Arovella Therapeutics (ASX:ALA) Presentation, FNN Online Investor Event, November 2021

Arovella Therapeutics Limited (ASX:ALA) Managing Director and CEO Dr Michael Baker provides an update on the company’s recently acquired licence from Imperial College London for its invariant natural killer T-cell (iNKT) cancer treatment cell therapy platform, and on the company’s lead oral spray product ZolpiMist, a version of the insomnia drug, Ambient or Stilnox.

Arovella Therapeutics is a biotechnology company. And what we focus on is two major areas, cancer, but also conditions that affect the central nervous system. And for one of our major highlights, it’s a big deal for the company. We acquired the license to what’s called an invariant natural killer T-cell therapy platform or iNKT cell for short and we acquired that from the Imperial College London. So again, a top 10 university, which is quite exciting for the company and we are really working hard to focus on developing that now for the treatment of blood cancers.

Another key point for our group is we’ve got a very strong board and management team, which we’ve only recently added two new directors to the team, as well as a senior self-therapy manufacturing expert for our lead program in the self-therapy space. And we’re also the only company that’s actually that holds the patents for a drug called Anagrelide to use that drug for the treatment of metastatic disease and we’re going to be converting that into an oral spray for a safer product. And for our most advanced product, it’s a product called ZolpiMist, which is to treat short term insomnia. We signed a license agreement for a global pharmaceutical company start-up that’s now also TJ approved. So we’re expecting that product to be on the shells in calendar year 2022. And for that same product, another one of our partners, Teva, the world’s largest generics manufacturer also received approval for that drug in Chile, which is great. So again, we’re looking forward to commercialising it in that territory.

Now in terms of the company overview, we’re currently valued at just over $20 million as of September 30, we had about just over $5 million as cash in the bank. So we’re not actively looking to raise money. On the shareholder front we do have some good supportive shareholders in the top five, some high net worth, but also institutional investors. But of course it’s always important that we know that we’re getting new investors on the register that understand the biotechnology space, the investment horizon, but also the returns that can be achieved in this sector.

And in terms of our product pipeline so we have, as I said, two major focus areas, we’ve got cell therapies, but also we have a platform to convert drugs from solid dose forms into oral sprays and I’ll talk more about the lead program in each.

So for our cell therapy, our product ALA-101 is a cell therapy that we’re using to target CD19 or cancers that have a protein called CD19 sitting on their surface. That’s currently in the preclinical stages and we’re working hard to take that towards a phase 1 clinical trial in humans.

On the oral spray delivery platform we have our lead product as I mentioned, ZolpiMist, that’s approved. We have two partners already for that product and I’ll talk more about that in a moment. But we’re also developing on the oral spray front, a number of other products, one for migraine, another one that I mentioned before for treatment of cancer, and we’re also working to reformulate a cannabis product and also working with Sanofi top pharmaceutical company to reformulate one of their products.

So let me just talk a little bit more about ZolpiMist and what it is. So, as I said, it’s a drug that we’re using. It’s being used to treat short term insomnia, and it’s actually an oral spray version of the insomnia drug, Ambient or Stilnox. And it’s also formally Sanofi’s blockbuster drug. And why we think this is a really important drug at the moment is because prior to the COVID-19 pandemic short term insomnia had a very high prevalence anywhere of about 9.5% in the US. But what we’ve seen over the course of the COVID-19 pandemic is that we’ve actually seen a sharp rise in the incidence of health issues. So we do think this has got an important role to play in the market. And as I mentioned, we do already have a license and distribution agreements with Teva, the world’s largest to their manufacturer, and also the global pharmaceutical company starter. And so the efforts are now ongoing to commercialise in the two territories for those partners, Australia and also Chile. So currently we’ve got about a population of more than 375 million people under license with Teva covering Brazil, Chile, Mexico, and start covering Australia with an option for New Zealand. But we are looking to add additional territories to that list.

Now I’ll just switch gears and change now to our other lead product in the cell therapy space and our iNKT cell therapy platform. And why we’re so excited about this platform is firstly, it’s an exclusive global license covering human disease. So we can use the platform for any area and we’re looking at cancer initially, but that might be followed by other diseases. As I said, it comes out of Imperial College London, which is a top 10 university worldwide, really putting it up there with the Harvard’s and MITs of the world, which is again, testament to the quality of the technology. And in this space, this stands out as it is a little bit unique because it’s what we call dual targeting. So these particular immune cells, two ways to find, catch or stick onto cancer cells and kill them. And the first target we’ll be looking at, as I said, it’s a marker on cancers called CD19, which we know is expressed on numerous blood cancers, but we’ll be looking to target additional cancers and as I said, also, other disease areas.

So again, quite unique to this platform is the fact that most cell therapies need to be taken from the actual patient, modified and then delivered back to the patient. So we have a unique product here that we think can start from a healthy donor. And so we actually believe that will be a better product to begin with because it hasn’t seen the ravages of cancer, chemotherapy or radiotherapy, but also in the line with that, if it’s a product that comes from a healthy donor, it improves the supply chain. So we think we will likely have a more effective product that’s also more affordable. And so for all those reasons, we do expect that as we progress this towards clinic and through clinic, that this will generate commercial interest from large pharma.

So I’d like to just explain what it is exactly, because it is a little bit complicated, but as I said, what we do is we start from a healthy donor. We take blood from that donor and inside that blood, you have a range of immune cells that have of just depicted here. And you might think of those as the soldiers of our immune system. So their job is to go around and eliminate anything that doesn’t belong and cancer is one of those things. And what we know about the iNKT cell therapy platform is it is incredibly potent and already can kill cancer cells and hence why we’ve got it here depicted as an armed soldier. And as I said, they naturally target and kill cancer cells that happens because of this little pink piece that sticks up here called an ITCR, but they also activate other immune cells once they’ve been activated. And as I mentioned before, they can be used off the shelf from a healthy donor because they don’t cause graft versus host disease, which is again very important. And when we combine them with what are called chimeric antigen receptors, which I’ll discuss in a moment, we actually see improved killing or cancer killing over what we see for conventional cell therapies.

So just to give you an idea of what a chimeric antigen receptor is because they are important because they really build out the platform of this technology. So we start with an immune cell. As I mentioned, before this in our case will be an iNKT cell. We take those reprogram them so they produce now the CAR or the Chimera antigen receptor. And what we end up with is an immune cell that has all these CARs sticking out on its surface and the part in green we design so it can specifically recognise something on a cancer cell. And that’s what we see when we give them to the patient. They find the cancer cell and they trigger its destruction.

And so what we’ve seen over the last few years is that Chimeric cancer antigen receptor cell therapy has revolutionised cancer treatment, primarily because of the enormous positive impact that they’re having in terms of we’re actually using the word cure. When we talk about cancer, which is quite remarkable. And the two that were most earliest approved were KYMRIAH and YESCARTA in 2017. And in 2020 had revenues of over $470 and $560 million respectively.

And so, as I said, we have a CAR-iNKT cell therapy. So it is unique from those that are approved because we don’t use T-cell. We use the iNKT cells. And this is how it would work on a diagrammatic level. So we’d start with the iNKT cell, which has its iTCR, as I said, that confined and killed cancer already. We reprogram that cell to have a CAR targeting a particular cancer of interest. We deliver those back to the patient. And then what we see is the iTCR binds to a marker on the cancer. The CAR also binds to another marker on the cancer and that’s the dual targeting. And then we get release of components that trigger the cells’ destruction.

And so what we’ve actually seen for the work that’s been done to date is we’ve had very promising results and published in very high, high regarded and top tier journals. And so what we see is that the product, as it stands, the CAR 19-iNKT cells are likely to be a very effective treatment for cancers that produce CD19.

And what we were seeing again, in comparison to the conventional cell therapies is that we actually get much faster killing of cancer cells and that’s what we see over here on the right. We see that all the cancer’s been eliminated in our technology and not others. And we also see that animals survive for longer, which would be important, obviously thinking for about a treatment for humans. And so again this research has been over a number quite a number of years, but it really validates the use of our iNKT cell therapy platform as a treatment for cancer. And so where we’re at the moment is we’re expecting to select our manufacturer to produce the product for clinical trials. And we’re aiming to select that manufacturer in Q4 2021.

So this is where we’ve been since acquiring the technology. As I mentioned, we acquired the license in June of this year. So it’s only a few months ago, but since that time we’ve already executed a research agreement with Imperial College London. So we can continue to do more work to build out the platform.

We’ve recruited a self therapy manufacturing expert out of a $1.3 billion company. And we’ve also added two stellar board members, Dr Debora Barton and Dr Liz Stoner, both US based to our board. And again, they see the value and the potential of the technology. And we’ve also assembled a scientific advisory board consisting of the inventor as the chair of that board, but two really world class and world recognised immuno-oncologists, Dr Reuben Benjamin and Dr John Maher. And so, as I said, the next step for us is to select the GMP manufacturer for the technology. And once that happens, we’ll produce the material that’s required for use in a phase 1 clinical trial. And then as we move, we’ll have the necessary meetings with regulators like the FDA and make sure we’re doing all the things that they need us to do before dosing a patient in a phase 1 clinical trial for blood cancers that produce CD19.

And a really important aspect that I mentioned earlier is we’ll look to source and work with additional chimeric antigen receptors or CARs so that we are really leveraging the platform nature of the technology.

And so again, when you look up for the conventional T-cell therapies, there’s quite a number of players in the space, probably hundreds of companies. But when we look at the iNKT cell players, there’s actually only four companies in the market as of today. And all four, all three of them, I should say, have had significant transactions except for Arovella since probably the last six months or so. So Appia Bio raised $52 million in May and then entered into a US$875 million deal with Kite Pharma. Their preclinical stages as well, MiNK therapeutics just listed recently on the NASDAQ and currently valued about $568 million. Kuur another phase 1 iNKT cell company were acquired for about all up $185 million in cash equity and milestone payments. And of course, Arovella we’re currently valued at $21 million, but we see that there’s clearly a lot of room for upside as we develop the platform further.

And so, as I mentioned, we do have a very strong team. Paul Hopper our chairman doesn’t need a huge introduction into bio technology in the Australian space and also probably across into the US as well. Myself, I’m a research scientist by background with a PhD in biochemistry. As I mentioned, we just appointed Dr Debora Barton in August, she’s got a phenomenal background in oncology as a medical doctor before moving into large pharma. And she’s now currently the chief medical officer of another cell therapy company as well. David Simmons is great from a compliance and corporate governance point of view. And as I mentioned, we just appointed Dr Liz Stoner last week, actually. So she’s formerly an assistant professor at Cornell. Again, one of the top US universities moved into big pharma before entering into biotechnology companies where she was the interim CEO of a company that ended up being sold for a billion dollars. And now she’s also an executive partner at a well known life science venture capital fund in the US MPM capital and David Phillips, who also has a very long and distinguished career in the biotech life sciences and healthcare industry.

And so just to summarise Arovella as it stands today. So, as I said, we’ve got a really exciting platform in our hands that we’ve only recently licensed, and we’re really looking forward to developing that for the treatment of initially blood cancers, but expanding out the repertoire with new CARs. We’ve certainly got a world class leadership group with extensive experience in drug development. And the way we see it at the moment is we are on a growth trajectory, certainly working with leading edge cancer treatments. I’m very much looking forward to expanding the platform, but also the team as we move and excitingly as well. I think it’s nice that for a little biotech, we will have a product in market in 2022 through ZolpiMist, which we’re expecting to reach Chile and Australia.

And with that, I’d just like to say, thanks again, everybody very much for taking the time to listen in today. I appreciate it. For those of you that are not already on the register, I look forward to taking any questions via email or telephone, but again, thanks to finance news network and everybody for their participation in putting the event together. Thank you.