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Message: RVX AGM 12/22/2020 - rough transcript

Sorry a bit late. Happy holidays. 


 Annual and Special Meeting of the Shareholders of Resverlogix Corp. and Corporate Update Presentation

December 22, 2020


Moderator: Welcome to the corporate update presentation of Resverlogix Corp. I would now like to turn the conference over to Donald McCaffrey, President, CEO, and Chairman of the Board of Resverlogix Corp. Please go ahead Mr. McCaffrey

 Donald McCaffrey: Thank you everybody for attending today. We would have done this version anyway because of COVID, but in typical fashion for a Resverlogix AGM we have a major snowstorm here in Calgary and at my home we got between 18 to 24 inches of snow overnight so it was a little tricky even getting here for this presentation. But pleasure to be here.


On slide number two we have our forward looking statement as usual.

 SLIDES THREE & FOUR (are identical)

And slide number three, just a bit of a review for some of the people on the line who may be new.

As you know, we’re a Canadian company with a cardiovascular drug called Apabetalone, and we’re a pioneer in the area of epigenetics. That is where we have the ability to turn disease-causing genes on or off.

We had the extreme pleasure of receiving the FDA breakthrough therapy designation in February. It’s the highest designation other than drug approval that a company can get. And at the time, we were one of only 130 drugs to ever be awarded this, and the first mainstream cardiovascular drug ever to get such an award. So a lot of it was based on the uniqueness of our drug. We’ve tested in 4,200 man-years of treatment, and it has demonstrated  positive biological effects on patients in disease areas such as cardiovascular disease, diabetes, chronic kidney disease, non-alcoholic fatty liver disease, vascular dementia, pulmonary arterial hypertension, and soon to be COVID-19.

Now on that, I’m sure most of you have seen today’s news announcement from Resverlogix about our work in COVID-19. Now I’ll just recap this a little bit. Back in March, 23rd to be precise, a group of 22 global universities working in a Manhattan-Project-style approach to eradicate COVID studied 20,000 drugs and published on 63 of them. We were one of those 63.

So since that time we’ve been doing a lot of work. We’ve shown up on a few other short lists as well. One out of a European university group, I believe it was October, and we were on a shortlist of four on that one.

So during all this period of time, we have very diligently moved forward into studying COVID. But as you know, that’s not something we can study in our own labs. There’s a certain level we can get to and then the final work, especially in human cells, has to be done in a BLC-3 laboratory [should that be BSL-3?], which we do not have. So we had to line up with everybody else, like the hydrochloroquines [hydroxychloroquines?] and the Remdesevirs and all the others that were being tested, and there were a lot of them. So in the fall, about August, we finally got into a few labs, three of them.

And the results have been spectacular.

We do not highlight the results in today’s news release for a very very specific reason. And it is that it is work of other parties that is non-published yet. It will be published. I have reviewed the data, and I can tell you I am very pleased with what I saw. We had set a certain bar that we had hoped to establish, and I can say we far exceeded it.

And the timing of receiving that data is pretty good because there’s another publication that came out, and I think it’s not even in print yet; it doesn’t go to final print until January 5th. This is just out on line so it is public. It’s Proceedings of the National Academy of Sciences of the United States and it is directly involving BET inhibitors as targeting the transcription regulators of – what you see on the title is – SARS-CoV-2. That’s actually the real scientific name of COVID-19. We try to put them both on, in brackets or not, just so – on one hand we’re performing properly for the scientific community and on the other hand we’re not confusing the heck out of our investors. [?! He really doesn’t credit us with much intelligence, does he?] So their chatter and their work that they’ve done in there is showing some very important stuff.

Really what’s going on with COVID-19 is it’s attaching to human cells by utilizing BRD-4. Now remember, we’re a BRD-4 inhibitor. So reducing BRD-4 is a good thing. But after it’s attached, it actually uses a human receptor or two, one of them called ACE2 and another TMPRSS2, and they’ll have some cute name for that soon, I’m sure. But especially with ACE2 and some of the others, we have a huge reduction of those as they are inflammatory types of markers that are turned on. And this is why a lot of the really sick patients or the people who die are people who have events of other kinds already. Diabetes, chronic kidney disease, heart disease, pulmonary diseases. And their ACE2 inhibitors are highly turned on. Our publication with American Heart last month showed those are the exact types of inflammation markers we turn way down. More than 90%.

So very encouraging, very exciting, and a lot of logic as to why this is working with our drug. Because our drug does stuff no other drugs do.


Now on slide five, this is an interesting slide that was sent to me last month. It came out on CNN and if you see the big dots are cancer, and these are deaths per year in hundred thousands [?! The diagram is in thousands, not hundreds of thousands] – cancer is 612, Heart disease is 670. And this came out, must have been right around the US election, because it’s showing 250,000 in the US alone for COVID. Unfortunately, that number is now over 300, and by the time we get into a full year of COVID, it may even match cancer or heart disease. So it’s not the worst killer, but why it’s such a problem is because our health system is geared for the existing diseases like cancer and heart disease. When you add a whole new gamut like COVID, it’s problematic, very problematic. And our health staff and people in hospital facilities, which I have three daughters in that position, it’s very difficult on them and everybody around them.


Now slide six. The near term events and planning. So we do have our FDA designation. That does not have a time limit on it. I guess it originally did. There was a time limit on having your first meeting with them, which – that was done with us in June. It went quite well. We have a great group of people we’re working with there co-designing the program. The way it has been laid out is the FDA has set it up so we have the possibility of having an interim analysis at half way point and showing that the drug works. That could be as early as 2022. We give no guarantees there but that’s pretty exciting for us that that is a possibility. And all or most of the BETonMACE 2 patients will be receiving again top standard of care. As our fantastic results we got in BETonMACE 1 were enough to get us breakthrough therapy designation, and that’s on top of standard of care. So the FDA is very aware that this drug has the potential to have a huge impact on the area we’re working in, cardiovascular, diabetes, and chronic kidney disease, or the metabolic diseases. So although COVID is catching up as a killer, metabolic disease is already there. So we really look forward to knocking some of that down.

We’ve talked quite a bit in the last while about partnering options. It is going extremely well except for the part about COVID -19. When everything went crazy again here this fall it has slowed down and mainly for the reason of clinical trial launch. We can’t launch a clinical trial of this size in the middle of a pandemic. We can launch COVID-19 trials. You can launch small oncology trials, but this type of trial – it’s very difficult, so things have to calm down somewhat.

And it’s been interesting because it’s given us more time to get more people caught up and involved in the partnering process. It is getting pretty busy. I can tell you over the last month, it has been exceptionally busy with us preparing and working and presenting to multiple pharmas in different types of approach. Some of them are looking at huge trials that would cost up to 150 million dollars. Of course in all of these, we are negotiating that the partner will pay for that trial. Some of them have quicker more clever faster types of designs that could be done that would come in you know at half that, maybe 60 million dollars. So it’s given us the opportunity to really work hard, and to get this right.

Also at the same time, some of these groups have opened up some of their internal services to us. One case I can think of is the CMC or the chemistry [they} have been really able to help us with their standard of review and really work and upgrade that at no cost and we’re not committed to working with that group. So very helpful, we’re not just sitting around, a lot has been done here, designing and moving forward on the faster trials that we can like COVID-19 and really making sure we get the right partner that best suits what the investors and shareholders and stakeholders in the company really need to see. And that’s expediency and finance covered by others. 

So the early COVID trial could start as early as Q1. And those are small and fast trials, and unfortunately there’s no shortage of patients right now. So we would be able to proceed on that. And the patients in that trial will only be on drug for about two weeks. So we should be able to get some very solid data by Q2.

And the pulmonary arterial hypertension trial – that started a long time ago and it stopped because of COVID in both Quebec and Alberta. And it restarted in Quebec. I believe it’s still restarted but I think it’s about to shut down with Quebec again this week. Alberta’s shut down still. So it is a cumulative type of technology we’re doing there so eventually that data will be compiled to a point that the trial will be deemed complete. But again that one is highly dependent on COVID because you can imagine pulmonary and COVID go hand in hand. There’s not a lot of extra workers and space in those particular units. They’re the ones that are jammed full.


OK, now to the – you know - where we are in the process here.

So the requirements for a successful drug launch are listed here on slide seven. So really we look at efficacy, safety, regulatory approvability, mechanism of action, publications, where’s the science world taking about this, and strategic commercial pathway. We have all of this in place now, so this is why so many pharmas are talking to us in so many different directions, different indications, different sizes, etc. It’s good because this has really been proven out. It works. We know that. I’ll show you that on the next slide here.


On slide eight, this is one of our better efficacy slides showing that in our BETonMACE 1, the patients’’ reduction in death, heart attacks and congestive heart failure was 63%. This is above and beyond the top standard of care. And the p value here of 0.0002, what that means is that there’s only a 2 in 10,000 chance that this data is inaccurate. So it’s this type of data that sold the FDA on breakthrough therapy designation and we applaud them for moving that forward.


Slide nine is a copy of that designation and it includes all of the different titles you’ll hear in certain FDA designations like fast track. Well that’s included in breakthrough designation. There’s tax breaks; you can register the trial much faster at NDA; much shorter reviews; you can do it at the interim analysis of the BETonMACE 2 trial. So we’re really working on that as you’ll see in the next few slides.


One of the areas that we’re going to enhance in that trial is chronic kidney disease. This is data that was presented by the head of nephrology at the UC Irvine, Dr. Kam Kalantar-Zadeh. In October he presented this at one of their top US nephrology conferences. And it really shows a strong strong difference between placebo patients with CKD and Apabetalone patients with CKD, being chronic kidney disease in the below 60 range. Below 60 is when you’re considered to have CKD. And that would be stage 1, and then you go 2, 3, and 4. And by the time you get down to a GFR of 15 or lower you’re going on to dialysis. But these poor nephrologists, they don’t really have any drugs to give these patients. It’s just managing through the system, trying to make them comfortable and slow it down as much as they can. So this type of drug certainly got the eye of the nephrology community. And for us it’s very important as you’ll see on the next slide, because the {patient enrichment strategy, or sorry}...


The sicker the patients are the more effect our drug has on them. Because we’re turning off those inflammation markers that are being turned on by COVID and by diseases like chronic kidney disease, diabetes and cardiovascular diseases. So in BETonMACE 2 we want even more CKD patients. So in this case we’re going to have about a 20% higher risk factor, which really helps on the number of events you’re going to get so these are the annual MACE events. This is going to be about 20% higher than the BETonMACE population. So to accumulate 600 events in the BETonMACE 2 trial, it’s going to move a lot faster, which will be quire beneficial.


OK, we also greatly understand our mechanism of action. Our in-house team has published almost monthly on this, some months two publications. So this is one of the positive side effects of COVID. Normally we’re busy running around and traveling to conferences here, there, and everywhere, and distracted with lots of work here in the lab and stuff. Now everybody’s at home and has plenty of time to write papers. So we’re getting some very good publications out. It’s a complete treat to see acknowledgement from others now, like the Proceedings of the National Academy of Sciences, the American scientific group there in today’s announcement. And it’s almost weekly now where major publications are coming out on BET inhibition and its importance. And don’t forget, we are at least eight years ahead of anybody in this. There’s no short cut. There’s nobody going to show up out of the bushes that all of a sudden me too. We’re it. So it’s pretty exciting with all that COVID data, and with our cardiovascular data. Our cardiovascular or metabolic program is our lead program. It always will be our lead program, but boy is it exciting to have the option of helping out, of being one of the hopefully helpful drugs moving forward in the COVID world.


Now, I mentioned publications. This is as of last May, and there’s probably another hundred, maybe two hundred since then, because so much attention has been given to BET inhibition because of COVID. There are tons of papers, but when you see almost 5,000 percent increases in publication over a ten year span, that tells you you have a very active area. So to hold that ten year lead, and to have near-term benefits from that, we’ve all waited a long time. To have those near-term benefits right around the corner is pretty exciting. It certainly is for me.


And safety, another one of the markers of things that we have to get right to make sure we have a proper launch. Safety has been very good. We have the breakthrough therapy designation, which mainly was reviewed for the safety. So that’s getting an endorsement basically on your safety from FDA – on your safety and your technology – that’s a pretty exciting event. If it didn’t happen right smack in the middle of the launching and lockdowns of COVID-19, it probably would have had a much more significant positive impact. But we don’t doubt for a second that will come shortly.


OK, and the strategic pathway. We know where this drug works. We can start with smaller population groups like are listed here. And you know, it’s not so small – you’ve got eight million patients that are listed here. In orphan indications you wouldn’t have 25,000 patients around the world. So this is a truly broad program that has very exciting global opportunity. And for us, it’s the design and picking the right partner, which of these gets to the market fastest. Because we’re going to do them all. But in what order is it going to be best for our investors and stakeholders in this company, and who is stepping up to that. It’s exciting to be in these meetings; I’m actually having a lot of fun again. So it’s good times.


Now the additional indications. We still have all these to work on above and beyond the main categories on the previous slide. But the pulmonary arterial hypertension, that is in progress now. And officially now, so is COVID. So we’re taking it seriously, moving it forward as fast as we can in the areas that we think it will have the most advancement. Especially in our new COVID world.  


OK, intellectual property. This just continues to add good news.


On slide eighteen here, it’s growing. We added a couple more just two months ago, or I guess really a month and a half ago here, with the SGlLT-2 [inhibitor] combinations, [and] the DPP4s. These are really important, because in the US our main patent for composition of matter extends into 2034. With this kind of addition around the world, it can take our patents out to 2039, 2040, in that range. So really a nice, healthy patent extension. And that helps when you’re dealing with major pharmaceutical companies.

We are dealing with companies that own some of these SGLT-2s [inhibitors], and what an SGLT-2 [inhibitor] is, it’s a new type of drug for diabetes. They’ve been very successful, and this particular market is expected by 2025 to reach 25 billion dollars a year in sales. Then along comes our drug and it makes them work 63% better. That’s exciting. And having the longer intellectual property protection is very helpful.


Now on slide nineteen, these are some of the milestones from the year. It’s been a crazy year to say the least, in everybody’s life. We all know that. But we started by highlighting that these diabetes drugs that we’re working with had huge impact. And then we introduced that to the FDA, breakthrough therapy designation and we were awarded that in March. The publication I mentioned at the beginning on March 23rd, with the 22 universities highlighting us – out of 20,000 drugs, highlighting as one of the top 63 in potential. So that alone is highlighting a direction we should be spending a lot of time on and we did. In March that was published in JAMA as well, that’s a pretty big journal. In June we had our COVID clinical [?] program launch. We also had our CKD meeting, the ERA-EDTA. That’s a mouthful, but it’s a very very big kidney disease conference in Europe. And of course yes, this year it was virtual like everybody else. But huge response off of that, because those doctors as I mentioned, they don’t have anything for their patients. So this is a real plus for them to see this research going in this direction. The FDA confirmed the key aspects of our BETonMACE-2 program. In August we started getting some more financing. In October we erased, converted an entire 12 million dollar debt plus the interest. So that was a phenomenal help to the company, a real pleasure to have that in the rearview mirror. October again major publications on COVID-19. That was the European one. In November we filed the extra intellectual property and in December we’ve been putting together the launch plans for COVID-19 and that will have its first patient in Q1 of 2021. It will move quite fast as well. So we’re excited, and everything is moving forward.


And the last slide is really the management team. And as you’ll see, everybody’s doing well and working hard.

We’ll go to Q&A now and there’s I think a question on that anyway, so I’ll address that.

Thank you very much.

 I’m going to have a drink of water and then I’ll move right into the Q&A. I’ll just read out some of the questions and answers. We didn’t screen them too much; we combined some of them. A lot of the suggested questions have just been covered now in the management presentation here.


OK, so first question. What is the status of the BET-on-MACE-2 [trial], given FDA breakthrough therapy designation for Apabetalone. Can you review all available options to move the program forward, as well as expected timing?

I think I covered that in the presentation, but I’ll touch on it just a little bit more. It’s dynamic right now. In these types of trials you try to –you know, this trial will probably have about 200 different sites many of them in Europe, in the United States, in South America, and in China. Those are the very areas that are being pounded, with the exception of China oddly enough; those are the very areas that are being absolutely pounded by COVID right now. So we, like everybody else, especially in the larger trial structure, we just have to wait. And we’re excited; we’re ready to go. We’re beefing up the chemistry. We have options of switching to a fixed-dose combination, that’s after the trial [?], or potentially to a tablet form pill taken once a day with a tine released [dose], or staying as is and doing the chemistry in parallel. And a lot of that effects cost and timing and length of the trial. So we’re trying to do it in the most efficient way that meets the approval standards of the FDA and of our new potential partners.

OK, question number two. Can you provide any updates on the October 6th news release announcing the thirteen million dollar private placement or other financing options as well as timing?

OK. The answer really is “stay tuned.” We have just voted on this particular aspect. After the meeting today we will release the votes, and there will be a later update on that, but I can’t comment before market close. And I think we’ve touched on where we’re going with that. We are moving forward and we have several options of financing going forward as well. And again, as a public company we can’t touch on those here. But we do have the options of up-front money from our potential partners who will be paying for the clinical trials and/or working with our royalty position, that’s often done, and having those funds pay for the trial, and/or the existing shareholders are also an option, especially the major shareholders. And as you’ve seen with the commitment from some of our more recent ones, in taking out the debt position, we have a very good working relationship and we have very good major partner shareholders in this company right now.

OK. Third question is what is the status of the COVID-19 program? I think I’ve answered that in today’s news release and then some update. I’m really excited about that one. More so because I’m sick and tired of hanging out at my house. And we’re all in the same boat. And if we can have a therapeutic that is added to the, you know an extra quiver in the arsenal of moving forward against COVID-19, I would be very glad to help out. And the scientific data behind this really seems to say we’re there. So very exciting.

The fourth question is how are the company and its personnel coping with COVID-19? We had a bunch of these, and one of the questions was have we made any cuts to staffing. And the answer to that one is no. We are very loyal to our people. We have phenomenal staff. They are hard-working and have done an enormous amount of work from home. The lab staff come in and rotate on schedules, alternate days, half-days. So there are only two or three people in the entire 20,000 square foot facility here, well protected. They have the option of staying home if they do not feel comfortable. So we’re following all of the rules and more. Remember, we’re a high-tech lab that is used to dealing with toxins and different material like this. So these people are all trained in that. This isn’t anything new to them. But we are following restrictions. We have had outbreaks in this building that we’re in, and have adapted as required. But so far so good, everything in this area. We follow the physical distancing and rotating schedules and all of this. It is important to stick to and for the staff who are listening, thank you.

OK, another question is have we had to slow or stop any programs. And the answer is yes. Those programs that are involving large clinical trials have slowed. We haven’t stopped any programs, but there are things we would probably be doing more of if COVID wasn’t around, because the partnering and everything else would be complete. But with that dragging a little bit with COVID – that’s alright. We’ve got plenty to do as I mentioned, in writing publications, doing partnering due diligence – that is actually a lot of work, especially when you’re doing multiples.

OK. The last question that was on the list here is the company still pursuing an additional public listing on a US exchange. And the answer there is we are not pursuing a listing on a US exchange at this time. And as discussed on this call, we currently have several positive ongoing developments that enable us to move our program forward, as well as working on this COVID program. So I don’t think we’re missing out on anything there right now. The markets are pretty good in life sciences, but overall not so good. But for us I would say we’re swamped right now doing what we’re doing. So we’re trying to create value and our management and board believe what we’re doing right now is the best thing to do. When that switches we will go back and look at the US exchange. We have kept in touch with all of our contacts down there pretty much monthly, and our friends at Rothschild – so we can do that when the time is right. We can do it quite quickly.

OK, thank you again for attending the presentation. And I’d like to wish everyone a happy holiday season. And stay safe. Wear a mask and take a vaccine as soon as you can. Thank you very much.

Take care.


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