Resverlogix Conference Call 02/04/2021

 

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 Slide 1 - Welcome

 

Conference Operator:

 

Welcome to the Resverlogix Corp Update Conference Call and Webcast. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. If you are listening through the webcast, you may submit your questions using the text box provided in the left lower quadrant of the screen. If you are on the call and wish to join the question queue, please press *, then 1 on your telephone keypad.  Should any caller need assistance during the conference call, please signal an operator by pressing * and 0. I would now like to turn the conference over to Mr. Donald McCaffrey, President and CEO of Resverlogix. Please go ahead.

 

 Donald McCaffrey:

 

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 cell phone interruptions here, but last week with the weather we’ve had here in Calgary there’s been some of that. So if that happens the operator will reconnect me right away. Thank you very much.

 

 Slide 2 – Forward Looking Statement

 

On Slide 2 – These are our forward-looking statements, as usual. So on to slide 3...

 

 Slide 3 – Resverlogix at a Glance

 

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 todays subjects First of all I will also apologize for the delay in the presentation [Feb 4 vs. initial schedule of Jan. 28]. Last week, well, by Wednesday of last week it was pretty apparent that the data that we were about to present would be outdated within about 48 hours, so we chose just to bump it back a week in order to make sure that we can properly update our audience here and not have to change it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 include the financing update previously announced with Sheikh Abdulgader Aboud Baeshen from Saudi Arabia [President and CEO of Baeshen Trade, Abdulgader Baeshen Co.] We’ll update you on where we are with BETonMACE with the design upgrades and partnering options, and most importantly we’ll talk a lot about COVID-19. There’ve been some major developments there that I think you will be as in favor of as I am.

 

 Slide 4 – Financing Details

 

So on Slide 4, regarding the financing details. So we had announced on October 6th that we would be doing this particular financing, and priced it, etc. 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 15th, but we’re on track and doing better than we’d even anticipated.

 

So subsequent to that original announcement, ORI Capital converted their original debt position of approximately $17.5 million Canadian, or $13.3 million US. They 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 3rd, part of our discussions with the Sheikh was 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 and 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 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 22nd 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. And that was also part of the process.

 

So since the AGM we’ve been working diligently to get through all the processes there, and the 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 for my complete belief that your work will serve all mankind, I am participating in this initial investment.” So we thank him very much. They’ve been a 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.

 

 Slide 5 – BETonMACE2 & Designs and Timelines

 

Now Slide 5 is a transition into – we’re going to talk a little bit about the BETonMACE2 design. Some people call it the BETonCKD, but the official name will be BETonMACE.

 

 Slide 6 – FDA Approves Breakthrough Designation

 

And as you know, on Slide 6 the FDA Breakthrough approval; we received that one 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 and be patient. But during that time we’ve been able to advance and create a better program going forward in my opinion.

 

 Slide 7 – Timeline Option Review – Five Year Global Development Plan

 

So on Slide 7, this is your standard approach that pharmaceutical companies use. This has been discussed in detail with different potential partners. Don’t freak out over the five years because I have no intention of following this plan. I think the next two plans that come up here in this presentation will show you a much better direction.

 

So the pharma companies, I mean they were going to pay for this but five years is too long; we all know that. And in 2021 their goal was to enhance the chemistry. And we worked with their chemists at 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 dashed 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 and money to do this that’s the best approach to go. But it’s not the best for our company.

 

 

 

 

 

So they would be doing reformulation to a tablet; a fixed-dose combination with an existing SGLT-2, also good; a timed release so it can be a once-a-day formulation instead of twice-a-day, that’s also good; pre-clinical scale-up of commercial supply before starting enrollment, that’s a luxury; and the preparation for this chemistry could be 12-18 months.

 

So as you can imagine, it wasn’t a big seller, because I think five years is - five 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, at 10,000 patients (We have – in the next slide I’ll explain how you can reduce that by quite a bit) - that would last until the end of 2023. And so our interim analysis, which the FDA has already given us permission to register the trial off of - as long as it’s successful that is - our interim analysis wouldn’t take place until 2024. So trial completion would be about five years in total, and the cost of this particular trial, mainly due to the size and the length, is over $200 million dollars. 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.

 

 

 

Slide 8 – Targeted Global Development Plan

 

I refer to this as the targeted approach. And by 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’s all about, is 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 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 just, 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, and as I’ve stated here, we believe because of this targeted approach, we know who the patients are. We now have nephrologists etc. 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 ones, but it won’t be 7-90 days any more. It will be 7-180 days from an event or 7-365. 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 this is what’s highlighted on this slide, is the interim analysis target should take place about six or seven 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 in 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 that we will hit that target. If you think about our last trial where we had 67% relative risk reduction in the patient group that represents this particular model, that would be diabetics, chronic kidney disease patients, and those on SGLT-2s. And 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 hit it early.

 

OK and the cost here is much lower, sixty to seventy million. I know people are concerned that they would much rather see use partner on this than to lose or to try to finance it on our own. At least it’s something we could finance on our own. And as you know from past, we’re pretty creative as far as minimizing dilution.

 

I believe that one of our partnership discussions will come through, and we will be able to proceed with a partner on this. And look forward to it.

 

 Slide 9 – BETonMACE2 – Design Considerations

 

OK, on Slide 9, we can discuss a little bit more in detail of what this BETonMACE 2 trial would look like. I already mentioned the extension of the time frame. And to us, the 7-90, 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 eGFR rate for the kidney we’re going with a tighter range that will most likely be 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 60-75 had a very very low number of events. So this is better. This will create a larger amount of events as you’ll soon see.

 

And again, SGLT-2 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. So instead of about 15% on them, in this trial we anticipate it probably will be closer 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 the year 2040, so we’re pleased with that addition.

 

So the primary endpoint will be time to first occurrence of narrowly defined MACE event:  being cardiovascular death; or MI, a heart-attack; OR hospitalization for congestive heart failure CHF, another category that we did exceptionally well with. It was a pre-specified secondary endpoint in the last trial, and its success was quite high.

 

OK, the trial size is a lot smaller, only 3,600 patients and 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 about 300 events. So this patient population has more events, they happen faster, and we get to that interim analysis much quicker. [Total number of events 600-650, 300 is interim analysis, which MAY be enough to call official trial success.]

 

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.

 

 Slide 10 – Patient Enrichment Strategy

 

So on Slide 10, this is just a little patient enrichment strategy to show you some of the differences. The BETonMACE target patients there were in a category that usually has 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 we’ve gone with 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.

 

 Slide 11 – COVID-19 Phase 2 Trial (cover slide)

 

Now here’s some exciting data on COVID-19 and our Phase II trial that we’re about to launch.

 

 Slide 12 – Apabetalone as a Potential Therapeutic for COVID-19

 

So on slide 12, this is a compilation of some of the material that has come out since March 23rd when the first publication came out stating that BET bromodomain and Apabetalone in particular and ACE-2 inhibitors are all very good therapeutic approaches for reducing or eliminating COVID-19 infections.

 

Now for these two slides, this one and the next one, please keep in mind when you read SARS-CoV-2, that is the real name of this particular virus. It’s called COVID-19, it used to be called the corona virus, it’s had two or three different names. But the scientific name for publications is SARS-CoV-2, just so that doesn’t confuse anybody.  

 

Now since March 23rd there’s been multiple papers come out on this. These people required live COVID labs. A BLS3 lab, I believe it’s called. [BSL3 - bio safety level 3] so you can study this program. So some of the universities etc. that had this in place were able to hop right on this information and start studies on Apabetalone or other BET inhibitors. And 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’s 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 is titled “The effect of BET inhibition on inflammation-induced cardiac dysfunction and SARS-CoV-2 Infection”, so basically the COVID impact on the heart muscle. It’s an excellent study and it utilizes Apabetalone. 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 one will be submitted shortly; it’s “The effect of Apabetalone on ACE-2 expression and SARS-CoV-2 replication in cell culture systems”. So basically a study designed to see, does Apabetalone reduce viral infection in human cells. In particular in this case they’re pulmonary or lung cells. 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. 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 papers, also I’ll mention 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, uh, well

 

One of them’s involving Alzheimer’s and MoCA work that was already done.

 

One of them’s involving Fabry disease in preclinical models.

 

Another one involves Apabetalone on brain endothelial activation.

 

There’s one on (?)FXHD(?) Effect HD (?) [?]. That’s a type of multiple sclerosis. (?)

 

 (? Sorry I couldn’t catch that. Listened a few times. Sounded like FXHD but not sure.   

 

   Neither option came up in Google. Thought maybe by HD he meant Huntington’s

 

   Disease, but that is not a form of MS to the best of my understanding.)

 

And another one on basically the mechanism in contrast to pan BET inhibitors vs. our selective 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.

 

 Slide 13 – Number of US Deaths Due to Current Diseases in 2020 (November 2020)

 

On Slide 13, I just wanted to reiterate, this is the slide that I showed during the AGM and it was published with Centers for Disease Control information and Highway Traffic Safety Admin – CNN puts this out. And the big bubble there of COVID-19 deaths at a quarter million, this was in November - That’s a newbie to the party and that means that’s the extra stress on our hospital systems. The others stay relatively the same throughout the years, so you know what to prepare for and how to budget and what infrastructure you need in your hospital system. But when something like COVID-19 comes along, that’s where you have this huge increase.

 

 Slide 14 – Number of US Deaths Due to Current Diseases in 2020 – Updated to February 2021

 

So on the next slide on 14 – This is where we are today. This is just deaths in the United States alone. It’s about 460,000 now. It was only 250,000 in November. So this is sad.

 

The other numbers I didn’t up date. As I mentioned, they’re annual numbers so they’re pretty much going to stay the same. But this COVID problem 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.

 

 

 

Slide 15 – Repurposing Apabetalone for SARS-CoV-2 Infection with a Dual Mechanism

 

 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 epigenetics mechanism, and understanding what we’ve learned over the last ten 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 can potentially lower, but also our drug causes ACE 2, which is a receptor on the outside of a human cell, it causes it to be reduced.

 

Now ACE 2 receptors are usually very prevalent in very sick people. Diabetics, heart patients, kidney patients – the very patients that are having the most problems with COVID-19. And that’s because COVID uses that receptor to enter the cells. And once it’s inside those cells, it takes over the cells’ 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. This is your body trying to fight the infection and it turns on all these anti-inflammatory properties [sic, but I think he meant to say inflammatory]. And they stay turned on They stay turned on because BET bromodomain stays on that site and keeps them turned on. Our drug is a BET inhibitor.

 

So we not only have the ability to stop the infection part of the problem, we have the ability to reduce the cytokine anti-inflammatory [sic, again] part of the program. No drug out there can do that,

 

This is also acting at a point in time in drug development where there are no other drugs for this. Drugs like Remdesevir 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.

 

 

 

Slide 16 – COVID-19 CLINICAL TRIAL LAUNCH IN Q1 – 2021

 

Now on Slide 16, 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 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 are 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, but we will still continue this chemistry program, because we believe that with positive results from this Phase II Trial, we should have data before mid-year, 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 pre-selling their vaccine and pre-partnering so countries and payer groups are first-in-queue, that’s exactly what 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 - some countries would proceed with administration of this drug without FDA approval or EMA in Europe. This is a very advanced drug. The safety profile time lengths etc. 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 partnership 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 ACE 2 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 the trial would be four 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.

 

 Slide 17 – COVID-19 Treatment Study

 

So slide 17 is a description of this particular study. It will be an open label study. So we will be seeing what goes on as it goes on. Hospitalized patients must be over 18 years old and can go up to any age. The oxygen levels etc. are all standard.

 

What we’ve done is now that there’s a lot of activity out there, we’re working with a CRO who’s already done twenty different COVID programs. It took us forever to get into the cell labs where we could do our own cell studies. And finally we got outside of Canada we got into three 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, costs to the systems etc. And for us there seems to be – any papers we’ve read, there’s nobody who is 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 anti-viral and anti-inflammatory so that puts us in a very very unique light. Secondary endpoints will be going after the biomarkers like IL-6 IL-8, TNF-a, CRP - all areas that we have extensive data for Apabetalone and know we have a profound impact in these areas. So going forward it’s exciting times.

 

 
Slide 18 – Questions & Answers

 

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-thon 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 Radio-thon. 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.

 

OK, 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.

Conference Operator:

 

Certainly. We will now begin the Question and Answer session. Once again if you are listening through the webcast, you may submit your questions by using the text box provided in the lower left quadrant of the screen. If you are on the call, to join the question queue, you may press * then 1 on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speaker phone, please pick up your handset before pressing any keys. To withdraw your question please press * then 2. We will pause for a moment as callers join the queue.

 

 Once again, to join the question queue over the phone please press * then 1. Or from the webcast submit them through the textbox on the webcast frame.

 

 We will now read out questions that have been submitted via the webcast.

 

 Moderator:

 

Thank you. The first question comes in from Toby Ma of Mackie Research Capital. Why combining SGLT2s and the company’s candidate would create therapeutic synergies? What’s the scientific rationale behind this?

 

 

Don:

 

Hi Toby. Thanks for the question. Very good question and the answer’s 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 major adverse events, being death, MI, and congestive heart failure. Stroke was also in that particular category. We had a 67% synergistic reduction in those numbers. So we are synergistically benefitting, not just with SGLT2s but also with DPP4s. So we filed patent extensions on those. And we have been talking extensively with the major companies and also with 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 the 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 and go over the details we’d be pleased to do so. Thank you.

 

 Moderator:

 

Thank you. The second question comes in from John Vandermosten of Zack’s Small Cap Research. I really appreciate the targeted development plan. I wonder if in addition to focusing on event frequency in patient selection, if any precision techniques for enrollment were considered, such as evaluating biomarkers for patients at the genetic response or if it was applicable in this type of trial or application.

 

 Don:

 

OK, thank you John. We looked at that approach, and the problem was time. Because if we go down that route, due to centralized labs, etcetera, 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 eGFR, the better. The FDA was the one who asked us to lower our low-end eGFR. I stated earlier, I think in the last trial it was 30, but they asked us to lower it down to 20 because the data was pretty strong. The lower we go the better it gets. Because the drug is working in those that are sickest. Once you go over 60 eGFR, 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 we can follow up again. Same deal. If you have some suggestions before we launch this trial I would love to hear them. We’ll review them, and every bit helps, so thank you very much.

 

 Moderator:

 

Thank you. This is a second part also from John Vandermosten from Zack’s 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 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 timeline be?

 

 Don:

 

Yes. Good question. An accelerated path will be used. And we can initiate that path after we have these first hundred patients dosed. And as I mentioned earlier, the excitement there is that the turnout 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. In some countries as I’ve mentioned, we’ve talked before about the potential of named patient programs which could cover a cytokine storm patient. 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 problems, but it’s certainly going to be a help. The vaccines are important. Especially now while everything else is still in development. Going forward, you’re going to see a lot of people follow our path with this type of therapeutic approach. Thank you.

 

 Moderator:

 

Thank you. The 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.

 

 Don:

 

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. 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.

 

 Moderator:

 

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

 

 Don:

 

Hi Christoph, How’re you doing? No it’s not underpowered. Matter of fact, it’s powered to 90%. 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. So - but thank you for the question. It is a good question.

 

 Moderator:

 

Thank you. This will be final question. This question comes in from J. Dietrich. Thanks Don.

 

With such a strong COVID therapy, where is the support from Alberta, Canada, US governments to accelerate the program?

 

 Don:

 

I missed who that’s from but I appreciate the question. Who is that from?

 

 Moderator:

 

From a J. Dietrich, private investor.

 

 Don:

 

Ok, thank you. 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. They see fixated on vaccines and new vaccine programs in facilities that aren’t even built yet. None the less, I think they will eventually 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 and as many places as we can  So hopefully the Canadian governments get on board. And we would be very pleased to speak to any of the Premiers. 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.

 

 Conference Operator:

 

Thank you. This is all the time we have for the question & 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.

 

 Don:

 

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. I look forward to talking to you again very soon. Take care.

 

Conference Operator:

 

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