Hello everybody, and thank you for joining the StageZero Fourth Quarter and Year end 2022 Earnings Conference Call. Joining me today, is StageZero’s Chairman and CEO James Howard-Tripp.

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 StageZero'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.

With that, I would like to turn the call over to James Howard-Tripp, StageZero's Chief Executive Officer. James, please go ahead.

Thank you, Rebecca. And, hello everyone and thank you for joining us for this call.

It's at the end of a what is truly been a tumultuous three-year period. If we think about where we were in 2019, when we were getting ready to actually introduce or fully introduce Aristotle to, with the advent of COVID, the immediate pivot that we had to do to the PCR testing for COVID, that took us through the better part of two years as we came out of that and life was just beginning to return to normal.

We had Russia invade Ukraine and we had all of the impact on the global economies. So it's been a very interesting process because from being a cancer company to being a COVID company to going back to doing what you set out to do, which is a cancer company.

Along the way we were able to do a number of things. We have built the telehealth system, which we believe was important.

It turned out to be absolutely pretty critical, critical to what we did, particularly as we went into COVID, the critical with what we do now as well. In addition to that the discussion we have had with employers led us to look for a very strong partner in the clinical area.

That led us to the acquisition of the Care Oncology franchise. And what we were able to do during the period with COVID, we’ve actually begin to prepare for it to integrate it.

And as we began to reemerge back into the real world post COVID, we were able to reengage with all of the employers who've been talking with the healthcare systems, the labs, the benefit managers, just all of that group, and began to be able to deploy that full suite of program. So it’s that I will actually talk to.

So if you look at the current cancer crisis, I mean we invariably talk about it as an absolute tsunami. We all know what happened to cancer screening during COVID, it went down to essentially single digits.

As we came back, everyone had to get back into the swing of things, but of course we were, we slow to get going again, but we were also missing all of those intervening years of screening. And so we’ve seen a lot of very late stage cancers coming forward and everyone is trying to get back to finding it early.

I sat with a group, on the Corona side a little while ago and they told me that, for example, about 80% of their resources are focused on trying to get about 3% improvement for patients. They're all looking for ways to get this to be better.

That really plays in a number of areas. One find it early, we'll talk about that a lot in a moment.

The next thing is you need to have the right interventions. You need to be able to triage patients, you need to sort them out.

You need to be able to have treatment measures for them that will talk about the metrics study and where we go with that. And then you need to have the whole prevention aspect, notably the risk factor, modification.

And then you've got to be able to do it all via telehealth. You need oncologist supervision through all of this.

You need to do it on both sides of the border in North America. And these things take time, one to build, two to test, three to fund, and then to make sure that you can deploy them.

So for us right now, it's very much an issue of deploying what we have and purely execution. We're actually in a very nice place.

So if you look at -- excuse me, I will apologize. I'm just coming off of COVID and the residual cough won't go.

I think, the number to focus on more than anything else is that the number one catastrophic health play for self-funded healthcare plan, that is huge. That's 100 million Americans.

It's about a 100 -- sorry 100 million employed Americans. There's seven Americans in total.

And the overall national and economic burden, is a staggering 150.8 billion. So that's where you need to go.

What do we do is we'll show you in a case later on, we very significantly reduced costs? That's what it's about.

Why its early, that we've shown these slides before, but you change your five-year survival rate, usually, you very often turn it on its head. We use the colorectal cancer, we often talk to, when you go from about a 90% five-year survival, if you find it early to about the 10% to 14% survival, if you find it late, more than two-thirds of colorectal cancers are found late.

Therefore, it demonstrates why we have to find the early. And this rule is the same for essentially all cancers.

The cost savings too is just huge. There's essentially a 2 to 4 times increase in costs for treating late-stage cancer.

The only way that you get to do it, never mind the survival aspect, which is critical. The only way that you get to deal with this is you have to find it early.

Why can we do this? And we have, some other groups can't.

Well, the first is Aristotle, and we'll talk a little more about that in the moment. With Aristotle single blood test, multiple cancer, very particularly, it confined early cancers as well as it confined late stage cancer.

Secondly, we have built out the program of AVRT in perhaps ways that we weren't initially looking at, but we built it out into the employer program, we built it out into the TREAT program. As we use elements of that, and I'll explain that as we go along, but without having these three pieces together, it's actually difficult to deliver the kind of programs that employers actually want.

Aristotle, the work offered essentially almost 20-years worth of work on our side started with Eli Lilly and Pfizer moved out into development of ColonSentry from there into the first mRNA gene expression test that actually will indicate your likelihood of having that particular cancer, your probability of having that particular cancer. We have high sensitivity and specificity will typically go for 99% specificity.

So it’s about as accurate as it possibly can be, and then the sensitivities are very high as well. I think, it's fair common to say that in general we're better than the standard tests that are out there.

In fact, significantly better than the standard tests are out there. And we do all of this off of a single sample of blood.

So, Aristotle cancer today, yes or no? The next piece with this as well, what about the probability of developing cancer tomorrow?

It ties together in two ways. One is a series of attendant risk factors, but in actual fact, we've been able to move that across into the TREAT program as well, because it gives us, a series is a biomarker against which we can mention the protocol or the utility of the protocol that we're administering and we plan to affect risk factor modification.

This is the other piece that employers have asked us forward. So as you bring the program forward, it's a matter of how you implement it, but can you do it all the way through.

What they're not ask recently a yes no answer on the fact that you may have cancer. They're looking for much more than that.

This is what event does. And the way we do it is that the biomarker testing will essentially flag across a whole series of areas, one of which is cancer, but bearing in mind that metabolic syndrome is a risk factor into all of these.

It’s an insulin resistance with some very interesting new data on how various cells, body immune cells, as well as cancer cells take up energy and how they use it. And an actual factor, very often when you start treatment, you'll get an increased insulin resistance.

Increased insulin resistance makes it more difficult for the cells to actually take up the energy that they need. If the immune cells are the more critical piece in that, in fact, normalizes insulin resistance could increase the efficacy of the immune system.

And so you actually get a very positive response. Again, I'll take you back to some of the results that we've got out of the metric study.

So all of these tie together, and so when you're an employer and we're sitting with you and employees, we will look across this whole series of factor. And we cannot not only give strategies by which you could work with, with our docs in order to remunerate the risks, and that is critical.

This is something that is of great interest for the insurance companies as well, reinsurance as well. And so we're in discussion with them.

Final piece in all of these, is our process is really our difference, and so it really is an ability to come forward and to say, right, we can work with you all the way through this, but we'll talk in a moment about the Ontario firefighters. This has been absolutely critical.

At the same time that we've been working with the OFFA to with the Health and Safety Committee to begin to get the testing underway, we've had to build the entire system behind this to ensure that the firefighters could not only get tested, but the fact that if they get positive findings, they can actually get triaged and then get the right kind of handle into the healthcare system. This is critical as is telehealth.

So all of the time our process is truly a big part of our difference. If we look at the market opportunity, then the value proposition and some people would say, why should I be interested in this company?

Why should I buy the stock? We would tell you it's for the reasons that we're going to go through in the next series of slides.

One, look at the size of the self-funded employer market. We've long said that this is an actually key area for us.

The 64% of the employed workers in the U.S. are covered under self-insured or self-funded arrangements.

That equates to what I was talking about earlier. That's approximately a 100 million Americans.

If we talk about the U.S. alone, remember the U.S.

is our primary market. It's about 157 million people in total.

And if you look at companies and the way they grouped from a self-insured, in 2020 nearly 75% of the self-insured companies had 500 employees or more. It's huge.

The opportunity is really large. The case study that we've shown, and we use breast cancer, but of course it applies to all of the cancers as we've run it through, shows as we run all the way down the model that the cost avoidance is approximately 58%.

This holds by and large for the great majority of the cancers that we would look at. And I think a question that we've been asked before is that this includes the cost of the testing into it.

Well, when you take the cost of testing and you divide it by the number of cancers we look at and run through, the cost is negligible, it comes down to less than a $100 per particular cancers we're driving through. So the cost is negligible in that sense.

So again key cost savings if you find it early, cost savings if you screen, you find it early and you treated early. The second case study as we looked at with the firefighters.

And this for us has been particularly important. It's not only the very large 86% of all claims called firefighter work related deaths from cancer.

And I'll tell you that again, 86%. Just think about that.

It has to be dealt with. You look at the large number of firefighters, and this is Ontario remote.

There's 30,000 in total, 11,000 of full-time, 19,000 of volunteers. This is a program that they want to apply to all of them.

Part of what we were asked to do was not only help them establish a program and bearing in mind that they were working this through all ranks at all different levels, but to help them identify and answer a whole series question who's most at risk? If it age, is it duration of service, is it a combination of both?

Is it exposure to certain kinds of fires? Is it one area of Toronto versus another?

Is it Toronto versus rural here? Where do you get your greatest risk?

Can we measure this? Can we track it?

We've taken time to work with them to actually present in front of the various municipalities to make sure that we get it into the budget process. Why?

Because we didn't want it to be thinking a one off deal that's done once the year. We wanted this to be ongoing multi-year, year after year.

It needs to be part and parcel through the process. And so that's the key thing.

We can tell you that in actual fact we begin the formal testing process next month in April. So we're often we’re moving.

Are we going to deploy it? It'll be Aristotle Cancer today.

It'll be reverse metabolic pathway panel. Are you developing cancer tomorrow?

Depending upon the results that we get out of that, will dictate how you go through the triage. Bear in mind the triage from outside the supervised by oncologist.

We've also built out the full support system. So for example if someone in the GTA is diagnosed with a positive result, can we hand off with to the right groups all the way through to the hospital system can ensure that they get worked up completely to ensure that if they’re positive they get treatment completely, they then get followed through.

We built that system that is now in place. Together with this, we'll be doing a health economics analysis.

Obviously, people are interested in Howard contrast, it's the data that is homicide critical as we build it through. And as we said, it's city funding.

It's multi-year, and we're starting now. Worth looking at the KPIs, that we established for 2022 as we were coming out of COVID.

And then also we'll talk about 2023 and where we're going. The key thing with 2022 is the integration of Care Oncology, both in the U.K.

and the U.S. and in the redesign of a lot of the programs that they fully integrated with what StageZero brings forward.

As we move through 2022, what we did was, before COVID essentially come down to put it close to zero in the first quarter, we then moved directly into cancer testing again as we built it out. But bear minds that it isn't an immediate turn on, it isn't an immediate switch, and everyone goes, right, we're ready to go.

The first thing is that organizations had to get back to being normal. They had had to decide that they were in matter of fact surviving, and they could begin to focus back on employees.

As they started with all of that, we needed to make presentations to them. We needed to bring it into their budget of processes it goes, we're not doing just individual tests off of one employee, we’re doing many tests with many employees, and so it has to fall into the formal budget process.

To a large extent a lot of that has now been going forward and is in good process. We engaged very strongly with the Ontario firefighters as we talked about.

We presented at the conferences, we developed the proposals to take the management in cities. We've sat with the management groups in front of the cities as we've taken it through.

And we are -- as we mentioned, the approvals are starting to come through, and we're getting ready to move right now. We begin with those groups, as I mentioned, the study pool.

We integrated the full AVRT process into it and of course into the latter part of last year we initiated testing in the U.S. that is what first responded in general.

And that process continues. At the end of -- part of all of this is, we had to move very quickly.

We had to make sure that our house was as lean and mean as it could be that we were at all times prepared to drive it through. So in the latter part of 2022, we had to look at how the care oncology groups were operating.

We had acquired groups that had more staffing, had larger infrastructure that was necessary. In addition to that, some of the IT, for example, had to be rebuilt.

So, we undertook all of those aspects as we brought it forward. And by the end of 2022 in the U.K., we essentially had the unit at breakeven, in the first quarter of this year, we actually have the unit above breakeven and we anticipate full profitability by the second half of 2022.

I think it's worth talking to the revenue as we drive it, in particular as we bring the new programs. So if patients stay with us within the Care Oncology scientifically for 12 plus months.

The average revenue per patient in pounds is essentially about £1100. What we're doing with the new enhanced protocol, as the new enhanced protocol includes biomarkers, it includes tailoring, that is on an ongoing basis, and perhaps I can explain that this week.

We initiated treatment with one particular patient with the protocol as it was as he became aware of the new protocols we are bringing look forward, he asked to upgrade the new program, went into the biomarker testing, and for example found that a series of these biomarkers were significantly out of line. It is not something we would've seen before or that he started the can would have seen before.

What we did was immediately bring him back in. We adjusted the protocol as we worked with him, and in actual fact he was delighted because he took better results out of all of this.

So it becomes a very fact driven, the goal driven, results driven program as we've taken through, and of course it allows us to produce the type of results that we believe we saw out of the metric study. So that's where we go.

As we move with this, obviously it's incremental pricing and incremental pricing we believe will have a fairly marked effect. It markedly moves our gross margins.

So, we're also planning for an EU launch in 2023, and so we will look for expansion there. We will start with individual countries and then expand out.

Turning to Care Oncology in the U.S., we did fairly similar. We reorganized into the back end of 2022, to where we actually have a much more efficient organization.

The same, IT issues remain the same programming issues as we work through them. And right now having reorganize, we're approaching breakeven and we expect full implicit -- sorry, full profitability in the second half of 2023.

Key is we have launched the expanded Care Oncology protocol. Again, patients stay with us for an average of about 12 plus months, and revenue under the existing program has been essentially just under $2,000.

But the enhanced program, particularly it’s the built out with the lab test, but everything goes with that. That pricing essentially doubled.

It's critical, it gets more physician time, it gets more nursing time. It will now get mental health support, it will get better pharmacy support.

In addition to that, we have the abilities we talked about to set very specific goals also for the biomarkers and then to track the patients against it. It's been accepted very well by patients that it's exactly what people are after, but it makes a very significant difference to what we do from a revenue perspective.

Canada too is a very significant market. Canada typically has fewer options for patients, and so we're actually just beginning on the Canadian side as we're expanding out working with groups that put in case of the Canadian side, and that literally is kicking off as we speak.

So very, very positive across all of this. If you look at it, let's say for every 1,000 patients that we would have within our system, and we have several thousand patients in, if we converted all of them or for the current pricing as we've looked at it every thousand patients are essentially worked about $3 million in revenue to us.

So if we have a thousand, it's $3 million, if we have 2,000, it's $6 million, if we have 3,000, it's $9 million. You can build the models from there.

It's worth talking about the METRICS study. It's one of those events that I think you really stop and look at.

And so very you glioblastoma, as the work was initially done in glioblastoma stage 4 patients. Why?

Because outcomes are typically very poor and treatment options are very limited. Therefore, the course of the disease is relatively short.

What the group did was add, the C&C protocol of adjunctive to standard of care treatment, remember standard of care is generally surgery first, radiation second, and then chemo third. And what they saw within an 18-month period was a doubling of overall survival.

It went from about 14.8 months to 27.1 months. And, we looked at three-year survival in percentages another 64% versus 28.

Now it's a relatively small study. It's going to be followed up with METRICS II, but we're very hopeful that we will continue to show the same results as we build it out.

We will be doing it in the U.K. as well as in North America.

We're already talking to the Toronto groups that will be involved. And so we're actually very excited about this.

Bear in mind that we deal with all cancers. This may be an example of glioblastoma only, but we deal with all cancers.

This too is very important not only to cancer patients, but obviously as you talk to employees as well. Thereafter, what we can do, and particularly as you pull it forward, so it continues to build it up.

The employer cancer screening program we've talked to is front and center for us. Absolutely critical piece of how we have built our organization of where we expect to go.

So short recap, we're talking about 64% of U.S. employees, U.S.

our major market, that's about a 100 million employee individuals, it's about 157 million Americans in total. Cancer is the number one driver of cause in place for catastrophic healthcare.

Bearing in mind the companies carry that, but they actually share it with the reinsurance groups really to scroll the groups like that as they work with. So it has equal relevance to them.

And the economic burden overall is a staggering 150.8 billion. Therefore, you want to intervene as early as possible.

The other pieces we talked to is that approximately 75% of these self-funded plans have 500 or more employees. This is as of 2020.

We've started with the first responders. We've talked about that.

We're well down the budget process. Some of it kicking in now, some of it will kick in during the year.

I think it's really important that we talk to the fact that you don't turn these programs on and everyone lines up at the door on day one. What you do is you turn the programs on and then people feed in across the years as it goes.

So we are looking for incremental utilization as we build on now, but we're also looking for a group to start today and then probably not finished for two to three months. And so it'll feed in all the way through this, and so it takes time to get it going, but once it moves, it moves pretty quickly.

Just to recap, again, the Ontario firefighters 30,000 in total, 11,000 full-time, 19,000 part-time. And we've go to the cities for multi-year funding so that we can continue to build it all the way through.

We also build the data for them. All of this drives through.

We will be at some of the conferences this year, the first one in fact is in May. And they've asked us to have a booth and to actually draw blood at the group.

So we will begin to do those things as we move through. It's a really nice way to think about doing it.

Benefit providers are key for us. Benefit providers work with the employers.

They take innovative plans to them, and they are focused on giving them plans that they produce or maintain their costs. They obviously interested in giving the best benefits that they possibly can for employers and employees, but they need to maintain cost, and if at all possible reduce cost.

Remember, that if you can show a 2% cost reduction to an employer, you typically get their interest when you're delivering the kind of cost reductions we talk about, you absolutely can get the interest. So benefit providers plays a huge part of what we do.

In addition to that in just in terms of straight Aristotle tests, we built a network of labs across the U.S., we're in discussion with much larger lab groups as well, looking at how they can independently offer Aristotle. From there we're talking to healthcare groups as well.

And so, we are looking for that to come on stream as we move out during the whereby, we incrementally expand our reach. I think, it's worth talking to what the revenue is.

If we do a single Aristotle test, we have a price at $949. But we do a single Aristotle test, that's essentially what we get from it.

If you work with an employer, we're also going to do the metabolic panel with the consultation that drives through that. That's an additional 795.

So just even just beginning to move in with that, we're at a much, much higher level. What we will then do out of that is don't forget that a significant number of the employees are going to test positive for what are the aspects that drive through the metabolic pathway panel.

They are likely to take care in the risk mitigation programs. Again, something that employers are demanding.

And then as a result of that, they will stay with us. And so, we've said, well, what if one quarter of these people do it?

And you see what it does is it takes the revenue from a straight Aristotle 949 to more likely 1,600 to 2,400. So there is a very sound economic rationale from our perspective to doing this other than just giving employers what they're after.

In summary, I think, as we've talked about cancer is the the number 1 catastrophic cost for self-funded healthcare plan. Early cancer detection is critical, absolutely critical.

It markedly reduced cost, it markedly improves employee five-year survival rate. 40% of cancers are avoidable.

You've got to have the risk modification program, what that means you've got to be looking for them in the first place. So it comes back again to the screening, but the right kind of screening and you have to flag that.

Telehealth, critical, oncologist or let's say physician oversight, but in our case, metabolic oncologist oversight, which is even better. Absolutely critical.

Employers need to know that you tend to take care of their employees who test positive. They don't just want a lab result.

In addition to that, your involvement, how many workers are employed in the healthcare plans? That's over 100 million.

We talked about how many employees are in the 500 plus group of that 75% of the self-funded employers. And which from the case studies, if you look at where we're at, just how significant you can change the costing.

We're well above the 2% threshold which groups typically look for. And from there, it is really an Aristotle to as the advert of the risk factors, both can stand on the road, but they're much more powerful when they use together.

With that, we actually look forward to what we believe will be a very good 2023 growth. We are very aware of the fact we have to execute.

We've been put in a strong position at this point, and as long as we execute and as to ensure that we've got an adequate supply of cash to fund what we're doing, we believe that we can achieve our objective. Rebecca, back to you.

Thank you, James. Thank you everyone for joining us on this call.

If you have any questions that we have not addressed, please submit them via the form, that you have accessed this call. Thank you.