...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!
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Meeting items not in archived file. Main item seemed to be board affirmed.
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.
Thank you for attending. As I’m sure everybody knows, this is a short year for us because we re-aligned our year end, which had some significant advantages for our highly overworked staff.
Slide Two is our forward looking statement, and we stand by our comments and our forward look.
So Slide Three is just a brief glance at Resverlogix. Ninety-nine percent of the people on line will know who we are and what we do, but we are a very unique company with epigenetic technology that is getting a lot of recognition as of late and we will continue that upward trend. We were awarded the FDA Breakthrough designation in 2020 and we’ve been advancing that quite nicely despite this horrific pandemic that we have been dealing through. And we do feel that we’ll move fairly fast from this point because we do have 4,200 man-years of treatment and safety results from this drug in cardiovascular disease, diabetes, chronic kidney disease, liver disease, vascular dementia, pulmonary arterial hypertension, and very soon to be in COVID-19 patients.
So on Slide Four, this is something that we’re very proud of that only two months ago we were awarded Health Canada approval to advance into COVID trials and this is a very very big step. We’re pretty excited. And as you’ll see shortly we’ve been pretty busy behind the scenes on moving this forward.
Now during these times it is extremely important to get validation of what we’re doing, because everybody and their dog want to prove that they have something that might work for COVID-19. And so to have our dual-mechanism approach of both dealing with the very deadly cytokine storms and the ACE-2 expression where the virus actually enters the cell and starts its replication cycle. So to have both of those is quite fortuitous. And unless you’re somebody like Donald Trump, who got screened every single day, an anti-viral like Remdesivir that he was taking doesn’t help that much, because by the time the damaging cytokine storm takes place, most of the virus is already dead and gone anyway. So it’s the damage left behind that’s the killer and the problem. And a 39-page publication in Cell, the number one biology and biochemistry publication out of 298 various ones really confirmed that for us. And yes, we would like to snap our fingers and make things happen immediately after that was published, but that’s not the world we live in right now. We are working very well and very hard to move this forward.
Now on Slide Six, this is a presentation slide that I showed in December of 2020 at our last AGM only six short months ago. And we were showing the U.S. death tolls here – 250,000 deaths by COVID at that time.
And as you see on Slide Severn, we’re already over 600,000. So is it slowing down? Yes, it’ll slow down because of the vaccines. The vaccines are a very very important part of the overall program. Reducing the number of people exposed is critical. The problem with this virus is it mutates so fast. And with any percentage of unvaccinated people it is going to continue to be a problem. Despite what politicians might be telling you and think and probably believe, we haven’t seen the end of this one.
On Slide Eight, I’d like to give you an update of where we are on the clinical trial launch. I think this is what a lot of people are most interested in right now. Remember, like I said, we’ve only had approval for this program for two months. Clinical trials listed the trial start as June 12th. But internally, a trial starts once you start spending money. And that was in April, sixty days ago. So rapid response has been made in these two short months. We’ve signed a very experienced CRO to handle this trial for us. They already experience with twenty COVID trials under their belt. So they bring a lot of knowledge and expertise to the table with us. We’ve designed a proper and affordable program. We’ve revised it a little bit, cutting back some expenses on what are now deemed out there as unnecessary lab work and probably saved an extra half a million dollars doing that. So it slows you down maybe a week or two here and there, but our job is to get it right. And get it as affordable program as possible. We’ve also arranged a back-up plan in Brazil. As we all know, we’re all experts on COVID now, whether we like it or not. We all know that these bubbles shift and change around a lot. So if you’re just working in Canada and you run through a slow-down it could be six months before you have a proper patient base. I believe our results will encourage a lot of people to want to be in this trial, so... We can’t guarantee time frames; we can’t tell you when things are going to happen in advance because they are not in our control. We certainly can tell you when they happen, and that’s what we will be doing. But we do have Brazil all set up now as a backup. Well, it’s not just a backup, it will be going in parallel so as the waves of patients shift around, we feel we’re well covered.
We’ve also in this short period of time confirmed principal investigators. We have pending ethics approval reviews at various hospitals in Ontario, Alberta and Quebec. And the first full submission will be later this week. We were able to re-label the drug and transfer it from Europe, moving it around. So there’s a lot of activity that was taking place behind the scenes. You don’t just say hey we’re in a trial let’s dose somebody tomorrow. It doesn’t work that way.
All this has been done during a massive pandemic, with considerable competition. At year’s end last year I was telling you that there were 3,200 COVID related trials ongoing. There are currently now 5,900. And yes the yoghurt one is still in there. So there’s a lot of distraction a lot of stress on an already extremely stressed medical system. The doctors and staff are burnt out, many taking leave to recover. I’ve seen it personally. And after putting all of their life-saving efforts and incredible work that they do, watching politicians and non-vaxxers treat the reality as a joke and it’s very harmful for our medical staff and their well-being. So we need to rethink this in the future.
Our dual mechanism approach is bringing great hope and expectation to these people, so we expect this to be a very positive result. And really the dual mechanism of – in the first place trying to stop COVID from even getting in to the cells through the ACE-2 receptors and the PPH4 – that’s a very good opportunity for us, but being able to stop the cytokine storms and turn back the clock on that is exactly what was highlighted in the Cell publication from the Australian group. It’s a phenomenal publication, very helpful, and they were showing the reversal of the damage. So it’s not just about COVID. It’s about the damage and the cardiovascular, pulmonary and kidney, and trying to correct some of that going forward. It’s the unique approach we have in the dual mechanism.
Slide Nine. So how are we going to do all this? We are still a very small company. We’ve enlisted a very experienced group in Eversana. So on Slide Nine, you’ll see the details of this group. They work all of these areas. These are areas that we have basically little to no experience in. So trying to roll this out on our own would be a bit of a slow-down and a hell of a learning experience. So we chose a path that minimizes financial exposure. It keeps our revenue base, and it maintains full ownership of the program going forward. So Eversana is an advanced company. They are purposely built to overcome external pressures and act as our commercializing engine. That’s their business model. They excel at key needs like patient services, channel, field solutions, plus they bolster that with other critical solutions to complete what we need to fully commercialize our product. But it’s not just their infrastructure. It’s the fact that they contractually commit to bold guarantees - guarantees that frankly, others cannot make. They cover up to 50% of the costs and the risks, paid back only out of future sales and not paid back if sales don’t exist. 3.5% royalty is an up-side for them on their side on North American sales. That’s a deal I would do any day of the week. I think this is an incredibly positive business model for a Phase III company like ours. The structure is also designed such that it has no encumbrance on future pharma deals. A low, reasonable buy-out has been set, so that if pharma wants to take over in the future, they can easily do it. So it is a marvelous system.
On Slide Ten, it shows that we’re just basically working with them and adding strength. They have 3,500 employees around the world, working in 25 locations. Working on over 150 brands right now, serving 80 countries. Our deal is for North America to start with, but this is an opening. We speak to them almost every day. They’re very excited. They view this as one of their top opportunities ever. And we happen to agree with them. It’s the dual mechanism that has them quite impressed. And remember these people are all from top 25 pharma companies and they know what they’re doing. So I think this was a brilliant move for the company to move forward and step in this way.
Slide Eleven. OK, now we’re going into the lead program which is also advancing.
So on Slide Twelve, just a brief reminder that yes we are working with the FDA. And we’ve mentioned in past presentations that as soon as COVID slowed down a little bit over the summer we wanted to be ready to launch this particular program full-speed on BETonMACE-2. And it is raring and ready to go.
On Slide Number Thirteen, this is still all based on very solid efficacy data. The drug works. We have a hazard reduction of [63% with] p value of 0.0002. That’s pretty darn incredible. And moving forward, we also – on the following slide –
Slide Fourteen – the Kaplan Meier curve for CKD (chronic kidney disease), with a 52% reduction in the hazard ratio [p=0.03], also phenomenal news. So there’s a lot of publication data going out on this now, especially in the kidney world. The publications that this has been going in are the top publications in their field. These particular doctors really haven’t had a lot to cheer about over the last century as far as advancements in chronic kidney care. And I’m told that in the inner circles this is being viewed to as the biggest breakthrough and they’re equating it to statins in the cardiovascular market, when statins came through and the big difference that made in reduction of deaths and events by over 30%. So that’s a nice comparison to have. We’re working forward on that.
Slide Fifteen. So we have maintained that this will be a trial in and around the 3,600 patient range, and this is on Slide Fifteen. The global development plan has not changed in the last short little while. And we do anticipate this to be an approved trial at the interim analysis, which the FDA has agreed that that would be a registerable point for this trial. As far as financing for the trial, we’ve done an exceptional job of working on that. We have partners in China that are responsible contractually for their portion. We have full ability to get this done now and you’ll hear about that over the coming months.
Slide Sixteen. Now the Resverlogix 12 Month Key Milestones – The first six on here, because it’s 12 months and we changed our year-end, pretty much were well known. And the last six, starting in March with that Cell journal publication – you can’t get a better endorsement out of scientists than that one. Well, actually maybe you can, the FDA Breakthrough Designation is pretty equivalent. So having both of them, we know where we’re headed. We want to go faster as well, but we’ve been dealing with the pandemic just like everybody else. So being able to move from Cell to getting the April Health Canada approval for Apabetalone in COVID – was a very big step. Then also in April we had a very strong publication in pulmonary cells or lung cells with our friends from the Buffet Cancer Institute. (It’s not that Buffet; it’s his cousin.) And that’s with University of Nebraska Medical Center. Very top notch facility, especially in viral. They boast having one of the top Ebola researchers in the world in that facility, and he is actually a gentleman who worked on our program. So also in April the American Society of Nephology published very positive kidney data, and this is the one that’s being likened to statins in the kidney world. So we’re doing well. We’re doing very well, and allowing us the time to structure these properly, finance them properly, and move them forward is exactly what it takes. And that’s where we are. So in May we also closed over 12 million dollars in financing, and most people read about the 6 million part with Hepalink, however there was other financing as well, because we do not want to be reliant on any government as far as financing this COVID trial or other work. We do believe those programs will be fully financed, but we’re ready to go. We’re ready to go now. In June, well we just talked about Eversana. That is a critical deal. Eversana views this as a quarter billion dollar deal over a ten year period. They’ll be working with us as partners, and we like it. So it’s been a wonderful group to work with and because of them and my staff’s very hard work, you’ll be hearing a lot of announcements as they happen. We won’t be speculating on when things are going to happen during a pandemic. So we will announce them when they happen. And they are moving along quite fast.
So on that note I would like to thank you very much for spending some time with us this afternoon and allowing us to update you a little bit on where we are. And you will hear from us soon. Thank you very much.
This concludes today’s presentation.
Thank you for participating, and have a pleasant day.
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