Resverlogix Corp. (RVX) Earnings Call Transcript & Summary

Thank you for standing by. This is the conference operator. Welcome to the Resverlogix Corp Update Call and Webcast. [Operator Instructions] And the conference is being recorded. [Operator Instructions]. I would now like to turn the conference over to Mr. Donald McCaffrey, President and Chief Executive Officer of Resverlogix Corp. Please go ahead, Mr. McCaffrey.

Thank you very much, and welcome, ladies and gentlemen, to our presentation this afternoon regarding the clinical and commercial update what's been going on in our program for the last little while. And we will we have a forward-looking statement here as we will be making some projections going forward. And we also will do a quick review of where we are. We'll have some new listeners online today. So we want to bring them up to speed about what our program is all about and why we're so excited about moving forward. So today, we are a first -- here's the highlights. We are a first-in-class Phase III asset. And we have already demonstrated the cardioprotective benefits in cardiovascular, diabetic and kidney patients. And we're using an advanced epigenetic mechanism, where we have discovered how to turn on or off multiple disease associated genes. So it's a very effective process that is actually dealing in hundreds of proteins at a time instead of the customary 1 or 2. And it's been proven very safe. The FDA breakthrough therapy designation is an indicator of that, where we were awarded this last year, and we'll be applying it to our Phase III BETonMACE2 trial, which is upcoming. Now we also were awarded that particular program. It's the highest designation you can get from the FDA. We were awarded that because we were able to demonstrate a 63% hazard reduction in death, heart attacks and congestive heart failure. And that had a statistical valuation of a p-value of 0.0002. So extremely highly statistically significant, and that was very helpful in getting that breakthrough therapy designation. Now we've also received many publications, et cetera, going forward. The company itself now, I believe our number is at 38 and there are hundreds of others involving the field we are pioneering here, including some of the top journals in the world, there's about 296 academic journals out there and #1 and #2 consistently are self in nature, both have published on apabetalone in the last short while. The sale publication is actually 39 pages and it was spearheaded by Monash University in Australia and my lab staffs that I'm very proud of. We're also in nature, and that was a group of 27 universities studying 20,000 drugs to determine which ones may have potential to help fight COVID and be repurposed for that procedure. And we were on their short list of 63. So we're very, very pleased with that. We've also had the ability to advance commercialization. And we're going to talk about that a little bit at the end of today's presentation. We have partnered with a new type of business model, a company called EVERSANA, and they are a phenomenal company to work with, and you'll see that from some of the progress we're making in parallel. So sometimes, stakeholders don't get enough information because we're working behind the scenes, moving things along in parallel. Today should answer some of those questions on how far along we are. It's very far along. So Health Canada has also granted us approval to proceed with this trial. And further into our slides, you'll hear other approvals that are in place. Okay. On Slide 4 here, this is our development pipeline. And we are sticking with cardiovascular disease as our lead program. We think it is a very exciting opportunity. However, the COVID program has given us an opportunity to early launch our overall program, which should help quite a bit in our enrolling our next trial plus as far as moving it forward. Now the COVID program here is expected to get an initial readout in Q1, this slide since December, but we will not make that. It will be Q1 of 2022. So just around the corner, and we're doing enough follow-up work, especially with EVERSANA, that will allow us to catch up to the schedule and be ready for a full-on commercialization at the appropriate time. Our follow-on programs are going to be chronic kidney disease. It's one that has also just recently published quite a bit of data showing the ability to reverse some of the damage of kidney disease and to drop the hazard risk ratio by 50%, which is also an enormous number. And we're also still actively working on pulmonary arterial hypertension. This is an ongoing program. These are ongoing trials. They're investigator-led and being paid for and moved forward by the Laval University. So we're very, very pleased with what's going on with that one as well. Excuse me, I'm kind of trouble with my slide deck, just one second. Okay. Now we're going to talk a little bit about the high-risk cardiovascular disease program, some of the clinical updates and where we're going, and then we will move on to the COVID program. So we do have the FDA breakthrough therapy designation, and it was a result of our very safe and promising BETonMACE1 program, and we have 4,200 man years of toxicology knowledge up to 4 years. So technically, that's as much or more than all of the COVID vaccines combined. So we do know quite a bit about the safety profile of this drug, and we'll continue to apply it forward. And of course, the -- this program is quite an honor. And as described on their own website, breakthrough designation is for a drug that treats a serious or life-threatening condition and primary clinical evidence indicates the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies. And that's exactly what we showed in the last trial, as you can see on this particular slide here. The purple I always like to stress is our placebo line, but that is not an ordinary placebo, that is placebo plus top standard of care. So all of those patients were being treated as best as medicine can treat them today. They are on high-dose statins, beta blockers, ACE inhibitors, glucose management. So they were being well treated. And with the addition of just apabetalone, we dropped the rates, the hazard reduction in death, heart attack and congestive heart failure by 63%. That's an enormous number. When the statins hit the market about 30 years ago, they were able to enter the market with a 30% hazard reduction. This 63% is on top of high-dose statin. So we're very proud of this and where it's headed. Switches very fast. Okay, it's not just cardiovascular either. As you can see here, this is our chronic kidney disease patients in the BETonMACE trial. This is also published data, and they were highly effective as well. And this is really good news for nephrologists because right now, nephrologists really don't have a lot to their patients. They manage them through Stage 1, 2, 3 and 4, then they're put on dialysis. And the next step is unfortunately death. So being able to reduce these events, the main causes of death in CKD patients is an enormous move forward. A 50% reduction with a p-value of 0.0095 is highly statistically significant. So there's a lot of buzz in the nephrology world about a drug -- this drug that's upcoming in the next couple of years for their patients. So we're glad to be on the way to that category. Now the BETonMACE 2 trial is ready to go. And we have been on and off waiting for COVID to subside. However, we believe we're going to be one of the key groups to help it subside. And in doing such that will increase the demand of enrollment of patients in our main program. So we believe we will catch up quite quickly and enroll this trial extremely fast compared to BETonMACE1, probably in the third at the time. So we have designed this in conjunction with the FDA acting as our consultant partners on this. That is part of the Breakthrough Therapy designation status. Another part is fast forward. And we are allowed and we will be doing an interim analysis after having approximately 300 events of the planned 600 events. And that should be at a time frame about 18 months out. And we believe it's going to be quite positive. The FDA has agreed that at that interim analysis, we are showing a 20% reduction in events. We are fully approvable and can start marketing this drug. Now I am going backwards on purpose here because I want you to have a look at where we would be. It would be 75 weeks. Well, clearly, we will crush that 20% if we come even close to that in our chronic kidney disease patients, but also in our cardiovascular patients. So we should be able to easily surpass that 20% and therefore, really circumvent the length of the trial, the cost of the trial and such. So we're very pleased to be working with the FDA. It's nice to have this option and it's certainly effective for both the patients and the stakeholders in the company. Now going forward, this trial is a bigger trial than BETonMACE1, and yet it costs a lot less. BETonMACE1 was about an $80 million program. And this particular one is going to be in the 60% range. It might even be lower. We're working on something really interesting right now. We'll talk about it when we can. So our slice of the pie here will be about half of that number, so maybe $30 million in that range. And our partners in China, who have been very good partners, Hepalink. We'll be working on the program as well, covering some of the expenses. So this trial will be 3,600 patients, and I'd say it's cheaper because of our safety profile. In the first trial, different points of the trial, we were having to do lab tests every week. That means patients have to come in. Doctors have to be there, expenses are way up and now much more spread out. I believe it's around 2 months right now. So great savings in the overall trial here. Now let's get to the COVID program. And let's start by a refresher here. Yes, there are a lot of COVID trials ongoing, and there are a lot of them fighting for all the same patients. So it has been slower than anticipated, but it is picking up steam now and will pick up steam a lot faster when we were able to start displaying results from this particular trial. One advantage we have is that we are a very unique mechanism of action that pretty much covers all the stages of COVID, not just the antiviral stages. We're getting all the press in the last 2 weeks in both good and bad press. And we will show you some of the reasoning here shortly. Now one of the key aspects is we are an antiviral. We are a very strong antiviral. I believe in the cell publication, they were comparing it to remdesivir and showed that we are slightly stronger than remdesivir, which is currently used. So that is a real plus. And going forward, it's certainly not going to hurt us, but we don't believe that's our overall strength. And having the multifaceted mechanism of action gives us huge advantage all the way through COVID, especially at the dangerous particular, which is the inflammatory response phase. Now this slide, I like to show and it looks a little busy. But in the middle, the 2 diners there, the Tier 1 and the blue one are 2 of the main phases of COVID. COVID is a very tricky virus to deal with because of its very stealthy nature. Predominantly, most people don't display symptoms until around day 8. That's where the problem starts. Because antiviral has a very small window to work in because of that. So the antivirals are -- if you start them on day 8, well, by day 10, the viral infection phase of the disease is over already anyway. But what happens is at around day 5 before the symptoms, it can trigger an inflammatory response. And these are the people who end up hospitalized. These are the people that we can all think back at the beginning of this [ form of ] COVID time and the miserable pictures we were seeing out of Italy and Spain, people thrashing around in respirator rooms and how thoughtful that was. Those people no longer have COVID, an antiviral is not going to do them any good. So the approach here is to try to slow it down with antivirals. And if Pfizer's drug can do that, wonderful. But it's when they get hospitalized, it's causing all the problem here. That's when we get the shutdowns. That's when the economy goes sideways again. We're about to do our fifth wave of it. And I don't think people really want to wait around for wave 10 to decide that working on the anti-inflammatory response is actually a cheaper, faster way of doing it. We don't have to treat 7.5 billion people. We just need to treat those of concern, maybe those that have tested positive or in our first trial, those that are hospitalized and try to cut back their hospitalization time from the average of 11.9 days or, say, 12 days and up to 23 days average if they have cardiovascular issues. So that's what's clogging up the system. If we can turn off the anti-inflammatory, which is called cytokine storm, we can shut that off early. That's a huge step forward. Now everybody can throw a story or 2 about what drug works and ivermectin and remdesivir and everything else, and some may work, but some may not work. You have to look at it not in the clinical trial setting, but in a real-world setting. So let's take Donald Trump, for example. Donald Trump was a pretty obvious target as he was going to get COVID before his election, all the handshaking, all of the events he was going to. So he was being tested every single day. So on day 1 or 2 of confirmation of COVID, he was administered what we believe was 5 rounds of remdesivir at $3,200 a shot. While you're the President of the United States and you can afford to get tested every single day and afford a very expensive drug regime. You're [ lucky ]. But that doesn't work in the real world. So going forward, if you're not detected till day 8 and you're approaching it with an antiviral, and I don't knock the antivirals, we are an antiviral. We are a very strong antiviral. I just don't believe that's our main strength. And I'll show you why on the next slide. Because of our dual mechanism -- this slide also looks very busy, but most of the story is in the middle there in the yellow dots and the blue dots, and I'll explain what's going on. These are patients who had cytokine storm conditions, but they are not COVID patients. This is from a study that we have done and published in New Zealand, where the chronic kidney disease patients that we were testing had COVID light conditions. And you can see that on the left-hand side in the orange dots. This is just one of the pathways we tested, but it's a pretty clear way of showing the response. Everything in the orange and yellow means that part of the acute phase response pathway was highly activated in these patients. That pathway of acute phase is one of your body's main ways for fighting invading pathogens. It's been a very important part of the system. And it's also a very important part of COVID and the inflammatory response part of COVID and why patients are dying. So these systems are being turned on and they stay on at full tilt. So it's the patient's own immune system that's actually killing the patient. It is caused because of COVID, but the COVID virus portion has come and gone. So an antiviral isn't going to have anywhere near the impact that a combination antiviral and anti-inflammatory is going to have. What you're seeing on the right-hand side is every one of these protein points that make up this acute phase response pathway has been turned down in 1 day. So imagine if we can do this kind of impact in a COVID patient -- and this is the type of proteomic work that we'll be following up with those patients as well, showing that this and the other pathways that combined for a cytokine storm have been cooled off. And if we can do this in a day or 2, whatever, less than 12 or 23, we are a very effective tool in the fight on COVID. And we -- in our cell publication, we were able to demonstrate this as well in an animal model, where they artificially induced in cytokine storms in mice because mice can't get COVID. They don't have that H2 receptor that we're so good at suppressing. So they don't get it. COVID doesn't get in their cell walls, and therefore, I can't replicate. So the cytokine storm is very important. We induced it in the mice with chemical entities and create it to happen. And then those mice 75% of them die. But when treated with a BET inhibitor are very approach, you can reduce it to 0, not a single mouse die. I would say that's a pretty effective approach. And that's where we're headed moving forward quite quickly. And now for the good news. We have had some very good updates and the trial is now officially active. We have 14 patients being screened in Edmonton. The UFC facility there began actively screening last week, and we're moving it forward very fast. Last week, there were more patients than in this week, so there is a bit of a lull coming. But believe me, we are in for a storm of new COVID patients. So this will move quite quickly. And I'm very pleased to announce officially that Brazil is now fully approved. We are able to start dosing patients there as well immediately. We've already shipped the drug. You need full approval before you're allowed to ship the drug. So we have that drug in ship, and we will start commencing with patients there at -- just after the Christmas break. And this is very important to have at least 2 sites up and going because as I mentioned earlier, last week, there were a lot of patients in Edmonton. This week it dived down. We give it 2 weeks, though, and we are going to have a storm of patients, unfortunately. So -- and we all know why did it take long to learn the name of the new one, did it. So going forward, this is very, very helpful. Now another update that is extremely helpful is in relationship to our FDA Phase III program. And we have put together a very prominent infectious disease advisory committee, and I'll go over them on the next slide in a minute, them of them anyway. There are 7 members of this, 3 of them have already received approval from their very prestigious universities to go forward. The other 4 are in the process of doing such, and we will announce them all shortly but 3 of them today. We would be impressed. And again, this is for the COVID-19 Phase III program. That is going to be a very interesting program because on the advice of the 7 highly ranked individual, they are the head of infectious disease for their various institutions. And they're an impressive lot. But we've designed this trial a little bit, and it is going to move quite fast because we are no longer just accepting patients in hospitals. We will be advancing this to accept patients at [ petites ]. So as soon as the patient is diagnosed with COVID, we will be able to enroll them in our Phase III FDA program here. FDA final approval on this is still required. So I shouldn't get ahead of myself on that one, but it is going exceptionally well. That's just a process that we're working through with our partners and our staff. No hiccups there at all. So going forward, the availability of patients as compared to the ongoing Canadian trial is quite a bit higher. So you need more patients, you need 1,200 and that's one and you only need 100 in Canada. So we should have both moving along full speed imminently here. So we also are expanding sites. We now have a Calgary site that is near ready. They're just doing their final Ethics Committee's approval. And there is a new system in Alberta and BC, where facilities such as you'll see can use Ethics Committee approval from other facilities in Alberta or BC. And this particular one looks like it will be the first one of any kind of clinical trial to be able to utilize that new system. It's designed to try to cut down a lot of the bureaucracy that we go through. I know I have been skewing -- we're just about to start. I'm glad this is an active ongoing trial now, but there was a lot of extra stuff thrown at us and a lot of delays, some academic, some government some interference. But going forward, this is moving fast now. We have other sites in Canada lined up as well. Ottawa looks promising, and we'll be heading into British Columbia right away. Based on where the new COVID numbers are in Ontario, I think they'll finally be getting in line as well. And we have some Arab sites lining up, doing their preliminary work. We've got a few of them there. The one that will probably win the race is first in will be Morocco. And they have an advantage of just like in Canada, our dual language system includes French, so it's Morocco. So -- but it's already labeled in French. That's a great time saving and cost savings for us. So we're moving that forward quite nicely as well. So you can see there's been a lot of advancements. But with the help of EVERSANA, the 7-member committee, 3 of which you see here today has been put together. And we're talking the Division Chief of Infectious Disease at UCLA. I think that title in itself speaks well for itself. We're talking one of the top people at Emory School of Medicine in Atlanta and Professor of Infectious Disease at Albert Einstein. These are really big names in the field, and so are the other 4. So helping this move forward, getting their advice and design approval that's approvable by the FDA that would allow us to go into an earlier stage of the infection being as soon as they're diagnosed. And believe it or not, that actually helps cut the cost of the trial and the timing of the trial. So that will speed things up quite nicely for -- and I don't care which trial finishes first, the 2B in Canada or the 3 going to be both keep moving along because they have been difficult to get going, but there's a lot of reasons for that, a lot of fear, a lot of politics and a lot of academia and the way we go, we're up and running. Now these people are firm believers in what we're doing and the approach we're doing. And I hate to tell you that in our first meeting, 7 out of 7 believe that COVID [ here going ] to stay, there is no quick fix for it. So -- and these people know their stuff. So that's the bad news. It's not a Christmas present. The Christmas present is being able to control it. And they believe that these are their quotes in regard to this subject. This is organized and a little meeting organized and run by Arizona was extremely encouraging. But really having a safe drug that shows activity against both viral infection and inflammation, that was a key and being able to potentially benefit the other agents being used. That was from Dr. Barry Zingman. And Carlos Del Rio from Emory very much in the same help that the infection is we have to keep the patients down in the hospital and alleviating the longer-term effects of the infection. That is critical. So that is -- we're working hard towards that. That's one of the biggest benefits our drug has over anything else. Pfizer, Merck, you name it. The antivirals are going to be helpful. They have a very narrow window, which they can work in. But it's once a patient turns the hill or is subjected to long-term effects. That's the area we play in, and we believe we play in it alone. So now let's talk a little bit about EVERSANA and the partnership. For some of you, I noticed some blogs going around some people, you guys most certainly do poke your noses in a lot of places, trying to figure out what's going on with the program. And some of you were quite impressed to find out the volume and quality of the people EVERSANA has been hiring directly for this program, very busy people, a lot going on behind the scenes, and I hope I can justify just some of it today here. I must admit every time and we have often have meetings a couple of times a week, full detailed disclosure on what's going on. I come away from every one of them, just [ tell ] that we've done in this partnership with EVERSANA. I think it's the best corporate move we've ever made. This is a graph there showing how they view this situation and how they view things like the introduction of a Pfizer or a Merck drug and how that may or may not affect their positioning here. What it's actually done is it's made our goals and efforts even stronger because we are highlighting to the medical communities where our strengths are in the anti-inflammatory and the antiviral but also the long-term patients being -- some of these patients, as you'll see in a minute, some of these patients have had this long-haul COVID effect for a long time. We talked to anybody who's had any major COVID effect and how awful it is, can you imagine if you're in that boat for a year or longer. It's it's not going away with what is currently offered. As you see here, their analysis is really in the back half of this disease where we operate, we operate in both, but that's where we have some exclusivity. Dexamethasone is just an old steroid, a critical steroid. And it's been helpful, but it's not exactly major new medicines and oxygen yes, need it. But again, not exactly groundbreaking. Remdesivir is being used in the antiviral phase. I think it's a no-brainer that Pfizer's will get in there as well. It is a very harsh drug, in my opinion, it has a lot of hair on it as far as toxicology. They figure it's okay because of the very short window, people will be taking it. The Merck one I don't know, based on the data, I don't know. It may go forward, will governments be procuring it like ours? Probably. Will it get used? Not if there's an alternative. So that's how we look at it. That's how they look at it. They actually look at percentage chance of revenue increases based on what the others aren't doing. So actually been positive in our partnership discussions moving forward. Now let's see here. This slide is just talking about this partnership and the architecture of the deal itself. So what you're not seeing, and you're not meant to see it, but it's active and it's worked. It's ongoing. It's work is making it easier for approvals, making it easier for the procurement process. And on the approval side, we are going for NDS coded filing in Canada. So a fast-tracked approval. Work on that has commenced. We're working on education, the education burden of COVID community in the hospitals, et cetera, making them more aware of what's actually going on and what is an alternative coming their way, access to their drug, assuring that our clinical and CMC programs are aligned that there will be plenty of drug available. So that is an active program as well. Availability. Some of these new drugs and stuff, I think I believe it was in the globe last week. There was doctors complaining about talk of all these new drugs at Pfizer and Merck, et cetera, and then no access to them. So it's having them and having them available are 2 different things, and adoption of COVID patients to this particular approach. COVID patients, especially those that are there now are on sickle lot. Our trials at testing patients and such, it could be doing more, but a lot of these people are anti-vaxers in their antidies. You're going to ask them to sign up for a clinical trial. Most likely, your answer is where to stick it. And going forward, the more availability of ease of use, et cetera, that we can get out on this drug, take it for a few days, it's a pill. You're not infused with something. You're not staying in the hospital. So this has some real benefit. And with the Phase III trial, the way it's being designed now and where some of these patients who would have been hospitalized will never see the hospital now and that's what we need to stop these hospital plug-ups. In September when Alberta, we had to shut down all of the oncology and the heart operations and everything. And most of you know how I feel about that and what it's cost our families. So this is a good way of stopping that and adherence to the program, getting the people comfortable with just a short time stay on this drug is going to have profound impact. Now all of these may sound simple, but they are not simple, and they do not just happen. EVERSANA has laid out some incredibly positive PR and education programs that really are hard working already at getting this for regulatory adoption in Canada and in the U.S. So regarding our parallel programs, this part is regarding the Canadian side. We've already had initial discussions with Health Canada. This isn't just the Health Canada approval letter, that approach that was done last year or earlier this year. This is getting the drug approved, getting it on the emergency management, which then gets you on the procurement list. That work has already commenced. And we often have stakeholders who are a rate that our government more involved in doing more things. It's not wise for us to be rattling any favors in that direction. We are very actively and closely working as best we can moving this through the system and laying out the groundwork to engage this NDS [ golden ] approval, expedited authorization pathways and the rolling submission process. So we don't need to get all 100 patients in to start this process. We've started it already. We are an active trial, which allows us to start it. So we have field medical operations are in place at some of the really key and talented people that EVERSANA has been hiring to move this program forward. So yes, hats off to them. We're dealing in 2 programs here though as well because we have to do the same thing in the Phase III. Some of you may remember from previous updates that we are going into a separate Phase III, the FDA had -- we presented our Phase IIb plan to them, and they wanted us to go right to Phase III. So that's what we're doing. And this has been moving along quite nicely. Q1 this will the -- Q2, it will be accurate, such as the one that we have in Canada here now. And this is the one that the 7 advisers are working on, but we're getting great advice from them moving forward. We are not infectious disease experts by any means. So it behooves us to bring those who are on board, and that's exactly what we're doing. So we're developing the resources to engage the medical community that's hiring the right people, training them, onboarding them in a proper fashion dealing with a couple of new things. Epigenetics is one, and COVID itself is fairly new to all of us. We wish it would go away, but it won't. Raising the awareness of the CBD specialists and the broadcasters who have the mic who can talk about what's going on. We can send out news releases, but most of them end up in the round bid. They get outdone and voiced by the big guy. The big guys don't have the science and the technology we do. But we're getting there, and we're getting a lot of support along this as we go and seeking insights from the top leaders, and that's how this committee came together with the full-on support assistance of EVERSANA and facilitating the onboarding, as I already mentioned. So we are ready to hit the road running here. This will be a lot faster start than the Canadian trial. And no offense to any of the people involved in the Canadian trial one. It was just a process of a lot of chickens running around in the art at the same time, all trying to accomplish the same thing with the same patients. So it's difficult. And just a refresher on EVERSANA, they are a 3,000 person -- they have 3,000 employees around the world. So for us to try to do this with 40 employees, don't hold your breath, it's going to take forever. And they've catapulted us up to the front of the list here and the awareness of the people who matter here. They're in multiple countries around the world, and we're excited to keep moving this forward. And of course, although we're working in parallel on certain aspects, we're also prepped and ready to go on many others because as you may recall, EVERSANA will be doing the distribution, the sales, et cetera, they are top to bottom [ full meal deal ] and they're ready to go. They're organized, they're fun to work with. So sometimes you don't feel you're getting enough information. It's because we're busy, we're small and we're moving things forward. And we do come out with the key information. I think we've had a very busy news year this year, much more so than the last year. So we'll keep it up and we'll keep moving it forward. Okay. That's the end of the portion here. And just before we start Q&A, I will touch on finance a little bit. We are continuously moving this forward, self-financing at the time. We have a lot of reasons to keep doing that while we're working on other deals. This is a clinical and commercial update. We will do a financial update in Q1 and -- probably early in Q1. But keep in mind, we continue to do private placements, including this REIT, at far higher than market trade, we will not do private placements. If some people want to sell as low as they're selling now, now better. But for us, we have drawn the line at that $0.85 unit level and still selling at that. So who's ever selling you're keeping yourself. But anyway, going forward, we will get back to that. And I'm pretty sure you'll be impressed with what we've been able to accomplish over the last few months. So thank you very much. I think you go right to the Q&A.

So our first question is that Canada recently signed purchase agreements with Pfizer and Merck for their oral COVID-19 therapeutics pending their approvals. How do you think these agreements and similar ones with other governments will impact the market for apabetalone?

Well, I actually -- I'm actually pleased to see our government doing something on this. As most of us will recall, we got little -- I've said the back of the vaccine line by the government not being a little proactive. Most of these agreements, especially the Merck one and even the Pfizer one and they're contingent on approvals, and there's lots of conditions in them. The Merck one, I don't know if that one will ever happen. There's lots of drugs out there that can have a 30% window in an antiviral that don't have the complexities of -- and the toxicity profiles of that particular drug. So who knows? But going forward, it doesn't matter if Merck is making billions of extra and so is Pfizer off these procurements good for them, but are they being effective? Are the doctors seeing what they need to see in their patients. And my guess is the unique mechanism that we have, we're far outside of that. It should impress the committee that we have. And just from the 3 names that are released, you can see that it is pretty impressive. So there are about 6,000 different COVID trials ongoing. So it is difficult for us and everybody else to move forward. But we are the only one with the dual mechanism. There are a couple that are combo programs running 2 or 3 drugs at the same time. But this particular approach and being epigenetic, having been shown in our New Zealand patients where we could turn off that cytokine storm conditioning one day, this is what's needed to clear those hospitals. This is what's needed to calm the anti-inflammatory cytokine storm portion of this. And going forward, we do like to see government's involvement because we are asking governments for procurement. We are aligned up in several places for procurement. And as soon as we can start sharing some data, that is going to be quite a windfall for this company. We don't know when that is, so we will not even give a prediction. But because I usually miss my predictions anyway, especially during COVID. But going forward, this work is already underway, and we believe it's important that the governments do get involved, and they should have conditions. If our drug ends up not working and procured revenues already, those money should go back just like anybody else's. Next question.

My second question is that a new variant Omicron has emerged and seen to be spreading? Do you think apabetalone will be effective at treating Omicron and other COVID-19 variance of concern?

Yes, I do. And I have been predicting these Lambda Delta for over a year that this would be a path we would end up going cyclical on. And that's why I'm convinced that although it's hard to get these trials going. It all comes down to science at the end, and our science stops every one of them because it is a strong antiviral. However, if they get through because the antiviral windows small, they get through, we are the anti-inflammatory portion. So it's that unique mechanism, dual mechanism that gives us the potential to benefit the patients all the way through here, adverting excess inflammatory reactions that can cause the severe and lasting organ damage. Part of what we're also trying to build in our Phase III is a small continuing part of the trial that will help the potential long haulers and reverse that. So yes, I do believe that the study shows that apabetalone will have an impact on any variant in COVID for coronavirus tank. Next question.

Our third question is that there are many documented cases of patients suffering from COVID-19 symptoms long after the initial infection has went its course? Can apabetalone help address chronic COVID-19 or so-called long COVID?

Yes. And there are now hundreds of thousands of Canadians and millions of people around the world who are suffering in the lingering effects of COVID-19. In that cell publication, they were focused on cardiovascular cells done at Monash University, and they were showing that post COVID. I'm not talking long haulers. I'm talking to everybody, 25% of their patients were showing signs of new cardiovascular disease. 25% of their patients were presenting with diabetes for the first time and 40% of their patients were displaying kidney function problems. So we haven't even begun to tackle the first phase of COVID, but the lingering effect phase is going to be there. And we were very pleased to see and hear from those people in Monash and on the news, the reports that were doing saying you in the cells, you could physically see the reversal of the damage when treated with apabetalone. So this is something that we believe highly in. It's something that we've studied. One of the main culprits involved with COVID is from a domain 4. And we've studied it for 20 years. This is something we know more about than anybody on this planet. And I would put every top university in that category. So for us, yes, we believe that the control of BRD4. So what happens is once these infection sites get turned on, whether it's C reactive protein or whatever the pathway is, the bromodomain 4 sits on that site and keeps it turned on. And we come along and remove it. So in simple terms, it's like putting a shoe in the door, you can't close the door. You got to get rid of the shoe. And that's exactly what we're doing. Next question.

The fourth question is at your agreement with EVERSANA is exclusive to the United States and Canadian markets. Do you have any plans to expand commercialization beyond these markets?

Yes, we do. We have been in active discussions already, advanced active discussions. We will get back to the market on that in -- when we can announce it. But I would just like to say that based on our working relationship with EVERSANA, I'd go to battle with them any day. So, it's a good company to be working with.

Thank you. This concludes the question-and-answer session. I would like to turn the conference back over to Mr. Donald McCaffrey, for any closing remarks.

Okay. I just want to thank everybody. It's been a long couple of years because the COVID slowness and everything else, we're all battling different wars here and there. But we do appreciate people hanging in there and believing in this drug. I am just thrilled to see the high level of academics and experts that are starting to surround us and get actively involved in this approach. We think it's by far the best approach, and it can be activated quite fast. So thank you again, and have a good Christmas season. You'll hear from me early in the new year. Take care.

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.