Vitasora Health Limited (VHL) Earnings Call Transcript & Summary

Good morning, and welcome to Broker Briefing, Australia's premier digital platform for brokers and investors, live streaming video presentations. I'm Jane Morgan, and thank you for joining me today for our March Tech & Biotech Investor Webinar. Today, we'll be joined by 6 companies: NeuroScientific Biopharmaceuticals; Emyria; Vection Technologies; Respiri; Nanoveu; and Invex Therapeutics. So up first, we are joined by NeuroScientific Biopharmaceuticals with the ticker code NSB, for an update about their lead drug candidate, EmtinB. To tell us small, I'm joined by NeuroScientific's Managing Director and CEO, Matthew Liddelow. Good morning, Matthew. How are you?

Hi, Jane, how are you?

Great. Let me bring up your presentation.

Great. Thank you very much, Jane, and thank you. I appreciate the opportunity to present today, and thank you all those who have come online to watch this presentation this morning. We'll go through to the next slide. Please note the disclaimer that just briefly phased up before, but we'll move into a brief overview of who we are and what we do in NeuroScientific. We're a drug development company that's focusing on developing peptide-based therapeutics that have disease modifying potential for neurodegenerative conditions. And neurodegenerative conditions are essentially diseases that damage nervous tissue mainly of the brain. We have a lead drug candidate called EmtinB, which Jane mentioned at the top of this webcast, which is a first-in-class treatment that we're developing for Alzheimer’s disease, multiple sclerosis and glaucoma, first-in-class does mean that it's the first of its kind to make it to market if it does make it to market later and down the track. And more -- it's probably for us, the most exciting point for this company at the moment is the fact that we are transitioning EmtinB into its first Phase I clinical trial in the first half of 2022. Next slide, please. Looking a bit more from a corporate overview of the company. We listed on the ASX midway through 2018 with a market cap of approximately $50 million. Current market cap sits at approximately $42 million, and we have a net cash position of $9.5 million in the bank. And our Board and management team is a good mix of technical expertise and also Capital Markets experience. Most notably, we had Paul Rennie, who is more commonly associated with Paradigm, but a very successful biotech executive who joined the company as Chairman midway through last year. We've also expanded our team to actually include some additional operational staff as we head into clinical development this year. Next slide, please. Now a little bit more about the patient groups that we focus on. The biggest problem with neurodegenerative conditions is the fact that most of these diseases don't have a lot of treatment options available to them. And even if they do, a lot of the drugs are not very effective. And a good example of that is Alzheimer's disease in that currently, you've got a selection of drugs that really only treat symptoms, and the bandwidth of research that's focused on is very, very narrow. Therefore, there hasn't been a lot of other options that have come on to market in the last 25 to 30 years. Multiple sclerosis is a little bit different in that you do have effective treatments for one part of the disease, which is the earlier part of the disease, but as that disease progresses and symptoms get worse, these drugs become less and less effective. So the biggest issue for addressing this problem really is the fact that you don't really fully understand what the problem is, and it's hard to develop the solution you don't know the problem is. But we're pretty confident at NeuroScientific that we've got a very good workaround to finding a solution to these problems. Can we go to the next slide, please? Our lead drug candidate, EmtinB, is modeled on a human protective protein. So our research really does involve really developing mimics that essentially copy or stimulate the body's own defense mechanisms to fight these diseases or protect the tissue damage that's being done. And EmtinB is modeled on a subset of a particular part of a human protein, and it does stimulate that protective effect. And it targets a receptor that is highly expressed on the cells in the brain. So it works across multiple different types of neurodegenerative diseases, even though the underlying cause of those diseases is not completely identified. If we go to the next slide, please? So having a look at Alzheimer's disease specifically, we've been able to validate that defensive mimicking activity of EmtinB in a number of models of Alzheimer's disease, and essentially, we've -- even in the gold standard animal model where you can see here, this is the data from that particular study in which there's a 70% increase in actual memory improvement, which indicates that we are having a protective effect on the tissue of the brain and maintaining structures of those cells. Next slide, please. Multiple sclerosis is a really exciting indication for us in that we are getting site to develop a really large body of evidence there, based on data that's impacting multiple different pathways of multiple sclerosis. And today, we've been able to also show an effect on the human inflammatory response. So we are potentially an option that could treat all aspects of what so far is sort of the pathology of multiple sclerosis in the earlier stages where there's a really strong inflammatory response. And in the later stages, you get this degenerative response of the brain cells. So EmtinB has a potential to work across all those pathways and provide a solution to patients at all treatment stages. Next slide, please. Another focus for us is looking at degenerative conditions of the optic nerve. The optic nerve is essentially a host of nerve cells that transmit what you see from your eye to be processed by our brain and the connection there. And there's a number of conditions that affect that optic nerve, the most common one or prominent one is glaucoma because I think the pressure build up in the eye actually causes the cells at the back of the eye to be affected and actually die or will be damaged, and therefore, you get a reduction of vision. And what we've been able to show in a large animal model, which was a pig model, and that's very important due to the fact that structure of the pig eye is very similar to the human eye. And we're able to actually maintain the structure of those cells that's -- form to the optic nerve, and be able to maintain integrity of the optic nerve in transmitting of that signal mechanisms, which at the moment in that actual disease space, there's variable treatment options, but nothing that really slows down the progression of the damage to the optic nerve. Next slide, please. So our current development pipeline involves streams of research in neurology and ophthalmology, and then we have individual indications within those streams of research, with Alzheimer's disease being one of the leading indications for neurology. And then our glaucoma research is the leading indication for ophthalmology, and we do some exploratory studies there as well. But one thing to note with these particular streams of research is the safety data that we are generating in the preclinical stages to allow us to enter into the clinical development stages, can be reused in other indications. So we don't have to repeat that safety data -- the preclinical safety data over and over. We actually -- due to the mode of action of EmtinB being the same in all those diseases, we can repurpose that data across many different indications. Next slide, please. For -- to get our research done to the level and the quality that we demand, we use the best companies in the world. Some of those are local companies that we use in Australia. And a lot of those companies are international companies that we partner with. We've also said about getting in preparation for our first clinical study later this year in the first half of this year. We've put companies in place such as Linear and Agilex and Imeka, companies that will support our clinical development phase of the company. And also, we just spent so many things part of getting ready to actually execute on the clinical study. Next slide, please. And while we have a host of milestones that we are due to report on -- throughout this year, really the big one for us will be this -- executing on this first-in-human Phase I study in the first half of 2022. This is the one milestone that all our investors have been waiting for and also interested parties that are looking to invest at a certain stage at a certain catalyst in the company's history. And this is one of the big ones for us. And so there's a lot of excitement and enthusiasm around the company as we are really very, very close to making this a reality very, very soon, and we'll provide further updates very -- in the near future, detailing more aspects around this clinical study. And on that note, that wraps up the presentation from me for today. Thanks, Jane.

Well, thank you for that, Matt. Great presentation. Looks like you've certainly got quite a fair bit of news still coming up. We've got a couple of customers come through, so I'll jump into them. So has the drug been proven safe to use? And when do you expect to have an indicative cost for it?

Well, yes. Well, the drug been safe to -- proven safe to use in animals, but we are about to take it into the first human clinical study to sort of demonstrate that initial [indiscernible] well. But one of the thing -- one of the biggest aspects in developing a drug is obviously looking at the feasibility of that drug once it's a marketable product, and obviously, that's something that we've paid particular attention to with EmtinB as well.

Thanks, Matt. Just another one. So can you go into the MOA of EmtinB?

Mode of action is based on what basically binds to a receptor that is expressed on the outside, so not to get too technical here, but it targets a receptor that is very common to many different cells that are expressed in nervous tissue. And it's on the outside of the cell, so it's called the LRP1 receptor. Now that receptor does a host of things once something binds to. But we bind to a specific part of that receptor, and that induces suppliable pathways and regenerative pathways within the cells.

Wonderful. Well, thanks for that, Matt. That's all we've got time for today. I encourage webinar attendees to reach out by the contact details on the bottom of the ASX releases [indiscernible].

So next up, we have a presentation from Emyria, with the ticker code EMD. To tell us more about their clinical-stage drug development, I will hand you over to Managing Director, Dr. Michael Winlo. Hello, Michael.

Hi, Jane, how are you?

Thanks for joining us again. Let me bring up your presentation.

Great. Yes, you want me to kick-off?

Yes, all yours.

Wonderful. Okay. Well, good morning, everybody. Thanks for joining, and a real pleasure to present an update on the progress that Emyria has made in the last 12 months and where we're heading next. So for those who haven't followed our company, we're a biotech company that uses real-world data that we collect from our own patients that we treat at our own clinical service subsidiary, and we use that information to develop independent drug registration program for major unmet needs. Next slide, please. So somewhat uniquely, we're a biotech that's managing our own clinical service. Next slide, please. We're collecting really exceptional real-world clinical data from these patients. Next slide, please. And then using those insights to build out our drug development program. So the data informs both the dose forms that we develop, but importantly, the indications that we pursue because we have that background insight on what treatments are working most effectively for which patients. Next slide, please. So today, that really has allowed us to build two major platforms. One is using ultrapure cannabinoid-based medicines, that's predominantly the prescriptions that our patients seek when they are referred to our clinics when usual treatments have stopped working for them. And we've been able to use that data to develop two stand-alone programs so far in our portfolio, that's EMD-RX5, EMD-RX7 for low-dose and high-dose CBD indications, respectively. Our initial opportunity for EMD-RX5, the most advanced program, is for an over-the-counter treatment for psychological distress. But we see both of these candidates are having the potential to address multiple indications. And we've also designed the program in a deliberate fashion so that they're also suitable for FDA and other major global markets as well, and I'll explain more about that shortly. Next slide, please. The second dimension to our biotech business is a really exciting asset. This is a library of more than 100 MDMA analogues, which have been built over 10 years. So we're not doing this from scratch, actually coming at this from a running start. And these unique chemicals have a huge range of potentials, both as next-generation psychedelic-assisted treatments, but also as potential therapies for a range of neurological and non-neurological disorders as well, and we are rapidly leading the screening and development of that library. Next slide, please. Terrific. So really to put this into a picture about how we approach drug development, we'll talk through our cannabinoid development program. It really involves 3 steps here: learning from our real-world patients; developing a really high-performing and unique dose form; and then pursuing that registration activity. Next slide, please. So mentioned the data, this is really the heart of our business. And we have collected information on more than 6,000 patients, and of course, that's growing every month. We are able to see which kinds of cannabinoids are working for which problems and in which patients. And to give you a sense of the diversity of the data that we have, we have children as young as 2 that are treated at our clinic, patients as old as 98. We are touching a wide range of cannabinoid dose forms and dose strengths for more than 40 different clinical indications. And from that, we can draw really profound insights on what doses are working most effectively for which patient groups, and of course, that informs our drug development programs. Next slide, please. One of the things that really stood out to us, I guess, being in this space was the need for better delivery systems for cannabinoid treatments. Clients have inspired a majority of our -- well, up to 40% of registered treatments, I should say, have had their original origins from plants. The one that you're probably most familiar with would be antibiotics, which is famously found in the penicillin mold. But things like statins, a very commonly prescribed drug for high cholesterol; aspirin, a drug we're all familiar with, all came from plant origins. But of course, the pressure for reliability, for scale, for high-quality manufacture and regulation has meant that these medicines don't stay in their plant form. They eventually become regulated biopharmaceuticals. Next slide, please. But with the cannabinoids, we're kind of stuck at this sort of 2.0 phase. We really haven't seen the transition into what we think is cannabis 3.0, that true biopharmaceutical development. We're still dealing with tinctures, oils, droppers, even smokable flare in many cases as well. We have more than 250 different products in Australia now, only one registered medicine, but none of those really in that biopharmaceutical form. And we think that's required for us to really reach the patients and the market opportunity that exists. Next slide, please. So how are we approaching that? Well, one of the first problems we need to address is a really important one. That's the bioavailability of CBD. It's notoriously poor. And what that means is only a very small percentage of the medicine that you ingest orally actually makes it to the bloodstream where it can do its work. So when you swallow a tablet, some of that will slip through the gut and exit. Some of it won't be absorbed across the gut wall and not even get into the bloodstream. Of the medicine that actually makes it through into the bloodstream, it encounters the liver, and the liver is your primary organ for metabolizing and breaking down drugs. And what that ultimately means is that a very -- only a very small percentage of medicine actually makes it through into the bloodstream, as I mentioned. The cannabis can be as low as 6.5%. That's a pretty costly way of delivering medicine, if we consider the out-of-pocket costs for CBD. It can be high as $0.05 to $0.10 per milligram. So -- next slide, please. So one of the things we had to do is look at using new technology to really try and lift the bioavailability of CBD, and we're really excited to add some successes here relatively rapidly. And so we ran a key dog study on two leading formulations, EMD-RX5 and EMD-RX7, where we're able to achieve more than double and nearly 4x as much bioavailability compared to the leading registered medicine, Epidiolex. We are now taking RX5 into a Phase I, and dosing should start for that next week. RX7 will follow with a Phase I. And now we have two really high-performing CBD dose forms for our drug registration programs, and we see opportunities for a range of indications. Being able to deliver more CBD, more cost of -- with more CBD to the bloodstream, I should say, would be improved by bioavailability, means we can use less CBD to get a similar effect, which means for a more cost-effective medicine, lower side effects and a lot of potential. Next slide, please. So one of the key things we're also focused on is ensuring that our CBD is as pure as possible. We use a synthetic origin for that. We think that gives us cost advantages over the long term and certainly some purity advantages, too. This is a complex slide. I should mention that our slides will be available on our website and through the ASX platform later today. I encourage you to download that and take a good look at some of these slides, but I won't spend time on that, other than to say that the purity of our CBD has been deliberately developed to meet FDA requirements. Next slide, please. Great, so just quickly through our RX programs. Next slide, thank you. And next slide, again. One of the first indications we are targeting is psychological distress. These are symptoms of anxiety and depression that are very prevalent in the adult population. Next slide, please. And as noted by the White House, an area of focus for them as well. So psychological distress is the first target indication we're seeking for an over-the-counter medication. What is psychological distress? Well, it's a cluster of symptoms, as noted on the slide here, can result in symptoms as anxiety, stress, depression, GI upset, sleep disturbance. It's more common in patients with chronic disease, and it is -- has a rising prevalence. Importantly, there's no over-the-counter medicine for the short-term treatment of this, and so we think that's a huge opportunity for us. Next slide, please. So what would that mean to have an over-the-counter treatment? That would mean that patients could collect this medication without requiring a prescription. It makes this treatment available through the national pharmacy network. Estimates have been -- could achieve a $200 million a year market, so a massive opportunity. But for us, in our program, this is really just one of the stops on the way to larger markets, bigger unmet needs, globally and elsewhere. But we've developed our dose form to meet the requirements for TGA, but also for FDA and other global markets as well. But this will be one of the first demonstrations of the speed of registration we can achieve with our model. Next slide, please. I'll go -- well, this really just says that we've -- taking our insights from data from our real-world patients, that's where we observed a benefit in psychological distress that's allowed us to develop the dose form that we have, and now we're pursuing registration of that treatment. Next slide, please. A technical slide, really to show that lots of progress has been made. Our Phase I is coming. Next slide, please. And what allows to be followed here is now further development of novel cannabinoid dose forms, including CBD/THC combinations, again, with multiple indication potential for that as well. Next slide, please. And here's an update on our timeline. Again, take a look at this from our website. I mean, needless to say, we expect to conclude the pivotal trial programs this year and have our submission in. And then that's up to the TGA to take -- to review that application, which could be approved as soon as end of this year or early next year. Next slide, please. great. The other key part of our platform here, I'll just do a quick time check. Thank you. Next slide. We'll go through this quickly, is the MDMA analogue development work. Psychedelic-assisted therapies are showing tremendous promise for some of our most serious mental health disorders globally, and consequently, attracting large investment and a lot of innovation. Next slide, please. And again, next slide. And so we think we have a really unique opportunity to develop this as well. So as I mentioned, we're in partnership with UWA, are now screening and developing, expanding a library that was already 100 analogues large. And these are MDMA molecules with slight variations, which we think can have potential for a range of indications. And so now, we're screening and sorting through that library and looking for safety profiles, we're looking for higher potency, potentially faster-acting molecules, and really give ourselves this tremendous diversity and the opportunity to pursue independent drug development programs for a range of major unmet needs. There's a huge appetite for fast directing MDMA to allow therapy sessions to be much shorter than 8 hours. And there's a huge appetite for neurological treatments also with small molecules that can cross the blood brain area, and we have that in this library. Next slide, please. Next slide. This is just a quick update, which you can take a look at. And we can go through this quickly. It might add a good passthrough down to the corporate deck here. These slides touch on some of our innovative research programs, our patent portfolio, which is growing. Next slide, thank you. And into the corporate structure, two highlights here is that we have this tremendous Board with experience and prior FDA approval successes, notably, Dr. Karen Smith with 20 FDA approvals, also previously the Chief Medical Officer at Jazz Pharmaceuticals, which purchased Epidiolex and that whole portfolio of GW Pharma for $7 billion early last year. Now our final slide is our corporate deck, just really to show that we have a terrific registry as well. If we've got the next slide. But needless to say that one of our key holders there is Tattarang, who took an interest in our company last year and now holds 5% of Emyria. So we've got a really tremendous register, great Board and a huge market opportunity ahead of us, and the team to take us there. Thank you very much.

Michael, thank you so much for the great presentation. We've had a few questions come through, so I'll jump into it. Now I know, you did mention this on the call, but -- so it sounds like your dose forms have multiple applications. How do you decide what indications to pursue?

Yes. So that's a really good question. So obviously, we're taking our guidance from what our patients are revealing to us through the data we collect. So importantly, we're not just checking in on people how they're going, we're asking really specific questions. the kinds of questions you would normally get asked maybe if you're on a clinical study. And so those validated assessments tell us what doses are working for which patients. And from that, we pick the most promising indications and can pursue those.

Thank you, Michael. And will you be working with THC as well?

Yes. Today, we've not announced anything about THC, but absolutely, many of our patients respond to that and seem to require THC for the more serious symptoms and clinical problems. And I think there's a massive opportunity for a really well developed, highly bioavailable, pure biopharmaceutical with THC as well. So yes, we plan to do that soon.

Wonderful. Thank you for joining us again, Michael. And as Michael mentioned, please log on to the website to download the complete investor presentation. Thanks again.

Thank you. Thanks for your time, everybody.

So next, we have a presentation from Vection Technologies with the ticket code VR1. To tell us more about their real-time technologies for digital transformation, I will hand you over to Director and CEO (sic) [ COO ], Gianmarco Orgnoni. Hello, Gianmarco.

Hi, Jane. Thank you for having me. And good morning, all, and thank you for attending this presentation. So today, I'm going to give a brief 10-minute overview on the company and on the part of the road map and the expansion road map for 2022, 2023. Next slide, please. So please note the disclaimer. I also note that the presentation has been uploaded this morning and is available on the ASX platform. Next slide, please. So the challenges that enterprises face today. So the pandemic has significantly accelerated the resurgence of significant challenges, and enterprises today are struggling to address these challenges in this uncertain climate. So from the management of remote workforces and what is so-called hybrid work to the green push of net zero emissions and also having to manage the existing digital systems or complex digital systems within this hybrid environment, it is becoming ever more complex. So this solution of Vection Technologies brings to market is called INTEGRATEDXR. So next slide, please. So you might be asking, what is INTEGRATEDXR. So INTEGRATEDXR is the combination of Vection Technologies' suite of digital solutions that INTEGRATEDXR with a diverse range of technologies and combinations. So integration is the keyword here. So we're assisting to our combinatorial trend. We've got multiple technologies that eventually -- when combined will eventually lead to the so-called metaverse. So we go from XR to digital humans, from nonfungible tokens for NFTs and digital assets to e-commerce, all the way to the infrastructure necessary to run this ecosystem and the technologies. So while XR essentially is an umbrella term, it defines virtual reality, augmented reality and mixed reality, and this is where we're really, really focused and this is where the value of the company lies. So all XR technologies essentially is a -- takes the human to screen interface to a new level, to the next dimension, to the digital world, and it modifies it. So if you're immersing yourself in a virtual environment with complex virtual reality, which is VR, if we are adding or augmenting our real-world surrounding expectation elements, this is augmented reality, so AR. And when we combine them, we've got mixed realities, so MR. And altogether, that term is XR, and this is exactly what we do. So we target key challenges stemming from hybrid and remote work via the adoption of our integrated XR tech solution suite, which is key to this combinatorial trend. Next slide, please. So some numbers. So today, we just released, just a month ago, our biggest ever half year results since the commencement of our strategy circa 3 years ago. So revenue was up 1,100% to $9.3 million in revenue for the first half. Today, we're over 100 people, covering essentially all key geographies. And we've got a revenue guidance for the full financial year of $17 million to $19 million, which is up from essentially the $3 million circa revenue, which we had in the previous fiscal year. Next slide, please. And we're working in a very broad and important market. So digital transformation is essentially a huge opportunity for INTEGRATEDXR. So we go from a spend on digital transformation from 2019 to 2024 of over $10 trillion forecasted. We've got $1 trillion plus in spending on Future of Work technologies forecasted for 2024. And we've got 57% of total technology spend that will be on digital transformation in 2024. This is up 42% from 2020. And instead of all of these macro trends, we've got XR. So an XR market is forecasted to be valued a staggering $460 billion by 2025. Next slide, please, and this is a very key slide for us. So these are the pillars of what we do. So we go from XR Core, so our proprietary XR technologies, that enable the integration. So this is very important instead of the combinatorial trend. And it enables vertical applications of key features for specific industries. Next slide, please. So this is our road map. So our growth is essentially driven by organic and inorganic growth. So our focus today, in terms of M&A, is to identify companies, next slide, please, that will enable us to drive organic growth via acquisitions of other companies that are essentially focused on different range of elements that we're looking for. So we go from key XR technologies. So the industry is moving very fast. There's fantastic players that are coming to market. Integration, so the combinatorial trend and being able to realize value via the combination of XR technologies with the convergence of other technologies. We're looking at artificial intelligence. We're looking at digital humans. We're looking at multiple other technologies that can really bring value in this lead up to the metaverse. We're looking at verticals, so the creation of the solutions that are specific for verticals or industries. So we go from health care to automotive, to the fashion industry and so on and so forth. And we're really looking also to expand our geographical presence. So today, what's happening virtually in the whole globe going from Asia Pacific regions, so Australia, India, Middle East, Europe and U.S., so we're really looking to grow in these markets. People. So people are always important to what we do. So the technology needs people that can really bring to life the creation of this new world, of this metaverse, of this digital world. And also, we're always looking at adding new clients. Next slide, please. So this is essentially to explain that the XR market is highly fragmented. So we're looking at a lot of small players that operate in niche markets, and this is really the opportunity for us to leverage off this fragmentation of the market. Next slide, please. And to become a true leader in the XR space, we need to expand our XR development capabilities. So this is very important, especially with big corporations that are coming every day into this market. And we're really looking to disrupt this market by really upping the level of our XR development skills. Next slide, please. And this is the opportunity essentially for scale. So we've got a very interesting portfolio of clients today that operate globally that are adopting our INTEGRATEDXR suite day in and day out. And the adoption -- and the acquisition of new companies will enable us to really scale the adoption of our INTEGRATEDXR solution among new clients in existing verticals, but also in new clients in new verticals. So again, it's inorganic growth that drives organic growth. Next slide, please. And again, this is to explain our presence today, so Australia, India, Middle East, Europe and the U.S., and we're really looking to scale globally within these markets. Next slide, please, next slide. Our history. So we commenced the essential strategy in 2017, 2018, and from there, we really transformed the company, really focusing on these technologies into the digital world. And we've created exponential value for our shareholders and also for our clients. So we're really, really focused and laser focused on creating value for all stakeholders. So being clients and being shareholders, the vision of the company is to create value for these groups of companies and people. Next slide, please. So we've got a very strong leadership team that covers the whole globe. So again, from Asia Pacific to Europe to the U.S., a very strong management team that covers all these features. But we also have got a very strong advisory board with Dr. Next slide, please. And we're working in a very broad and important market. So digital transformation sets a huge opportunity for INTEGRATEDXR. So we go from a spend on digital transformation from 2019 to 2024 of over $10 trillion forecasted. We've got $1 trillion plus in spending on future of work technologies forecasted for 2024. And we've got 57% of total technology spend that will be on digital transformation in 2024. This is up 42% from 2020. And instead of all of these macro trends, we've got XR. So an XR market is forecasted to be valued a staggering $460 billion by 2025. Next slide, please. And this is a very key slide for us. So these are the pillars of what we do. So we got from XR, XR Core, so our proprietary XR technologies, that enable the integration. So this is very important instead of the combinatorial trend. And it enables vertical applications of key features for specific industries. Next slide, please. This is our road map. So our growth is essentially driven by organic and inorganic growth. So our focus today in terms of M&A is to identify companies, next slide, please, that will enable us to drive organic growth via acquisitions of other companies that is essentially focused on different range of elements that we're looking for. So we go from key XR technologies. So the industry is moving very fast. There's fantastic players that are coming to market. Integration, so the combinatorial trend and being able to realize value via the combination of XR technologies with the convergence of other technologies. We're looking at artificial intelligence, we're looking at digital humans, we're looking at multiple other technologies that can really bring value in this lead up to the metaverse. We're looking at verticals, so the creation of the solutions that are specific for verticals or industries. So we go from health care to automotive to the fashion industry and so on and so forth. And we're really looking also to expand the geographical presence. So today, what happening virtually the whole globe going from Asia Pacific regions, Australia, India, Middle East, Europe and U.S. and really, we're looking to grow in these markets. People. So people are always important what we do. So the technology needs people that can really bring to life the creation of this new world of this metaverse, of this digital world. And also, we're always looking at adding new clients. Next slide, please. So this is essentially to explain that the XR market is highly fragmented. So we're looking at a lot of small players that operate in niche markets. And this is really the opportunity for us to leverage off this fragmentation of the market. Next slide, please. And to become a true leader in the XR space, we need to expand our XR development capabilities. So this is very important, especially with big corporations that are coming every day into this market. And we're really looking to disrupt this market by really upping the level of our XR development skills. Next slide, please. And this is the opportunity essentially for scale. So we've got a very interesting portfolio of clients today that operate globally, that are adopting our integrated XR data suite day in, day out. And the adoption the acquisition of new companies will enable us to really scale the adoption of our INTEGRATEDXR solution among new clients in existing verticals, but also in new clients in new verticals. So again, it's inorganic growth that drives organic growth. Next slide, please. And again, this is to explain our presence today, so Australia, India, Middle East, Europe and the U.S., and we're really looking to scale globally within these markets. Next slide, please, next slide. Our history. So we commenced the essential strategy in 2017, 2018. And from there, we really transformed the company, really focusing on these technologies into the digital world. And we've created exponential value for our shareholders and also for our clients. So we're really, really focused and laser focused on creating value for all stakeholders. So being clients and being shareholders, the vision of the company is to create value for these groups of companies and people. Next slide, please. So we've got a very strong leadership team that covers the whole globe. So again, from Asia Pacific to Europe to the U.S., a very strong management team that covers all these features, but we also have got a very strong advisory board with Dr. Siegmar Haasis for the automotive industry. So [indiscernible] for [indiscernible]; and Vittorio Terzi who was -- who is a very strategic partner in terms of our strategy into the consulting world. Next slide, please. Corporate snapshot. So today, we've got circa $111 million in market capitalization. We've got $20 million cash at bank as of the 31st December 2021, and we're really looking to create value from a position of strength. Next slide, please. And this is our vision, so creating a fully integrated world powered by INTEGRATEDXR. Thank you, Jane.

Thank you, Gianmarco. Great presentation as always. A few questions have come through, so I'll jump into them. So what geographic market do you see as being the largest for the technology?

I would say, Europe and U.S.

Wonderful. And have you considered a partnership with a large global company to accelerate growth?

We've got -- we're working on a number of partnerships, and it's really important for us to really bring a concrete result in these partnerships before we're able to announce anything to the market.

Thank you, Gianmarco. And actually just -- sorry, a Twitter user has just come through as well. So how is the XR business unit going? And when will we see some big traction here?

The traction is already there. So every day, we're seeing more and more interest in the XR market. So we're laser-focused on generating significant revenue from a whole suite of solutions and to really bring to life our vision in the XR market.

Wonderful. Well thank you for joining us today, Gianmarco. We look forward to hearing further updates.

Thank you, Jane, I appreciate it.

So next, we have a presentation from Respiri, with the ticker code RSH, a company leading the way in the development of innovative eHealth solutions. To tell us more, I will hand you over to the CEO, Marjan Mikel.

Thank you very much. I thought what I'd do today is focused on providing an overview of the company, but really focusing on one of the pivotal moments in the company's history and one that's very tactical but important to us, and that is the launch in the U.S. marketplace. We received FDA approval in the marketplace in March last year, and it is a huge opportunity for us. As a background, Respiri is a medical device and SaaS company that focuses on respiratory medicine. Our revenue streams are generated by a business model that looks at selling devices itself, the Thank you very much. I thought what I'd do today is focused on providing an overview of the company, but really focusing on one of the pivotal moments in the company's history, and one that's very tactical but important to us, and that is the launch in the U.S. marketplace. We received FDA approval in the marketplace in March last year, and it is a huge opportunity for us. As background, Respiri is a medical device and SaaS company that focuses on respiratory medicine. Our revenue streams are generated by a business model that looks at selling devices itself, the wheezo device here, and also the SaaS -- the monthly SaaS fees that come along with that, that allow physicians, hospitals, payers and patients to access the app that's required to make the device work. We launched in Australia in October 2020. And as we've always said, Australia was our little sandbox, and the objective of that was to learn as much as we possibly can from the experience here. And some of those learnings were very, very positive for us, others were a little painful. But nonetheless, one of the things that came out of old experience was the need to accelerate our launch in the United States. And I'll get into more about that in a moment. And it's not just about the fact that the U.S. is 15x the size of the Australian marketplace. There are many other market parameters that make it so attractive for us. As a background, asthma as a disease, say, is the third largest to afflict the human race, third only to cardiovascular and diabetes. It affects about 350 million patients across the globe, 3 million here in Australia itself, and over 26 million in the United States. So it is a huge marketplace and grossly underserved. Yet today, when a patient leaves the care of their physician, that physician and that patient have absolutely no transparency around whether or not the intervention, the prescription that the doctors put together for the patient is, in fact, working. And unfortunately, that does lead to exacerbations, does lead to attacks and does lead to deaths. One in 10 patients in Australia and across the globe will end up in hospital because of an asthma attack, at least once in 12 months. And even in this great country of ours, 300 people still die of asthma every single year. So clearly, something is not working. The U.S. market is a market that we launched in December last year, and we were lucky enough to spend a month over there just recently. We had to accelerate all that. We're 9 months ahead of our scheduled launch because it's so important to us. And as I said, what I'd like to do now is just give you all an understanding of why the U.S. is so important to us. Next slide, please. Now it is a huge physician-led and reimbursed marketplace. That's not the case here in Australia. The Charter of Medicare in Australia is for diagnosis and treatment. We have a wonderful health care system in this country. Unfortunately, it doesn't cover remote patient monitoring and does not have preventative medicine, so it's out-of-pocket. Important to understand that we are working through a bespoke model through remote patient monitoring partners, and they are particularly excited about adding wheezo to their portfolio because they're the only ones that have it. So there are no pricing discussions necessarily that happen with their customers. They as customers being doctors, ACOs, accountable care organizations that stands for, a conglomerate of hospitals, et cetera, that deliver health care, and also doctors. Now we -- when we just come back from the U.S. and wheezo has been extremely well received by payers, physicians. And that was, as I said, confirmed at the American Academy of Allergy, Asthma and Immunology, which was held in late February. As I said, we do have FDA approval, so we are already selling product. And in the first two months of sales in the U.S., we've just sold just under $200,000 worth of wheezo in that marketplace in a very short period of time. Important to note that in the U.S., asthma accounts for about $82 billion in financial burden on the health care system in that country. So again, something is clearly not working. And when we talk to stakeholders, part of that problem is that unlike other disease states like cardiovascular, diabetes, today, there is no way for a patient to be monitored by their treating physician in a remote setting, and wheezo handles that situation. So it is reimbursed at the moment. And as I've said, we can demonstrate to doctors that the presence of wheeze demonstrates that there is a significant reduction in lung function as it's measured by spirometry or FEV1. So if you can hear wheeze, your lungs aren't working properly. So we're also attending a major conference in the not-too-distant future, in fact, next month. And that conference is with the National Association of Accountable Care Organizations. So these are a combination, affiliation of hospitals, pharmacies, payors that basically come together to provide a one-stop shop when it comes to helping patients with conditions such as asthma. Important to note, in the month that we were in the U.S., we secured our first reimbursement-led remote patient monitoring customer and that was with Michigan Children's Hospital. So that happened in a very, very short period of time. And as I said, together with our partners, we've got an eye on 100 qualified leads, which we're following up again, and we'll be spending quite a bit of time in the U.S. moving forward to take advantage of these things. Next slide, please. As I said, there are -- in the U.S., there are over 26 million patients with asthma, that's 1 in 13 people. Every year, 1.6 million patients end up in an emergency ward. The cost of that to the system is about USD 8,000. One in 20 patients have COPD. That's just shy of 900,000 ED visits. But they're a lot more expensive when it comes to the way they treat it. Now remember, this is just the ED business. It doesn't take into account if they get admitted into the hospital wards. In this instance, it's just shy of $28,000 every time a patient turns up to a hospital -- or a hospital's ED unit. So really, respiratory disease places a significant burden on the health care system, not just in the U.S., but everywhere. Next slide, please. I thought I'd focus on one of the reasons we -- or some of the reasons we accelerated our launch in the U.S., albeit, a 15x size market to Australia is very attractive. But far more importantly, a lot of the headwinds that we faced here in Australia do not exist in the market dynamics in the U.S. For example, wheezo is reimbursed in the U.S. marketplace. It is a physician-driven situation over there, which it wasn't here. Important to note that the U.S. is one of the only markets in the world where it's the actual doctor that gets reimbursed for handing out one of these to their patients. So they are financially incentivated to provide this to a patient above and beyond the care that they need to be providing. We have remote patient monitoring partners, two of them, high-quality partners, and I'll get into who they are at the moment, that have established relationships with not just physicians but also payors and the like. Important to note that our partners get remunerated on the annuity streams that we generate on a monthly basis, so our SaaS platforms that they receive as a fee for service for providing the devices to the doctors. In the U.S., the pricing of wheezo is significantly higher than it is here in Australia. And we continue to generate significant revenues for that, and the margin is roughly about 30% at the moment. The annuity streams, depending on the sort of service that our partners are providing, are somewhere between USD 5 and USD 20 per month for us, so that's on top of the device sales. Important to note that the private health insurers in the U.S. do feel the pain because they cover the cost of the entire health care delivery. It's not like here in Australia where the private health insurers don't cover anyone that's admitted into a public hospital. In Australia, if you're a crook, you end up in a public hospital. So if you got an asthma attack, you end up in a public hospital because that's the best quality. That's not the case in the U.S. And as I said, at the end of the day, the market is a huge opportunity for us. Next slide, please. I just thought I'd take a moment to demonstrate the financial benefit that physicians get with every single one of these devices that they hand out. At the moment, there is nothing available to pulmonologists to really take advantage of the remote patient monitoring CPT reimbursement case. Most of the work that's done in that area is in cardiovascular disease. So they're pretty excited about having an opportunity to provide these wonderful services to their patients and get remunerated for them. So fundamentally, every time a doctor hands out one of these things, that can earn up to $1,200 or just shy of $1,300, U.S. that is, a year per patient. On top of that, if they then take into account the chronic care management CPT reimbursement case, that's another, let's call it, roughly $1,000. So for each patient that they potentially put on wheezo, they could make $2,000 a year. And important to note that in the U.S. the services around wheezo and patient interaction can actually be outsourced by the doctor to remote patient monitoring organizations, like those organizations that we partner with, which we're very excited about. Next slide, please. I thought I'd take an opportunity, we had a wonderful time in the American Academy of Allergy, Asthma and Immunology in late September -- sorry, February. And there's a list of organizations, hospitals and the like that we had very extensive discussions, numerous discussions during the conference, and have been asked to come and prepare an assessment of wheezo for them to take to their necessary decision makers. So we're very excited about what this is happening. We've already had quite a number of additional follow-up meetings to this. And as I said, everything's looking very positive because as I said today, for these institutions in asthma and COPD, there is nothing available where they can provide patients with remote patient monitoring to help them understand where the patients are heading towards an attack and stop that from happening. This is what this device does. They're also very excited about how easy this device is to use. That was one of the things that really came across very strongly because currently, the way they diagnose patients is typically with a questionnaire, so it's very subjective. And to work out the lung function, they use spirometry. And the instruction to patients when they're using this spirometer by a doctor is typically something along the lines of, I want you to exhale until your lungs come out of your mouth. That's how difficult spirometry can be. And if you look at children and the elderly, that's just not going to happen. This device is normal tidal breathing, records the breathing, Bluetooths it to the phone up into the cloud, and it's real information in real-time from the real-world that the doctor gets their hands on. Next slide, please. We're also very excited we were approached out of the blue by a major pharmacy group in the U.S. to do an in-store pilot for wheezo using the flexible savings account and the health savings accounts, which basically are accounts that are fed by remunerations of companies for patients. And basically, what it is, is as money is set aside for patients to use when they're out of pocket for a particular health care situation. So this would eliminate patients needing a co-pay in the pharmacy setting in the U.S., unlike the situation here in Australia. So as I said, we're talking to a number of major insurers on the West Coast, and they've been already evaluating wheezo for some time now. So we're very confident of getting some positive results from that in the next few months. And as I said, the size of these organizations, they cover between 900,000 to 5 million lives, and as I said, there are a number of more that we're actually working with at the moment. Important to note that in the U.S. as well, apart from reimbursement, there are what we call the Federal Communications Commission's grants, which are made available to those areas that are less fortunate than others when it comes to health care provision, and these are typically around about $1 million per institution. The United States Department of Agriculture also does these things because they are responsible to helping make sure that people who are feeding the U.S. are, in fact, being looked after when it comes to the health care. So we have quite a number of grants that have been submitted in for wheezo through one of our partners, and we expect to start seeing some results from this particular process in the next month or so. Next slide, please. One of our health care partners is Access Telehealth. As I said, they have secured our first RPM of wheezo customer in the Chicago Children's Hospital. They commenced the promotion of wheezo in mid-January, so it hasn't been that long, and we're making some great traction. The important thing from our perspective is that they also have a patient engagement model that, as I said, doctors can outsource that particular task to them. And it is very similar to the model in the U.S. to what we do here in Australia, or did in Australia with the remote asthma monitoring program where it was physician-led and had a group of asthma nurses engaging with patients to help them better understand how to manage their conditions. In Australia, it's not reimbursed; in the U.S., it is. As I said, they -- that we attended the -- they attended an RPM conference in Las Vegas, and again, we're still working on the number of very positive leads we've got from that. They funded and attended with us, the American Academy of Allergy, Asthma and Immunology, and I spoke about that at some time. And it is important to note, that it is a very cost-effective way for us to actually enter the U.S. marketplace, given that our partners are very much committed to helping fund much of the marketing that goes on in that particular country. So we've had initial orders finalized. And as I said, they're a very highly experienced credentialed team, very pleased to be working with them. Next slide, please. mTelehealth is our other RPM provider. They actually commenced promotion at or in mid-December. As I said, they've already purchased just shy of $175,000 in revenues in the first two months. They have undertaken a major campaign for wheezo with their customers, and the response has been unprecedented. And that's not what I'm saying, that's what they're telling us. And we can honestly say that our morning shifts, where we talk to our customers in the U.S., and our time in the U.S. was very, very busy because of the work and leads that this have generated. They're actively engaging with 30-plus customers, including those organizations that I've just put there. So we're working right across the gamut of people who have a vested interest in making sure the patients with respiratory disorders get the necessary care and monitoring when they're not with their physicians, and in doing so, minimize the impact on the health care system. So they've been in business for 11 past years. Next slide, please. So I just thought I'd finish where I started. It's a huge marketplace that's physician-led, the U.S. We've got best-in-class remote patient monitoring partners. As I said, wheezo has been very well received by payers, physicians and unprecedented when it comes to the response we've got from that. We do have FDA approval. We're already selling in the U.S. As I said, the burden of respiratory conditions in the U.S. is huge, just shy of $82 billion. Important to note that we do measure physiological parameters. So we qualify for reimbursement right now, and that's clearly the case, as you can see. We do know that for wheeze to manifest, lung function has to be compromised, and that is really important because that gives doctors confidence in the new technologies that we're providing them with. And as I said, we've got plans moving forward to make sure that we take advantage of some of the other forums that we have in generating more leads for the organization, and as I said, the next major one will be with the accountable care organizations, which are major groups that really do provide an integrated health care solution to patients. And as I said, we've already secured our first remote patient monitoring customer in the Michigan Children's Hospital. And we're really well-placed with a pipeline of opportunities that keeps us pretty busy moving forward. So we're looking forward to being able to announce some significant partnerships and customer engagements that will lead to significant revenues moving forward. So thank you very much for that, and I'll hand over.

Marjan, thank you for the great presentation. Unfortunately, you have run over time. But I would encourage any webinar attendees that do have questions to reach out directly by the contact details on the bottom of the ASX releases. But thank you so much for joining us.

Thank you. Sorry about that.

The next presentation is from Nanoveu with the ticker code NVU, a company which has developed a suite of technologies and products to protect against viruses and bacteria, including COVID-19. I will hand you over to Non-Executive Chairman, Scott Beeton. Good morning.

Thank you, Jane, how are you?

Well, thank you. Let me bring up your presentation.

All right, thank you.

All yours.

Ready to go. Okay, thanks, Jane. Also, I'd like to welcome all investors to today's presentation. As Jane said, my name is Scott Beeton. I'm the non-Executive Chairman of Nanoveu. I'm very -- I'm extremely proud of being here today to present to you our exciting company. As I'm still relatively new to Nanoveu, I thought I would start today's presentation mentioning some of the reasons why I decided to join the company back in September last year, what really excites me about the business. What I saw was an early-stage business that had the potential to be a high-growth story. The business is ASX listed, has a very exciting portfolio of COVID fighting products. It's highly scalable with a huge, huge addressable global market, and has an impressive client list. What I also found when meeting the Board and the executive team was a group, a very entrepreneurial and very passionate, successful people. Hence, I jumped at the opportunity to join Nanoveu as they sort of had many of the ingredients required for success. If we can just go to the next slide, please, Jane. And next one. So basically, what is Nanoveu? As I mentioned, we're an early-stage company. We're listed on the ASX. Our market cap is relatively small at $6.5 million, and we have approximately $2 million in cash. We're leading the world in the development of antiviral and self-disinfectants. Next slide. Where we are now, we've developed a suite of products that fight against viruses and bacteria, including COVID-19 and SARS. In essence, we have products such as sprays, wipes, disinfectants and protective films that help protect you against viruses such as COVID-19. Our products help you stay safe, whether it be at home, at work, at the shopping center or even on the bus or the train. What we've done, we've built a global distribution network that continues to expand with new distribution partners and JVs being added. We also have opportunities to expand our business and add scale through potential acquisition. Next slide, please. Our business has assessable IP with technology sourced through Singapore's top research and academic institutions. What's important there is what we're trying to say is that a lot of our IP, we're not actually out there spending too much money in the development ourselves. We source our technology through partnerships with Singapore's researching universities. So it's very important for us. That's the way we assess our IP. I mentioned we already have our distribution network around the globe, but what we do, we have clients who buy directly from us, but we also -- our main distribution strategy is through distributors and JVs. Very important for us as a business is seeking regulatory and legal approvals in certain marketplace. And we've recently just announced that we received our Class 1 medical device with the U.K.-based medicine and healthcare products regulatory agency. And in the U.S., we -- our Nanoshield product has been approved by the Environmental Protection Agency or EPA. And so, as you can see, we're in our early stages, we have the products, we have different solutions for it. And more importantly, we've got the regulatory approvals in key markets now, and also Singapore to be able to go out and promote our various products to the marketplace. Next slide. What I've got here is just some screenshots of our core product, where we have solutions for touchscreens. We have films and tapes. We have our self-disinfectant robots, which is pretty cool. We have a video on that to show you shortly. We're involved with masks, and we also have our wipes and -- that are going to protect surfaces. But our last part there, you can see our global client list. We've got some Tier 1 clients around the globe existing, which is great for the company. Next slide. So right here, we've just got a video, and if we can play that now. Thank you. [Presentation]

So unfortunately, the sound, I don't think worked. But that was just highlighting what our Nanoshield product was. And you would have seen that there's a lot of -- in high touch points where our film can go over to protect certain surface areas, and again, protect you against COVID. As I've mentioned, our marketplace, it's a huge global opportunity for us, and the addressable market is very large. You can see from the slide, 8.1 billion in 2022, forecast to over 53.5 billion in 2028. So it's a very -- it's a large addressable market, huge growth potential. And Nanoveu, we have our various products in this marketplace to be able to be successful of that huge market opportunity. Next slide. I did mention how important is these milestones for the company before to get the different approvals in key regulatory markets. Many of you may not know exactly how hard that is to get. And it's something -- for instance, for us in the U.K., it's something that we thought would be granted a long time ago, and that's just come through now. So it took us -- approximately it was 9 months just to get this approval through. So these are milestones for the company, and it sets us up for future sales opportunities. So we've got our approval for the NDA in Singapore. We've got the medical class fund device approved in the U.K., and the EPA approval in the U.S., which is our -- 3 of our very -- our key market and huge opportunities for us to now distribute and turn the different products and solutions we have into sales for the company. Next slide. [Presentation]

So as you can see just from this last little teaser with our robot, it's a pretty cool solution we have. So that's our solution in hotels whereas you're sleeping or in the middle of the day, robots go up by themselves and they will spray in the public areas of the hotel. So in closing, I'd like to say it's a very exciting period for Nanoveu. As I've said, we are rapidly expanding our product range and our underlying business. We've received key regulatory approvals of our products. We have global distribution partners in place today where we're growing the number every day. It's a very large addressable marketplace. The business has a number of growth opportunities in front of us, as you can see, from our expanding product line, regulatory approvals and this growing global marketplace we're in, but also through potential acquisitions and M&A. So I think it's fair to say our journey has just started, and I'd like to thank you for your time today. Thank you. Back over to you, Jane.

Sorry, I'm having a few technical issues here.

[indiscernible] one, but it's okay.

Yes. We were actually having a few technical issues on that one, and I apologize. Look, let me jump into a quick question. So can you please talk more about your growth plans, both organically and through acquisitions?

Yes, definitely. Well, I mean, I think I covered that. The most important thing for us to be able to sell the type of product range we are and just say that we can fight COVID and language like that, we needed the regulatory approval. U.K. is a recent one, Singapore and U.S. has been for that. That's the key point from regulatory approval. Second one is obviously working with our distribution partners to grow our sales channels in different markets such as the U.K. So there's just an example. We've had a distribution partner in the U.K., ready to go for a long period of time that hasn't been able to sell because we've been waiting for the approvals to come through. Now we've just got that. So there's a market now that's just opened up for us. The second thing I'd probably like to say there is around acquisitions. I don't want to drum that too hard to think that we're just going to go out and try to buy everything. But I think any ASX-listed company should always be expanding how do you add scale into your business. And one thing that we're definitely looking at is how we can add scale, and it's not always just through revenue, it's scale through people, different technologies, reoccurring revenue. And we have a number of opportunities that we are looking at as a company, but there's nothing ready to be announced at the moment.

Wonderful, Scott. Thank you for your time today. And of course, all copies of presentations will be available online in the coming days. But thanks again.

Thanks, Jane.

And finally, we are joined by Dr. Thomas Duthy, the Executive Director of Invex Therapeutics with the ticker code IXC. To tell us more about their repurposing of approved drug, exenatide, I will hand you over to Tom.

Thanks, Jane. If I could have the first slide, please, that would be great.

Let me bring it up for you. All yours.

Right. Thanks very much, Jane. We can go to Slide 2, which holds the important disclaimer information for today's presentation. Turning to Slide 3, just the corporate company snapshot. So Invex is a clinical stage drug development company with an expressed focus on an orphan disease called idiopathic intracranial hypertension, or IIH. We are taking an existing drug, known as exenatide, and repurposing this drug as a trademark in proprietary formulation, Presendin, to treat this disease. We are in Phase III. We require a single Phase III study for market approvals in the U.K., Europe and Australia, which I'll come to. We have orphan drug designation in both the U.S. and Europe for this particular indication with exenatide, Presendin. The addressable market is large and growing, which we calculate at $1.6 billion annually. I draw your attention to our capital structure. We have a very strong balance sheet that will see a Phase III program fully -- or the Phase III program fully funded through to market approvals. And our enterprise value relative to that opportunity is reasonably skinny at $13 million. Our major shareholders there, you can see directors and management hold 17%, our top 20, 58%. And our Board is extremely well credentialed in both drug development and expressly within the area of idiopathic intracranial hypertension. Professor Alex Sinclair, who's a co-founder with Dr. Loveridge, she is the world's leading expert in idiopathic intracranial hypertension; and Megan Baldwin, who joined our Board last year. Some of you may be familiar with her, she is the current CEO of Opthea Limited. Next slide, please. Before I tell you about the disease in more detail is I'd like to share with you the opportunities as we see it here at Invex. So I've mentioned the TAM. But if you slice and dice that TAM to focus on where our nearer-term product registrations lie in Europe and the United Kingdom, that represents about $1 billion annually in addressable market. Perhaps unlike other drug development companies investors will see from time to time, this is a completely unencumbered drug therapy market for Presendin. There are no approved treatments for IIH. There are no new treatments in clinical trials for the exception of ourselves who were targeting patient recruitment late this half for our Phase III trial. So really, there is an urgent market need for new therapies. And from a drug intervention perspective, this is a chronically administered drug as proposed. Without the drug, the patients will very quickly relapse with their disease symptoms, which I'll come to on the next slide. Supporting clinical data. So we have Phase II data that provided us a very confident and clear statistical signal and a clinical evidence of efficacy in that population that bodes well, we believe, for our Phase III program. There's no significant safety concerns either over the 12 weeks of treatment. That's not unexpected, given that the drug we're repurposing, exenatide, has been approved for Type 2 diabetes for many years and been in many millions of patients. So we're somewhat unconcerned about any deleterious safety issues here, but we are innately focused on ensuring that we design this Phase III trial expressly to meet the primary and key secondary endpoints to support a market registration. We've built a very strong -- sets of various -- very strong barriers to entry for competition, not least of which is our orphan drug designation in the U.S. and Europe, which provides 7 and 10 years market exclusivity, respectively. That's the first barrier. The second barrier is we have issued patents for the use of exenatide in IIH and other pressure-related disorders of the brain in both United States, Europe and Japan. And these patents extend out through 2035, and that's about the [indiscernible] patent extensions. Next slide, please, Jane. Most of you, I'm sure, have not heard about this disease, idiopathic intracranial hypertension. So this slide really just summarizes how important this disease is, albeit, it is a rare disease. So the disease manifests effectively as a dysregulation of cerebral spinal fluid secretion in the brain of patients, and that leads to increased intracranial pressure or brain pressure. So think of it a little like expanding a balloon in a glass jar. The balloon, being filled with cerebral spinal fluid and the jar, clearly as you see, is the skeleton. These patients do typically manifest as women of child-bearing age who have obesity. There's no non-recourse, hence idiopathic. And the incidence, which is increasing, is around 4.7 persons per 100,000 population or [indiscernible], excuse me . 90% of these patients suffer headaches that are progressively more severe and frequent, hence, the glass jar-balloon analogy. This is a major cause of patient morbidity. And up to 25% of patients will -- can suffer impairment and vision loss as a reflection of the increased pressure and the compression effects of that pressure on the optic nerve. The impact is large and growing. These patients have a very poor quality of life, repeat hospital administration. And the only tools at the disposal of clinicians at the moment are invasive neurosurgical procedures to just to lower the intracranial pressure by venture of a shunt at the back of their head to draining the fluid, or in the case of the optic nerve, to [indiscernible] the optic nerve itself that is to sort of relieve pressure on that, and both of which have 50% failure rates. They're not an ideal course of intervention, hence, the need to develop new and effective drug treatments. The solution is well based in strong signs developed by Professor Sinclair, who I mentioned is on our Board. It's a very -- I'll just tell you, exenatide is what's called a GLP-1 receptor agonist. And the link between GLP-1 receptor agonist and IIH was formed and forged by Alex Sinclair, and that's where the bulk of our intellectual property lies and also our orphan drug designations. And so we're effectively repurposing or taking this existing drug and conducting clinical trials to support a registration in a new indication, which is IIH. And we -- as I said we were the first to show that the GLP-1 receptor agonist, being exenatide, was able to show us -- show safety and efficacy in an IIH population. Next slide, please, Jane. I won't go into too much detail on the TAM and how we cut the TAM. But what investors should note here is that, albeit, there's a small number of patients, only 60% of these patients are diagnosed. Interestingly, we would expect the diagnostic rate to increase over time, commensurate with the development of clinical diagnostic criteria in 2015 and a set of rule books on how to treat this disease, both of which are written by Alex Sinclair and colleagues in 2018. So that bodes well for -- that's more awareness and more diagnostic -- or a higher diagnostic rate. These patients will have long-term commitment to drug therapy. 4.5 years, give or take, is the duration as referenced in the clinical literature. But really, the market drivers here are quite substantial, and this disease is expected to show annual growth of 3.4% per annum, which is driven by increasing obesity, as I mentioned, increase awareness. And we note that even a small 10% increase in the diagnostic rate of this disease is an additional $300 million in TAM for this particular indication. Next slide, please. The critical components for us are bucketed here, is really four things. It's the manufacturing piece. Can you make the drug? Can you make it cost effectively? Can you scale the drug? And are the cost of goods commercially viable? We'll come to that. The second piece is the clinical piece. Can we show by way of a registration-directed clinical trial of this drug, Presendin is efficacious in the disease IIH regulatory? Do we -- or can we receive regulatory clearances to not only commence the study, but do we -- and can we receive regulatory clearances for approval of the drug upon clinical success? These are key ingredients. And finally, the funding piece. So we have $31.4 million cash in the bank, and the funding we have is consistent with our ability to complete and register this drug in IIH. Next slide, please. The partnership we have is with a Korean company called Petron, which we signed in September 2021. This is a very strategic relationship with Petron. They have a significant expertise in long-acting peptide formulations, expressly exenatide. And this really, for us, derisks our clinical and commercial development for Presendin because we are able to leverage reams of preclinical and clinical data held by Petron to submit with our clinical information as part of the dossier for regulatory clearances to commence the trial. That is a material saving in time and cost, which we previously estimated to be $3 million over 12 months. The financial implications, I think, are even stronger for Invex and the shareholders. We are purchasing once-a-week Presendin from Petron at a fixed price per dose for clinical and commercial sales. There are no royalties. There are no milestone payments tied to future sales. Their manufacturing is present by way of a 16,000 square meter GMP facility in Korea for this exenatide formulation we are using. Interestingly, that would support around 12,000 patient doses per month, which equates to over AUD 200 million in gross sales, if we were to simply price the Presendin asset at the reference price for the use in drug for [indiscernible], which is the exenatide formulation in Type 2 diabetes, which I mentioned. So as a baseline assumption, we have an ability to manufacture already at scale, and we have a relationship that allows for capacity expansion in the future, should the need arise. And as I mentioned, this is a once-a-week formulation. Next slide, please, Jane. For those of you who love console diagrams and clinical information, here you go. This is the Phase III trial study design. So this is a randomized, double-blind, placebo-controlled multicenter clinical trial to determine the safety and efficacy of Presendin in IIH. We are looking to establish upto 37 centers across Europe, the U.K., Australia and the U.S., 240 patients, 24 months, recruitment. The primary endpoint is the change in intracranial pressure at baseline and at 24 weeks. So a very simple lowering of pressure at 24 weeks versus the baseline is how we power the primary endpoint. The key secondary endpoints are all related to the clinical manifestations of this disease, noting headache and vision. We also are clearly needing to look at safety. As I mentioned, we feel safety will be okay. We are looking at the production of antidrug antibodies as this is a peptide agent. Importantly, we are also establishing quality of life measures, which are important for those payor discussions for reimbursement upon regulatory and clinical success. As I mentioned, the study is designed to meet the requirements for approval in the U.K., Europe and Australia. We are including centers in the United States, and the reason we're doing that is to help us with informed discussion with the U.S. FDA. I'll come to this in a moment. But essentially, we elected to pursue a European strategy, first and foremost, principally because the two regulators differed in how they thought about a registration directed trial for Presendin, and the Board -- in very significant consultation, which took a number of months with clinical and regulatory advisers was that this design, as we put forward to investors, is the lower risk, more strategic pathway. And clearly, the results will be very useful for us to determine the next steps with the U.S. FDA. But with $1 billion in TAM in opportunity for us in Europe, we believe, this is absolutely the right strategy for shareholders. Next slide, please, Jane. I mentioned the regulatory strategy, Europe, Australia and the United Kingdom through the MHRA. As I said, the study is designed to inform the FDA and to help us work with the FDA on how they think about a registration for IIH in a -- or at a later date. And it's important to note that we were tireless in our pursuit of trying to harmonize a single Phase III study, noting that most drug development companies, investors will see is there, if they're not orphan, they typically require two pivotal Phase III trials. This is just one trial. We -- yes, we were unable to sort of harmonize into one global study. But that's okay. Next slide, please. Just a summary and our outlook. Single Phase III trial, $1 billion in unencumbered addressable TAM. We think there's a scope for the rapid incorporation of Presendin into IIH treatment guidelines, which we developed initially in 2018 by Alex Sinclair and colleagues. The reason I say that with some level of confidence is those same treatment guidelines have to now a first-line new drug treatment as it has an approved standard. So typically, in drug development, guidelines are followed somewhat residuously by clinicians and incorporation there as a treatment intervention, does lend itself to adoption and does lend itself to payor coverage. We -- I mentioned, we have that economic evaluation, which helps drive our reimbursement strategies at a later date. Our U.S. centers are going to be progressively enrolled and established, and that bodes well for our FDA work. This is potentially the first and only IIH drug, and we're fully funded to complete this trial through to registration. And I note that our corporate overhead, which excludes the noncash share-based payments in our R&D, which is directed to this Phase III trial, is around $1 million annualized as a December 31 run rate. So we are not spending shareholders' money unnecessarily on corporate overhead, we are directing it to the study. Next slide, please. And with that, I'd like to turn it back to Jane. Thank you, Jane.

Thank you so much for that, Tom. Great presentation. There's been quite a few questions coming in, so I'm just going to jump into them. So could you please elaborate on why there are no competing drugs, either approved or under trial?

Yes, for sure. So there is a number of off-label type drugs, one of which is called acetazolamide, which has been around for 50 years, although a live better analysis through the Cochran database established that, that drug, albeit, it does get some use in IIH, is not effective and lacks the evidence. I think part of the problem has been the lack of diagnostic criteria in this disease historically, but I think most importantly is the very strong inventive step of Alex Sinclair who has linked GLP-1 very strongly to lowering pressure in these patients. That's the first time that we've shown them by her clinically, and that, I think, bodes well for why we anticipate having a reasonable shot on goal here, but also probably explains why previous drugs were either failed or were just since they're not hitting the right receptor to lower pressure.

Another one. So we're just repurposing an existing drug as opposed to developing a new one, shorten the commercialization timeframe?

It does measurably by virtue of the fact that we can leverage the -- particularly the safety and toxicity data of the reference drug, exenatide, which is for -- which is currently sold in two formulations, Byetta and Bydureon. So we can take that package of information. We can also take the package of information from Petron and their work. And so what it means is that we bypass a lot of those traditional drug development steps, not least of which is a $3 million to $5 million preclinical spend to prove the drug doesn't cause any onerous effects in animals and particular animal models, but also we have bypassed a lot of the Phase I human safety work, pharmacokinetic data, dosing regimens because of that relationship with Petron. So it really saves us, I think, overall, between sort of 3 to 4 years possibly, noting of course, we are also not required to run two trials. We are required to one -- to run one, it's a bit of a tongue twister, sorry.

A few more popping up. So approximately how long do CTAs take to be reviewed and processed?

It depends on the jurisdiction. So the FDA is pretty clear cut, I'll start with that one. So an IND filing, in a best guess, for new drug filing is 30 days. The FDA will either stop the clock and tell you, you need to do certain things, or if they say nothing, you're essentially clear to commence the study. In Europe through the EMA, European Medicines Agency, and the MHRA in the United Kingdom, that can vary, but the timeline, give or take, is around sort of 60 to 80 days for each of those. In Australia, you typically go through human regulatory -- sorry, Human Ethics Committee review first as a -- and that's done at the hospital level. We filed an HREC in late December of 2021. We're still waiting to hear back from the Ethics Committee. Once we hear back, which we expect this half, we'll be able to essentially start to enroll patients because we've accredited several sites in Australia already.

Well just on that then, the next question is, so if Australia's CTA is successful, will the recruitment process for Australia commence immediately or will you -- will the company wait until other CTAs have been filed and approved?

It's a good question. So think of it like a rolling process. As the CTAs are filed and then approved, we can then legally start to recruit patients. So we would anticipate for no other reason and in fact, it was the first filing that it's likely that the first patient will come from Australia. And as I mentioned that the other 3 filings in Europe, the United Kingdom and the U.S. will be progressively made this half, and as I mentioned, we expect to have that patient in late first half this calendar year.

And just a final one that's popped up. So is the company still in discussions with the FDA?

We've completed our process with the FDA. With this -- let me clarify that. As it relates to the trial design and the requirements that the FDA infused onto Invex, that completed in 2021, and the results of that are we are not pursuing a registration strategy in the United States currently, but we are enrolling in U.S. sites. Our engagement with the FDA right now is clearly the completion of the IND filing. And so the outcome of that filing, as I mentioned, is 30 days, give or take. That's our level of interaction with the FDA. But there'd be absolutely a lot of dialogue in the event that we are able to show a strong statistical and clinical efficacy result from our Phase III trial. It's not out of the grounds of possibility the FDA would consider changing their view, I guess, on how they think about Presendin's registration, but at this juncture, we will be educating and liaising with once we've banked our Phase III and loading the R&D process in between.

Wonderful, Tom. That's all we've actually got time for today. There are quite a few questions coming through, so I would encourage you to reach out to Tom directly by the contact details on the bottom of their ASX releases. But Tom, thank you for your time.

Thanks, Jane. Thanks, everyone.

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