SUDA Pharmaceuticals (ASX:SUD) Presentation, FNN Online Investor Event, November 2020

Company Presentations

SUDA Pharmaceuticals Limited (ASX:SUD) Managing Director and CEO Dr Michael Baker provides an overview of the company, discussing its OroMist technology, Zolpimist and Anagrelide products, strategy and outlook.

Thanks for the introduction, Clive, and thanks to Finance News Network and also Shaw and Partners for hosting this event. And certainly thank you to everybody for dialling in. And I look forward to taking you through what we do at SUDA Pharmaceuticals. As Clive pointed out, we are a biotechnology company and current focus is specialising in taking medications as they exist in solid dose forms and spraying them into the mouth as an oral spray, so they can reach the bloodstream by crossing the lining of the mouth.

Next slide please. The usual disclaimer. Next slide.

First and foremost, so we have a pretty refreshed board and management team over the last 18 months, with myself joining at the beginning of the year. So in addition to using our OroMist™ technology to create oral sprays, we're also actively focusing on finding new technologies to add to our portfolio, and the technology in our portfolio focuses currently on oncology, so cancer treatments, but also treatments for the central nervous system.

And just going a little bit more detail about our OroMist™ platforms, so the technology we use to create oral sprays, the reason that we do that is because we can work with drugs that have already been approved. So we know they're safe and we know they're effective. We're just putting them into a more suitable dosing format. And the nice thing about that is because we know that all that information exists, we don't need to complete all the work that typically goes into a drug development program, which could save us in both terms of time, but also cost.

For our lead product, it's a treatment called ZolpiMist, which is for the treatment of short-term insomnia. And we recently received TGA approval for that, which is a very big milestone for the company. We're very pleased. It's our first regulatory approved product. And importantly, that approval will feed into the submissions that we've got in place for our current licensed partners. And those partners' territory is covering more than 550 million people.

And again, a nice thing about working with drugs that we select is we can pick the markets to play in. And as I said, we focused on oncology and the central nervous system markets, and they are all multi-billion dollar markets. And we're very pleased, earlier in the year, we completed an entitlement offer and we have strong shareholder support. We were looking to raise $3.5 million. We had offers from $5.2. And so again, we're very pleased with that level of support. And certainly we look to prioritise our shareholders moving forward.

Next slide, please.

And so to take you through the OroMist™ platform itself. So the question is often, why bother taking drugs as they exist in solid dose forms and converting them into oral sprays? And the very simple answer is that we know that there are a lot of benefits if we're able to successfully do that. And the first is that we increase what's called bioavailability. So that's the amount of drug that gets into the bloodstream and is available for use. So if you look at that curve on the graph on the right hand side of the slide, the first bar is actually set to 100% and that's when we stick a needle into the arm and get drug in that way. And only second to that, do we see for sublingual sprays and intra-oral sprays, we can get up to 90% to 95% into the bloodstream for some drugs.

And if you look to the very right-hand side of that graph, you see that tablets, pills, and capsules, you only get about 10% to 30% of that drug actually available for you. So big advantage is that we can reduce the dose and potentially have safer drugs that way.

And another big advantage is, because we're basically spraying into the mouth, that should cross the line of the mouth and get directly into the bloodstream. We know that the drugs will work faster. And again, when we talk about treatments for things like insomnia or migraine, where there's pain associated, having a faster onset of action is a really important feature.

The other nice thing is that it opens up access to different patient groups. Patients that are nauseous have trouble swallowing tablets, but also a significant proportion of the population actually suffers from the inability to swallow, a condition called dysphagia, but also in the case of things like seizures or paediatrics, we see that there's advantages for oral sprays. So for all those reasons and the fact that we're not giving needles or inhalables, we see there's likely to be increased compliance for taking medications.

Next slide, please.

Now a really key part of a biotechnology company's strategy moving forward is to have robust IP, and we do have that already in place. We've got a number of pending and granted patents covering our platform to convert drugs from solid dose forms to oral sprays, but we've also got patents that cover some of our specific drugs. For example, I've listed Anagrelide there, which we're developing for use in cancer. We've recently had two patents granted in Japan and Australia, in addition to the patent we had granted in Europe already. And as we look to bring new technologies into the business, a key part of that strategy is looking to bring in additional IP.

Another form of intellectual property is the form of technical knowhow. Again, we've developed over a long period of time, the ability to take drugs as they exist in solid dose forms and convert them into oral sprays. And that does require some pretty complicated chemistry.

Next slide, please.

Again, another important feature of our business model is creating robust partnerships. We've got some very high-profile names already in partnership for our technology. Sanofi is one of those, it's a top five pharmaceutical company. We're working to reformulate one of their products. It also highlights the barrier to entry for people to try and get into this space. Sanofi is a top five pharma. Theoretically, they could try and do what we're doing, but they choose to work with a group like SUDA.

Teva is the world's largest generics manufacturer, and Mitsubishi, a top 10 Japanese pharmaceutical company. We're working with both of those for our insomnia product. We're working with Strides, a large Indian pharmaceutical company, and Ordesa, a large Spanish pharmaceutical company, as well as two local medical-grade cannabinoid players, Zelira Therapeutics and Cann Pharmaceuticals. So again, creating new partnerships is a part of the business model moving forward.

Next slide please.

So first and foremost, for our business strategy, it's really important to point out, we are a biotechnology and drug development company. And what that means is we take drugs as they exist in early stage development, and the idea is we progress them right on this slide, through the various phases of drug development, all the way through to approval before the products get commercialised. And as we move to the right, that's where we create the most value.

So for our lead, I should point out, we're in the unusual position actually, that we are actually a revenue-generating biotechnology company. And the way we do that is when we partner with our particular partner companies, we look to take upfront payments to get access to the platform. And as we move through some of those defined steps, we look to take milestone payments as well as royalties of commercial sales.

So our lead product is ZolpiMist, the product I mentioned earlier for the treatment of insomnia. As I said, we recently got approval for that product through the TGA. Really importantly, that submission is going to feed into the submissions for our partners, Teva and Mitsubishi. And also, as I said, we're developing sumatriptan in conjunction with a large Indian pharmaceutical company, Sumatriptan. We've got two partnerships with medical-grade cannabis companies, Zelira Therapeutics, and Cann Pharma. And we're also working with a group called Ordesa and Sanofi to develop their products into oral sprays. We can't name those products, unfortunately, due to commercial sensitivities.

Now over on the left-hand side here, we've also got another arm to our business, which is internally-developed products. And so one of those products that we're developing is called Anagrelide and that's for the treatment of cancer. But what we're looking to do, as I said, is bring new technologies into the business, and you can see in the middle of that pipeline, we see that there's a space in the preclinical and clinical region for us to bring new technologies into the business to continue to develop internally.

Next slide, please.

So I'd just like to take you through a little bit more about our lead product, ZolpiMist. So it is the oral spray version of the drug Ambien, which is formerly Sanofi's blockbuster drug and better known in Australia is STILNOX. So as I mentioned, we have already license and supply agreements with Teva, the world's largest generics manufacturer, as well as Mitsubishi Tanabe Pharma Singapore and MTP Korea. And we've got the rights to the rest of the world ex North America, but just those partnerships alone, we already have territories' license covering greater than 550 million people.

As I mentioned, we did receive TGA approval and that does feed into the submissions for our partners, which should assist them getting regulatory approval and getting the drugs commercialised. So we are in discussions to secure an Australian partner for that product. And importantly, we are in discussion to secure additional territories to roll out that drug to as much of the globe as possible.

Next slide, please.

Now, the other product I'd like to just discuss briefly is Anagrelide. This is the drug that, as I mentioned, we're reformulating for use in the treatment of cancer. So it is an approved drug already, so we know it's safe, we know it works. Now, it was previously developed for the treatment of a condition where patients had too-high blood platelet levels. And that can be damaging if people have thrombonic events. But what recent research has shown is that platelets play a very proactive role in supporting cancer growth, cancer spread, and even potentially masking the cancer cells from particular and newer immunotherapeutic treatments.

And so what we're planning to do is take that drug and repurpose it into an oral spray so we can give it to cancer patients and in doing so, again, literature supports that we'd be in a position to increase cancer patient's survival, which is very important.

So the first question that comes up when we talk about this project is why not just give people the tablet form of the drug, which sounds perfectly logical. Only, when that drug goes through the digestive tract and goes through what's called first-pass metabolism in the liver, it actually gets converted into an intermediate that's bad for the heart. And also, an injectable formulation does not exist, so the idea for SUDA is we create the spray, spray it into the mouth, it crosses the lining of the cheek, gets into the bloodstream, and we shouldn't have the production of that intermediate that's bad for the heart.

So we recently completed some work or using animal models and showed that that was the case. When we sprayed Anagrelide into the mouth, we could get more into the bloodstream and we didn't see as much of that intermediate being produced. So we believe we can lower the dose and have a safer product to hopefully increase lifespan for cancer patients.

So we're still working to finalise the oral spray to create a pharmaceutical-grade product. But as I mentioned earlier, a really important part of that strategy is to continue to secure intellectual property around that program. And we've also got Dr Richard Franklin working on that program, who is a gentleman that was involved in the early-stage development and registration of the drug across Europe. So we're building a very nice team around that program.

Next slide please.

So, as I mentioned, a key part of the business strategy for SUDA moving forward is bringing new technologies into the company. And so over the last 18 months or so we have refreshed the board and the senior management group, and a big part of the expertise and skillset within that group is the ability to source, evaluate, and acquire novel technologies. Now we already focused on oncology and the central nervous system, and these are the areas that we'll be continuing to look for additional assets to bring into the business.

Next slide please.

And just to give you a bit more colour on the team. Our chairman is Paul Hopper. He doesn't really need a huge introduction to the biotechnology space. He has over 25 years experience in life sciences, biotech, pharma, and commercialisation, and probably most notable on his CV is he joined Viralytics as the chairman, I think, when it had a market cap of around $10 million and it was sold to Merck in 2018 for $500 million. He is also the chairman of Imugene, and late last year they brought a novel oncolytic virus for the treatment of cancer into their business. I think again, the market cap is hovering around $100 million. And now that sits today at about $440 million. He's also the executive chair of a privately-listed company called Chimeric Therapeutics, and they've recently licensed the technology from the City of Hope. And they're looking to IPO to raise $30 million with a post-money of $61 million.

And so for myself, I have a PhD in biochemistry. I had a very long research career before completing an MBA and moving into drug development, where I was part of a senior leadership team, taking drugs from the early stages of discovery phases through to clinical trials. Then I joined one of Australia's leading healthcare-specific venture capital firms, bio science managers, before coming on board to SUDA. So again, I've got a very strong amount of experience in sourcing, evaluating, and investing into requiring new technologies.

And our head of business development, David Phillips, who was also an exec director, and he's also got a very strong background in pharma, biotech. He was also formerly the managing partner of SR One, which is GlaxoSmithKline’s corporate venture capital fund. So again, David has a very high amount of experience in again, sourcing, evaluating, and acquiring or investing into new technologies. And our non-exec director, David Simmons, he's formally a senior audit partner with EY and certainly brings a very appreciated amount of corporate governance and compliance to the board.
 
Next slide please.
 
And so with that, as I said, I think it's really important to highlight that for SUDA moving forward, a big part of our business strategy is to utilise the team and the skillset that we've brought in to find, evaluate, and acquire new technologies to bring into the business. We will, in line with that strategy, continue to expand the team that we already have, but also bring in other people with deep biotech drug development and pharmaceutical experience, both on the technical, but also the commercial front.

As I mentioned, a big part of the currency for a biotechnology company is having robust intellectual property. So we'll continue to build that for our OroMist™ platform, but also for any new technologies that we bring into the business. We'll also be looking to work with existing billion-dollar drugs for conversion into oral sprays using our OroMist™ platform. And again, a big part of our strategy involves creating those big pharma partnerships, which we'll be looking to do. As I mentioned, we've already got a number of high-profile partnerships in place with the likes of Teva, Sanofi and Mitsubishi.

And as I mentioned earlier, we do have strong support from our current shareholders. And certainly we look forward to continuing to prioritise our shareholders as we move forward.
 
Next slide please.
 
With that, I'd just like to say thanks very much again to Finance News Network and to Shaw and Partners. I'll put my contact details up here because I don't think there'll be time for questions, but if anybody would like to reach out and get in contact with me, I'd be happy to have a chat or to answer any emails. And thanks again for your attention, and thanks again.


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