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Top-Line Primary Endpoint Results for Phase 3 BETonMACE Cardio Outcomes Trial were Announced September 30th ****Detailed Trial Data to be Presented at AHA Late Breaking Session Nov 16th & Company Webcast Nov 18th******
Message: Transcript RVX_191031_AGM
coming out strangely large - but here it is.
Resverlogix - October 31, 2019 - Annual and Special Meeting of Shareholders
1. Title Slide
2. Forward Looking Statement
OK, we do have our forward-looking statement. And it’s the usual.
3. Executive Summary
So for the executive summary we’ll just go over a few highlights.
Today’s presentation is probably going to be shorter than usual because of embargo rules, but I’ll explain that as we go through.
There’s still a very high unmet need in the diseases that we’re working on. ACS, renal disease, cognitive impairment.
As a matter of fact some of these are getting worse rather than better in our general population.
Apabetalone is the first and only in-class Phase III select BET inhibitor
Moving forward, we’ll talk a little bit about what we can on the BET on MACE trial.
And on November 16th, the results from this trial, the real results, the exciting results will be presented during a late-breaking session at the American Heart Association Conference in Philadelphia.
So what does that mean? What’s a late breaking session?
That’s a very prominent podium position.
Usually when I go to these types of late breaker sessions, you’re in a room with a couple thousand key opinion leaders and doctors.
It’s a big deal.
So we’ve been very cautious about not spilling the beans on where we are.
The data that we have from this trial is critical.
It’s very important to our company and our future.
So we’ve been very quiet about it.
I’ll share some ideas and thoughts here today,
but I won’t share any of that data for the obvious reasons.
I know everybody would love to have it today,
But at the expense of losing your position...
And i have seen Pfizer kicked off the podium for...
(coughs – excuse me, well there’s the answer - is my cold gone – No.)
I’ve seen Pfizer removed from the podium for putting out news releases with too much in it and that type of stuff, so they’re not going to bat an eye at bumping us off of there.
So we really want to be very solid in our presentation of that
So we’re technically embargoed ‘til November 16th.
And at that point in time, the presentation will take place.
We have an additional presentation at AHA
And then on the morning of November 18th, which is the Monday, the 16th is a Saturday,
On the Monday pre-market, I will be doing a webcast discussing the data in even greater detail.
Basically “lifting the kimono” so to speak.
We’re really looking forward to that date and to being able to share that with you.
It’s fantastic for us to have this kind of Phase III data.
This is something we’ve never had before.
This is a key ingredient in getting to the next stage.
And the only data that will still remain embargoed will be the cognitive impairment data.
And it won’t be embargoed for long.
There is a CTAD conference, which is Clinical Trials on Alzheimer’s Disease,
A major CTAD conference on December 4th to 7th.
I believe our data is being presented on the 6th, I’m not sure...positive.
But at that point in time, we will also do the same thing and detail the cognitive function data as well.
It’s not in the embargo for American Heart because they don’t care about cognitive function.
So it’s not part of our presentation or what’s being disclosed there.
So we also know from the BETonMACE trial that we have a very safe molecule.
The safety data will even be presented, probably on the 18th.
Some of it’s presented at AHA.
And we already know we passed nine data safety monitoring board tests without a single problem.
And I’m very impressed with the data, so we’ll see where it goes.
And again, we’re in a great position still with our intellectual property.
We have a very robust position, composition use, manufacturing.
And we have IP protection in various countries ranging from 2027 to 2034.
So we’re in pretty good shape
4. Apabetalone Mechanism of Action (DNA, RNA, Protein)
I’m just going to briefly touch on this and remind you guys why we’re different than everybody.
You have your DNA; everybody knows what that is.
When a message is sent out to form RNA, which then tells the body what protein levels to make,
Something has gone wrong in the transcription of our patients.
And whether it’s diet, environment, disease - it doesn’t matter.
The original message has been changed.
So our job has been to change it back.
So most drug development takes place at the single protein level,
which is great if you have a single protein disease.
Chronic Kidney isn’t. Cardiovascular isn’t. Alzheimer’s isn’t.
They’re multi-factorial diseases.
So by working up here at the transcription level, it gives us a huge advantage.
And that’s why this drug has such exciting potential.
5. Apabetalone Mechanism of Action (Complement, Vascular Inflammation, Reverse Cholesterol Transport, Acute Phase Response, Vascular Calcification, Coagulation Cascade)
And before we’ve gone through some of the major areas this covers.
Complement system, which covers your body’s invading pathogens,
Vascular inflammation, Reverse Cholesterol Transport, Acute Phase Response,
Calcification, and Coagulation.
So these are all areas that are very very pertinent to the main diseases that we’ve been working on.
6. BET on MACE Timeline
Now you know the BETonMACE timeline so I won’t spend too much on this.
It started in 2015, so that was a four-year trial.
A lot of work and good job staff.
Our staff did an incredible job on pulling this off.
Most of the time a major pharmaceutical company, they’ll run three four or five Phase 3 trials and then pick the best data and move forward from there.
We don’t have that luxury; we were lucky to get one in.
So it’s very different for us and I think we were highly effective in what we did with BETonMACE
And where it will go once the full data set’s out.
7. BETonMACE Study Design
So we know the design of the trial, I just put it up here just as the reminder
it’s versus placebo.
But I also like to keep reminding people that placebo is top standard care.
So when you see our data in November,
that’s better than any of the top medications/therapeutics in the world can provide,
so it makes it pretty exciting moving forward for us.
I hated having to put out a news release a month ago that said that we missed the statistical analysis.
Simply that means the powering of the trial was a little light.
It does not negatively affect the data of the trial. The data is the data.
(On slide, N=2425; active arm apabetalone 100 mg bid plus standard of care; control arm placebo plus standard of care. Standard of care includes 40-80 mg atorvastatin or 20-40 mg rosuvastatin.)
8. BETonMACE a Global, Multi-centered Clinical Trial
And of course as you know we ran this around the world.
So that was a lot of work.
And it was pretty impressive.
We got a lot of support from these groups both in the past, present, and willing in the future, so...
(On slide, 14 approved countries, 220 different sites)
9. BETonMACE Study Parameters
Now this slide here, the BETonMACE parameters, what’s the primary objective
We’ve been looking at slides like this for four years and it’s still confusing as hell to a lot of people.
As to, what’s the primary endpoint, how do you measure this, and what did we learn from this trial?
So we can look at primaries, secondaries, and exploratories and all of that,
but let me show you something easier.
10. How will BETonMACE Data be presented at AHA?
This is called a Forest plot.
And this is what you will be looking at after AHA.
Now I didn’t put numbers on here,
because that’s the data that’s going to be shown at the American Heart Association.
But you’ve got twelve key points here.
The first one - the
“First occurrence of primary event endpoint” – (slide says “marginal miss”)
That was the main one. That was what was announced on September 30th.
All of these others are now about to be announced.
“First occurrence of primary end point or hospitalization for unstable angina or urgent or emergency revascularization procedure”
“First and recurrent primary endpoint events”
“Cardiovascular death or non-fatal myocardial infarction”
“Coronary heart disease death or non-fatal myocardial infarction”
“Non-fatal myocardial infarction”
“First hospitalization for congestive heart failure”
“First and recurrent hospitalization for CHF”
“First occurrence of primary endpoint, excluding undetermined death”
This is a lot of information.
So in a room of 2,000 doctors in Philadelphia, and a short presentation, how do they absorb this?
But that’s why you use a forest plot.
Because with a forest plot – I’m going to give you an example.
11. How will BETonMACE Data be presented at AHA? (with Hazard Ratio explained)
Here, the hazard ratio and the confidence interval are 95%.
So basically that means 95% of the time you’re going to get the same result.
And so ah... we didn’t hit the 95%, but you’ll find out how close we got soon enough.
And remember this is on top of top standard of care.
12. How will BETonMACE Data be presented at AHA? (with red circle on right side of 95% CI line)
Now data on this side of the line on a forest plot would indicate that the placebo was better than the dose drug.
13. How will BETonMACE Data be presented at AHA? (with green circle on left side of line)
On this side of the line it would indicate that the drug was better than the placebo.
So at AHA...
14. How will BETonMACE Data be presented at AHA? (with pretend data on right)
If those doctors end up looking at a forest plot that looks like that, they’ll laugh.
Because it means that placebo was considerably better than your drug.
And it would be a very bad forest plot.
15. How will BETonMACE Data be presented at AHA? (with pretend data on left)
That would be a very good forest plot.
So these doctors would be able to quickly understand,
Does this drug work?
Is this drug efficacious? Is safety included?
So we’ll see.
I’d like to tell you more, but I can’t.
So it’s the big tease time I guess.
But it is what it is.
I - with these three slides, really just wanted to explain to you
what you’re going to be looking at in November
Because we haven’t used the forest plot design for you before.
So all of a sudden we throw out a new type of slide
And you’re going to go, “oh what the hell does that mean?”
So at least you’ve got a foot in the door as far as the type of design that’s coming
And what it means and how to quickly read it.
16. FDA Timelines and Approaches
Alright. One more issue we’re working with quite diligently
And we have a face-to-face meeting on November 13th, so even before AHA,
Is our meeting with the FDA.
And questions and considerations around what will happen at that meeting -
This is not gospel, it’s still being developed -
Can Resverlogix proceed with the current registration of Apabetalone for some type of indication?
That’s a potential.
I’ve put up here that it’s a long shot potential, but it is a potential.
The next slide will show you that it’s actually common practice these days at the FDA
IF you have really good data,
and primarily mostly if there is no other competing drug already in the market.
And in many of our indications, there is no competing drug in the market.
So we’ll see where that goes and
I think it’s a long shot but I think we’ll push for it.
Even if they say no the first time, we’ll keep moving it forward.
Another approach is continuation of the BETonMACE trial.
How do you do that?
Well it’s called a bolt-on trial.
We can designate the first trial as an interim point.
So we’ve done an interim analysis.
And statistically we know our powering; we know it now.
So we’d be able to add x number of patients, and just drug them for about eighteen months,
And then know that we have the powering to meet that statistical significance.
So that’s a pretty exciting option actually.
It’s way shorter and way less expensive.
Less expensive than starting a new trial over.
As I just told you earlier, the last trial took four years.
We’d need a bigger trial and it would cost more.
So if we have to go that route, we will.
But we’d be doing it with partners.
We don’t have the horsepower to go back in there and do this without a major pharma tied –
But we do....
And well, guess we can’t talk about it.
We’ll talk about it again after November 16th.
We’ve got a lot of interest in this company right now.
17. Overcoming Phase 3 Obstacles
So this is some of the varying Phase III data.
These aren’t all bolt-on trials but they’re different types of trials.
Just this year alone there were two drugs, both of them for infectious disease.
That were - - they missed their endpoint just like us.
And there was no other drug in the market.
Their data looked really good.
I think ours does.
And both of them were approved.
So it’s not the end of the world.
The stock market sure makes you pay for it, but it’s not the end of the world.
I think we’re in really good shape going forward.
These types of drugs, it depends on what they are, some demonstrate ability...
Here this one – ten patients died in the trial versus two in placebo, and it got approved.
Wow. That’s overcoming a hurdle.
We don’t have that kind of hurdle.
But anyway each one of them has
a pretty good track record for why it got approved after having problems.
And it does happen a lot.
A good one to even look at recently is Biogen’s.
So about 5 or 6 months ago Biogen announced that that drug had failed Phase 3.
They lost 20 billion dollar market cap in one day.
So it was a painful day for Biogen.
Last week they announced they’re going forward with it.
They’ve had it in discussions with the FDA and it looks like it will be approved.
And it went up 17 billion.
So this was a drug with a very narrow margin of success.
And failed their statistical endpoint in phase 3 data by quite a bit.
And yet it’s going forward.
So I don’t think we have a real serious problem here.
I’d rather be sitting up here talking about how great it was to have met that endpoint.
But I’m not.
So, we just look at –
I didn’t spend too much time, this isn’t by any means an exhaustive list.
Something I put together in about ten minutes.
And the bottom line is that this type of stuff happens.
Bolt-on trials, there’s one going on right now, and there was one approved right here.
So we’ll keep working with that.
The FDA has actually been really good to work with.
So we look forward to this next meeting with them and designing our go-forward.
18. Resverlogix - Short Term Timelines
On the short term
(Just one sec, I’ve got to get some water I’m talking too much.
Picture me drinking water. It must be a really boring presentation. Laughs.)
OK So obviously that’s today (Oct. 31st)
(And of course it snowed, we should put a snowflake up here instead)
The FDA face-to-face meeting is November 13th. So I’m pretty excited about that.
The Late Breaker on the 16th. This is big news for us.
And on the 18th, we will do our poster presentation at AHA.
Also on the 18th, I will do a conference call and spill a lot of beans, share a lot of data, show you where we are. Not only show you a Forest plot. I’m going to go a lot deeper than that. I’m going to take those Forest plots and break them down into normal graphs you can actually understand better. And see just how strong uh... well, I can’t say that... we’ll see how things go.
The CTAD conference is coming up so again the cognitive function data will remain embargoed ‘til December 6th, but that’s not that far off.
We had some of our clinical steering committee members approached me this week and wanted to know if it would be ok if we stretched the embargo until a major meeting at the end of March next year. Anybody in favor of that? I certainly was not. I thought it was comical that they even asked, but whatever.
So as with previous trials, we have mountains of data that take forever to get through. So there will be a lot of data done here that will also add value.
I can loosely point out that soon there will be at least one new patent filed off of this trial. And I it’s an exciting one to me. So we’ll see.
19. BETonMACE & Apabetalone
And that is it for what I can talk about and share publicly at this point in time.
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