StageZero Life Sciences Ltd.

Good morning, ladies and gentlemen, and welcome to the Stage Zero Life Sciences First Quarter Financials Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions after the presentation. If you would like to enter the queue at any time, you may press star 1 on your telephone keypad. If you wish to remove yourself from queue, you may press star 2. It is now my pleasure to turn the floor over to your host, Rebecca Greco, Head of Investor Relations. Rebecca, the floor is yours.

Thank you, Tom. Good morning, everyone, and thank you for joining the Stage Zero Life Sciences first quarter 2022 earnings conference call. Joining me today is Stage Zero Chairman and CEO, James Howard Tripp, and CFO and COO, Matthew Pietras. Please note that management's discussion today will contain forward-looking statements about anticipated results and future prospects. Forward-looking statements involve a number of risks and uncertainties, and Stage 0's results may differ materially from those discussed today. Investors should consult the company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The company disclaims any obligation to update these forward-looking statements, except as required by law. On today's call, Madge will refer to non-GAAP-adjusted EBITDA. This metric excludes certain items discussed in our press release under the heading Discussion of Non-GAAP Financial Measures, and any other items that management believes should be excluded when reviewing continuing operations. The reconciliations of Stage Zero's non-GAAP measures to the comparable GAAP measures are available in the financial tables of the Q4 2021 financial results press release on Stage Zero's website. With that, I would like to turn the call over to James Howard-Tripp, Stage Zero's Chief Executive Officer. James, please go ahead.

James Howard-Tripp, Chief Executive Officer, Stage Zero Good. Thank you, Rebecca, and good morning, everyone. Thank you very much for joining us. I was going to say it's been a busy quarter. In fact, it's been a very busy two years. I'm going to start with 2021 and just a recap of, I think, what we were building as we take it through, because I think it spills over very nicely into the quarter and then sort of where we are now. So if you look at what we did in 2021, clearly time of COVID, we used the COVID testing to dramatically expand our capabilities. I think equally as important with this is we brought in a whole series of very large partners, which meant that not only did we get the organization used to working with very large partners, but we got them used to working at a very, very fast pace in terms of all of this. We, instead of partnering with Care Oncology, and as groups we talked about that, we actually decided there was much better energy by bolting the two organizations together. And so we moved to actually acquired care oncology, which we did in September of last year, and obviously pulling all of those pieces together has been absolutely critical. We launched Aristotle in the U.S. and the greater Toronto area, and I'm gonna come back to that in just a moment. We launched the AVERT program in the U.S. AVERT, in actual fact, will go even a little earlier than Aristotle in terms of providing highlights as to where you could look should you be developing cancer. It ties very importantly to what Aristotle does because obviously if you find something on avert, you're going to then want to have a look in Aristotle. It ties to a series of strategies we're talking to healthcare groups about as well. We established the On-Site Clinic in Richmond, Virginia. This was to begin to build out physical presence from a clinic perspective something that we've now duplicated in a relatively large number of cities across the U.S. We broadened our strategic relationships. We talked about this just a little earlier. But if you look at the likes of the people we were able to bring to the table, Rexall, Sobeys, that's just on the Canadian side. You go to larger groups like government in dealing with it. You go to Maricopa County. You go to testing the U.S. State Department. Obviously, there's an interest for us beyond COVID, and this is what we're working with now. We commenced trading on OTCQB. That was important because it's part of our strategy of trying to get traded properly in the U.S. So being able to provide that kind of access is important, and it is still an intention that sometime in the future when appropriate to look at a senior board listing in the U.S. We expanded the management team of the board. Absolutely critical. If you look at who we have around the management table now, particularly building out even to our strategic advisory boards, we've got an absolutely superb group of people. Been there before, done it before, know how to do this, all of that really important. We raise money. Absolutely and critical. I think when I go to, when Matt first joined us, and I've mentioned this before, Matt's comment was good grief. You haven't really done all of this on 25 million in the last five years, but that's exactly what we had done. And I'd ask you to reflect on that on literally how much we achieve with literally how little money is we made it through, but we've built it and we've grown it. In addition to that, we did reasonable revenue last year. 5 million is obviously we would expect to surpass that this year. but 5 million is a good start. It was mostly COVID, but towards the latter part of the year, we started to transition into the cancer revenue. We've continued that through. That is really important. And I think the final piece with this, the revenue is 1.5 million in the fourth quarter. I think that's important because it was a mix of COVID and, sorry, it was a mix of COVID and cancer. If we move forward to what we've done in the first quarter, we continue that pace. We haven't slowed down in any way. If anything, we've actually picked up the pace. We've fully completed the integration of care oncology into and we've started scaling the various programs, but all over the world, US, Canada, UK, and Europe. That's absolutely critical. You've got to acquire an organization. You've got to bring it inside. You've got to get everything straightened out so that the systems work. Everything needs to be regulatory compliant, all of the boring things that go on in the background. But they have to be there before you can actually begin to fully scale. With those in place, we've started to scale. We're also getting to know where to push. And I think we're seeing some of that. People are obviously excited by what we've done with COC+. That's a result of knowing exactly where to push and how to push and beginning that process. We launched Divert in the U.S., critical. We extended the capability of the COC protocol to Europe, critical. Europe has 780 million people. Being able to access that, having the infrastructure to do that, knowing where to begin first, second, and third, absolutely critical. But all of that to build out. It's a market that is twice the size of the U.S. We extended the availability in the U.K. by launching VIRT into the U.K. as well. We started to participate in key summits. If you look at the Sea Summit, we were one of the key groups together with Jamie and Simon as they put that together to decide that we needed to take the entire concept of liquid biopsy and the fact that people can access, it's developing, it's true, it's real, it works, there's good solid science behind it. And so we help take it out. As you see, who was actually at the table as well, positions us very nicely as one of the leaders in the field, and that has led to a whole series of additional speaking engagements, particularly with large organizations to take it out. You can follow some of this if you look at our social media. We expanded the marketing programs for Aristotle into multiple new cities in the U.S. And this is important because speaking with some of our Canadian shareholders, I think there's a belief that Aristotle has been taken only to the GTA and that it's essentially not available anywhere else. It is available in the U.S. It's in multiple cities. Pretty much what we've done in the GTA and what we've done in Richmond is what we're doing literally city group by city group as we take it out. And so literally, month after month, we're actually adding to these and building it all out. I'll talk to the interaction between the various programs in a moment as well, because the COC protocol, Aristotle, AVERT, COC+, all tie and all address the same groups of people. We closed the additional financing last quarter and our revenue of 1.3 million. If you look at the fact that we were moving from COVID, COVID revenue in fact has come down very markedly. It's been picked up by the cancer revenue. It's beginning to move in the right direction. And so we now intend to continue to build on that. So where are we going from here? I think what people want to see is, you know, what do we have in line for 2022? What is it that we expect to do this year? And I'll walk through this with a little bit of detail. The first thing that we've done as we've talked to is we've been able to demonstrate that the promotion is dollar sensitive. So in other words, having got the various programs in place, if we push on it in the right way, we can actually get the incremental growth out of it. That is absolutely critical. So as we now begin to push all of those pieces in place, and again, I will reference COC Plus, which I think people saw this weekend. That's exactly what you do. That's the push as we drive on forward. We're expanding access to Aristotle in Canada. We'll go live in Alberta, the Calgary area in the next little while. We're also bringing up Quebec as we drive through. Those are the first, or I should say the first of the three jurisdictions, GTA being the other that we will drive through and we will then decide where we go from there. We're expanding large access across the US as I was talking about, but we're in the process right now of bringing up all of these additional states. In fact, right now we're live in Texas, we're live in Pennsylvania, we're live in Connecticut. We're about to go live in New Jersey. We're live in North Carolina. All of these are there. The additional states will come on as we move on out. The obvious intent is we want to make sure that we're very widely distributed. Why not just throw it out to everyone out there? We could do. But if you think about the fact that we're still coming out of COVID, you think about the support systems that have to be in place. You think about how we have to deal with the patients. It's absolutely critical. And I'll talk to this a little bit more when I actually go into the various programs. It has to be in a very staged way so that we can scale appropriately. We're back partnering with some innovative clinical groups. This is where we have typically been as these groups begin to come back on stream, get back to normal business. They're obviously open to this again. This includes the employer base. And there will be more to hear about this as we move out over the next few months. We want to launch Avert in the European Union. I think as I mentioned earlier, you know, 750, 780 million people, depending upon how you look at it, an extremely large market. Avert is often the leading edge for a lot of the pieces where people start. And so I'll take you to a discussion that we're having with some of the larger healthcare groups at the moment. They may do internal screens that essentially just say cancer, no cancer. What they're looking for is a way to actually then definitively be able to sort out what kind of cancer those patients might have and in actual fact to give it much, much greater certainty around probability. That's where they move to us. And so moving that up in that sense is absolutely critical. So those are the kind of things that we're building. And avert, as I mentioned, is critical. We're expanding access to Aristotle to treat and avert to countries outside of North America, UK, EU via partnerships. We've got considerable interest in that. We will bring those up in ways. And in fact, that may expand even into Aristotle as well. So it could be very, very interesting. We're adding additional cancers to Aristotle. I think as we've talked before, we're not looking to, in actual fact, try and do 50 cancers. We think that's an inappropriate strategy. We're going much more with a limited number of cancers, but notably those that have standard of care behind them. And what we want to do is we want to go deep with them. And so it's by deepening the offering, we want to be able to stage over time, select cancers, We're starting with colorectal. We're moving to breast and then lung so that we can be able to differentiate not only the stage of cancer, but obviously follow them over time. So that is what we've set for ourselves for 2022. And obviously together with this goes the incremental revenue that we expect to flow very clearly from this. Matt, hand over to you.

Thank you, Jim. And good morning, everyone. While we move on to the financials, Q1 was a really good quarter for us. It demonstrates quite clearly our stability and our growth as we evolve from primarily COVID testing to a healthier mix of cancer-based lab testing and clinical consultation. So in the first quarter, we had about $1.3 million in revenues, of which About a third of that roughly, $400,000 was attributed to the lab and then the remaining two thirds or $900,000 was attributed to the clinic. This resulted in a total comprehensive loss of roughly $600,000 or one penny per share on a fully diluted and basic basis. As we have always done, we continue to evaluate our investments in research and development and marketing, advertising, And, you know, we calibrate it associated with the resources that we have. And when you think about research and development, Jim talked a little bit about, you know, what we're planning on doing. And we've obviously, you know, continued to invest in the next generation of Aristotle where, you know, we don't just want to look at additional tumor types. We also want to look at staging and the phasing of different tumors. And so we put $127,000 in the first quarter in research and development. We'd love to put a lot more. to accelerate that growth and movement to the next generation of Aristotle. But we do that as we can. Same is true for sales and marketing. We spent roughly $500,000, $487,000 to be exact, on marketing and advertising. Again, that's a place where we'd love to put more money so that we can accelerate the sales funnel. But resources dictate our ability to do that. And that's where the investment in the future will come in to support both our research and development and our sales and marketing investments. On a total general and administrative basis, we're also looking at our resources on a continuous basis. Now that we're about six months out from the acquisition and we're looking at where we best optimize the resources we have and bring in new resources and reduce others, we'll continue to look at the general and administrative expense of part of our business. We spent roughly $2 million in the first quarter and we'll continue to keep our eye on that as we go forward. From an adjusted EBITDA basis, we had a $2.6 million loss for the three months ended March 31st. The difference is primarily driven by the revaluation of gains on warrants and contingent considerations. Moving to the next slide, we'll talk a little bit about the revenue streams and the revenue model for the organization because I really want to drive home the fact that You know, it so closely corresponds to our mission. And as you're all aware, our mission is to improve cancer and chronic disease outcomes through early detection and intervention. Well, when you think about how we generate revenue for the business, Aristotle clearly represents that early detection. And the clinical programs we have are the interventions. Let's talk for a couple minutes about how those come together. You know, you can access any one of these pieces of our product portfolio. but obviously we encourage, you know, the conjunction of both because that's how you get the best solution for patients. And so a typical patient will come in interested in understanding their risk for cancer and gain access to the Aristotle test. That's $14.95 per test. A patient may do that once a year, once every other year. It depends on their circumstance, right? But when you think about the first year of access to our programs, Aristotle at $14.95 is the first piece. very often patients will then enter into the AVERT protocol. Pricing for that in the U.S. is roughly $330 per visit, essentially $1,320 per year. So a patient in their first year with us will likely spend $2,815 for our programs. And, you know, as I mentioned, there's a hybrid here of transactional revenue and then this transformational revenue that results in a longstanding sustained relationship where we gain basically ongoing access to the patient over time. The TREAT protocol is priced at $925 for the initial visit and follow-ups are $330. So that's essentially $19.15 per year in the first year and then $13.20 thereafter. As you've all seen, over the weekend we launched the Care Oncology Plus platform globally. That's also similarly priced to Avert given its synergies and features. synonymous platform that it operates to avert. When you think about the revenue for this organization, it's driven in part by obviously laboratory testing and then the ongoing clinical consultation programs that provide for the interventions in sustaining health and wellness. As we move forward to the next slide and talk a little bit about our synergistic value proposition for patients, this gains access on a telehealth platform and I think it's important to rationalize where healthcare is moving today and into the future. Access is now much more easily obtained through online platforms and online interventions and telehealth platforms like we provide. The Aristotle test, it provides the output to the patient via a single sample of blood that the specimen can be collected at your home, at your office, or even in one of our laboratories throughout the United States, as Jim described earlier. Furthermore, the clinical consultations, our oncologists and our specialists have the ability to intervene with you on an ongoing basis via our telehealth platform through the products that we have, both the Abert and the Care Oncology Protocol called TREAT. I'll pass it off to Jim to tell you a little bit more about those products now. Jim?

Great. Thanks, Matt. I'll stay with the theme that Matt's just gone through, which really is the interconnectedness of all it is. And I'll tie them all together at the end. But just to go through again what the products are. Remember Aristotle? Aristotle, the first ever mRNA gene expression test for the detection of multiple cancers. High sensitivity, high specificity, which gives a good accuracy. All of that extremely important. We'll be publishing additional data on this as we go out through the year, so I think people can become as familiar with it as they need to. But Aristotle, I'm getting very, very good acceptance as it goes through, and I think particularly as we talk about deepening the effort. Right now, as we look at the colorectal cancer side, we're doing polyps versus stage one, stage two, stage three, stage four. I think as we've talked about, why is that important? It's important because if you give the gastroenterologist that information pre-colonoscopy, they have a much better idea of what they're looking for. And as a result of that, our data shows that the likelihood of finding the cancer is much greater, which is exactly what you want. It also is a very useful screening tool. And don't forget that in a lot of markets, stool tests are still available. the way that colorectal cancer is screened for, remember that stool tests have a very poor compliance rate. So clearly you need something better than that. So as we drive down this, providing greater information, providing the ease of being able to get to it, absolutely key. And it's beginning to get picked up really, really nicely. I'll tie that to the next program, which is actually the COC protocol. We call it TREAT internally as a way of differentiating it. But the TREAT study was initially developed by one of the founders within the group whose wife had breast cancer. Looked at it, didn't like the way the treatment was going, thought he could do better at that. He was in the teaching hospitals in London, UK. He had a lot of resources, and they developed that. The salient paper was the one that was published in glioblastoma, which actually showed a very marked improvement in survival benefit across 18 months with being on this, and there are follow-up papers to come from this. This has then been extended into multiple cancers. We do, for example, large numbers of women with breast cancer, men with prostate cancer, but literally treat patients with virtually every cancer out there. So it actually has proven to be extremely beneficial. If we move to the next slide, which is in fact a bird, what we did was we pulled the bird forward. So one thing about it, you have Aristotle where you can do the definitive screening type of cancer, not type of cancer. You go to COC protocol where you can treat patients that currently have cancer in terms of looking for a better outcome, notably with dealing with the metabolic pathways that either lead to the growth of cancer or lead to the death of cancer. You move to avert, which pulls it much forward from that. And so if you look at the metabolic pathways, you would in actual fact get all kinds of indications of metabolic pathway disturbance, These typically lead to chronic disease. Chronic disease very typically is a precursor to developing cancer. A lot of very established pathways. By finding them early and actually dealing with them, it actually works extremely well and you pull all of that together. I'll go now to CoC+, which is what we launched over the weekend. So, CoC Plus, in actual fact, is a response by us to a whole series of issues that were being presented into us by patients. And so, CoC Plus deals notably with those metabolic pathways, but in a way that is outside of the normal CoC protocol program. It deals a lot with nutrition. It deals a lot with supplemental guidance. It deals with stress, with sleep patterns. It deals with insulin resistance. It deals with a whole series of other issues, all of which we know contribute to the well-being and better outcomes for the patient. The response to it has been remarkable, and so this is where it actually all ties together. So we're literally just out of the door, and we're fully booked at this point. And we've been building up to try and make sure that we can actually deal with incremental patients as it comes through. But in addition to that, it's not just the CoC Plus that patients are coming for. We're getting incremental numbers of patients now coming for the CoC protocol. We're also getting incremental numbers of patients actually asking for the Aristotle test. So as it builds through, so you can see the interconnectedness of this and what Matt was talking to. As we go moving out, quite obviously, we've talked for a long time about working with larger organizations. We're in discussion with these. As I mentioned, we will make announcements over the next few months as we go forward. But together with this, the first question that we get as these groups all begin to return to normal or a degree of normal after COVID is how do we manage these employees? How do we manage the patients? How do we deal with this? And we're one of the very rare groups that actually have this infrastructure. We have our own oncologists, our own nurses. We have access to the dieticians. We have all of this. We can deal with this. We can actually triage either the patients or employees. We can begin to put programs around them. We can interact with their own physicians in terms of taking it out. And it's turning out to be as critical as we believed it would be because without this infrastructure, you actually can't do these programs with the groups. So we're obviously looking to a lot of very good things as we move forward with that. It all ties together strategically. We are uniquely positioned. We, instead of just partnering, as I mentioned earlier, we actually decided to bolt these two organizations together. We believe it's going to be absolutely strategic differentiation as we move forward. We have vertical integration, which allows us to manage all of the pieces I just talked about. But as a result of that, we also have integration of the revenue streams. Patients don't just come for an Aristotle, but they come for the interpretation of the Aristotle. A large number of them look for guidance afterwards. Clearly if they test positive and they go through to show that they have cancer and it gets treated, they are candidates for treat. If they have raised issues as it comes through this, they are candidates for revert. In the middle with all of this is COC+. These are the programs we can offer not only to them, but all of the large healthcare groups and employers that deal with them. It's absolutely important. The other thing, too, is we've got an amazing group of people around the table working with us, very, very experienced, marvelous physician group, and we get to be able to benefit from all of that. If you look at I think what is so key in this period now, it's quite obviously our ability to be positioned on the stage as a credible player, as a group that has stature, as a group whose science is recognized as being good, and that is actually developing really, really nicely for us. I think if we go back a little while, people were saying, where on earth have you been? We're not getting that anymore. People actually see us, know us, they're coming to us. We're not always having to go to them, they're actually coming to us. That's a very significant advantage. We're getting to speak with larger and larger groups as it moves on out. Why? Not only because of what I've just gone through, but also because we have the infrastructure. In fact, we're one of the very few groups that has the infrastructure that actually can do what we're setting out to do. We've sorted out a lot of the issues on the digital marketing and online advertising piece. And this is absolutely critical. I think there's often a belief that you have a product and you throw it out at the marketplace and see what sticks to the wall and you go from there. Doesn't work with cancer. Doesn't work all that well in healthcare. Doesn't work with cancer. You've got to be part and parcel of the cancer community. You've got to be within the groups. You've got to be recognized. You've got to be understood. You've got to be trusted. Building all of that is absolutely critical. And that's part of the infrastructure we've been building. And I think we can see that start a payoff as we look at what's beginning to occur out from CSC+. which is the first sort of immediate high profile launch that we've done right now. Now we're circling back across all the other pieces and pulling it up together with it. So it really works. And then just going back to where Matt was, really we want to continue to invest in research and development as we bring it forward. There are additional programs, additional opportunities, additional depth to Aristotle that we want as well. And I'll finish just with a recap of, I think, what we've laid out as our 2022 KPIs. This is how you can look at where we intend to go this year. You can look at us coming back and being able to tick the boxes to say, yes, we've done that in the way that 2021 was an amazing year and we pretty much did everything we said we would. First quarter of 2022 has been pretty much the same way. Now we look for the revenue ramps. Now we look forward to being able to continue to tick these boxes for you as we move out across the year. I think with that, Rebecca, do we have questions?

Yes, James, we have one question on the call, and then we have some questions in the webcast. Do we want to start with the question on the call operator? I see someone's queued.

Certainly. Okay. I will bring in the first question. As a reminder to the rest of the audience, if you would like to join the queue at this time, you may press star 1 on your telephone keypad to join the queue. And the question today is coming from Jim Morelli. Jim, your line is live. Please go ahead.

Yes, James. Thanks for the conference call. I'm just concerned with COVID. It put a damper on cancer screening, cancer treatments quite a bit. There was a rise in There is a rise in cancer because of it. I'm just wondering the effects of present worldwide events, inflation, cost of living. It's getting harder for the average Joe. It's going to be harder in the next few years to afford basic necessities and put food on the table. Where I live, it's over $2 a liter for gas. Loaves of bread are $5.99 a loaf. And flying, if you fly for work, coach is getting to be as expensive as first class was last year. Do you think that will affect us further in screening and treatments of cancer?

So thanks, Jim. That's actually a super question. We're obviously monitoring exactly all of that to answer it in a series of pieces. Starting with the return to screening, and you're absolutely right on that. We saw a massive reduction in cancer screening while COVID was around 2020 and 2021. I mean, some instances cancer screening was down kind of 86%. So just huge. You're right, we're seeing what's being described as sort of a tsunami of late stage cancers coming forward. So what it is is it's propelling everyone to move back to the screening stage. But it is coming back step by step. It's not as if everyone just turned the tap on immediately and went. It is coming back in different ways at different rates. The good thing is we're nicely positioned for that. And I think because going back to my comments about being right in the middle of the cancer community, you have to be part of that. If you're part of that, it works. If you aren't part of that, it's actually difficult. So we're very pleased with that. And I think we're starting to see those fruits. With respect to, yeah, the war in Ukraine, general disruption around the world, inflation, What we're doing, so one, we're actually keeping our prices as low as we possibly can so that we can make it attractive that way. But you'll also find that we've introduced payment plans. So that's the other way with it. We find most of the people coming in to work with us are sufficiently concerned. Again, if you go back to the audience, if it's someone that, gosh, I think I'll get tested for cancer today, they would probably be very concerned about price. We tend to not go anywhere near those. However, if it is someone whose brother has just been tested positive for cancer, it's within the cancer community, they're concerned about themselves. They know the survivor benefits. They also know the cost differential. The cost of treating early stage cancer is magnitudes different to treating late stage cancer. So it's not just survival of finding it earlier, it's actually the cost of finding it earlier. So all of that actually is playing fairly well for us. And certainly I think at least at this point, we're not seeing a drop off in utilization. If anything, we're actually continuing to see increases. So hopefully it stays that way. But yep, we are monitoring it very carefully.

Okay, and you had mentioned partner labs for Aristotle. I see Quest Diagnostics popping up whenever you apply for testing and stuff. Are they strictly phlebotomy service, or is this a partnership that you're in with Aristotle, or how does that work? Do they draw blood and everything is tested in Richmond?

Yes, so two different sets here. So Aristotle is tested in Richmond. So we have, in actual fact, a fairly large number of partner agreements with labs across all of the various cities.

So, you know, key with that. So, for example, if I talk with

I think I'm not speaking out of turn to say we're actually partnered with Sinai Health. So Aristotle samples in GTA actually go to Sinai Health for us. What they do is they do what we call stabilize them. So in other words, they can cross the border, they can get delayed over time. mRNA is very sensitive. You need to make sure you don't lose or corrupt the sample in any way. So for example, we do that. And so we're bringing those up all over the U.S. as we do this. It'll also allow us, for example, to do testing in a whole series of other countries that's actually a rather neat strategy. So on the one hand, we have all of those things going on. The other is we have a series of lab tests. So, for example, COC Plus as well as AVERT have a very specific set of metabolic tests that we want done. Quest is our US partner for that. Beyond that, we have a series of health groups, phlebotomy groups, healthcare organizations, some of it we do ourselves. You can come to our own clinic in Richmond, Virginia, for example, you can walk into the lab, into the clinic, we'll draw your blood there and then. And so we're setting those up. So we have very large numbers of everything from labs through phlebotomists that control the blood for us. All of that to make it as convenient as possible. Some people like a physical site to walk into. A whole series of others like us to go to them. And of course, don't forget, if you're working with, let's say, a healthcare group or an employer, then we need to go to them. So the same kind of infrastructure that we used, for example, with Maricopa County is the kind of infrastructure that we would utilize there as well. So we have all of that on tap.

Okay, and one last quick question, if you may, if I may. As an investor, there's a lot coming around the corner with your company. It's going to cost. Can we as investors expect another round of financing or another reverse split on the stock?

So to answer those directly, yes, we are going to need to finance going forward. We can't tell you exactly when. We'll sort it out. I would go to the comment I made in the beginning. Matt, good grief, have you guys really done this on $25 million? We've taken about $25 million in five years. If you think what we've done in that, we've developed all of these products, launched all of these products, acquired a company, integrated it, and generated revenue through this. I think you'd be hard-pressed to find another group that's done anything similar to that. So we know that moving forward, and Matt showed the sort of half million that we spent on promotion, We'd like to be able to put $1 million, $2 million, $3 million, $5 million against that as we move forward. Some of that will come from organic revenue growth, but obviously if we can spend more aggressively against it from a promotional side, it really helps. So I think the fair answer is yes, as fast-growing companies do, you finance when needed. On the reverse split, I know there was a lot of buzz in the marketplace. We did a reverse split some time back. We don't have a consolidation on the table. There's no logic to that. We would only do that if it were, let's say, we were in striking distance of being able to go to something like a big board U.S. exchange. Otherwise, no logic to us doing that at all. So that's definitely not on the table. Okay, thank you. Thanks. You're very welcome. Good questions.

Thank you. And the next question is coming from Bradford Scott. Bradford, your line is live. Please go ahead.

Yes, hi, James. I'm wondering, like, with being that everybody knows early cancer detection is critical and life-saving what is being done to promote this to both the Canadian government getting it on to health care system and also insurance companies in the US to have them offset some of the costs to the patients yeah

Let me just figure out how to sort of work through those pieces. Let me start with Canada first. Maybe deal with FDA and Canada at the same time. We know at some point it is going to be appropriate to take some of what we do, I'm sorry if the answer is going to be a little complicated, but some of what we do to of formal authorities like that, and by that I mean Health Canada as well as FDA. The issue, and you'll see the same, we're all talking the same line, ourselves, GRAIL, Exact Sciences, all of us, we're all talking the same line, which is that if we take the U.S. pathway, for example, it's probably five years, maybe seven years before you can accomplish what it is that you were just talking through. So you've got to develop all of the data that they would want to see in the way they see it. It's not that you don't have the data, but it's generally not automatically in the way they would want to see it. You then go through the approval process. All of this is probably going to take you two to three years. And then from the U.S. side, you're going to drop into what's called USPSTF review. They typically only issue rulings about once every seven years. You need to be within the cycle for that. So at best, at best, you're five years out, you may be a lot more than that. Now the question is, what do you submit? Everything that we're doing is so rapid. So if we submitted Aristotle today, it would have a colorectal cancer test that essentially says, yes, you have colorectal cancer, no, you don't. If we submit in a little while, we would have a Aristotle that has a colorectal cancer test that says polyps, stage one, stage two, stage three, stage four. It's a significant advancement. If we go a little further down the road, we would likely have something similar for breast. We'd likely have something similar for lung. So these are developing real time, which is why the U.S. runs what's called LDT, laboratory developed tests. 98% of the lab testing in the U.S. is not FDA approved because it keeps moving like this does, and you go through. So we're all figuring out how to work with those groups but take it through. But we all know that at some point we're going to have to figure out the exact strategy. But it's difficult to sort out right now because we are just moving too quickly. Now, going to insurance, insurance is important. And so on the Canadian side, we did two things because we get questions on this. One, we called a series of the private insurers, and we said, right, we know you do cover tests outside of Canada, lab tests out of Canada for this. Would you cover our tests? And the answer came back that said probably. And we said, okay, explain. And they said, well, if you, the patient, have the right plan with us, and you have it prescribed for you by a physician that is licensed to prescribe it, and you submit the invoice with the information, they said, yep, yep. Then, yes, it should get covered. We went further than that. We actually called OHIP, and we said, OHIP, how would you deal with this? And they said, well, you can run through preauthorization. And they said, we do this. And, yes, if there's preauthorization, we would run. So there's similar things on the U.S. side. We provide all of the patients that do the testing. We provide them with invoices. They can submit the invoices to their own insurers. The insurers, again, based upon everything I just went through, type of plan, type of deductible, et cetera, et cetera, may or may not reimburse you, and it runs that way. Will we talk to some of the insurers as we go down the road? Yes. Is there an effort to do some of this? Yes. In the U.S., there's actually an effort by kind of the pharma lobby in front of Congress right now actually pushing for these types of tests to get covered. without having to go through the formal FDA USPSTF route just because it takes so long, and as I said, what do you submit? So it's getting there, but that's the best answer we have at the moment. Sorry, that was long and very complicated, but I told you.

Yeah, okay, so if I understand correctly, then there is a possibility in Canada that certain insurance companies will cover part of the cost of the testing.

That's correct.

Okay, so each individual would have to verify with their insurance company.

That's correct.

The other thing is also, I mean, Biden has made it very abundantly clear that he wants to go full force on, you know, cancer detection and treatment, and he wants to, I mean, he's got some coined phrase for it, but, you know, it sounds like the U.S. is, you know, under Biden, is very keen on accelerating the processes that were bogged up before and trying to make things move a lot faster. So that's why I'm saying, you know, perhaps now is the time to get in front of the decision makers, whoever they be in the U.S., and say, you know, because if I understand correctly, Exact Science with their poop in a box, they get a lot of their testing is covered by insurance in the U.S., isn't it?

They do, but two things with that. One, it took them that protracted period of time. I think it took them nearly six years to actually get there from the point at which they began the submissions to FDA and then all the way through. So it took a significant amount of time. The other thing is their test, Cologuard, in actual fact, is the kind of test that it makes perfect sense to take forward because it doesn't move. This is the test. End of story. It doesn't move. It doesn't change. You take it in. Ours, as I was talking through, and in fact, Braille's talking about the same thing, and Exact Sciences, they're talking about what they're going to try and do with their Thrive platform. We're all saying the same thing. And the first question is, okay, what do we submit? What do we submit? and how do we deal with the changes that goes forward because by the time we get through approval in three years' time, even basic approval in three years' time, this test is markedly different, and it needs to be markedly different. So that's the piece we're all trying to answer. So that's why going to the insurers in the meantime is the way around this. And yeah, there's a significant amount of effort, not just by us, but a whole series of groups Biden's group, it's called the Cancer Moonshot. Canada actually has a similar initiative in terms of that. So are we aware of these? Yes. Are we talking with them? Yes. Are we talking with the various insurance groups? Yes. We'll do whatever we can to help.

Okay. One more question I'd like to address. I don't know, you must be aware, but there are certain individuals on social media that have been really Crossing the line in defamation in regards to you and the company. I'm just wondering, as an investor, don't you think something like that should be addressed?

We do. Thank you for raising it. We do. I will tell you, we take this very seriously. So everything from being in the hands of our lawyers through taking it up through all of the authorities, including to the OSC. So I think what I can tell you is that, yes, it is very visible and everyone is watching it. And, yes, we are definitely trying to do something about it.

Okay, good. Thank you.

You're welcome. Thanks for the questions. There are no further questions on the call. Thanks, Tom. Maybe we'll just have one last question off of the webcast.

We have Patrick McGarry's asking about what we foresee in terms of uptake from employers this year based on COVID moving to the background and whether we have any special initiatives for getting employers up and running. So maybe James or Matt, you want to just answer that one and then we're just about out of time.

Matt, shall I do that?

Sure, go right ahead.

So Patrick, one nice to hear from you. Thanks. The employers, but also larger healthcare groups have long been a target of ours. The good thing is that as we all come out of COVID, people are starting to come back and look at what they do. I think I've explained on a different call at one point that said, if you look at a large airline, just as an example, The large airlines until recently have been hanging on for dear life just to make sure that they can survive. They definitely weren't about to not try and introduce cancer testing programs. But as this starts to come back to normal, as people start to get a degree of normality back, it's exactly that. I think what we can tell you, we're definitely in discussion with groups. We're walking down this platform. Timing is always difficult. Wouldn't give you that but other than to say watch the space. We've got a mix of small and large groups as we move on out through this and so it'll be a matter of bringing it in. What is key for us is the infrastructure that we've built. With a lot of this we wouldn't be able to do it if we weren't constituted the way we are and I think as Matt sort of very elegantly was going through laying out the interrelationship between the programs That part, that part all very important. So yep, remains an absolute focus. Yes, it's coming back to life.

Yes, we are moving down that path. Okay, I think with that we're essentially out of time.

So thank you, thank you for joining. Thank you for the questions. They were actually very insightful and very helpful. And we look forward to continuing to report progress as we move on out through this quarter. Take care.

Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.