Resverlogix Corp. (RVX) Earnings Call Transcript & Summary

Thank you for standing by. This is the conference operator. Welcome to the Resverlogix Corp. Update Conference 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. Please go ahead.

Thank you very much. Welcome, ladies and gentlemen. It's a pleasure to be speaking with you today. This is a live call during the COVID times. Hopefully, we do not have any cellphone interruption here. But last week with the weather we've had here in Calgary, there's been something of that. So if that happens, the operator will reconnect me right away. Thank you very much. On Slide 2, is our forward-looking statement and as usual. So on Slide 3, we'll talk a little bit about Resverlogix. For those who are new to the story, this is a Canadian corporation, developing a cardiovascular and CKD, or chronic kidney disease, drug called apabetalone. And we are pioneering this technology. It has the ability to turn on or off disease-causing genes. So this is a big, big step forward. There's actually no change to the human DNA. And our exciting breakthrough technology places Resverlogix as a world leader in utilizing epigenetics to regulate disease-causing genes. Now today's subject, first of all, I will also apologize for the delay in the presentation. Last week at -- well, by Wednesday of last week, it was pretty apparent that the data that we were about to present would be outdated within about 48 hours. So we chose just to bump it back a week in order to make sure that we can properly update our audience here and not have to change it back a few days later. So the areas we'll be covering will be the financing update previously announced was Sheikh Abdulgader Baeshen from Saudi Arabia. We'll update you on where we are on BETonMACE with the design upgrades and partnering options. And most importantly, we'll talk a lot about COVID-19. There's been some major developments there that I think you will be as in favor as I am. So on Slide 4, regarding the financing details. So we had announced on October 6 that we would be doing this particular financing and price it in, et cetera, and we've been working on it steadily ever since. So I will update you on what's been done and where we're going. The original estimate of closing was January 15. We're obviously beyond that, but we're on track and doing better than we even anticipated. So subsequent to that original announcement ORI Capital converted their debt position of approximately CAD 17.5 million or USD 13.3 million. We converted it -- for shares. So we no longer have that debt position hanging over our head, which is a phenomenal pleasure, a blessing, to be in that position. Then on December 3, part of our discussions with the Sheikh were to have an estimate of fair market value presented. This was done by Deloitte, and providing a current valuation of just our core ACS program. And the valuation does not include the COVID-19, does not include pulmonary arterial hypertension or any of the other programs that we're working. Now this was a 63-page report. It is confidential, I'm just -- in advance, no, I cannot share it with anybody. The terms of the engagement with Deloitte were very specific to that point. But anyway, the report is very detailed and far exceeds -- it gave a range of potential prices and -- or values and they all far exceed our current market cap. So very satisfactory to our investor. It was also something he needed for part of his foreign review as far as exporting funds out of the Kingdom of Saudi Arabia. Now on December 22, we also had our AGM, and this question was put to vote as far as approving this particular transaction. And we received greater than 99% approval on that. So thank you very much. That was also part of the process. So since the AGM, we've been working diligently to step through all the processes there. And Sheikh has a quote for today. He says, "I am happy to join your esteemed company, Resverlogix. Upon the emergency circumstances of 2020," that would be COVID, "and my complete belief that your work will serve all mankind, I'm participating in this initial investment." So we thank him very much. They've been a real pleasure to work with. So we look forward to that. And in addition, the Sheikh has also requested an upsizing of his investment. So we will talk about the details of that when possible, and it should be very soon. So thank you for your patience on that. Now Slide 5 is transitioned into -- we're going to talk a little bit about the BETonMACE2 design. Some people call it BETonCKD, but the official name will be BETonMACE. And as you know, on Slide 6, the FDA breakthrough approval. We received that 1 year ago this week, actually. So very exciting. We've had very good discussions with the FDA and our planning partners. If not for COVID completely plugging up hospitals and systems, especially since the fall, we most likely would have been started by now. But we need to wait a little bit. Be patient. But during that time, we've been able to advance and create a better program going forward, in my opinion. So on Slide 7, this is your standard approach that pharmaceutical companies use. This has been discussed in detail with a couple of different potential partners. Don't freak out over the 5 years because I have no intention of following this plan. I think our next 2 plans that will come up here in this presentation will show you a much better direction. So pharma companies, I mean, they were going to pay for this, but it's -- 5 years is too long, we all know that. And in 2021, their goal was to enhance the chemistry. And we worked with their chemists and different companies and came up with some really good knowledge out of this. It was a very useful exercise. On the 2021, below it through the dash lines, you can see that there was an array of work that these people would do first. And it's good. They're very prudent. If they have all the time that's the best approach to go. But it's not the best for our company. So they would be doing a reformulation to a tablet. That's a good approach. A fixed-dose combination with an existing SGLT2, also good. Time release, so it can be a once-a-day formulation instead of twice a day, that's also good. Preclinical scale up to commercial supply before starting enrollment. That's a lot to reach. And the preparation for this chemistry could be 12 to 18 months. So as you can imagine, it wasn't the big seller because, I think, 5 years is -- 5 years more is way too long. So in this scenario, patient enrollment would have commenced in about mid-2022. And the last enrollment of a patient -- because the size, as you can see on the bottom, is exceptionally large, 10,000 patients. We have -- in the next slide, I'll explain how you can reduce that, but quite a bit. That would last until the end of 2023. And so our interim analysis, which the FDA has already given us approval to register the trial off of, as long as it's successful that is, interim analysis wouldn't take place until mid- to late 2024. So trial completion would be about 5 years in total. And the cost of this particular trial, mainly due to the size and the length, is over $200 million. And if this was our only option and they're paying for it, well, I guess that works. But let's go to the next slide and talk about some differences. I refer to this as a targeted approach. And -- but in targeted, we're going after specific high-risk patients. And these are patients that have more and more events. And this is really what the trial is all about. It's about the number of events, and we're going to talk about that a little bit more. So under this approach, we can start enrolling in this trial in the second half of this year. And the -- that's pending COVID-19. Like right now, a trial of this type, they just aren't taking place right now because the hospitals are filled, everybody knows the story. It's a mess. Yes, it's getting better. So as we wait it out with our partners, we'll design a launch time that is most effective. Launching now and just having a few patients dribble in isn't going to make the trial go any faster. We need to launch in a targeted fashion, enroll these patients very fast. As I've stated here, we believe because of this targeted approach, we know who the patients are, we now have nephrologists, et cetera, enrolling, not just cardiologists, we're not waiting for patients to have an event, these patients will have a lot longer time frame of having an event. So they will have had an event, but not a recent one. Well, some of them will have recent one. But it won't be 7 to 90 days anymore, it will be either 7 to 180 days from event or 7 to the 365. So that is a discussion that is taking place with the FDA. Now on this chart, you'll notice, I still have all those preferred chemistry upgrades on here. We don't need to complete any of those prior to starting this particular trial. We can do it in parallel. And that's what we will do. That shaves a lot of time off of the trial completion. So our goal here and what's highlighted on this slide is the interim analysis target of 300 patients should take place about 6 or 7 months after the last enrolled patient. So this gives us a much shorter window of proceeding with this. And we are using higher risk patients, which is actually better for us because our drug seems to work best in those most affected. And this case, they certainly will be affected. So we have the ability through our breakthrough therapy designation to advance this quite fast post interim analysis. And we do believe we will hit that target. If you think about our last trial where we had a 67% relative risk reduction in the patient group that represents this particular model, that would be diabetics, the chronic kidney disease patients and those on SGLT2s, we saw 67% relative risk reduction. In this particular category, we're only looking for 22% relative risk reduction to pass that interim. And as I said, we had 67% last time. So I think we're going to do -- hit it early. Okay. And the cost here is much lower, $60 million to $70 million, I know people are concerned that they would much rather see us partner this then to lose or try to finance it on our own. At least this is something we could finance on our own, and as you know from past, we are pretty creative as far as minimalizing any dilution. I believe that one of our partnership discussions will come through and we will be able to proceed this -- proceed with a partner on this and look forward to it. Okay. On Slide 9, I can discuss a little bit more in detail of what is BETonMACE2 trial would look like. I already mentioned the extension of the time frame. And to us, the 7 to 90, that was a self-imposed number on the last trial. So extending this out should not be a problem. It will add more events and faster, so that's a plus. The GFR rate for the kidney, we're going with a tighter range that will most likely between 20 and 60. And it's interesting, if you look at the last trial, I think we were between 30 and 75, that's just a guess. And the 60 to 75 had very, very adverse events. So this is better. This will create a larger amount of events, as you'll soon see. And again, SGLT2 inhibitors were used in the last trial, but they were pretty new on the market. They pretty much started the same year the trial started in 2015. So in this case, there'll be a lot greater number. We're not mandating absolutely everybody has to be on them, but we're leaving it up to their doctors. And so instead of about 15% on them in this trial, we anticipate it probably will be close to 70%. And that was a category that we had our highest success in, and that's a category that also we have our longest patent on out past year 2040. So we're pleased with that addition. So the primary endpoint will be the time to first occurrence of a narrowly-defined MACE event being cardiovascular death or MI, heart attack, or hospitalization for congestive heart failure, another category that we did exceptionally well with. It was a pre-specified endpoint -- secondary endpoint in the last trial, and its success was quite high. Okay. The trial size is a lot smaller, only 3,600 patients and they can be enrolled way quicker than our previous trials. And we won't talk too much about that strategy, but there are some unique opportunities there. And we're only looking for 300 events. So this patient population has more events. They happen faster, and we get to that interim analysis much quicker. And the -- all of these changes and additions to the trial are well thought out and should ensure adequate power and a high likelihood of patient benefit in this particular program. So on Slide 10, this is just a little patient enrichment strategy to show you some of the differences. The BETonMACE targeted patients there were in a category that usually have about 9.4% events per year. 11.4% doesn't sound like a lot more than 9.4%, but it's a 20% increase. So you've gone with a patient that -- a patient population that has a higher risk. And in this case, that helps us, more events and shorter trial and lower cost. So that's the program there. Now here some exciting data on COVID-19 and our Phase II trial that we're about to launch. So on Slide 12, this is the compilation of some of the material that has come out since March 23 when the first publication came out stating that bromodomain and apabetalone in particular, and ACE2 inhibitors are all very good therapeutic approaches for reducing or eliminating COVID-19 infections. Now for these 2 slides, this one and the next one, please keep in mind, when you read SARS-CoV-2, that is real name of this particular virus. It's called COVID-19. It used to be called the coronavirus, which have 2 or 3 different names. But the scientific name for publications is SARS-CoV-2. And so that's -- just so that doesn't confuse anybody. Now since March 23, there's been multiple papers come out on this. These people required live COVID labs, a BLS-3 lab (sic) [ BSL-3 ], I believe it's called. And so you can study this program. So some universities, et cetera, that have those in place were able to hop right on this information and start studies on both apabetalone or other BET inhibitors. As you know, this is the most advanced BET inhibitor, so we have a huge advantage there. So these studies have been coming out. And now we've also done our own and that data is about to be published as well. So beyond just these that are listed here -- and some of these we've put out news releases when they came out, but beyond these, there's a couple more upcoming that have already been submitted and are under Journal review. One's titled, The Effect of BET Inhibition on Inflammation-Induced Cardiac Dysfunction and SARS-CoV-2. So the -- basically, the COVID impact on the heart muscle. It's an excellent study and it utilizes apabetalone. And details on that study will come out once it's published, and that should be fairly soon. Another one is coming out as well. This will be submitted shortly. It's the effect of apabetalone on ACE2 expression and SARS-CoV-2, or COVID, replication in cell culture system. So basically, a study designed to does apabetalone reduce viral infection in human cells, in particular, in this case they're pulmonary or lung cells. And so our goal was to go forward and see if we can reduce -- the vaccine is going to be very helpful, but a therapeutic would be more helpful. If you could reduce the impact of the disease by even, say, 20%, you would reduce organ damage and there's a lot of organ damage from this disease. You would also reduce the possibility of the cytokine storms. You would reduce time in hospital and cost. So our goal was to reduce that. We were hoping maybe 20% would be great. I can't give you a number today. But I can tell you, it far exceeds 20%. We're very, very impressed with the results here, and they will be published shortly. So they need to get published, so we can get true value out of moving this program forward. And this is an incredible positive step forward for our company. So beyond just the COVID paper, so also I'll mentioned at this point that there are numerous other papers in publication right now, this is going to be an exceptionally good year for Resverlogix. And some of the papers will be put out by -- well, one of them's involving Alzheimer's and MoCA work that was already done. One of them is involving Fabry's disease in preclinical models. Another one involves apabetalone on brain endothelial activation. There's one on FSHD and that's a type of multiple sclerosis. And another one on, basically, the mechanism in contrast to pan-BET inhibitors versus our selected BET inhibitor. There's one on chronic kidney disease. There's another one on -- in combination with insulin treatment. So there's a lot coming up. Sometimes we get quiet, but this isn't going to be one of those years. This is going to be a very loud and proud year for the company. On Slide 13, I just want to reiterate, this is a slide that I showed during the AGM. And it was published with center for disease control information and highway traffic, CNN put this out. And the big bubble there of COVID-19 deaths at 0.25 million, this was in November, that's a newbie to the party and that means the extra stress on our hospital systems. The other numbers all stay relatively the same throughout the year. So you know that what to prepare for and how to budget and what infrastructure you need in your hospital system. But when something like COVID comes along, you have this huge increase. So on the next slide on 14, this is where we are today. This is just death in the United States alone. It's around 460,000 now. It was only 250,000 in November. So this is sad. The other numbers I didn't update -- as I mentioned they're annual numbers, so they're pretty much going to stay the same. But this COVID bubble has to go. Reduction through vaccination is going to help a lot. But there is a missing part of the program, and that's a therapeutic. And the therapeutic can begin as soon as symptoms of COVID start, and that's exactly what our drug can do. We're thrilled that this whole bromodomain approach and our advanced epigenetics is in place because this changes the landscape going forward. On Slide 15. Again, this is a more technical slide using the term SARS-CoV-2. But this explains why our drug is going to have so much positive impact. Because it has a dual mechanism, by working through the genetics mechanism and understanding what we've learned over the last 10 years about this drug and the mechanism. It has a double approach here. It can stop the infection of human cells. So the virus attaches to the human cells in a place that -- so does our drug. So just by taking our drug, that could potentially lower. But also, our drug causes ACE2, which is a receptor on the outside of a human cell, it causes it to be reduced. Now ACE2 receptors are usually very prevalent in very sick people, diabetics, heart patients, kidney patients. The very patients that are having the problems, the most problems, with COVID '19. And that's because COVID uses those cells or uses those -- that receptor to enter the cells. And once it's inside those cells, it is over the cell's machinery, and it becomes a little mini COVID-19 factory, cranking out more and more COVID-19. Then what happens next is the second part of the equation being the cytokine storm. And this is your body trying to fight the infection, and it turns on all these anti-inflammatory properties and they turned on. They stay turned on because that bromodomain sits on that site and keeps them turned on. Our drug is a BET inhibitor, so we stop -- not only has ability to stop the infection part of the problem, we have the ability to reduce the cytokine anti-inflammatory part of the program. No drug out there do that. This is also acting at a point in time where the -- at a point in time with drug development where there are no other drugs for this. Drugs like remdesivir and such, reducing cytokine storm, yes. That's further into the infection process. But early on and stopping it before you get there, that's what we believe this drug can do. And so we're excited about moving it forward. There's no question about it that this will have some positive impact. Now on Slide 16, I hope you're sitting down because I'm going to use the word revenue. We believe that because of the nature of this program and the desire of it globally to have a therapeutic solution, we have the potential to receive revenue in 2021. So exciting for us, no question about it. We're filing almost immediately within the next week or so for this program to commence. Patient enrollment should start as early as March. Maybe it will slip into April, but we will have patients enrolled in this very soon. We only need 100 patients. And God knows, there's way more than 100 patients available out there right now. We have set up with principal investigators already. This program will predominantly run in the United States. And the desired chemistry is not required to do this. The chemistry is in place. We will still continue this chemistry program because we believe with positive results from this Phase II trial, we should have data before midyear and quite possibly even sooner than that. The trial is only 28 days long and only has 100 patients, and we're expecting to see big things from this. If we see the positive results in Phase II, we will kick that chemistry program into full gear right to commercial scale-up level. And we will do that with partners. We will do that in various sites around the world because, just like the vaccines -- preselling their vaccine and prepartnering, so countries and payer groups are first in queue, that's exactly where we have the opportunity to do here. And it is an exciting option and it's something we are going to pursue hard core. We would be required to still do a Phase III. Some people would proceed with administration. Some countries would proceed with administration of this drug without an official FDA approval or EMA in Europe. This is a very advanced drug. The safety profile, time lengths, et cetera, far exceed any of the vaccines that are in production. This particular program has thousands of man years of treatment and safety profile in place and breakthrough therapy designation from the FDA. So we will proceed at as fast a pace as we can, but emergency supply and manufacturing and partnerships agreements could create a commercial opportunity for us in 2021 and long-term potential for this program is also exceptionally strong. And that's because this is not specific to SARS-CoV-2 or COVID-19, this is specific to those viruses that use ACE2 and the other terminals to enter the cell. So unlike the vaccines, which some of them like Moderna are already starting a new vaccine for the mutations that have happened, this would not be in the same category. This is a therapeutic for this program. So trial would be 4 weeks, and we're pretty excited about this, as I'm sure you can tell. And again, it's a fairly cheap program. We can finance this internally and we also have applications out to government bodies. We have received approval for a large funding from the Canadian government. However, they don't quite understand the system here. They want to start with us going backwards and doing animal studies. So I think we'll pass on that one. But anyway, the overall program for us is getting pretty exciting. And you will be hearing a lot about it in short order and regularly. So Slide 17 is description of this particular study. It will be an open-label study. So we will be seeing what goes on as it goes on. And hospitalized patients must be over 18 years old and can go up to any age. The oxygen levels, et cetera, are all standard. What we've done is now that there's a lot of activity out there. We've -- we're working with a CRO who's already done 20 different COVID programs. It took us forever just to get into the cell labs where we could do our own cell studies. And we got -- finally, we got -- outside of Canada, we got into 3 of them that also paid for them, which was a pleasure. And they studied the lung cells, the heart cells and the kidney cells. So we have a ton of data to support this moving forward and believe that this will be a very successful program. The primary endpoint will be to show evidence using the World Health Organization standards that we are reducing viral infection, we're reducing time in hospital, cost to the systems, et cetera. And for us, there seems to be -- any papers we've read, there's nobody who's even close to a viable therapeutic that has Phase III safety data and the amount of programming behind it that this drug has. So we're repurposing apabetalone as an antiviral and anti-inflammatory. And that puts us in a very, very unique light. Secondary endpoints will be going after the biomarkers like IL-6, IL-8, TNF-alpha and CRP, all areas that we have extensive data on, on apabetalone and know we have a profound impact in these areas. So going forward, it's exciting times. That brings us to the Q&A session. But before we get there. I want to mention that during this week, it's an important week in Calgary. We're sponsors of Alberta Children's Hospital. And this is a tough time for them because this is the week they usually do their live annual radio fund -- their annual fundraiser. And as such, they're still doing it, but they're doing it virtually. And tomorrow, we're sponsoring one of the hours and adding to that program. But their phones are open now, and they are taking donations. The number is (403) 802-2700, and that's for the Kids Radiothon. And we really hope -- I know it's a tough year financially for everybody, but we really hope some of you can join in that program and help support the children's hospital. You can do that today or tomorrow, and that's (403) 802-2700. Okay. Thank you for putting up with my commercial there. And let's go to Q&A now. This is a live Q&A. So fire away, please?

[Operator Instructions] We will now read out questions that have been submitted via the webcast. The first question comes in from Toby Ma of Mackie Research Capital. Why combining SGLT2 and the company's candidate would create therapeutic synergies? What's the scientific rationale behind this?

Toby, thanks for the question. Very good question, and the answer is quite positive. In the BETonMACE trial, the patients that were on SGLT2s had a statistically significant p-value of 0.0002 reduction in MACE events. MACE events being the major acute cardiovascular events. Major adverse events being death, MI and congestive heart failure. Stroke was also in that particular category. We had a 67% relative risk reduction in those numbers. So we are synergistically benefiting not just with SGLT2s but also with DPP-4s. So we filed patent extensions on those, and we have been talking extensively with the major companies and also some that are presenting some new SGLT2s as far as working together going forward. The data has been fully reviewed by the people currently leading SGLT2 data sets, and they concur with our findings. So very exciting. If you want to call me afterwards and go over with one of our scientists on the line, go over the details, we'd be pleased to do so.

Second question comes in from John Vandermosten of Zacks Small-Cap Research. I really appreciate the targeted development plan. I wonder if, in addition to focusing on event frequency and patient selection, if any precision techniques for enrollment were considered, such as evaluating biomarkers for patient epigenetic response or if it was applicable in this type of trial or indication.

Okay. Thank you, John. We looked at that approach. The problem is time. And if we go down that route due to centralized labs, et cetera, it really slows down enrollment. But for us, I think we're in a great spot anyway because our patients are concentrated. When we're looking for CKD patients, it's easy to find them. Cardiovascular patients, they're everywhere as well. So those are the patients we want. The sicker they are, the better. The lower the GFR, the better. The FDA is the one who asked us to lower our low end -- I stated earlier, I think in the last trial it was 30. But they asked us to lower it down to 20 because it -- the data was pretty strong. The lower we go, the better it gets because the drug is working in those that are the sickest. Once you go over 60 GFR, your patients aren't that sick. There's not that much bromodomain to inhibit and there's not as much inflammation to be reversing. So I think we're in a very solid group there, but could follow-up again, same deal. If you have some suggestions before we launch this trial, we'd love to hear and we'll review them. And every bit helps. So thank you very much.

This is the second part, also from John Vandermosten from Zacks Small-Cap Research. What would need to happen to commercialize apabetalone in patients who have COVID-19 who are experiencing cytokine storm and tissue damage? It seems patients would need this now more than a vaccine, which some are still hesitant to take. Would an accelerated pathway be used such as EUA? And what might a time line be?

Yes. Good question. Yes, an accelerated path will be used. And we can initiate that path after we have these first 100 patients dosed. And as I mentioned earlier, the excitement there is that the trial is only for 28 days and it's only 100 patients. So we could have this data as early as May. And moving it forward from that point, yes, it would receive an emergency clearance pretty much everywhere we put it. If this human data looks anything like the live human cell data, this is an amazing breakthrough for us. And it's not just us looking at it. This is being picked up around the world, as was highlighted in all those publications that are already out and that are coming out. The ones involving our own studies on heart cells and lung cells will be out shortly, and that will also help in getting this to the emergency approval sections. And some countries may. As I mentioned, we've talked before about the potential of named patient programs, which could cover COVID storm, cytokine patient, et cetera, they can start taking it now in some cases. So we are pretty excited about where this is going to go. We do recommend -- and keep this in mind, we do recommend that you take a vaccine if you can get one. Please. This isn't a one-shot solution to all the world's problem, but it's certainly going to be a help. And the vaccines are important, especially now while everything else is still in development. But going forward, you're going to see a lot of people follow our path in this type of therapeutic approach. Thank you.

Thank you. Next question comes in from [ Bjarke Christensen ]. Are you going to exclude patients based on high LDL? Above median LDL patients appear to have no benefit in BETonMACE.

Excluding patients with high LDL, no. What we're doing is we are maintaining our HDL standard of low HDL. And people with low HDL are more impacted by this drug. So screening for the high LDL, I'm not sure that would have any impact. I would have to check with Dr. Sweeney or Dr. Johansson. If you -- [ Bjarke ], if you want to follow-up with an e-mail to me, I would gladly get a proper response for you on that. But it is not something that has been discussed in our clinical or partnering meetings.

Next question comes in from Christoph Boehringer of CD-Venture. Is a study with 3,600 patients too small or underpowered?

No, it's not underpowered. As a matter of fact, it's powered to 90%. And it's funny because, in some cases, the pure hard-core cardiovascular pharmaceutical companies, they want to power it up to 10,000. If you look at the CKD-related companies, they're wondering why it's so big. So we hit both. Those numbers are estimates now, and it definitely will be powered properly by the time it's launched. I'm not concerned about that. I've sat in every one of those meetings so far and all parties concerned are quite convinced that it's properly powered. But thank you for the question. It is a good question.

This will be the final question. This question comes in from [ Jay Dietrich ]. Don, it's such a strong COVID therapy, where is the support from Alberta, Canada, U.S. government to accelerate the program?

I missed who that's from, but I appreciate the question. Who's that from?

From a [ Jay Dietrich ], private investor.

Okay. Yes, thank you. Yes, good question. As I mentioned, we were offered some support from the Canadian government, almost, I would say, reluctantly. However, having to go back and do an animal study when you're sitting there with FDA breakthrough therapy designation is not an appropriate approach. So we continue to work with them. Hopefully, they will pay attention. They seem fixated on vaccines and new vaccine programs in facilities that aren't even built yet. But nonetheless, I think eventually, they will come around. Provincially, we have had recent discussions with provincial authorities, including as high up as our premier. I think our odds there are better. We continue to work. And I think the acceptance of this technology as a Canadian-born technology -- for some reason we seem to disavow our own technologies. But in this case, we're moving forward as fast as we can in as many places as we can. So hopefully, Canadian governments get on board. And we would be very pleased to speak to any of the premiers regarding this program because those guys have horrible jobs right now, as we all know. And there is no win-win scenario for them out there, and we would love to be part of the solution. Thank you very much.

Thank you. This is all the time we have for the question-and-answer session. If your question did not get answered, please feel free to contact the company's Investor Relations department. I would now like to turn the conference back over to Mr. McCaffrey for any final closing remarks.

Thank you very much. It is exciting times for us. Our finances and our debt are under control. That's been a downward pressure on the stock. So we should see some nice rebounding. But as soon as the expanded world learns about what's going on with a realistic COVID-19 therapeutic that can go into full-blown manufacturing very fast, I'm excited. I'm very excited. So let's make 2021 a lot better than 2020. Thank you very much. And look forward to talking to you again very soon. Take care.

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