Nyrada (ASX:NYR) Presentation, FNN Online Investor Event, February 2021

Company Presentations

Nyrada (ASX:NYR) CEO James Bonnar provides an update on its cholesterol-lowering treatment and brain damage drug developments candidates, and its strategy of advancing our drug candidates towards value inflection and early commercialisation.

Good afternoon, everyone. So, there you can see our disclaimer, which we'll take as read.

So, as Clive mentioned, Nyrada (ASX:NYR) is a Sydney based biotech company that was built around the idea that through innovation we can have a profound impact on the lives of patients. In particular in areas where there's unmet clinical need, where the current treatments are sub-optimal, or indeed don't exist. So, what I'm hoping to do in this presentation is help you understand why we're excited about our two lead programs, and not only do they represent significant medical breakthroughs, but also an attractive investment opportunity.

So the two programs I'm going to talk about today, this is Australian science developed here. The first is a cholesterol lowering drug that aims to reduce the risk of cardiovascular disease, and I'll talk a little bit about what's unique about our product, a little bit about the market, and what our plans are for that project.

The second program I'll talk about, and one that's dear to my heart because it's an area I've spent the best part of a decade working in, is a drug to treat secondary brain injury. And this is the injury that occurs following a traumatic brain injury, or a stroke. So, you'll see along the bottom that our mission is heavily based around commercialising these products early, so I'll talk a little bit more about that. And that leads into our business model and strategy.

So Nyrada is an innovator and early stage developer. We're looking at short timeframes for development, unlike other biotech companies. And the key criteria for selecting our programs are highlighted along the bottom of the slide. Essentially, what we're looking to do is tap into unmet clinical need where the market is large, and what we're looking to do is aim to be the leader in the market.

I mentioned our timeframes for development are relatively short. With our cholesterol lowering program, we're looking to commercialise that, or out-licensing after a phase one study, that'll be run here in Australia. And not only will we be looking to confirm safety in that study, but also we'll be looking for evidence that the drug works in humans.

So, I mentioned the short timeframes, one of the other advantages of that are low capital requirements. The brain injury program, the timeframe for that is, we'll look to commercialise that or out license it after a phase two study. And that's a study where we'll be looking at whether the drug works in the target patient population. So, these are stroke and traumatic brain injury patients.

So, first of all, we'll talk about the cholesterol program, and I'll just outline very briefly what the problem is in this area. I'm sure all of you will be familiar with the graphic at the bottom. And that shows what effect cholesterol has when it builds up to high levels in the bloodstream. What happens is it deposits on the inside of arteries, and it can cause a blockage which leads to heart attack and stroke.
Cardiovascular disease, which is the umbrella term covering those diseases, is a huge worldwide problem, and it affects a large number of people. In fact, if you're over 65, there's a 40% chance that you have this condition and that you're receiving treatment.

So, many people will be familiar with the statin drugs. These have been around for about 35 years, and for treating cholesterol, they've been the go-to drug, and they dominate the market. It's a very large market, it's estimated around about US$19 billion per year. In terms of numbers, to give it a local context, about 2.6 million Australians currently take a statin, and the statins account for the number one and two most prescribed drugs here in Australia. And the market leader, as you can see there, is Lipitor, that's a Pfizer drug.

The advantage of statins is that they're all now off patent. So, they're low cost and freely available. The downside is that they have a sub optimal efficacy, and that's highlighted in the graphic on the right. You can see that, in the US, around about 27 million US adults have high cholesterol and are taking medication. What's rather disturbing, I guess, is the stat in the middle, around 19 million or 70% of those patients are unable to reach their target cholesterol level despite taking medication. So, this opens up a large opportunity, and it's one that pharma companies have looked to exploit.

So, in the early 2000s a protein called PCSK9 was identified, and it's role in the metabolism of cholesterol was starting to be understood. So, drug companies worked to develop PCSK9 inhibitors and what they essentially do is they bind to this protein and they stop it from binding then to a receptor. And these receptors are important because they are what's responsible for removing cholesterol from the bloodstream.

The two leading drugs on the market. One is an Amgen drug called Repatha, the other is an AstraZeneca drug called Praluent. And last year, the combined sales for these two drugs were around about US$1.3 billion and growing significantly. One thing about these drugs, you'll notice in the image there that these drugs are delivered by an injector, and that makes them inconvenient to use, and they're also tremendously expensive. The treatment cost per year is around about US$5,000 to US$6,000. So, there's been a little bit of poor uptake in the market for these drugs.

So what Nyrada is looking to do is develop what's called a small molecule inhibitor, and this offers several advantages. The first is that it can be made into a pill, so it doesn't have to be injected. The second is it can be made very cheaply. And what we're basing this product around is patient convenience and cost effectiveness. One of the big problems with the PCSK9 inhibitor injectable drugs is a lot of patients are prescribed these drugs, but because of the cost and the inconvenience, they stop taking them after the first prescription.

For reasons of biology, these PCSK9 inhibitors work very well with statins, and that's one thing that's quite important because what we can do with this drug is we can combine the two, a statin and our drug, into one pill. So, we're really developing a single pill treatment that will enable anyone to reach their target cholesterol level.
So, just before the new year we announced some data from a mouse study. And what's special about this mouse model is that these mice have been genetically modified so that they metabolise cholesterol much like a human does. And what we found is that we got a really impressive dose response. And at the top dose, we got a lowering of cholesterol of 57%.

And to put that into context, the statin drugs that are available on the market, run in this model, deliver a lowering of cholesterol somewhere between 30 and 50%, and the injectable drugs I mentioned before, give a response of between 38 and 46%. So, our results stack up very well against the market leading drugs. What we also showed in this study was that the drug was well tolerated with no adverse effects.

The second program I'll talk about is our brain injury program. And in terms of the size of the problem, again, numbers out of the US, about 2.8 million people every year suffer a TBI. And that is from things like motor vehicle accidents, falls, and general head trauma. The drug we're developing also has been developed, not only for traumatic brain injury, but also for stroke, and that accounts for about 800,000 events, again in the US each year. So, the total patient population is around about three and a half million. What's really exciting about this program is that currently there are no FDA approved treatments for brain injury. So, this is a first.

So this graphic at the bottom here shows what happens following a brain injury. Immediately after the injury, a primary injury is formed, and nothing can be done about that. But in the hours and days that follow, you get a secondary injury occurring, and that's represented here by the green curve. And what we're aiming to do with our drug is depress that green curve, and lower the level of disability. So, what we're aiming to do here is improve survivability for patients and also lower the level of disability.

So recently, we just announced a three-way collaboration, which we're really excited about. And this is between the Walter Reed Army Institute of Research, and UNSW here in Sydney. And what's particularly exciting about that as it takes our brain injury program onto the world stage, and it signifies that there is plenty of interest out there. Traumatic brain injury in the military accounts for one in 25 service members experienced a TBI in their career. So, it's a number one health priority for the Department of Defense.

And what this collaboration will enable us to do is, A, have access to the top neuroscientists in the US. It'll also enable us to access specialised models that they have for injury that mimic things like blast injury, and penetrating ballistic brain injury from shrapnel and bullets. And it'll also open the door for non-dilutive funding applications in conjunction with Walter Reed.

So where we are currently with these programs, we have impressive proof of concept data for both drugs. And we're looking to take them into first in human studies. For the brain injury drug, it'll be middle of 2022. For the cholesterol lowering drug, it'll be at the end of this year.

Nyrada has assembled a very experienced and impressive board, an international board of very high caliber, led by our Non-executive chairman, John Moore, also on the board and a face that may be familiar to some of you through his work with Exopharm, is Ian Dixon. And Ian was really the entrepreneur and the founder behind the cholesterol lowering program.

Another personal point out there as Christopher Cox, and anyone who follows developments in the cholesterol lowering world will know that late the year before last, there was a deal done where Novartis bought out The Medicines Company in a deal worth US$9.7 billion. So, having Chris on board, Chris was the Chief Commercial Officer at The Medicines Company at that time, so having someone of his caliber on our board, I think speaks volumes.

So, just some metrics about the company. Currently, our market cap stands around $39 million. We've been listed on the ASX for just over 12 months, and our share price at close yesterday was 35.5 cents. And that represents quite an appreciation over our IPO price of 20 cents. We have a cash runway at the end of December of $4.1 million, and at our current cash burn rate, that'll take us through to the end of the year.

In terms of milestones, as I mentioned, we're looking to enter the clinic with our cholesterol lowering drug at the end of this year and our brain injury drug middle of next year, but there'll be plenty of news flow in the interim as we work through our preclinical programs.

So, just to wrap up, if anyone has any questions, feel free to email them through to the email address there. I've also included a couple of QR codes here, which you'll all be familiar with. These are the codes that you use when you check into your gym or restaurant. What these do is they'll take you through an animation which explains, in 60 to 90 seconds, how the technology works. So, with that, I'll hand it back to you, Clive, and thank you very much, everybody.


Ends

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