Nu.Q Vet by our global supply and licensing agreements, then to Terig who will provide a financial report. And finally, I'll provide an update on the great progress the team have been making with regards to another of our key pillars, Nu.Q NETs, as well as a brief update on Nu.Q Cancer. So without further ado, I'll hand you across to Tom for an update on what's been an incredibly exciting time for our vet team.

Thanks very much, Cameron. And good morning, everybody. I'm delighted to say that we've continued to make very strong progress in our mission to provide an accessible and affordable screening test to aid early detection to veterinarians and pet owners around the world. Last month, we were thrilled to announce the signing of a global supply agreement with a market leader in pet health care. Through the supply agreement, we are working with a market leading company as a worldwide provider of the new Nu.Q Vet Cancer Test through its extensive reference laboratory network for cancer indications in animal health. This is a breakthrough agreement, and together with our previously executed agreements, means the Nu.Q Vet Cancer Test cancer test will be available at a mass market level. I am absolutely thrilled that this agreement has been executed, and that the teams are now working towards a product launch. I very much look forward to providing further updates in the near future. And speaking of product launches, subsequent to quarter end, we were delighted to announce the launch of our Nu.Q Vet Cancer Test across the United States and the forthcoming launch in Europe by Heska Cooperation, also one of the leading global providers of advanced veterinary diagnostics through Heska’s Veterinary Diagnostic laboratories. I just want to repeat that this is the launch via Heska’s reference labs. This means that any veterinarian in the United States, the world's largest pet care market, can now order the Nu.Q Vet Cancer Test for their clients. Interestingly enough, this news broke the morning of the New York Pet show. And our booth was nearby the Heska team. And we mutually enjoyed a great deal of interest and interaction with the veterinarians and vet techs attending the show. And it's not just the US.…

Thanks very much, Tom. And thank you everyone for joining our earnings call today. I'll now provide a summary of the key financial results for the quarter ended September 30, 2022. We ended the quarter with cash and cash equivalents of approximately $16.4 million, compared with $16.7 million at the end of the second quarter, and $20.6 million at the end of 2021. During this quarter, we received approximately $6.4 million in cash net of underwrites fees and expenses through an underwritten public offering of our common stock. Additionally, we secured a further $1.5 million in non-diluted funding from the more invest capital risk in Belgium to fund an early access program for Volition’s Nu.Q product portfolio at key sites across the EU, UK and US. As of at the end of September, we've drawn down $1 million of this funding. Just for information during the third quarter, we made zero sales of our common stock under the aftermarket equity distribution program. We continue to manage our expenditures carefully with net cash used in operating activities averaging approximately $2.3 million per month in the three months for the end of September. Revenue reported year-to-date 2022 was approximately $187,000 versus $76,000 for the same period in the prior year. This revenue figure excludes the receipt of an upfront milestone payments of $10 million in cash from Heska Corporation received in March. It is worth noting that while this payment has been fully received and is nonrefundable, it has not been recognized as revenue in the period and has been accounted for as deferred revenue in accordance with the relevant accounting standard. As Tom mentioned earlier, it will be recognized as revenue over the lifetime of the point of care product which has not yet been launched. This was just the first of several milestone payments expected in relation to the Heska contract. We anticipate that the next two milestones will be achieved and payments totaling $13 million will be paid by Heska during the first half of 2023 with the final payments of $5 million due following publication of clinical use data in cat most likely in early 2024. Given our current balance sheet and finance expected in the short to midterm, we are confident we have the resources to deliver on our upcoming milestones. And to see as to the revenue ramp we expect to start following the worldwide launch of the best products anticipated in 2023. As we discussed on previous calls, given the product range, we believe we can develop from our proprietary nucleosomics platform. We believe our addressable markets are very significant, most notably in the short term with Nu.Q Vet and Nu.Q NETs and I'll be happy to discuss the total addressable market in future calls should that be helpful. I'll now hand it back over to Cameron for further business updates. Cameron?

Thanks, Terig. And thank you, Tom for those comprehensive updates. Great progress indeed. I will wrap up the call today with updates on two other product pillars, Nu.Q NETs and Nu.Q Cancer. Early in the third quarter and highlighted on our last call, we sponsored a GenomeWeb presented by Dr. Andrew Aswani at Guy’s and St Thomas' University Hospital London, titled, The Promise of Neutrophil Extracellular Traps, NETS as Biomarkers in Inflammatory Disease. This webinar is the second in a series was incredibly well attended with an engaged audience. To watch on demand, visit the GenomeWeb website. Also during the third quarter in collaboration with researchers at the University of Namur, and PolyBlood in Belgium, we published a clinical paper entitled NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients and Observational Studies, and a poster presentation entitled Evaluation and Comparison of NETosis Biomarkers in Sepsis and COVID-19 patients. At the International Society on Thrombosis and Hemostasis, ISDH Congress in July. Subsequent to the quarter end, we also presented data at the International Symposium on infection in the critically ill patients and international sepsis forum. The key findings presented are that levels of NETosis, as measured by our Nu.Q NETs test, are highly elevated in sepsis. And moreover, that the results of our tests correlate very well with the severity of disease. The severity of the disease is currently assessed using the sequential organ failure assessment SOFA score. This score is assessed on six separate organ functions , lung, cardiovascular, liver, kidney, the coagulation system, and the brain, our test results just a single number from a routine blood test correlated with the SOFA score, with something of great interest to the clinicians in attendance at the forum. These conferences were a real highlight of 2022 with many…

[Operator Instructions] Our first question comes from Michael Okunewitch with Maxim Group.

Hey, guys, thank you for taking my questions. And congratulations. Seems like you've made a lot of progress over the last couple of months. So I guess first I'd like to get a bit more on the ILYAD study and in particular how it differs from the lung work that you've done in Asia? And then what are the timelines for this study? Is this using one of your CE Mark assays? And could this potentially result in a commercial product if the data from that is positive? I know it's a multi part.

Yes, very good question. So obviously, we've had very good data from Asia, which we've talked about a lot. And obviously, during the pandemic, there's been issues in other countries there. So it's good to have a focus in Europe very close to our home. We're working very closely with the university in France. And they're absolutely world leaders in what they do. They've been running our tests and seeing how they work. And now they're very keen to see if we can be added to the national trial and the National Screening Program. So it depends on what assays they're testing a few different assays, what is the final product, but it could include part of what is currently FEMA that will be determined by the study. So the study they have underway now should be finished next year, by the end of next year. And the aim, if it goes as well as they would like would be added to the National Screening Program. They've got obviously everywhere lung cancer is a massive problem, and no less in France. So the government's really trying to do something about it. So we're hopeful, we've seen very good results as have they with what we do, as we have in Asia and adding it to their trial, and we'll see how it goes. But very encouraging. Absolutely top worldwide opinion leaders in this field, a great study, and we're really happy to be part of it, and we should have the first round or finished by the end of next year.

Oh, yes, thank you for that. And then regarding the study with Oncovet, is this a program that you reached out to them to do? Or is it something where they saw the potential of Nu.Q and then reached out to you to conduct the study?

Tom?

Hi, Michael. Just add to that, no Dr. Benoit actually reached out to us because he was very interested in our platform, and was his staff as well, has a number of Board of oncologists there as well, we're all very interested in and so we were delighted and flattered by his outreach.

All right, thank you for that. And then one last one. Sorry go ahead.

I think that's indicative and Tom can verify this from his point of view. We're doing a lot of vet shows and interest, the inbound interest has been absolutely fantastic. Tom, do you want to speak to the inbound interest. Is it normal level of interest from people?

Yes, this is I mean, just one last comment to Mike on Dr. Benoit he's also the president of Esvonc. That's actually where he initially made contact with us, Esvonc is the European Veterinary Oncology Group, which is similar to the American VCS Group, which actually Dr. Robles is President of who's our Chief Medical Officer at Volition. So we are continuing to attend, I am in London, obviously, this week, to attending the London Vet Show, we continue to spend a lot of time in Europe as well as domestically and the interest from my veterinary colleagues both on the oncology side, as well as the general practitioner side is quite robust, tremendous interest everywhere we go, and we are being invited to so you know, a lot of the conversations and a lot of the presentations that we're making, even the ones here in Europe right now, I'm personally being invited, and [inaudible] was being invited to speak, we just spoke in the Netherlands, we're going to be going to Portugal to speak there. So these are frequently coming from invites to us personally, as they were this past summer with reference to Germany and France as well. So we're delighted and again, flattered by the amount of attention the test is getting.

Thank you. It's certainly exciting to see how the vet programs unfolded. Just one last follow up to that question, and then I'll hop back in the queue. For that $5 million milestone from Heska once you get a publication in cats, are you suspecting that a publication from the Oncovet study, given that that is including cats could support this milestone.

Yes, we work, we're reaching out obviously, to get additional feline as well. And also, we like the fact that we're reaching out to additional KOLs to support the research that we're doing. And we'll look to see and align that the information and the studies that they're doing aligning up 0with the studies that were running in the US. So again, parallel studies, at different locations supporting the validation of our tests in the cat is obviously going to lend a lot of additional credibility to the value of our test.

And we strongly expect just from the last point to get to the critical mass we need for the product really to take off. We've had fantastic partnerships with the GI Lab in Texas, and in Singapore, but they are relatively small labs, and it's never going to be a large amount of running through them. But with the potential launches in the short term of Heska. And the other very big company, I think it'll generate demand or generate demand, and they'll support each other. And so we're launching, we think, on point of care, and in lab, reference labs. So we'll have it all covered, and just fantastic demand that the vet team has been generating. Hopefully, we'll meet the supply from the big companies, and would really expect to start taking off once they've launched the two big companies in particular, which would hope to be early next year.

And one other thing to remember, these 84 million dogs in the United States. There's close to 90 million cats. And we haven't even touched on the potential opportunity that's there. So obviously, the analytical studies we're doing on the feline is going to be immense for us as well.

The next question comes from Bruce Jackson with The Benchmark Company.

Hi, good morning, and thanks for taking my questions. A couple of follow up questions on the ILYAD study. Are they evaluating any other testing modalities in addition to CT and the Nu.Q test?

Not that I'm aware, no, from what my understanding, and it was the study I developed but it was where the only blood test and CT scan and then other lifestyle choices and areas but and smoking but we are to my knowledge, the only blood tests on there. So hopefully we could be a very important part. Because I mean, as you know, there really isn't another blood test to help. They're certainly not something routine, and can be run easily. So it's something we're very hopeful for.

And then in terms of how this plays out, so they finish up enrollment end of 2023. Tell us what happens after that in terms of the review period, and what their intended plan is in terms of developing national screening guidelines. And when those might be in place.

They're looking for a very comprehensive strategy. I think it was outlined a little in the press release, between mitigating smoking, CT scanning, mobile centers, where they can scan and test your blood, a very comprehensive program, because as you know, Bruce, lung cancer is incredibly deadly and happens all too quickly. So they're looking for a comprehensive program. And we're hopeful we'll find out after this trial has gone through to be a part of the system of what they do. So it'll be the running of the trial and the data we'd expect by the end of next year. And then the government will decide what the package is, which has -- been the government, it can be done reasonably quickly. They put a lot of resources behind it. And they're very keen to see how our Nu.Q platform works, given the data we've had in London, other cancers, they're very hopeful that we can be helpful to them. And I think it's very good now that we have a fantastic base in the vet space, a very good basis now in NETosis. And also very heartening to be back in the human cancer so actively in Europe now, as we have been in Asia. And don't forget that the DXOCRO study is also looking at human cancers, particularly the liquid tumors. So we've got a lot going on. And as Tom said, the rocket on the launch pad, and we've got so many things now, which are ready for liftoff. And we strongly expect the vet market to really take the demand to really grow strongly once the big companies launch which we expect to be soon.

Okay, great. And then turning over to the vet space question for Terig, on the Heska milestones the original payment is being amortized, are the upcoming milestones also going to be amortized over a certain period of time, or would those be lump sum payments to you.

So we will get them as lump sum payments, which we'll be able to use as cash, but they will be treated exactly the same as the first payment. So they'll be amortized over the life of the product from a revenue perspective.

And then with the new agreements that you've just put in place, how are those going to be coming to you in revenue.

So for the new agreement, we will get a payment every time they sell a test. So similarly to the way that every time Heska sells a test, Heska, where we will get a payment every time Heska sells a test. Similarly, every time this new company sells a test, we will get paid.

One thing to make clear here, Bruce, Heska, a fantastic partner, and they got exclusive of the point of care. But what we're looking to do in the reference labs, as you can see, we've got a bunch of reference labs and we'd expect a bunch more, we really want as many companies out there selling the product as possible. Because we get a very large, very reasonable percentage of the revenue in all the deals we're looking to do. So but we do not expect to get large upfront payments in the nonexclusive space in the reference labs. The most important thing for us with them is that we have large coverage with the biggest companies out pushing our products. Because as Tom said, point out there's 10s of millions of dogs. We know our target market in the US alone. So we want every vet having the opportunity to run the test on as many platforms as possible. And we're looking to get a similar structure as possible for each one in how much we get paid per test. So they're very lucrative for ourselves, particularly if they reach that potential, we expect them to reach.

The next question comes from Steven Ralston with Zacks.

If we could discover, talk about Nu.Q Discover. There was a -- you had a multiple contract sign that had an aggregate annual worth of $200,000 and they were expected to ramp up on during the fourth quarter -- second half of this year. Are those on schedule? You also said it tended to be lumpy?

Yes, it does be lumpy and so it is lumpy but so Discover we had a bunch of them as inbound interest end of last year, early this year. And as you rightly pointed out, we've now closed them all, the trials are all going very, very well, all different uses, and fantastic to see our platform being used in so many different ways by different companies, we will now use a cricketing term we're getting on the front foot. And we're making outbound interests to get demand up. So we'd expect to see a bunch more again next year. So the bottom line is, it's gone very well, the companies we've signed, the work is progressing very well, in a very wide range of areas. It is lumpy, and we are expecting a lot more. And we've actually now taken on some team members who will help us to really get on the front foot and to get out. Because there are potentially hundreds of different clients out there, we think so well, we've been very active now and expect that to really come through more next year, with a range of new contracts in the Nu.Q Discover space, as well as perhaps follow up on the ones we've already found.

Thank you. Over the last few quarters in the 10-Q, you've added quite a number of employees in certain areas. And I've noticed, at least in my model that your aggregate employee expenses, R&D and G&A are on target. But it's the mix is changing. I mean, the G&A expenses are actually going down and the R&D expenses are going up. Is there any significance to that?

Terig?

So with G&A, yes, we do try and keep the G&A, they are very much under control, where we have added is building out the infrastructure for the future business. So the support element. In terms of R&D, we've got, I think, within that number, we've got the innovation lab, which we've been staffing up and building out. So that's one of the elements that you'd see there. And I think also within the R&D, you've also got the production side of things which we've been building out. So it's basically building the infrastructure to support the business that we expect to get in the coming year.

All right, thank you.

Steven, as a company, we've been very careful to keep our administration costs as low as possible. And to really hire new people really at the front of the mind, so to speak, to make sure, as Terig said, the production we can really meet the capacity, we expect strong demand to be rising through next year. So we want to be able to meet the supply for that. And also our teams in the marketing of the products as well as the development of the products. So we want to -- we have -- we're focused on our current products very, very carefully now, as you can tell, and we're also trying to stay on the cutting edge of epigenetics. So we've done some research through the nucleo capture side and other work. So we're managing to do an awful lot with not very much of a spend, given how careful we are. And the adaptability of our platform is truly remarkable. We're doing all the things we're doing with exactly the same platform. So I think a lot of ways we have a very unique proposition.

Thank you. And my last question, could you provide an update on those marking studies being conducted by the National University of Taiwan?

Yes, so we've been back and forth with them quite a bit. Obviously, there has been some issues in Asia. And we've done a lot of work in Taiwan and China, we will provide more updates as they come through. Justin done a lot of work with them in colorectal and in lung. And once we have the updates to be finished and what the future looks like for those we will update. As you can see, the lung up particularly is going very well. That's why it's come back to Europe. And we will fully update follows when we have more information from the conferences, but we've been very, very happy with the partnerships we've had down there. And we've been hopeful, perhaps of getting some more work in Asia, but it's just starting to open up now after the very end of the lock downs of the pandemic. So hopefully that will be picking up a lot in different areas. But our team has done a great job spearheaded by Jasmine in keeping all going during these very difficult times due to the lockdown to the pandemic.

[Operator Instructions] There are no further questions at this time. I would like to turn the floor back over to Cameron Reynolds for closing comments. Please go ahead, sir.

Thank you all yet again for joining our call and I think it's going to be very exciting next few months as we launch a range of products in the vet space and make very strong progress including the studies in the US on NETosis and progressed all the human cancer side, it's getting more and more exciting, and we're getting some, hopefully some very big launches soon, which would really help generate a very increasing amount of revenue. So it's going to be a very exciting time. So please keep in contact, and I look forward to the updates coming soon. Thank you for your time.

This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation. And have a great day.