Host – Jonathan Miller:

Hello I’m Jonathan Miller, Vice President of SRAX. Welcome to the 2021 LD Micro Main Event with Resverlogix, ticker Symbol RVX on the TSX and RVXCF on the OTC. Founded in 2001, Resverlogix is a Calgary-based late-stage biotechnology company, and the world leader in epigenetics or gene regulation, with the goal of developing epigenetic therapies for the benefit of patients with chronic disease. Resverlogix is commercializing a new class of therapies called selective protein inhibitors designed to regulate gene expression. Through its gene regulation or epigenetic s of disease-related genes, Resverlogix aims to improve patient’s lives by restoring biological functions altered by serious illnesses such as cardiovascular disease back to a healthy state, leading to a new way to treat chronic disease. Please welcome Resverlogix.

Don McCaffrey:

Slides 1, 2 & 3: Cover, Forward-Looking Statement, and Disclaimer

This is Don McCaffrey; I’m President & CEO of Resverlogix. It’s a pleasure to have you here today. I’ll be going over our slide deck. We’ll start with the forward-looking statement and disclaimer as well.

Slide 4 Highlights

We have the highlights here. So Resverlogix is a very unique company. It’s a first-in-class Phase III asset with cardio-protective benefit in cardiovascular, diabetes, and kidney patients. We’re utilizing an advanced epigenetic mechanism, where we’re turning disease-causing genes on or off. So simple on or off switches as opposed to changing human DNA such as CRISPR or stuff like that.

We have breakthrough therapy designation from the FDA, so that is a very unique position to be in and we’re very excited about that. That is for our major adverse cardiac events program. And a lot of that was based on some very successful data that we had in our BETonMACE trial, where we showed a 63% hazard reduction with a p value of 0.0002. And this was for patients with MACE and hospitalization for congestive heart failure. We’ll talk more about that as we go.

We have had numerous publications including some of the top publications available in Cell and Nature. These most recent ones were highlighting. Apabetalone’s anti-viral and anti-inflammatory multiple approach to gene silencing and therefore shutting down the cytokine storms responsible for deaths in COVID-19 patients.

We have partnered recently with Eversana, a commercialization expertise company that will help us to commercialize that portion while we continue on our main program, which is cardiovascular benefits in diabetics, chronic kidney disease patients, and CVD.

So we also have Health Canada approval for moving forward with clinical trials in COVID patients.

We’re doing the same in Brazil. And we’re working with the FDA on a Phase III program in the U.S.

Slide 5: Development Pipeline

Here’s our development pipeline. And as you see, the top program is the high-risk CVD patients. We have completed our first Phase III and with the assistance of the FDA we’ve laid out the approvable second Phase III which will base itself on a primary endpoint of reduction of MACE events – Major Adverse Cardiac Events  - and we’re looking for a reduction in death, MIs and congestive heart failure.

Now we’re also moving forward with the COVID-19 program, and we have hoped to announce very soon that that program has commenced enrollment. It’s been difficult getting enrollment started with supply chains etc., regulatory bodies, and overworked staff at hospitals. So we’re pretty much there now, but just a little bit longer to go.

The high-risk CKD population is of great interest to us. And we’ll be moving forward with that as our last publication showed that we can actually stabilize and increase eGFR in our patient groups. So very much a benefit going forward for the nephrologists, who actually don’t have anything for their patients right now. Their patients are primarily just moved through stage 1, 2, 3, 4 into dialysis and eventually on to death. So very nice to have something going forward in that range.

Also our PAH program, pulmonary arterial hypertension also had a fantastic publication last month showing effective results in that again. That will be moving forward as well.

Slide 6: Milestones

Now as far as our milestones go, we have quite a few dealing with the COVID program, more high-risk CVD, pulmonary arterial hypertension, and regulatory developments so we are pretty excited about this. I think some of the best ones on here probably have to do with our main program, being the interim read out for our Phase III when we hit 300 events. We hope to start this trial later this year, and at 300 events in that trial we will do an interim analysis which the FDA has granted us the ability to register off of if we hit endpoints at the interim analysis. So we’re quite excited about that.

And of course going forward, the COVID program as it’s based around our cardiovascular protective portions of that program would also be a nice benefit that would support our go-forward program in cardiovascular .

Slide 7 Vascular Tissue Effect

Now this slide is designed just to tie everything together a little bit for you because we do have a bunch of programs, and one may wonder what is the main tie in. And the main tie in is vascular tissue effect. So we have that in the pulmonary arterial hypertension. But we also had a major publication last month dealing with the cognitive effects of the program – data from the last trial the BETonMACE trial - pre-specified data. So this was published in the Journal of Alzheimer’s Disease. And in patients that started the trial with low cognition, we were able to raise it and that is in my opinion a first in this area. A lot of people have been able to stop the decline of cognitive function or at least slow it down, but an actual reversal, this is a big step forward so we will be exploring this one and it is quite exciting for us. But as you see the main tie-in here is the vascular tissue effect. So in the cognitive end we will focus mainly on arterial benefits from that program, so the cognitive effect staying away from the hard-core Alzheimer’s to start with but working on the arterial effect of the reduction here.

Slides 8 & 9: High Risk Cardiovascular Disease Program – FDA Approves Breakthrough Therapy Designation

Now our high risk cardiovascular disease program is the main program. It is the one that is approved by the FDA with breakthrough therapy designation. So it’s nice to get that kind of recognition from the FDA. The last trial was run in 18 countries around the world and involved 2,400 patients so it was some very compelling data from that trial that allowed us to receive this breakthrough therapy designation.

Slide 10: Epigenetic Treatment of Cardiovascular Disease

Now the epigenetic treatment for cardiovascular disease - we are by far the most advanced epigenetics company in this field. It’s very helpful that we work in multiple categories. In dyslipidemia, inflammation, coagulation, and calcification. We also have a very strong effect, a synergistic effect with the SGLT2 and DPP4 markets. So those are very fast-growing markets that are about to reach 25 billion dollars per year in sales over the next few years. So our synergistic benefit of making them work better and our own work better is very helpful going forward. We are not just your single protein type of approach to therapeutics; we are a multiple pathway approach so it has quite the impact.

Slide 11: Efficacy of Combining Apabetalone with SGLT2/DPP4 Inhibitors

Now some of that data we can show you here in format – This is published data from our last trial. This is pre-specified data showing a 63% hazard reduction with a p value of 0.0002. And this is above and beyond not just placebo but top standard of care. So our placebo patients were all on top standard of care. Be it high-dose statins, beta-blockers, ACE2 inhibitors, glucose management – doesn’t matter. There were 500 concomitant meds involved in this trial. And we were able to reduce the hazard by 63%. When statins came on the market, that’s Lipitor, Crestor, and the like, when they came on market they were showing a 30% reduction in hazard. This is double that on top of those drugs. So all of these patients were on Lipitor or Crestor. So very very solid results on this, and again this is partially why we received the breakthrough designation.

Slide 12: Confirmed Efficacy for Treatment of High-Risk CKD Patients

It wasn’t just in cardiovascular. It was also in chronic kidney disease. So again this is published material, very successful data, and we’re showing a hazard reduction here of 50% with a p value of 0.0095. Look at the separation of the curve right from the very beginning of dosing we see these remarkable results. So again I mentioned earlier that nephrologists etc. currently can only manage CKD, we believe we’re at the precipice of being able to reverse the damage done. So we look forward to moving this program forward as well.

Slide 13: BETonMACE2 Design

Now going forward we have in conjunction with the FDA and under the terms of our breakthrough therapy designation we’ve designed a BETonMACE2 trial which will be run - hopefully it will launch by the end of this year. It’s a little bit trickier launching a bigger trial in the middle of a pandemic, but I believe we’re getting close to the ability to do this now. Supply chain has been worked through. We have principal investigators ready to go. We’re moving forward. We just have to make sure we don’t have to interrupt this trial due to COVID shut-downs.

The trial will basically be the same as the last trial except in the small bubble there you can see what percentages of those patients were CKD patients or on SGLT2s or DPP4s. And being that that was the very successful data that we had, we’re moving that up quite a bit in this trial with the approval of the FDA. So as many patients as possible will be on SGLT2s and DPP4s, and we’re going to try to get as many CKD patients as possible with a minimum of 25%. So moving forward pretty much the rest of this trial will be the exact same. And the endpoint we’ll be looking for – at interim analysis we’ll be looking for a 20% reduction in MACE events, whereas in the last trial as I mentioned a few times, we had 63%. So we do believe we’ll hit our interim analysis and that should be about 18 months from the start of the trial.

Slide 14: BET Protein Inhibition with Apabetalone Favorably Impacts Pathways Implicated in Cardiovascular & Kidney Disease

We have lots of reason and lots of study to show that this should work very effectively. And whether we’re dealing in vascular disease, chronic kidney disease, or vascular dementias, we have six main pathways that we’re affecting. We’ve studied over a thousand pathways. And these aren’t just our favorites, these are the top ones affected by our drug. And they are very important in metabolic diseases, being the complement pathway, vascular inflammation, reverse cholesterol transport, acute phase response, vascular calcification, coagulation cascade. Everything in blue titled around the circle there are publications that our internal staff have done on this very issue, so we are well published on our mechanism of action. And quite excited about where this is going. There are numerous other publications as well validating this new field of epigenetics.

Slide 15: Global Development Plan

Now this particular BETonMACE 2 trial – the entire trial will last about 3-1/2 years. We really do expect to see some early results here at the interim analysis. And we have an agreement with our partners in Asia that they will be funding half of this trial and we will pick up the balance. So a very affordable trial for us. Overall it’s planned for 3,600 patients and 600 events. And we expect to see at 300 events that we’ve already met our endpoint. So we’re looking forward. We’re getting very close to some meaningful results for the company.

Slides 16 & 17 – Dual Mechanism

Now let’s talk a little bit about this unique dual mechanism that we have for COVID -19. We are a very strong anti-viral, but we’re also an anti-inflammatory, and I think that’s where the strength is going to be here. Big publication in Cell – 39 pages – and we’re showing as strong as remdesivir which is currently used as an antiviral in this area. Some others you may have heard of this week from Merck. We like antivirals, but we don’t believe that’s where the strength is.

Slide 18: Disease Progression – Unique Dual Mechanism

The antiviral is tricky because COVID is tricky. You have it for around 8 days before you even know you have it. So if you’re getting tested every day like Donald Trump was, an antiviral could be effective, because you have an early approach to it. But we can’t in real life test our patients every single day. And if we’re starting too late with an antiviral it will not have the impact. It will have switched to the second part of the program which you can see in the middle here the diamonds, and that is the inflammatory response. Once you have switched to the inflammatory response, the COVID portion is dying or died out already. So the people in the respirator rooms? They don’t even have COVID anymore in most cases. They have an inflammatory response that causes a cytokine storm. That is many of your inflammation responses turning on and staying on. So what’s killing the patient is his own immune system that was triggered by COVID.

Slide 19: Cytokine Storm Pathways are Suppressed by Apabetalone

So this is just an example of human data that we have and have published. One of our pathways. One very important in cytokine storm, which is the acute phase response pathway. On the left hand side – very busy looking slide, but on the left hand side 0in the orange you see all of the protein markers that are turned on by the cytokine storm approach.

On the right-hand side in the blue, these are patients that had chronic kidney disease. These are not COVID patients yet but they soon will be. And in twelve hours we’re able to shut off these very key markers and put the patient’s system back to normal instead of leaving it turned on full.

So this is why we really believe that this cytokine storm approach on top of our antiviral approach will work effectively. We are moving forward with this as I’ve mentioned. We hope to have first patients in very shortly.

Slide 30: Health Canada Approves COVID-19 Trial

Now we have our no objection letter from Health Canada, and we should have one very soon from Brazil as well. And we are working on a Phase III document with the FDA.

Slide 31: COVID-19 Clinical Trial Launch in Q3-2021   (Isn’t it Already Q4?)

Going forward this will be a very fast program as there are plenty of patients around. Especially back home in Alberta where we are. We’re getting about 2,000 a day now and up to around 40 deaths per day. So we’re starting the trial in Alberta and we’ll expand to other regions in Canada, Brazil, and eventually our Phase 3 in the United States. We do have some potential to be doing this in the Middle East shortly as well. And again very affordable programs. In some cases there are some government-sponsored ability to pay for portions or all of these trials. Still working on that.

Slide 32: Commercialization Strategy

Now as far as commercializing this goes, a very successful company Eversana is focused on commercializing Phase III assets. We’re very fortunate to have partnered with them. It’s a new type of business model that has been very successful and we’re looking forward to our continued work and growing awareness of this program.

Slides 33 & 34 – Eversana

So as a company with 40 or less employees it’s very difficult to move a program like this forward, but now I have access to 3,000 employees based on this agreement. So these are all highly experienced people in roll-out of drugs in many categories. All of them have worked for major pharmaceutical companies.

But now we have full services in patient services, field solutions, channel, distribution, market access, compliance, consulting - So it’s the full meal deal and very affordable from our point of view. So we’re quite excited about moving forward with Eversana on this program.

 And again it builds towards what our main event is. COVID hopefully will be gone in a few years. Our drug approach with the anti-inflammatory works on all variants. So we do feel that this is a unique approach, but it will prep the market for our main program. 25% of all patients who finish with COVID are left with some form of new cardiovascular disease. 30% are left with diabetes for the first time. So this is a program that will lead very nicely into our main program, which starts out commercially hopefully in about two to three years.

Slide 35 – Highlights

So just to summarize we are a first-in-class Phase III asset focused on turning genes on or off. And we focus on disease-causing genes in this case. We have FDA breakthrough therapy designation. We’ve seen very solid results and great publications of them in the last year. Our Cell publication is 39 pages. In Nature there was a group of 27 universities studying COVID and 20,000 various drugs that they felt could be re-purposed for the fight on COVID. We came in on their shortlist of 63 and were published so we’re very excited about that. We have the commercial ability to take this to the market now with our new partners Eversana, and we have the regulatory approval to do such.

So I’d like to thank you very much for your time today. And I look forward to hearing from you with any questions regarding investment or our potential going forward. Thank you.