RVX Presentation at GCFF Virtual Conference – Investing In Innovation – 09/10/2020 

https://www.youtube.com/watch?v=jIKgbcz1_ng

Cover Slide:

We have some very exciting technology to share today and it’s really good times for us.COVID has slowed down many companies. For us it seems to have accelerated us. So we’re pretty pleased about where this market is going.

Forward Looking Statement Slide

So look forward statement is presented there. And today we’re going to talk about RVX - where it’s been and where it’s going. And it’s going quite fast.

Resverlogix at a Glance

So we are a Canadian publicly traded company and we have an advanced cardiovascular diabetes drug called Apabetalone.

We’re pioneering a technology that utilizes the ability to turn genes on or off. So we don’t change human DNA, we actually turn genes on or off, and that’s called “epigenetics”.

And this is a very important point. Apabetalone has recently been awarded the FDA breakthrough therapy designation. That happened in February, 2020. Unfortunately, what also happened in February 2020 was COVID, so we didn’t get the four to five times bounce we should have gotten, and we expect it shortly.

So this is the highest designation you can get from the FDA prior to registration. So the breakthrough therapy designation prior to us was only awarded to 130 other drugs ever. And none of them were mainstream cardiovascular drugs. So this is a major development for the corporation.

And going forward... This drug is very safe. It has been tested already in over 4,200 man-years of treatment. It has demonstrated potential in areas like cardiovascular disease, diabetes, chronic kidney disease, non-alcoholic fatty liver, and vascular dementia. So it’s huge markets, as Gilbert mentioned earlier. We will be proceeding into some of these quite fast.

Near Term Development Points

Let’s see here.

Our near-term development is very strong. With our FDA approval, we’ve had our first meeting with the FDA and been able to design the trial going forward, the next steps. And very exciting for us, as we got pretty much everything and more than we were hoping to with the FDA. They’ve been wonderful to work with.

We have an application that allows us to run a trial and then at the midway point if we’ve seen successful data, they will register the drug. So that is a big big advancement. That could happen, you know, halfway through a trial.  

So also going forward we’re also being able to combine SGLT2s – that’s a new type of diabetes medication – we’re being able to include that in the trial with all patients. Not only are we able to include it, we’re going to be able to select which one we include, so it really gives us a great advantage in dealing with partners in this field.

We also have more chronic kidney disease patients involved in this trial. So we’re going to get a two-for-one study basically. We’ll be able to prove definitively the effects on chronic kidney disease as well. We’ve seen very solid effects on that already, as I’ll share with you in a shot while. 

And we’ve also been encouraged by the FDA to look at other areas, like non-alcoholic fatty liver disease (NAFLD), or sometimes called NASH (nonalcoholic steatohepatitis). And this is a big market area and that encouragement is a real plus for us.

So moving forward, we have several development approaches. Our first development approach is actually partnering this with a major pharma. We see this as a very high likelihood at this point. We would be receiving a major up-front this year. This is finalized ... [TRANSCRIBER’S NOTE: I listened several times to this sentence, but did not hear “If” this is finalized or “As” or “When” or “Once”– but the recording is a bit glitchy – so use your own judgement about this. Clearly “This is finalized” has a different meaning than “once this is finalized” or “if this is finalized”, and I was not sure – given that other options are still discussed] ...and the company we’re partnering with would also be paying for the entire Phase III B trial. So this is a big step forward for us to be able to advance and reduce costs in such a significant way.

So the new partner would also include their SGLT2 inhibitor in the program. So they effectively will have the only combination data going forward to advance into new medications, and our data has shown strong synergy with the SGLT2, so it will give our new partner a very solid market position. And we’re proud to be able to present that as an opportunity.

And going forward we also would have milestone payments and M&A options based on the results of this particular trial.

So it’s a very good design. It’s a very equal design for both the pharma and the biotech, being us. Whereas depending upon the results of the trial, if it’s really solid we get paid more. And if it’s just ok but passes, the pharma isn’t paying too much. So it’s a good setup.

The second option is actually we can sell or trade off some of our future royalty rights to pay for the trial and include ourselves if we wish.

We also have a third option where we can work with existing and new investors to do this on our own.

I personally think Option 1 is the best - to team up now with a multi-national global pharma company that has weight in the field and sales people in the audience already and uh, in the field already.

Required Drug Qualities for Successful Commercialization

So going forward, what a drug requires to be successfully commercialized - you can have the best drug and the best trials going, but you really need to have the full package before it’s going to get out there and be successful.

So you want efficacy, or does the drug work?

You want safety, is it safe in the general population? We have that already as well.  We have efficacy.

Regulatory approval. Well we have the FDA breakthrough therapy designation, so that is fantastic. And that includes all of the aspects of a fast-forward development program, so that will go through the next stages to commercialization a lot faster than the normal drug. We’re very happy with that.

You also need mechanism of action. Understanding how the drug works. Our company is the most advanced company in the world in BET bromodomain inhibition. We have the mechanism of action, a lot more than general people know, and we publish regularly on this. There’s another major publication coming out on this just this week. So publications, we’re highly published, and we’ll talk about that a little bit more as well.

And a strategic pathway. A clear set pathway of where we’re going with who we’re going with, manufacturing chemistry, that type of stuff. Also already in place.

So we are set and ready to go. And going forward, it’s getting rather exciting from our point of view.

Efficacy – The Drug Works! Trials Confirmed a Highly Significant Reduction if Death, Heart Attacks, and CHF.

So back to these orders we just went through.

Efficacy – Does the drug work? Yes it does.

So the hazard ratio in the last trial, showing relative risk reduction in deaths, heart attacks and congestive heart failure. We showed 63% reduction in these events over standard of care.

So this isn’t just placebo. These are patients being treated as best as we can in the medical system today. And we can reduce these events by 63%.

And that is a hazard ratio [sic] or a p value of 0.0002. That means there is only a two in ten thousand chance that this data is incorrect. So, very exciting from our point of view.

If you look at the bottom panel there, the number of events, so in this particular chart we’re showing that the placebo patients – or placebo on top of standard of care – had 42 events. The people on Apabetalone only had 15 events. So that’s pretty solid going forward.

And the good news is that the drug is extremely well tolerated, even in combination with these newer drugs like SGLT2s [inhibitors] or DPP4s [inhibitors].

So we’re clearly obviously talking to the drug manufacturers that make those, because those are very very big important drugs. They’re going to do about 25 billion dollars in sales over the next couple of years, per year that is. And we make them work 63% better. Wow.

FDA Approves Breakthrough Therapy Designation

So going forward, we’ve already talked a little bit about this FDA breakthrough therapy designation. That’s a huge step forward and we’re very excited to have it. They’ve been very good to work with.

Kaplan-Meier Estimates by CKD/Non-CKD for MACE – Apabetalone Compared to Placebo

I want to touch on this one a little bit as well; this is the CKD data or chronic kidney disease data.

And going forward this will be a big part of our program as well.

And what you’re seeing here is that in the last trial we’ve already proven efficacy in that are showing a 50% risk reduction in events, and again these events are things like death, heart attack, and heart failure. So a 50% reduction for those patients who are on drug vs. not drug. And these are in the sick patients.

So when you look at the patients who are – their kidney levels are considered healthier, above 60 eGFR, vs. those below 65 [sic slide says 60] eGFR, you see quite a difference here.

So 50% reduction and moving to market.

Mechanism of Action – Understood at a Granular Level

This is a slide depicting how the mechanism works in epigenetics.

This is a little complicated so in the matter of conserving time, we’ll move forward a little bit. 

But basically on the bottom, we’re a reader. 

We’re a protein-to-protein interaction and fully reversible.

Whereas the first two, writers and erasers, are chemical-to-chemical interactions and not reversible.

Mechanism of Action – Unique, Effective, Highly Advanced!

Now this slide is very important. I will touch on it. Because this is how the drug works.

This is a new breakthrough in drug development.

On the bottom there you’ll see in that purple diagram, the purple squiggle there.

That’s representing proteins. That’s where most drug development has worked in the past.

And that’s great if your disease is a single-protein disease, where ours are not. 

Chronic kidney disease, diabetes, Alzheimer’s, heart disease. They’re multi-factorial. So you need advanced technology.

And on the right hand side, the newer technologies in drug development involve messenger RNA. And some of the work that’s happening there is involving COVID.

And on the top right you’re seeing genome editing.  Well again, that’s changing the DNA. And if you have a single-gene hereditary problem, that’s very important. But if you have a multi-factorial [problem], that’s not going to work.

 So the newest and the most advanced is on the upper left. And that’s epigenetic regulation. That’s what we do. And we’re the most advanced in the world at it.

So your original DNA message has been corrupted. It has been corrupted by either disease, diet, or environment. And what we’re doing is we’re re-sending the original DNA message.

So you can correct hundreds of protein problems at once. So this is an extremely advanced program and we’re the world leaders in it.

Publications on Epigenetics and RVX

As far as publications in epigenetics, I think this one alone describes it quite well. That you can see these 100 and 1,000 percent increases in the amount of publications over the past ten years.

And this is just proof of the advanced acceleration of this program, and we are one of the world leaders in this area, probably THE world leader in BET Bromodomains. 

Safety – BETonMACE Nov. 2015 – Sept 2019

Most of the data we’ve been showing you today is based on programs run between 2015 and 2019. And the safety in this was extremely high. And that’s part of why the FDA gave us breakthrough therapy designation.

 Business Strategy

Now as far as business strategy, we already have a partnership in Greater China, Hong Kong, Taiwan, and Macau. That is with ShenZhen Hepalink. They’ve been an excellent partner. Since working with us from day one they’ve increased their holdings up to 130 million dollars. And so we have a good partner, a good development group going on there.

We’ve also licensed in Israel.

And we’re in discussions with other global deals regarding licensing and/or co-development partnerships as mentioned earlier.

Strategic Commercial Pathway – Global Vascular Opportunity

Now going forward in strategic commercial pathway, that’s all laid out. We have quite a bit of program developed around high-risk acute coronary syndrome and high-risk chronic kidney disease and end-stage renal disease. We’re also moving into vascular cognitive dementia, and as I mentioned earlier some of the non-alcoholic fatty liver disease programs or NASH are looking exceptionally well.

Additional Indication Targets

Now the additional indications.

We have complement mediated diseases, neuro fibromas (fibromatosis), pulmonary arterial hypertension, that program is active right now and in progress in clinical development; muscular dystrophy, Fabry - there are an enormous amount of them, including COVID. Twenty-two universities around the world did a study of 20,000 drugs potential for COVID. They published on 63 of the most promising and we were actually the second one on the list. So we’re very pleased that that program is advancing.

Gilbert: Hi Don – there are a few questions waiting on line, so if you would like to answer those you can try to wrap up a bit.

Management Team

Don: Sure I’d love to. I’m wrapped up right now; I’m just showing the final slide with our management team. And most of these people have been around with the company for a great number of years. Dr. Wong and I are the founders. Mike Sweeney has come to us from Pfizer, eleven years in clinical development there. Ewelina Kulkowski is one of the – she is the lead person in BET bromodomain research in the world. The others have been with the company for up to twelve, well fifteen years now – so – a long term group. So I am open to questions. Thank you.

Moderator (Gilbert) & Don on Screen

[Transcriber note: Please feel free to correct my take on the questioners’ names. Was not clear on those.]

Gilbert: Thank you Don. So the very first question coming from the Chinese side here in the feed... A question from Oscar Xu, he asks what’s the status on the negotiations with the business partner to complete the Phase III trial?

Don: The status is excellent. We have multiple partner partners we’re discussing in multiple different formats. And I can say as of yesterday I’m very pleased with where we are and with how fast this is moving. We will see activity before the end of the year.

Gilbert That’s good to know. The second question coming from Paul Sykes (or Sacks?) here. He said you had a Chinese partner a few years ago. What’s their involvement currently with the company?

Don: I missed that question. We had a what?

Gilbert:  A Chinese partner that you had a few years ago. I believe he’s referring to ShenZhen.

Don:   Oh yeah, yeah. I’ve got that. Yeah, so I just mentioned that actually. ShenZhen Hepalink, they’ve gone from just a licensing and small ownership position, to build up to a 130 million dollar investment now. So our relationship has been excellent. I keep in touch with them almost daily. Unfortunately for me, that’s usually midnight my time.  

Gilbert:  That’s good. So you have to work over night now. So another question coming from Guan Er Chun [maybe?] here is what’s your three-year time frame or outlook with the company three years from now.

Don: Three years from now we expect to be an extremely large global player. I think you’ll see the advancement towards that towards the end of this year as we move into partnership with a major pharma. And the development of this company is straight up from this point.

Gilbert:  And I think that’s it for the questions. Thanks for your time, and thank you Don for coming out to give an update. I will forward those to you after the show.

Don: Thank you very much Gilbert. Good seeing you again.

Gilbert: Thanks, Good to see you as well.