—who is Emyria's Executive Chair. I will start by saying, well, good morning to you, Greg. Morning, Jane. Morning, everybody. Hi. Good to see you. Also with us is, next to Greg here, Mary-Ann Rennie, who is Emyria's COO. Good morning to you, Mary-Ann. Morning, Jane. Great to see you. You too. Okay, so housekeeping. The format is that Greg and Mary-Ann will step us through the presentation that has been released to ASX today. After the presentation, we will then open up the floor to Q&A. A reminder, if you would like to ask a question, you can do so. You can pop it into the chat function in the ribbon at the bottom of your screen at any stage, and we will get through to as many as we can in the time that we have after the presentation has concluded. For now, though, I will pass over to Greg to get us started. Over to you, Greg. Thank you. Great. Thanks, Jane. Mary-Ann, it has certainly been a very exciting quarter for us. A lot has been achieved, including the opening of our first Sydney clinic, first New South Wales clinic, which is really exciting. Matilda Nepean out in Penrith. Of course, recruitment of a lot more clinicians. We are still continuing to recruit. We have now got 18 beds across the country, which of course, across five sites, five clinics, four in hospitals, and one community center. 18 beds, so that gives us a total of 90 possible dosing days per week. At full capacity, of course, that is a significant amount of revenue that we are able to achieve. As many of you would know, we are rolling out a national network of clinics specially designed to treat mental health conditions, PTSD and treatment-resistant depression in particular. We are doing so in a capital-light fashion, so using hospitals, so existing mental health private hospitals. Renting beds essentially within that framework allows us to roll out at pace, and as I say, a capital-light fashion. We have now treated over 160 patients since the regulations changed back in 2023, which we will talk to in a moment, just by way of recap. It is certainly moving at pace now, and we have got a significant clinician workforce, most of whom are contractors, so we only pay them when they work with us in treating patients. Anything to add? Just that we continue to assess what other locations and sites that we will look to open up clinics into the future. Right. Yeah. Just by way of recap, if we go to the next slide, we can talk to why we are able to do what we are doing. We talked to the fact that we have a worldwide first-mover advantage, and that came about in 2023 because our version of the FDA, the TGA, decided off the back of some clinical trials coming out of the U.S. to create a pathway by which two psychedelic medicines, MDMA, otherwise known as Ecstasy, and psilocybin, otherwise known as magic mushrooms, can be used in combination with therapy and be prescribed by what are called Authorised Prescribers. These are psychiatrists who have TGA endorsement to be able to prescribe these medications, to be able to use these for the treatment of PTSD and treatment-resistant depression, respectively. As we can see down the bottom, even in Australia, there is a huge total addressable market. 1.5 million Australians suffer with PTSD, nearly 7% of the population, and 1.1 million with treatment-resistant depression. Just reflecting on that, our four-bed facilities can really only treat about 250 patients per annum. We are looking to roll out as many clinics as we possibly can to be able to address this market, but we know that we will never get to the entirety of the population that desperately needs these treatments. Yep. That is assuming that the conditions just remain with PTSD and treatment-resistant depression. As we know, there is quite a lot of research taking place in this space. In the future, we see other indications potentially being allowed for treatment, which means that these total addressable markets would grow quite significantly as well. It is a really important point. What we have done in devising the way that our clinics work is we have made them what we call drug and indication agnostic. As new medications come into the frame, and we are certain that this will happen over time, and as new indications like eating disorders, alcohol and drug abuse, anxiety disorders, even smoking cessation, as these potentially become available to us to treat, these TAMs just explode. Yep, very true. When we talk about the number of people that are suffering, that obviously has a massive impact on the patients themselves, or on people themselves, and on their families, friends, and workers, but it also has a massive health economic impact. We can see here from these statistics that between private health insurers, I mean, Medibank has paid AUD 2 billion in hospital admissions alone for mental health care over the last 10 years, nearly AUD 220 million in 2024 alone. That's a huge impost on our society from a financial perspective. Then you look at the Department of Veterans' Affairs, which we'll talk to in a little bit more detail. We know that our ADF and veterans are overrepresented in terms of being classified as having PTSD and treatment-resistant depression. Just last week, we saw some figures come out on this, which is just mind-boggling in terms of the impact that it's having on these cohorts. Mm. Yeah, very true. We know that over a billion people suffer a mental health condition globally. That's a huge, staggering number that just continues to increase. So, we're very fortunate, I guess, in Australia that these pathways have been created to help find new ways for treatments for those who need them. Mm. We are hearing anecdotally that life insurance is actually becoming prohibitive. Purely because of the number of mental health claims that are coming through. We are seeing that life insurers are paying out in permanent disability claims an astronomical amount per annum to people who potentially will never work again. I guess what we are saying is that the problem is only increasing, getting worse. HCF came out last week and said that essentially 90% of their gold tier claims are for mental health-related issues. Even private health insurance is potentially becoming unsustainable. A lot of people will not be able to afford what the private health insurers will need to charge in order to cover. Mm. Yep. Why do you talk us through the treatment journey for people who come into our program? Because I think it is important to understand the model, and also what it means from a financial standpoint for us? Yep. Look, just a reminder, it is obviously a highly regulated industry and area. An individual is referred into one of our clinics by a specialist or a GP. They are then screened through quite a rigorous process and deemed eligible or not by our Authorised Prescriber. If they come into our treatment or the active treatment protocol, they first need to taper off any antidepressants that they might be on. They come in for their first dosing day. That is where you take the medication and you have combined therapy. You have two therapists sitting in the room with them for that full dosing day, and they come back for three one-hour appointments within that same fortnight. They come in again and do the exact same structure, dosing day two, followed by dosing day three. Typically with PTSD, you have three dosing day treatments, and with treatment-resistant depression, two or three dosing day treatments. Then you move on to follow-up over the next 12 months. It is really important to us as an organization that we continue with our real-world evidence collection. We are learning from every patient, and we are learning improvements to the model. Research is a big part of our fabric as an organization as well. Now, just a reminder, Greg spoke to the fact that now that we have five clinics up and running, we have a dosing day capacity of 90, or bed capacity of 90 dosing days per week. A dosing day is AUD 10,000 worth of revenue to us as an organization. You extrapolate that is AUD 900,000 of potential revenue just in the capacity that we currently have. Now, just a reminder, you would have seen this slide a number of times, but we often get asked a question around, when is your break-even point? This is our dosing chart for a 12-month period at Perth Clinic, which is our most mature clinic. You can kind of see that dosing days are growing, and what is really interesting is that green bar, which suggests when we break even at a clinic, at a standalone clinic level. Then any dosing days above that moves you into profitability. So you can see that Perth Clinic has been tracking really well. Now, it is worth noting that even though there were 31 dosings in June, the clinic capacity has 80 dosing days per month. So it is profitable at around 40% utilization, and there is certainly significantly more growth that can take place there, and then positive impact to your bottom line. Now, moving into the quarterly highlights. As Greg said, it has been another great quarter. We opened our first Sydney clinic, which was great to see, with Matilda Nepean Private Hospital. We are thrilled to be there. It is a lovely clinic. We kicked off with actually workers' compensation approved patients, so it is great to see that funding is continuing to expand in that space as well, and from those funders, different funders. We also spoke about the fact that we had kind of resolved Authorised Prescriber capacity, because over the periods, we have had more Authorised Prescribers that have been approved across the nation. But for Brisbane, for example, we had had an additional three. We had gone through a period where we just had one Authorised Prescriber approved. Perth, we have also had additional prescriber approvals there, which meant we could then focus on the next kind of bottleneck that we were seeing, which was therapists. It was important that we could continue to recruit therapists to have enough dosing day capacity to treat the demand. We ran through another recruitment and training program, and we continue to do that. Our quarterly spoke to the fact that we were running another one in November. It is great to see that we are still seeing such great interest in this, and the interest is just growing in terms of therapists understanding and learning about these treatments. That is great to see. We had a record quarterly revenue of AUD 1.42 million, so that kind of speaks to the fact that utilization continues to grow. We also appointed former Secretary of Veterans Affairs, Dr. David Shulkin. He, from the U.S., was involved in both the Obama and the Trump administration, and he was responsible for the Veterans Affairs over there, nine million vets, a huge multi-billion dollar budget, 350,000 staff, and 1,400 facilities. When he was in the role, he spoke about the fact that he made brain health the number one priority for the Veterans Affairs, and that was in relation to the number of veteran suicides that were being seen to take place every year. He was really thrilled, and we are very fortunate to have him step into the position as advisor for us within Emyria. He was keen to take part in it because he saw this opportunity where we have got this three-year head start on the knowledge and the know-how, and given the fact that the U.S. is moving towards opening up the markets in this area, he was keen to make sure that we could take our knowledge and look to see how we can utilize it in the U.S. He has been brought on to help support U.S. commercial opportunities and partnerships. There is a specific webinar that has been done with Greg and Dr. Shulkin, which is certainly worth a watch. Done about a month ago, where he really speaks to why he is excited about this space. Greg and I were recently at a conference over in the U.S., where the Veterans Affairs guys were there as well, and they spoke about the fact that they are really wanting to ensure that they can provide access in the U.S. when these treatments become available through the FDA. I think they want to set up 10 clinics initially, don't they? They've identified already 10 clinics. The language at the conference we were at was, "We want to be ready day one, the moment that we can start treating." So they've identified clinics that are looking to be able to do this, and then they will continue on expanding that out with the significant size of their population that they have. Mm. I think it's important to put things in context as to why there's so much of a push in the veterans population there, and indeed for Australia. But in the U.S., I think 4,700 people who saw combat in the Iraq War died, but they have nearly 7,000 suicides amongst the veteran population every year. A massive problem. That's why there's so much of a push from a Veterans Affairs perspective, and I guess why Secretary Shulkin is so important to us, because of his relationship and the advice that he can provide us as to how to tackle that, potentially tackle that. Yep. Yep, very true. Moving on to, or continuing the vet space, you would have seen in our quarterly, we've said that we've had our first DVA approvals, which is great, so we're preparing to commence treatment in that cohort. We've got quite a pipeline that has built over time there as well, which is continuing to grow, so we're working through our ways. The eligibility criteria is a little bit different to the TGA. It's a little bit more stringent, so there's a process to go through for individual application approvals, which we're continuing to work through. The veterans typically have an over-representation in PTSD and treatment-resistant depression, just based on their frontline work and what they've experienced in their careers. Additionally, Greg was over at the FDA hearing. Emyria was selected to present at the FDA public hearing on the future of psychedelic medicines. I believe we were the only international company that put forward to actually be selected and able to present there in Washington. That was also a great achievement and some validation for us as an organization as to the knowledge that we've grown over the last three years. Mm. It was interesting to listen to the other presentations because really, they're talking about things from a theoretical perspective, whereas we were able to provide real-world advice, real-world information, real-world experience in treating real-world patients, and indeed with real-world funders, which is something that they're really exploring hard. That was really evident at the Horizons conference that we attended that you just mentioned. Yep. Yep, very true. I think Greg will elaborate on the FDA hearing in a little bit. Then this slide, continuing on from this just speaks to the momentum that is taking place and building globally in this sector. Compass Pathways, which you might have heard us mention a couple of times, they're one of the largest or the largest, most progressed company in the psychedelics medicine development space. It's looking like they might have their approvals as early as Q1 next year, assuming that they get it across the line with the FDA. But the talk seems to be about when rather than if, which is promising. Compass Pathways is looking for treatment-resistant depression as their first indication, and they're looking to expand after that. They're a multi-billion dollar company over there in the U.S., and they're one of a number, and they were all at the conference that we attended as well. But there's some other psychedelic companies that are quite progressed through their development stages as well. This was supported by the executive order that was announced earlier in the year, which was signed by President Trump, to reform, to accelerate access into this area, effectively to try and support enabling the research and potentially allowing these treatments to get to those who need it earlier or as quickly as possible. New Zealand's just announced that they're looking to open up over there as well. There's a huge amount that is taking place. There's over 100 programs in total that are in development at the moment. You can imagine over the last 10 years, that's a significant growth in this space and the potential for a number of different treatments. There's research taking place in addictions, in mood disorders, in eating disorders, in IBS, in post-Lyme disease treatment. It's extensive, the research that's taking place. That's why we're thrilled that our infrastructure can actually not only support the Authorised Prescriber program here in Australia, but the way we've set it up, it can also run clinical trials for these drug sponsors. We're already doing that with Psyence Biomed, which is a NASDAQ-listed company. We're running a clinical trial, so it's sponsor-funded. They pay for that service with us, and it's for adjustment disorder in those suffering from a cancer diagnosis. That's speaking to the Empax Global Partnership Program that we commenced officially in April this year. It's great to see that that continues on, and there are a number of discussions that we have going on to continue building that program as well. Onto you, Greg. Thanks, Mary-Ann. I guess looking ahead, we've got some pretty exciting stuff still to come. Mary-Ann pointed out that we're still looking at, or we continue to look at new venues that we might be able to open up, because as I said at the outset, the goal is to build a national network. We've got the five sites so far, but we do want to make sure that we bring these treatments and make these treatments available to as many people as we possibly can, and make the Empax Centre brand or Empax Clinics brand synonymous with the provision of psychedelic treatments in combination with therapy. As Mary-Ann said, we are looking at treating our first veterans. This is really exciting news for us. We know that, as Mary-Ann said, veterans are overrepresented in terms of suffering from PTSD and treatment-resistant depression. That is very exciting for us, and we really want to treat as many veterans as we possibly can, because we know that so many are suffering. We, as Mary-Ann said, are looking to pursue the U.S. and what partnership and commercial opportunities we might be able to explore over there. Certainly, in talking with Secretary Shulkin, he sees that there are some significant inroads that we might be able to make, potentially initially with Veterans Affairs, as you might think, but there are other courses of action that we might take also, so we're continuing to explore those. One of the things we're also looking to do is grow referrer education. We can't market. The TGA doesn't allow us to market directly to the public, but we can market to referrers. We are going about educating them across the country, across Australia, in terms of what we are able to provide and how we go about doing that. Even last week, we had a chap, I think, come in and see one of our leading psychiatrists, and he said he was off to Mexico for ibogaine treatment. We said, "You don't need to do that. You can come right next door." Clearly, there's still a divide in terms of what the public knows, and it's up to us to try and educate as much as we possibly can, because we now feel that these treatments are what you might call mainstream treatments, as opposed to where they were potentially three years ago, a little bit more fringe. Of course, we, as Mary-Ann said, are looking to leverage our clinical infrastructure and the experience that we have in delivering these treatments to support drug sponsors from overseas. That's a really exciting part of what we're doing, because we think that will also allow us to potentially move into other jurisdictions beyond our Australian borders, not just in the U.S., but potentially in places like Europe and Britain as well. There's a lot of excitement building in this space, and it's up to us to take advantage of these opportunities. Anything to add, Mary-Ann? No, I think that sums it up well. Back to you, Jane. Excellent. Well, thank you very much for a great roundup of the quarter. With that, I'll now open up the floor to Q&A. A reminder, if you'd like to ask a question, you can do so using the chat function in the ribbon at the bottom of your screen. We've had a few come through already, so thank you to those who've submitted questions. First one here, "If possible, could you please share your view of the number of dosing days needed for the group to be profitable, and whether you have a potential timeline to achieve this? Hmm. Oh, I might take that one. Jane, we've been fairly protective in terms of looking at what our both gross margins are and in terms of forecasting. We're, as I think everyone would appreciate, a very young company, and I think it would be somewhat fraught. We're still in growing phase, so it'd be somewhat fraught to explore that in any real detail, which is why we've talked about what it means to become profitable at a clinic level. So, all of our clinics, between that 15 and 20 type dosing days per month, start to achieve profitability. Otherwise, there's some research that's been done on us, which is something that we're comfortable with, and I guess people can have a look at that to better explore what profitability might mean. Yep. Yeah, I agree, and I think it's worth noting, as I emphasized during the presentation, that, as Greg said, 15- 20 for break-even, and that allows quite significant capacity still to take place, or there's utilization growth that will just add to that profitability. Hmm. Yeah, a bit of a headwind there. Yeah. Got it. Okay. Hello. Is Emyria in the process of setting up clinics in New Zealand, and what are the plans for the U.S.A. market? We've touched on some of those today. Are there any hospital or institutional networks you are already talking to in setting up a similar clinical model you currently operate in Australia? Let's tackle the first one first with respect to New Zealand. I think the pathway or the model that has been devised in New Zealand is quite different from ours here, and there are only a couple of psychiatrists there that have been given approval to treat using these medicines. Initially. Yeah. I think the short answer to that is we would need to see things open up more considerably before we would explore opportunities in New Zealand. Clearly, it is very close to our borders and something that we are keeping a very close eye on. In terms of the U.S., I think we have been fairly open about saying that we are probably not going to establish our own clinics, our own bricks and mortar in the U.S. That has tended to be a bit of a graveyard for Australian companies. We would never say never, but what we think we are most likely to do is leverage the IP experience and, I guess, the workflows that we have developed to a gold standard and leverage those into the U.S. so that those wanting to provide these treatments in the first instance, we can help expedite that outcome for them. Thanks, Greg. Okay. Quite a different question here. Is it in the best interest of the therapy to always use the same supplier for the molecule? It's an interesting question that's come through. We have a number of different providers, and we ensure that the short answer is that's not clear, but we ensure that there's consistency for the individuals in play there. I presume they're talking about the It's hard to know if they're talking about the same molecule, different supplier, or if they're talking about the two different molecules. But it's very clear from the TGA that the molecule for PTSD treatment, there's only one molecule allowed for that, and there's only one molecule allowed for the treatment-resistant depression. I think it'd be fair to say we don't really want one supplier, just one supplier, because then we would be— Yeah. Surety in supply. —too bound to them, exactly. Yeah. We've created redundancy by having a multitude of different suppliers. Thank you. Revenue reached a record AUD 1.42 million for the quarter. What were the major drivers of that growth, and how should investors think about revenue progression as clinic utilization increases? Well, I think the major drivers are obviously opening up more clinics and also utilization. That's really where we're at the moment, is looking at increasing utilization within our existing infrastructure and then exploring what other opportunities might present in other states and territories over time. But the major driver at the moment is to get as many therapists as we possibly can, because they tend to be our bottleneck, don't they? Now that we've got sufficient numbers of Authorised Prescribers, it really is the number of therapists that we have that dictates how many patients we can get through, because demand is generally very strong. Really, it's about increasing utilization. Thanks, Greg. Keen to understand how these clinical programs have been able to generate such strong outcomes while seemingly reducing or removing some of the psychotherapy components that have traditionally accompanied psychedelic treatments. What are your thoughts around how the FDA plans to implement these treatments post-approval in the U.S.? It's an interesting one, because obviously Australia was opened up in a slightly different way with a regulatory pathway created, and it's all about the therapeutic model and less about the molecule. Over in the FDA space in the U.S., it's about a traditional drug development approval. There's been quite a lot of public information around how the FDA assesses the therapeutic model that goes around the molecule, et c. Certainly with the Compass product, they are looking for a way that is going to be digestible by the FDA. I mean, we have a strong stance that therapy is a very important part of the process here. What's interesting is that potentially there are molecules that don't need eight hours. You don't need to be sitting in the room for eight hours. It could be shortened to four hours, and that doesn't mean that you're reducing the amount of effective therapy. It just means that you're reducing the amount of time that you actually need to be within a facility. It's an interesting one. Obviously, we're waiting to see if approvals occur and how they're approved and what model is going to be laid over. I think that there will be a model that's approved, and then there'll be gold standards. Hmm. I think I'll pick up on that theme, if that's okay, Mary-Ann, because in talking with Secretary Shulkin, we were talking about the different models that might be deployed in the U.S. Certainly, there's some discussion about almost no therapy, just having people who monitor a patient's progress during the course of a day, all the way up to being what we do, which is to provide two therapists in the room, which is based on clinical trials. Our protocol, if you will, is based on the gold standard clinical trials that came out of the U.S., as I said earlier, back in the early 2020s. His view, so Secretary Shulkin's view, is that we should not deviate from the gold standard, irrespective of what some entities may do. His view is that our model, being gold standard, is what we should look to deploy if we do so in the U.S., because obviously it's a fairly litigious sort of nation, and deploying to the gold standard helps to, I guess, mitigate some of that risk as well. I think it is fair to say. Sorry, Jane. I was just going to add to that. Fair to say that we do a lot of real-world learning from data iterations as we continue to grow our knowledge here. I think models will continue to evolve as well. Great. A follow-on question from the same investor. If you could also just comment on how the industry thinks about scalability if significant therapist involvement remains a requirement? Yeah. I mean, having the infrastructure in the first instance is really important, and that was quite a theme that was coming across at this conference, is you need the infrastructure there, and then you need the personnel. I think everyone is aware of that it is quite an involved treatment. Scalability is definitely there. That wasn't a concern. It was about just setting it up and getting the infrastructure and the individuals in place and well-trained. Anything to add to that? Well, I think it depends what jurisdiction we are talking about. The U.S. has a very significant number of therapists, so in terms of being able to and across different disciplines, I think in terms of being able to roll out there, scalability probably won't be an issue. Here in Australia, it has been one of our bottlenecks, but we are starting to see that open up. There is certainly a lot of interest from therapists, which is why we have been able to recruit as many as we have. I guess, ironically, it also creates a little bit of a moat for us in terms of because we have now recruited so many to our stable, if you will, it is actually becoming more and more or increasingly difficult for competitors to look inside, or to get the inside running. Yep. I think it is also fair to say, with all of the research that is taking place, there are different molecules that have different treatment protocols, and that is why our infrastructure is agnostic. If there is a shorter-acting or a less involved treatment that is approved, then we are able to introduce that into our infrastructure as well. Great. Okay, thank you. As we stand at the moment, you have covered all the questions that we had in the queue. I will just put a final call out. This was designed to be a brief quarterly update, but final call out to anyone that might like to ask a question. Now is your time. Otherwise, we will let you all continue on with your day after what has been a busy couple of weeks in the markets, no doubt. Okay, nothing coming through. Greg, why do I hand back to you for closing comments? Yeah. Look, I think the next quarter ahead is looking just as exciting, if not more so, as we continue to build on what we have achieved in what I think is a very short space of time. We have actually come a huge distance, particularly when you consider that this is a world first. I mean, we are having to help the regulators understand how this all comes together and plays out. We certainly see that we have a responsibility to do this as well as we possibly can, and as I said, to a gold standard. In terms of international expansion, we are obviously looking at that, as you have heard. Look, the next three, six, 12 months are going to be a very exciting time for us, and I think that we will see a lot more positive news coming out. Yep, I would agree. Thanks, Jane. Thanks, everyone. Excellent. Well, thank you both, and I will add my thanks to everyone that joined us today. We will make a copy of the recording available after the fact if you would like to watch it back or share it. We look forward to keeping everyone across Emyria's progress. With that now, I will say have a good day and invite you all to disconnect. Thank you. Thanks, Jane. Thanks, everybody. Thanks all.
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