 All right, great, thank you. So my name is Shlomi Raaz. I'm the founder of Elucis. So clinical trials have revealed that psychedelics are antidepressant. And Johns Hopkins has recently initiated a trial into the use of psilocybin for treatment of depression specifically associated with Alzheimer's disease. I mention that because the therapeutic potential of psychedelics extends far beyond psychiatry. And so for 6,000 years, peyote was used as a traditional medicine. Its primary use was to relieve pain and to treat inflammation. The medicine man, when asked by Richard Evan Schulte's, the father of Ethnobotany, said that we use peyote the way the white man uses aspirin. In 2008, our scientific founder, Charles Nichols, at LSU discovered that some psychedelics are hopefully anti-inflammatory of dose concentrations that are unlikely to be perceptible. In 2013, a few blocks away from here, I found that Elucis pursued this particular opportunity. I was at the time at NYU, studying to be a psychotherapist. And that's when my training from my days at Goldman Sachs kicked in, and I realized that this was going to be a huge opportunity. So I'd like to say we were the first psychedelic company, and quite ironically, our first objective was to develop these drugs for sub-perceptual use. And so we have conducted clinical trials with LSD at sub-perceptual dose levels. We've also developed an entire pipeline of new chemical entities that appear to be hopefully anti-inflammatory at sub-perceptual dose levels. And we are going to be treating chronic inflammation associated with aging. Aging both drives inflammation and is driven by inflammation, a process called inflamaging. And the compounds that we are developing have efficacy in multiple translational models. So whether it's inflammatory bowel disease, whether it's respiratory asthma, whether it is cardiovascular disease. And strangely enough, if we can move quickly, the first psychedelic drug may be approved for ophthalmology. And that's where we're focusing our initial efforts. And so ultimately, we were inspired by the example of GW Pharma. And so from a cannabis perspective, that's where we're coming from, which is to take a stigmatized drug and make it a valuable medicine, develop it just like any other life science company. And that's what we're doing. We are dedicated to the transformation of psychedelics as medicines. And we think that given the preclinical evidence, the opportunity dwarfs that of anything that we've seen, certainly in the cannabis space. And it's very exciting to be involved in that effort. Let's start on the line here. Right. Yeah. Yeah, thanks for having us. Florian Kothauer is here for the time of my experiences. We are a mental health care company that is also looking at psychedelics, but more broadly an innovation that's on the space of mental health. And our core focus is basically communications. It's addiction, depression, and anxiety. And we started at a time, basically, out of very personal motives. So the founder and, more broadly, a team member had a very personal exposure to mental health illnesses or disorders. So myself suffered from anxiety disorder in my teens. We're taking years old. So for me, therapy worked quite well. And then there was another life event two years ago when we lost the mother of my wife to cancer that then deeply traumatized my wife. And for her, the usual treatment pattern that are available, our standard of care, didn't really do anything, didn't really work. So a friend of mine and co-founder of the Thai actually pointed us to the therapeutic potential of psilocybin. And it was going on in Japan Hopkins in 2016, and then Barbara L. Griffith. And that was basically the starting point that we realized as it was such a healing experience from a wife when she had a high dose of psilocybin years ago, where it's sort of legal. And yeah, that was kind of the main driver. And we started one 12 years ago, had complex pathways of one of the first portfolio companies, or platform companies, and then moved on to onboard, not all, over the last one and a half years, seven more companies that are dedicated to really make a leap forward in this space in terms of bridging the gap of what's available right now and what's desperately needed for the millions of people that suffer from these three indications. Thanks. Yeah, okay. So my name is Craig Kelly, I'm a scientist by training. I worked in the foreign industry for the last 10 years. I've been working in various biotech companies. I've been doing this orders and since about July, I've been working with the IT team as the CEO of Perception. Perception is one of the portfolio companies. Perception is not per se a psychedelic company, but I think because we're developing our ketamine, which is one of the two bisoners of ketamine. And ketamine's been on the market as an anesthetic for 50 years, a lot has known about it. But I think the discovery over the past decade on the increase in use of ketamine for treatment of depression in an all labelled setting has really opened up the door for what I will call mental health treatments that were inspired by some of the psychedelic. So we are developing our ketamine, which on paper actually looks like the less open isomer of ketamine. And but when you look closer, and when you look at the animal pharmacology, there is a very strong argument that the antidepressant effects are gonna be much more separated from the sedative effects or the dissociative effects of the other antidepressant or the receding mixture. So this is our goal, is to develop our ketamine for the treatment of depression. We consider ourselves a mental health company, not a psychedelic company. And in fact, we're hoping not to have a psychedelic side effect of pyroclastic or ketamine or another. So I wanna start with kind of a larger question here. Obviously we are in the early stages of research as you guys can speak to, but from a business or financial perspective, how do you decide what specific ailments begin targeting and how do you look at the research coming out of that? You feel free to chime in, but we'll start. Okay, well, so when I started way back a few blocks away from here, the original thinking was, how can you treat the greatest amount of suffering or the least amount of effort? And how do you create the greatest commercial opportunity? Because you have to attract a lot of capital to conduct clinical trials and to do life science. And so the thought is that this shouldn't be done any differently than traditional life science. And so we should identify the fastest path to market with the greatest unmet need. And so psychiatry is very difficult to develop in. And certainly I have a tremendous amount of respect for maps and compass and your son and all the efforts that are underway to treat depression. Ophthalmology and inflammation not as difficult because it's very definitive. You can see the drug work, right? There's no question as to placebo effect, or very little question. And so our thought was the 60% of human disease burden is associated with chronic inflammation. So that's probably a good place to start. Then let's go based on the models that we have, the animal models that we have, and let them guide us towards the indication. And so we use those animal models to guide us towards optimizing the drug. And so looking at the unmet need and then looking at the pre-clinical data, we then factor in the commercial opportunity. And if you line, if everything is a check on all those boxes, then you move forward. Now, our first study is with microdoses of LSD. And that was because if you don't know the name of the drug, it hits every therapeutic target in Alzheimer's disease. However, if I walk into a venture capital office and ask for money to do an Alzheimer's study, I'll be lucky not to get punched in the face because there's been so much money lost in Alzheimer's therapy. Better to start with a much faster path to market with something with much lower risk. And then when we establish group of concept in tissue that looks a lot like the brain, you know, the retina is really the front end of the brain, then we ask for the bigger checks and we go after the widowmaker in pharma, which is Alzheimer's. Yeah, can you keep going? Yeah, yeah, I couldn't agree more, I guess it's not a surprise that we also followed the approach of looking at the amniotic elite and the commercial potential. So I think in general, we can split our approach to induction therapy that tries to tackle trauma or lack of meaning that is often the underlying cause of addiction and depression, and then more as maintenance or bridging therapy with the other compounds that we have in development what's kind of a common approach that we have is that all those compounds are inherently dearest as they have. In one way or the other, proven to be safe or efficacious in humans, either in a googly or based on the data that we have for instance on the psilocybin from the 50s and 60s. So psilocybin has been or has been sold by senders back in the days. So basically looking at compounds where we're fairly certain that there are no big surprises on the safety side and we at least have any gold evidence that they're efficacious, such in the case of psilocybin, iodine and so forth. So that's to your point. Yeah, and I think to echo Florian's point, which is a very good one, I'll just quickly. Using anecdotes and historical data, I think this is really what gives this area a very attractive profile from an investor perspective. The fact that these compounds were in use for 6,000 years is a pretty long phase one study. And I think also echo the point regarding the safety profile, being able to use compounds that have extensive testing in preclinical studies gives this area a huge degree of attractiveness from an investment perspective. There's I think 40 or 50% of all drugs fail at phase one. And the fact that we know that these drugs will not fail at phase one from an investor perspective, we think is a very attractive profile. I would have a few comments to this because I agree with both of you, I think. And maybe this is biased from 20 years of karma, but I think you really wanna start with the end in mind in any investment. How are you going to get out of it at the end of the day? Are you going to sell it to somebody? Are you going to market this yourself? And if so, how are you going to do that and do you have the resources? So I think with any investment, and especially in the life sciences, you really have to look at three things. Is there a personal commitment? Are you excited about the story? And the story can be personal. The story can be, I just love the science and I wanna see if it works. The story can be the patient, which I hope is always in our minds, in our hearts somewhere. And then you have to start thinking about other things. Is the team in place or can I put the team together? So you have the story or the science, you have the team. And then you have to start thinking about and you have to be brutal about this. What is gonna go wrong in this story? What is gonna go wrong? Biotech should be presenting to their board of directors every quarter. What is the experiment you're gonna do that means we never have to meet again? Because if you can pass that hurdle on a regular basis, you're going to be de-risking this program. You're going to be making it sexier for the next round of investors or for the person at the end of the day. But you really have to have, you have to have a dispassionate look at the data and you have to basically separate yourself from all of the things that got you excited about it in the first place. So I'll turn to a pretty basic question. Obviously your research subjects, the US are federally controlled. Can you talk about some of the difficulties with A, like accessing quality supply and B, maybe even the funding to do so? And whoever wants to start can jump in. Well, I think so, yeah. We can. All right. Any other communication? We're gonna jump to a few things. So in this deal, I think the fact that you're dealing with controlled substances will always put, it's not necessarily a hurdle, but you can usually, I just found the regulatory agencies to be actually quite reasonable when you talk to them and you lay things out and you have the proper controls in place, but it will slow things down. So it'll be more denied if it's more of an issue of speed than anything else. In any clinical trial, picking the right patients, getting access to the patients, having the right KOLs, it's gonna find you to test some growth. Yeah, and maybe adding to this, I think we've seen since 2017 that the regulatory agencies in particular, the FDA is very open to new ways or new innovation in this space, especially also psychoballies. So a mass-received breakthrough therapy designation for the NVMA-assisted psychotherapy for PTSD 2017, followed by cumbersome pathways with psilocybin for kidney-resistant depression, and also USONA-received it for a major depressive disorder. So we see a great openness in the space from regulatory agencies as well as also from the science community. So this year at the AACMP in Florida, there were different panels that were actually putting this on the agenda and talking about psychedelics as a potential medicine. So that's very encouraging from my perspective. And in terms of funding, I think it was mentioned, I think in the previous talk. So over the last two, three years, I'd say traditional, investors were reluctant and skeptical. But this year at JPM, we saw that this is really changing and that there's a real interest in not picking up from a farmer, but also from the more traditional crossover funds, biotech funds. So that's very encouraging to see. Yeah, I would say, so I was a naive amateur walking into all of this. I came from a background on the trading floor and so I had to learn how to conduct a clinical trial and do all of this. And so it was quite strange. My last day at Goldman, if you would have asked me what's more likely? You're abducted by aliens or you're sponsoring a clinical trial, getting LSD to be elderly in London, right? Well, I've heard of alien abduction. And, but there we were. And so what were the hurdles of doing that? Well, the good thing about LSD is that it has a remarkable safety profile, right? And it has extensive preclinical literature. So when we approached the MHRA, which is the UK Regulatory Authority, and we came in with the thought leaders in the Alzheimer's space saying, hey, this is worth a try. They were not only supportive of it, but very encouraging. And I'll just echo the point that Florian made here is that the regulators are clearly not a barrier. They're in fact, waving the green flag. They are very encouraging. They know more about this space than many of the scientists in this space, right? And in terms of its history, I'm quite impressed with their knowledge, both the FDA and the MHRA. I would say that the other challenges, patients, certainly recruitment rate, as any good clinical trials expert will tell you, it's just about how many patients you can get in and how fast you can get them in. We were advertising for our studies on the back of double-decker buses, which kind of blew my mind. Would you like to participate in a study? Didn't mention LSD, getting a recruitment rate high enough to get your trial done quickly is really crucial, because every moment in the clinic is costing you a lot of money. And then lastly, in terms of the capital, I think that's really the big question. And again, I point to GW Pharma, right? They're a $4 billion market cap company, but back in 1998, no one wanted to touch them. And the way they got their first clinical trials funded were from individual investors and family offices before they were able to attract institutional capital. I was also a JP Morgan, and I had a lot of great meetings with very large, very well-known VCs, and they say, oh, this is very exciting. We want to back you, but get the asset to phase one B first. And so there's an opportunity for investors that are not traditional life science investors to play a crucial role with a lot of the companies that may not be kind of venture backed. And so I think there's a unique opportunity, but that window is going to be closing very quickly. So I wanted to drill into that a little bit. Can you paint a picture of who is funding this region now proportionally? Obviously retail and administrative family offices, but when will we see the first pension backed VC, like, what's that? I think that's probably a better question for Florian, because a tie has raised a significant amount of money more than any other for-profit venture in the space by far. I would say that if you look at our cap table and who funded ELUSA so far, my wife kids that I used to have money and now I don't. So certainly I put in all my money into this because I'm never going to see anything like this again. I'm all in. And the people that came in either were convinced that I knew how to make money, they knew nothing about psychedelics, or they had some sort of life changing experience and that they were committed to the mission. And so what's interesting is that oftentimes people think that investing is kind of a neocortex type of thing, like you evaluate this, you evaluate that. I found that to be not the case after 15, 20 years of trading for experience. It's just emotional. And to the extent that people feel like it's a good investment, then they tend to be involved in this space. Asset managers, they act more like herd animals. And so once the lead steered starts moving in this space, you'll see the whole herd moving to the space. Florian, same question. Obviously, like Shulmi said, you guys have raised a lot of money discussing what you'd like to discuss. Can you talk about what your investment space looks like? Yeah, sure. I think you can basically identify three groups in general that we can talk with or that we raise money from in the past. So certainly the visionaries like Peter Thiel and Steve Gerbson were involved in, or were at work with Facebook, Tesla, and Spice, I think they really believed in this. They did something big there that deserves to be backed. So it's gonna be impact investors and mostly family offices, billionaires that believe in the cause that we're doing. And the second group is more than we'll mention investors, kind of as I would maybe call them. So looking for the next trend after cannabis, after crypto, and seeking a good return of investment. And then the third pocket, and that's something that is picking up now only over the last month. I would say serious interest from pharma and more traditional biotech investors that we're so far staying away from the field. Terry, similar question. I mean, obviously you've been in the field for a long time. How's working with a ketamine, I guess, different than any other drug that you've developed in your career? So I actually come from the research side. Research side, yes. But it's an important differentiation because for that question, I'm used to being the first person to ever made a molecule. Ketamine's now in the market for 50 years. It was made in the 60s or the 70s. So for me, it's really a good often question to really sort of skip the whole classic R&D pace and can move right into development. But it's actually an interesting molecule because it's been, R-ketamine, not ketamine, that's very, very important that we talk about the single-aximum here. R-ketamine has been half of every dose of ketamine that's been dose for the last 60 years. You talk about, you know, 6,000 years of phase one. This has been phase two, three on the market for generations. And that extremely high dose is compared to what we're going to be looking for. So there's this tremendous database that gives us the two things you need in a molecule. You need to show that it works. Well, we know it's going to be safe. I don't think there's any doubt about this. Even our informal discussion with regulatory agencies, they accept this. They certainly want us to go back and doxomize and cross some T's, but they accept the fact that this is going to be safe. That's the doses we're going into. And now the question is, is it going to work? And what does that window and what does state mean? So we're pretty sure from the animal work and from some anecdotal studies that our ketamine is going to be a very effective and rapidly-acting antidepressant. Our challenges are to figure out how to dose it and there are various ideas there. And our real challenge is to show that this compound has a therapeutic window between activity and sedation or disassociation or disassociation that makes it suitable for home use so that it doesn't have to be given in the clinic for a psychiatrist's office. And if we can get those marks, this is going to be a tremendously powerful tool for patients and for psychiatrists. And that's our goal. So I want to take a forward look now at the policy side of things. What, I mean, in very broad strokes, like where are we going to see some of these compounds maybe a decade down the road? Like are they going to be rescheduled? Who have you different schedule? I'm kind of curious about what your perspectives are on that and Florida may be excited to do it. Sure. So hopefully in patients, so that's our focus. And so, you know, I'm generally skeptic about kind of the legalization and enriching this field because it's such a powerful compound that should be given a safe and very huge clinical setting in, so that's the time's conviction. So it should be likely to be kind of a proponent for recreational use here. So I guess it will take another three to five years to really roll out the psilocybin therapy. So that's basically the most advanced compound that we have in development on the assigned platform. So basically demonstrating that it's scalable that it actually can reach the patients in a stable manner. And then also with the other compounds, I think scalability is one of the key challenges. I think it was also raised in the last talk. So that's what we're dedicated to kind of put money behind to then also see how you can treat those molecules to make the duration shorter and then to kind of, well, while maintaining the efficacy to kind of demonstrate that it's scalable, but for us it's really about getting better treatments for patients, not so much think about what could be happening from a policy perspective in 12 years. Sure. Tommy, do you have that perspective on that? Yeah, we're focused on like a different space. So psychiatry has its own challenges in terms of having to do this inpatient or not inpatient. The drugs that we're developing by definition have to be outpatient. And so the good thing is that there's very well-established precedent for this. Many people don't know there's actually an FDA-approved psychedelic on the market. It's not a great trip, but it's called Orcasirin, Belvic. And so Belvic, when you take four times the recommended dose, you're gonna have a bad trip. And therefore, when arena pharma got FDA approval for the drug, it immediately went to the DEA and the DEA scheduled it, scheduled three, right? There's another great example, jazz, pharma and Zyram. Zyram is also GHB. GHB is scheduled one, but Zyram is scheduled three. And the reason why it's scheduled three is that jazz, pharma created a risk mitigation system to prevent the misuse or diversion of that drug to people that were abusing it. So I think that the answer, for example, LSD, if we demonstrate that LSD is efficacious in preventing Alzheimer's disease, there will be a way to get it to patients. And I think that the answer there is frankly you look at the safety margin. The safety margin for LSD is not gonna be great, right? If you take twice the recommended dose, you're gonna have some psychoactivity. And therefore there will have to be a robust risk mitigation system in place, which is something we're developing and we think is a core part of the intellectual property. But when it comes to ophthalmology, when our safety margin is better than Lercasurin, then we would expect to be scheduled four or even unscheduled, depending on the safety margin we demonstrate. And the FDA and the DEA have been incredibly clear on this point. And so I don't think there's any ambiguity in terms of how these drugs are gonna be classified or regulated. Okay. And I think in general, once you have extra proven medical use, that it has to be rescheduled in a certain period, so. And we've discussed this a little bit that the regulators are forward-thinking on this, but how much of your roles is educated regulators? So I'm gonna start with you. Yeah, zero. The education maybe is more about how the drug actually has effect in the disease, but as it relates to policy implications or educating about psychedelics in general, I can tell you that the representatives of the FDA, the DEA, the MHRA, they've had a tie and compass roll through town. They've had Rick Doblin talking to them for at least a decade. They've had Usona and Hector talking to them for at least a decade. And so just by process of osmosis, if nothing else, they know more about psychedelics than I think, again, a lot of researchers do. And so I give a lot of credit to the regulators. There's absolutely no amount of time that we have to spend to educate them about this class. And I would just say that we're not in those discussions yet. We've been lost my thought here. So, but I think in general, there is a knowledge base there. And we just have to make sure that any acceleration of a path, the regulators will always want things done completely and thoroughly. And we just have to make sure that any diversion from that, because in our case, that means been around for a long time, it's completely justified, it's completely discussed, it's discussed in the old point, and we don't go in with the assumption that, of course, they're gonna let us get by with this study instead of that study because it's been around for so long. So I think that discussions with regulators should always be an open discussion. It should be a peer discussion. And you should understand what their job is. Just like they understand that your job is to bring in patients. So we're coming up on the end of our time here. Should we take it over to Q and A? Is that sure? Questions? How should we do this? Can start right to laugh. Hi guys. So I have two quick questions. First, for Terry, how do you think of the academy to to addressing depression as opposed to LSE or other psychedelic compounds because I'm seeing that both potentially are cured. So how do you think of, what is heading in the right solution versus psilocybin? That's my first question. How do I answer the non-psilocybin? So I'm not sure I'm qualified to do this. I'm a PhD chemist, not an MP psychiatrist. So, but I would just say that right now at least that there's a lot of clinical use of ketamine mob-labeled and depression clinics. And I think that there's a growing understanding of how to use at least ketamine in clinical use. And I really don't know how that compares to, for example, to use of LSE and clinical use, which is probably a very good idea.