Psychedelic Invest’s first Investor Hotseat livestream was broadcasted live on Thursday, May 26th. Host, Dustin Robinson, of Iter Investments, was joined by Anthony Tennyson of Awakn Life Sciences. As the CEO of Awakn, Anthony was asked the questions every investor wants to know but never gets the chance to ask.
This format of hard-hitting questions from Dustin, followed by live questions from the audience, made for a fast-paced knowledge-filled event.
Transcription
Hi everyone and welcome to the first episode of investor Hot Seat. My name is Dustin Robinson I will be your host by way of background. I am the Managing Principal of ieder investments which is an investment firm that invests in early stage psychedelic companies, including the
company we have on our first episode today awaken? Well, there are a lot of different media companies that are covering the psychedelic space as an investor, I just felt that a lot of them are all of them. Were really just not asking the questions that I wanted answered as an investor, really the challenging questions that I feel CEOs need to be prepared to answer. So our goal here at Investor Hot Seat, is to basically provide our investor audience with the information they need to provide to get the most educated they can to make a good decision when investing the agenda for each episode, what we’re going to do is we’re going to have first we’re going to have a five minute presentation from the CEO, obviously, five minutes is a short period of time. So there’s going to be a very basic overview, then I’m going to come in and ask about 30 minutes of questions, the most relevant questions that I think investors should be asking. And then we’re going to have around five to 10 minutes reserved for questions from the audience. So if you have any questions whatsoever, you don’t need to wait till the end, you can just drop them in the comments box. And at the end, I’ll be sure to, to address those questions. Also, since this is about investing, we have a couple of quick disclaimers. This is not a solicitation for investment and psychedelic investors not advocate to invest in any of these companies. This is for informational purposes only. And we encourage you to read the full terms and conditions on the psychedelic invest.com website. So without further ado, I’d like to welcome our very first guest, Anthony Tennyson, the CEO of awaken Anthony, I’m going to pass it to you for your presentation. And then I’m going to ask you a q&a. So you have five minutes, and you’re on the clock.
Dustin, thank you very much for having me on today. It’s a pleasure to speak with you and to everyone who’s logged on today. And it’s also a pleasure to be kept on the clock. So awaken in the 40 minutes, sorry, the four minutes and 40 seconds that we have left. And we are a biotechnology company who are researching, developing and commercializing therapeutics to more effectively treat addiction, with a near term focus on alcohol use disorder, which is a condition that affects 400 million people globally, and for which the current standard of care is poor.
We do two things in awaken Life Sciences. We do research and development, and we do commercialization. And in our r&d activity, we have multiple r&d work streams, to de risk our investment, the business for investors, we are active across three compounds, and multiple addictions, again, to de risk it for investors. We have clinical stage research, and also preclinical stage research. The second thing that we do is we commercialize those therapeutics. And we are doing that through currently through two revenue streams. One is clinics, and we have three clinics operational to in the UK and one in Norway. And the second work stream is more traditional therapeutics commercialization where we’ll package up everything that we do, and we’ll add licenses to the addiction treatment industry starting off in the US. We have four differentiators that really set us apart from other biotechnology companies in the CNS space in general, but psychedelics companies in particular, one is a significant market opportunity for awaken. We have a laser focus on treating addiction
20% of the planet suffer with a substance addiction, and many hundreds of millions of more people suffer with behavioral addictions. The approach that we’re taking to treat addiction by targeting brain circuits that hides the behaviors that drive the addictions. That Polly pharmacology approach enables us to develop treatments for both substance and behavioral addictions. It is a the single biggest unmet medical need of modern times. And the industry that is meant to be providing treatments is deeply underperforming. It’s $100 billion a year industry with about a 25 success rate 75% failure rate. So that’s a differentiator wellness, we’re pushing we’re bringing innovative, proven therapeutics to bear to a large but underperforming industry. Second differentiator is our team. We have a world leading team with deep deep expertise in biotech research and capital markets, including a world authority and Professor David not the second or the third, I beg your pardon. differentiator for us is our data driven science. We have proven efficacy for the use of ketamine assisted therapy to treat alcohol use
disorder, people coming into that trial are sober 2% of the time, that seven days a year, Dustin, people were sober. Coming out of that trial on the proprietary arm without trial, people were sober 86% of the time in the six months post treatment as a radical improvement, leading through to a significant improvement in liver function, and reducing the probability of fatality, for people who drank that much from one in eight to one in eight. We have other proven efficacy as well. And the fourth differentiator for us is the significant financial opportunity we believe we can present because of the maturity of our research, successful phase to be successful phase two a on preclinical assets, when you stack us up on our market capitalization against other companies in this industry. And indeed, the wider CNS biotech space, we are relatively under under undervalued because of the market dislocation that’s currently in place. And furthermore, we from a financial perspective, we have direct awaken more, because we are actually revenue generating in our second financial year. So that’s it, we’ve got we’ve got three core activities, or three, three core pillars in the business. We’ve got our r&d business, where we’re developing those combined therapeutics, that approach to treating addiction, targeting brain circuits Pati pharmacology approach using drugs and therapies in combination that’s new. So we’ve got a small clinics business, which enables us to fine tune the delivery model for our therapeutics before we commercialize them at scale, that clinics business enables us to generate real world evidence to support interaction with regulators, and also to generate revenue to de risk awaken for investors. And once we fine tune the delivery model for our therapeutics, we will commercialize those at scale. And we’ll start doing that later this year, early next year, buy out licensing in an off label fashion, what we’ve developed in our r&d business, fine tuned in our clinics business. And we’ll commercialize that into the addiction treatment clinic industry in the US. And it’s worth bearing in mind for the audience here that there are between 10 and 15,000 Addiction Treatment clinics in the US generating $40 billion a year in revenue, and they have a 75% failure rate in what they do. All right, I think your five minutes is out. We gave you an extra couple of couple seconds. But you did a great job. Great to have you on Anthony, how’s it going? It’s going very well, Dustin, it’s good. Good to see you. Again. Good to talk to you. Yeah, great to talk to you. So before we jump into the operational questions I have, I want to spend some time talking about the stock price and the financials, the s&p index right now is down about 50%. From its February peak, the ETF the psychedelic ETFs, are down about 60 to 70%. Year to date, you guys went public at $2.50. Your stock is currently trading at about $1.20. So I’d like for you to just take some time and talk a little bit about the stock price movement relative to the rest of the industry. Indeed, happy happy to do so. So to put that in context, and we went public in June of last year, we went out the gate or $2.50. Canadian in h2 last year, we were the second best performing stock in the psychedelic sector. And we were actually the second best performing stock in the psychedelic sector up until mid January. And then the capital markets on macroeconomic headwinds caught up with us. And we are down since then. But since we’ve gone public, we are down 40%. On our go public price, I think it closed the business yesterday, that stacks up against a negative 50% for the SPI index, which is the main biotech small cap biotech index, and against 68%, against the psychedelics indices. So we are indeed down on our go public price. But over the same period, we are actually outperforming the marketplace by being down less. And we believe that we despite this market dislocation, and because of our little drop in share price, and we represent a significant investment opportunity for shareholders, because of the market dislocation because we are relatively undervalued. I believe that’s just my opinion. And because of the maturity of our research, the catalysts that we have coming down the track, and the fact that we’ve de risked the business by having a revenue stream in our second financial year. Yeah, and just to add another statistic on there, the top four companies right now, that are psychedelic trading stocks are actually down 44% year to date. So it looks like you guys are also beating the top for stocks as well. That includes companies like Ge Ge research, compass, pathway, mind, med and so on and so forth. So, with the current market conditions, one of the things that we’re very focused on in our fund is ensuring our companies have proper runway. For these current market conditions. The market is just a total mess. There is not very much capital out there. So it’s very important you have the right
One way, I know that you guys recently just did a private placement, I’d like for you to talk a little bit about what kind of runway that private placement gives you and what milestones you believe you’ll be able to achieve with that private placement capital. So that private placement extends our runway when we went public, we had 12 months of runway, but we went public at the end of June last year. And so that private placement extends that runway.
We are in a unique position in the fact that a lot of our significant CapEx items are completed so far are committed capex items are completions, for example, our hit to lead program that was led by Evotec, the refurbishing and opening of some clinics, and the completion of the world’s first study into behavior and addictions. So we have the ability to dial up and dial down activity, which gives us a bit a bit of flexibility, Dustin, and but we are a biotechnology company, we are looking, you know, we will always be looking to raise money. And the more money we raise, the more we can get done. And the more the closer the I don’t know if this is even a real term, but we can bring our milestones in close we can reduce the timeline to execution and achievement of milestones is what is what I’m trying to say. And so we’re happy with where we are right now. But like all biotechnology companies, we are always looking to we always will need to raise more money. I’m going to press on you a little bit further on that. So specifically, what milestones will you think you’ll be able to achieve before you guys need to raise additional capital? Obviously, you could always, you know, increase your budget, reduce your budget sounds like you guys are pretty flexible with that. But with the current capital you have, what are the milestones you guys want to achieve before you gotta go out to market again? Yeah, indeed. So we have completed the world’s first study for behavior using developing a pharmacological treatment for behavioral addictions. And we completed that two weeks ago, we announced today that the data generated from that study has enabled us to file a PCT patent on the use of ketamine, its metabolites, and its derivatives to treat or behavioral addictions. So what we want to do is you want to do a deeper dive onto gambling disorder, which is a disorder that affects 400 million people. And we can fully fund that deeper dive into gambling disorder. And the next step after that would be to move into a phase two B trial for gaming disorder. So we can’t, we can’t do that second part. But we can definitely compete the deeper dive into gambling disorder, and progresses into enabling to get into a phase two on a gambling disorder with a compound that we never fully have, we believe we will have a strong commercial position in and second thing that we can progress is we have a successful phase two B trial for ketamine for alcohol use ketamine assisted therapy for alcohol use disorder completion, the results were published in the American Journal of Psychiatry in January of this year. And we have a phase three fully designed. And typically speaking, a phase three trial of that size would cost in the region of 10 to 15 million Sterling. And we have partnered with the University of Exeter and the national healthcare service in the UK. And because of that partnership, the total ticket price for that trial is somewhere in the region of about 2.2 million Sterling. And we’ve applied for a grant from the UK stage for two thirds funding for that trial. So if we are successful in securing that grant, we can also begin an execute that phase three trial with the cash that we have on hand. So those are two key milestones one moving from phase two, the interface three, for a condition, where we have efficacy proven before a condition that affects 400 million people for which the current standard of care is poor. And the second is a deeper dive into gambling disorder, which is a condition that also affects about 400 million people and for which there is no current standard of care. And around a molecule that we actually now have based upon the partners we filed a reasonable IP moat around. Got it. And so now let’s jump into some of the operational aspects of the business. So I know you have two different divisions, one doing r&d One doing clinics, you know, both are very capital intensive and require a lot of focus in and of themselves. So you’re doing both of these and we saw when the market was really hot. A lot of companies wanted to do this. They wanted to have kind of this since psychedelics are known, you know, to have the compound in conjunction with the therapy, a lot of people wanted to have the clinics that will be delivering this therapy, and when money was easy to come by, wasn’t the worst idea to have. Now what we’re seeing is a lot of companies are pulling back from that strategy. You’re seeing companies sell off their clinical assets or spin them out couple examples are field trip and we sauna, and they’re really now starting to focus more just on drug development. They recognize it’s highly capital intensive requires a lot of focus
Is and with the market being where it is they wanted to both those companies wanted to really focus on on drug development very challenging to focus on both of those businesses, both the both the r&d, and on the clinic side. I know you guys have not taken that approach of spinning them out. So I’d like you to address that. Is your plan to keep both of these businesses under awaken? And if so, how do you plan to really execute on these highly capital intensive, highly resource intensive businesses. So
I don’t want to comment on other people’s businesses or business models, but for us, it’s highly complementary. We are conducting research on ketamine for the treatment of behavioral and substance addictions. Ketamine is an approved medicine. And we can deliver these services in an off label fashion in the clinics, enabling us to generate real world evidence to feed into the target product profile for what we want to bring into the phase three trial and to support interactions with the regulator. Very importantly, it also enables us to generate real world evidence to support interactions with payers. And I think that’s really critical, is it’s the so what’s next that I don’t think enough people enough people are thinking about in this industry, you can focus on getting through your milestones, your stage gates with r&d. But if you get even when you get regulatory approval, you’re not even at the start on you might be able to see the start time but you’re not the start time. Right, you’ve got to start thinking about how do you what is it that you are going to bring to market? Are the payers going to be interested in what you bring to market? Have you asked the right question in your Phase Three design, that it’s now going to be acceptable for the regulator so that you can, you can even get your marketing authorization to first place the clinics is critically important for us. It enables us to understand the delivery model for these therapeutics. And if you look at what we’re doing to treat addiction. It’s the third evolution Dustin, in treating addiction. Addiction is is the biggest unmet medical need globally. And the first evolution in treating addiction was talk based therapy, which is the AAA, it’s admirable, but it’s got a 90% relapse rate. Second evolution was something like drugs and therapies used in sequences, something like Vivitrol blocker agent blocks, the uptake of alcohol increases the probability of getting through detox to enable you to get into top bass therapy afterwards, top bass therapy still based on 12 steps, what we’re doing is we’re using drugs and therapies in combination to disrupt the brain circuits, the highs, the behaviors, and then bring in Priority psychotherapy, that’s new. So if we want to commercialize this at scale, to fulfill our purpose as an organization, which is to democratize psychedelics, and to help as many people as possible, we need to understand how they’re going to be delivered in the real world. So that when it comes to having a conversation to the 10,000, addiction clinics in the US, that are generating $40 billion a year in revenue, but aren’t doing a political job, we need to be able to walk the walk and talk to talk. And so having the clinics is highly complementary, and highly supportive for us. Because we are in clinical stage late clinical stage with a compound that we can use off label in the clinical environment. If we were only operating on doing our research on preclinical assets. Now, there wouldn’t be any complement across the two. But it’s really important that we have the two together so that we understand the real world. And one just key story and the answer and have one key thing we’re learning is that the therapists is the rate limiting factor for in our clinics business. And we believe in the true scaling of this, these solutions and treatments to help as many people as possible.
And ketamine is works well, from a therapist perspective, people are only, you know, there, you can treat Pete two people per day. They’re, you know, eyemask on headphones on. So it’s relatively easy for the therapist, if you look at the traditional psychedelics of psilocybin, MDMA and LSD, six to eight hours in therapy, which is quite intense on the therapist. Right? If you can imagine doing that for your job Monday, Tuesday, Wednesday, Thursday, Friday, with different people each day, all of whom going through a hero dose, reliving some really, really difficult experiences in their lives. That’s tough going Majan doing that for 369 12 months, by the time you get into your second year, third year, your job, you’re going to be under pressure. So we believe then that the therapist in traditional psychedelics could lead to burnout or therapists moving around the industry, lack of shortage or lack of supply of therapists, war for talent for therapists, drives up the cost. And we’re understanding not because we’re doing the doing as well as developing and so for now, that works very well for us. Second thing is enables us to generate revenue. Each one of our clinics can generate a pipe $4 million top line. Let’s say to make the math easy for me today because it’s laid over this over the water. We have 10 clinics that’s 40 million US top line revenue for an
Early Stage biotechnology company, and they can kick out about 25 points and margin. So that’s $10 million, either database or free cash flow at a business unit level, that they can then reinvest back into the biotechnology business and annually on a non diluted manner. That’s, that’s okay. And again, it D risks awaken as an investment proposition for investors. Got it? You know, I think I agree with you that they’re highly complimentary, I think where the challenge is, is really capital allocation, right? Where are you allocating capital? And I agree, once these clinics are at their height, generating a lot of revenue, there’ll be generating cash flow, but I know in your deck, you talk about opening, I think it’s something like 15 to 20 clinics within the next couple of years. My question is, you know, if you go walk me through the financial model that or how much does it cost to open up one clinic? How long before your break even on that clinic, and then I’d like to talk a little bit more about that EBIT de number as well. Because for some amount of time, as you’re opening up, if assuming you’re still have that, that a very aggressive plan and opening up that many clinics, it’s definitely going to be very capital intensive. On the front end, once they’re all up and running, and they’re back there breaking even obviously, net, then it’s all cashflow positive. But I think if you’re scaling up that fast, you’re gonna have a lot of challenges with capital allocation. So could you walk me through some of the numbers? Just how much does it cost to open up the clinic? And how quickly do you expect to breakeven? Well, I’m just gonna say prayer, opening comments, this is definitely the hot seat.
These are the kinds of questions that the CEO should be asked, and he doesn’t normally get asked in most of the podcasts. So just first thing and I’m not dodging this question, but we are publicly traded. And I haven’t I haven’t given those kinds of details X externally. So I’m not I’m not avoiding the question. I’m just going to provide the information that I have already provided externally so as not to walk across anyone. And so we are not buying the buildings, we are leasing the buildings, and we refurb the buildings. And and so it’s not like we’re not deploying significant investor shareholder capital into buying buildings. That’s not what we do. It’s reefer it’s reasonably cost efficient, and not to get into the weeds. But there’s different approaches in different locations in the Nordics, the landlord will pay for an awful lot more if the refurb and the m&e work themselves, they will rent allies an awful lot of the refurb work, so you’re not paying for it upfront. UK is a bit different. Landlords are tricky buggers in the UK. But so there are ways that you can be more judicious in your use of capital to open revenue generating assets. And the question then is, what’s the ramp up time? So when do you get to break even on to profitability. And again, we haven’t spoken about that externally. But we do have good coverage from our analysts. Everyone off Miranda spoke from the banking ama so people can look to the staff report where the HC W report and get an understanding of what the numbers mean, from the clinics business. But as far as I’m concerned, it’s right now they’re highly complementary. It supports us on generating real world evidence, a positive feedback loop between clinics, clinics, and research. And really importantly, it enables us for when we want to go and scale into the US that we are actually coming and talking to the clinic operators using the language of clinic operators. And we have the war stories, and walking the walk and talking to walk talking the talk of clinic operators. And from a cap x perspective, we are very careful and making sure that we put the capital into the place that generate returns for shareholders. And that’s my job. One of my job’s is to create value for shareholders. And we’re very careful in doing that. Absolutely, yeah. And I appreciate that. I think it’s a good time to time to talk to the viewers just about saying, you know, we’re going to be interviewing some public companies, which comes with its own challenges with what they could disclose. Similarly, with private companies, there’s certain restrictions on what they could talk about. In addition, generally, when you’re talking to some of these companies, you need to sign an NDA to really get to the true confidential information. So I want the viewers to all understand I will be asking some tough questions, and I will try to tow that line. But there will be instances where CEOs just can’t can answer either for compliance or confidential purposes. So let’s, let’s move on to your r&d program. So the way I see we kind of have three kind of buckets of r&d programs, you have your ketamine program, you have your MDMA program and you have your NCAE program. So first, I want to talk about what you’re doing for ketamine for AUD unbelievable results. 86% success rate, compare that to the current standard therapy of I think it’s like 25% success rate, you know, horrible dropout rate. So the results have been absolutely incredible. Right and you guys are moving into a phase three clinical trial. The problem is, ketamine is already an approved
substance, right? So you’re not going to get a patent on the compound itself, you’re probably also not going necessarily for data exclusivity. So my question for you, I’m assuming you get approval of ketamine for alcohol use disorder, what is the moat for the company that would potentially stop other generics from producing it? And basically taking up market share? Yeah, that’s a great question. So
why are we looking at addiction in general, and alcohol use disorder in particular, as our near term focus? Well, I think it’s everyone is, by one degree by zero degrees or one degree of separation, no, someone who’s been affected by addiction, and alcohol use disorder, you know, in Ireland particularly.
And the current standard of care is poor. There’s typically speaking a 75% relapse rate for alcohol use disorder treatments, but the market that’s meant to be providing treatments is significant. If we take the UK alone, the NHS controls 90% of the marketplace in the UK, because they are the national healthcare service, and they pay for 90% of all services in the UK, they spend $3.2 billion a year on treating alcohol use disorder doesn’t work. So what we’re doing is we have we have a successful phase two B trial, we’re working to bring that forward into phase three, and it’s an n equals two AC trial. Typically speaking, a trial like that will cost between 10 and 15 million Sterling. And we’re partnering with the University of Exeter in the NHS to bring that price all the way down to 2.2 million Sterling, which D risks for investors because of the IP challenges. And we’ve applied for a grant from the UK stage for two thirds funding for that. So potentially, our cost for that trial will be sub 1 million Sterling, and we should hope to have an answer from the UK stage on that grounds. And before the end of q2 this year so imminent and and if successful, will aim for REG an ethics later this year on first patient or first participant I should say early next year, that as part of a plan for us to seek to secure currently to seek to secure marketing authorization for ketamine assisted therapy to treat alcohol use disorder. And it is the combination of ketamine and proprietary therapy that’s copywritten and protected that we will be bringing to the MHRA and the UK authorities to secure marketing authorization for our way of using ketamine to treat alcohol use disorder in the UK.
There are various routes available to build a further IP moat around the molecule. We have hired the former head of sales for Vivitrol and former head of sales of the EU for the US for Vivitrol. Vivitrol is a generic of naltrexone, and it solved a compliance problem for no tracks alone, which is used to treat alcohol use disorder. People would take a pill every day, that was the dosing regime. People suffering from alcohol use disorder may or may not forget, remember to take the pill, so no tracks alone, put in a subcutaneous slow release. So have put put no put the null tracks known in slow dissolving carbon setup, subcutaneous injections have them release over a month. That’s all it is. And it’s just that unique delivery mechanism gives them an IP most and they generate a full PATINS full reimbursement, madman or sorry, product liability insurance full reimbursement generates $350 million a year for alchemise who own that brand. So we are looking at additional ways to put an IP moat around ketamine taking inspiration from a route of administration approach. And when we know more information right now, I will be happy to come back on decision this offseason provides you with more details. We’re going to take you up on that I actually have the same question for MDMA, MDMA, once again, it’s a compound you’re not going to file a composition of matter patent on that. And you’re probably not going after data exclusivity either on your MDMA program. I assume your answer as far as the moat that you will be creating around that similar to what you’re looking to do for ketamine. Yeah, I mean, I think the route of administration is there’s less flexibility around the route of administration for for cap for MDMA, because of the volume and the size tends to lock this stage. It looks like being an oral pill, but we are looking at options for that. But it will most likely be as the seeking to secure on label use for the combined therapy, combination of MDMA and therapy together. And then the third thing we’re doing is around using ketamine to treat behavioral addictions. And we filed a patent to a PCT patent yesterday announced it today, which if successful, means that we will be the only company that can commercially use ketamine, ketamine, its derivatives or its metabolites to treat a range of behavioral addictions that affect between 800 and a billion people. So that’s a that’s a stronger IP position. And then the fourth workstream is NCS and we like ketamine how treats works in the clinic, can we like him? Do you may as well, but mg may pray the other answer I gave earlier on it
MDMA looks like it might take six to eight hours to work in the clinic with a six to eight hour recovery window. And even it comes into the clinic later than 11 o’clock in the morning. And looking at an overnight stay three shifts and staff, it becomes expensive different planning permission, different infrastructure. So we’re looking to take the benefits of MDMA and make it available in a shorter treatment window. And we are developing novel compounds on novel scaffolds that interact with the known receptor sites for MDMA, and further potential receptor sites that we have discovered as a team. So novel compounds, novel scaffolds interacting with known and newly discovered receptor potentially discovered an effective receptor sites for MDMA. And we have completed a hit Delete program, identify two series of drug like properties, we’re just testing those in a few animal models to see which will be the lead and which will be the backup. But those are fully proprietary compounds. And the great thing about our business model is because we’re working with ketamine and MDMA, in the clinic, near the clinic stage research, or to fine tuning the therapy side. And we’ll get we’re learning how that works in the clinic and in the real world, we will then bring that together those therapies together with our own components into a fully proprietary platform in due course. And so just so I’m clear, the the intact digit and class of families, the new chemical entities that you’re you’re working on, how exactly do they improve upon, for example, MDMA, MDMA is an incredible compound and has a lot of benefits. I’m sure there’s some setbacks. So what specifically, are you guys looking to improve upon with these, this other new class of intelligence? Yeah, so again, we need to be careful about not not sharing the magic sauce here. But its route of administration is answered, it’s half life, so that we can get to a treatment center that we like, and then also, and you may, it’s great, but it doesn’t have from a, from a pharmaceutical perspective, it doesn’t have a perfect safety profile. We know it’s safe from a psychedelics perspective. But that doesn’t have a perfect safety profile, because it gets metabolized into different things. And it’s not enough to stop anyone that’s doing anything anywhere else. But just we are looking to then develop it on a novel scaffold. So we’re not just taking the NGA molecule and tweaking it, we’ve got developed brand new scaffolds that will be entered it will be potentially
act like MDMA in a quicker window, quicker onset, shorter Half Life, enabling us then to solve the biggest problem of all, what’s the most valuable asset in the world? It’s time, time because time equals cost. If we can do something if we can develop something that enabled delivers the benefits of MDMA, in a shorter window reduces as the path of least resistance, right the infrastructure is set up, the global infrastructure is set up to deliver therapy or combined therapies in one or short, short, relatively short durations. If we can develop an intact agent that works in two hours, our clinics, other clinics, when it’s delivered at scale, can deliver a treat, treat two people per room per day, as opposed to one person per room over a 24 hour period, because you’re looking at an overnight stay. That’s where the that’s where the point of differentiation, dew point of differentiation comes in. Got it and a lot of companies that are focused on NCS right now we’re really looking to partner up with Big Pharma, we saw that with mindset for awaken as far as your strategy for commercialization. Is it your goal to take these NCAA ease all the way through clinical trials? Or do you envision that you’ll potentially partner up with maybe a big pharma player to really push in all the funding to push them forward? So that’s a great question. And I don’t have an answer there are there are multiple pathways forward for us. My job as CEO is to deliver value for shareholders to deliver, you know, improved therapeutic results for my clients, and to enable my team or my colleagues to have great careers. And so with the first one, for value for shareholders, there are certain value inflection points that occur along the NCAE development pathway. Usually, that is, after the successful phase one trial or safety has been proven. And then again, after a phase two B trial, or efficacy has been proven. And you know, right now, the current plan is to stick with these campaigns through all the way but my job is to always be open to ways are there ways that I can partner with people to create additional value for shareholders, improved work environment for my colleagues, and accelerate better outcomes and increase broaden availability to these life changing therapeutics to as many people as possible. Got it. And I have a whole list of additional questions. I’m asked one more question, but I want to let the audience know you guys have any questions? Drop them in the box. We’ve had it
Couple questions, but not many. If there’s not questions, I’ll probably continue with my, my own questions, but this is for the audience. So please feel free to ask any questions, just drop them in the box. So so my my final question potentially, is really about around your licensing partnership, business, you know, you guys, once again, incredible results in your ketamine for AUD D studies.
And, you know, obviously, whatever methodology you’re using in those clinical trials is extremely valuable. And it’s, it’s working. But my my skepticism around it is that, you know, you guys are looking to essentially license out those methods to other clinics and addiction centers that could potentially use them and hopefully get to have the same success as you guys are having. I think that sounds great from just a rational perspective. But I think we often live in a irrational world where egos get in the way, and from the clinics in the addiction centers that I know, you know, they currently have access to ketamine, right? You guys don’t have that patent, like ketamine, they could currently deliver ketamine for AUD off label using their own methodologies, maybe they don’t get an 86% success rate, maybe they get a 70 or a 60% success rate. And they shouldn’t be happy with that. But some, some of them I think, will be a little bit adverse to sharing some of their revenue with someone else to use their methods when pride gets in the way, and they think that they could just use their own methods and get a pretty good success rate. So I’d like you to just kind of address that. How do you plan to convince the market that clinics in the addiction centers, that is the right approach to partner up with you guys? And and have you guys had much traction? I know you said you guys were planning to roll that out maybe in the next few months? Just curious if you guys have had any traction with that strategy? Yeah. So if we take in sort of break it down a bit, why are we doing? Why are we considering licensing partnerships model. And the reason that we’re doing that is we’ve got a three stage commercialization plan for things that we develop in the r&d business. Stage one is in our own clinics, and with ketamine, we can commercialize ketamine, in our clinics off label in advance of security marketing authorization, there is a marked up but there’s a rate limiting factor, because we’re only going to have whatever number of clinics is between 10 and between 15 and 20.
There’s 1510 to 15 housing addiction clinics in the US alone, they tend to generate about $40 billion a year revenue. They tend to operate at single digit origin by 7%. And they tend to have a 75% failure rate.
We believe in a few things in the company. One of them is to democratize psychedelics, and democratization means on label insurance, public health care support. The other thing we believe in is something called doing the bloody right thing. And it’s doing the bloody right thing is making this methodology available to as many people as possible, even whilst we were awfully. So our licensing partnerships is a way to enable a large but deeply underperforming industry to become better at quantities that are meant to be bloody doing anyway. So are we going to license that age to all 10 to 15 pairs into clinics? No, we’re not. We just don’t simply have the infrastructure to ensure quality control? Are we going to work with a select few partners that will enable us to maximize our impact? Yes, that’s what we’re going to do. We’ve hired the ex Head of Sales for Vivitrol for the western region of the US. He knows the owner of every addiction clinic personally in the western region of the US, and through the rest of the US through one degree of separation. So do we know the good actors and the adequate actors? Yes, we do. Are we going to partner with the good actors who will be interested in delivering from a brand perspective, delivering awaken, delivering the only methodology that’s been proven in clinical trials have 86% efficacy that they can then use in their advertising materials? Yes, there are the people that we’re going to work with. And obviously, we’re going to have a contract in place that protects the IP, then we’re also going to train them in the delivery of the IP. And then we’re going to provide them with a system that enables them to efficiently interact between their clients, or colleagues or clients in the delivery of the service. And so all of that we believe, will just create the path of least resistance for a certain cohort of clinics that are interested in investing in quality. And then we’d hope that when we’ve done the numbers, we’d hoped that we’d make them more profitable. And they can then reinvest and more effective which you know, they should want to do, and then they can reinvest that profit, that additional profit into acquiring talent growing their business, and it’s those companies then that will move into a leadership position or gain market share, and other people want to follow him behind them. Love it. Well, you know, for the sake of all the millions of people that are suffering for it
Edie, I truly hope you guys are successful. The idea that we could potentially help 86% of the people suffering with this condition is just absolutely tremendous. And then obviously, you guys have the work you’re doing on other behavioral addiction stuff as well. So really hope you guys have the absolute best success with rolling out that program. So we do have a couple of questions. One of them is actually sounds like it’s kind of a joke, but I think it also does get to kind of a misconception in the industry and it says, you know, how about ketamine addiction? Right? And I think what they’re saying is, you know, how do we ensure people don’t get addicted to ketamine? So, you know, I don’t know if you have any thoughts as far as you know, the addictiveness of ketamine and really, what you guys are doing won’t proliferate any sort of ketamine addiction, pandemic epidemic. Absolutely. Happy to hear him. Good question. So, first of all, let’s just take a look at ketamine. Right, ketamine is on the WHO list of essential medicines. It is one of the most widely prescribed painkillers in the world. It is safe. It was developed by the American army as an alternative in Vietnam as an alternative to morphine. It’s called a buddy paying hitter and it doesn’t interfere with the breathing system or the blood system. So you tend not to tense you don’t tend to overdose from ketamine. Yes, there are stories of people become addicted, becoming addicted to it recreationally. And but the amount of ketamine that we use, we use a rep sub anesthetic dose three times over the space of two to two and a half months during the treatment program. That is not a sufficient volume of ketamine to develop any resistance to it, or indeed, to become addicted to it. And again, it is an incredibly safe medicine. It’s on the WHO list of essential medicines. And we’re using ketamine, because it is particularly helpful for what we want to do. We are developing those combined therapeutics, drugs and therapies used in sequence, using drugs to disrupt the brain circuits. That high is the behaviors that drive the addiction. And ketamine does three things. And it’s really important people, I’ve found that that’s very useful for us. There’s a strong disassociated effect with ketamine in the southern stop sub anesthetic dosing, and then a recreational setting. That means you get an antibody experience looking down yourself in the here and now. But with our treatment program, where you have a prep session, ketamine session and an integration session, in the prep session, we bring the issues to the surface. And so during the disassociated effects, people get to look back on the totality of their life, and the times at which they may have made decisions, poor decisions or had events in their lives that increase the probability of them becoming addicted. Second thing ketamine does, this is really important for certain types of addictions, ketamine disrupts memories. So memories are dynamic, as we call them memories up, that we they get replayed and they actually get affected and adjusted before they’re laid back down. If you bring those Maxam on some types of addiction are particularly driven by memory. So some of the memories of an early exposure to gambling an early exposure to pornography, the sight of a pub, the smell of a pint, those trigger that predicted rewards that come through in the brain, so short circuits itself. So if we can bring those memories to the surface during the prep session, during the ketamine session, those memories are disrupted as a laid back then they become less impactful on the individual and less impactful on their psyche, and therefore less likely to trigger that short circuit. The second aim for 30 and ketamine does is neurogenesis or neuroplasticity. A lot of people are probably familiar with the psychedelic space, that’s really important. Your brains up until the age of 18, or 19, or Britain things are grown new neural connections. After that they focus on being efficient, trimming all those connections. That’s why you get locked in repeated behaviors, repeated behaviors, repeated addictions, but addictive behaviors, external stressors, come on short circuit, just go back to the learned behavior. Ketamine disrupts that enables us to recalibrate the brain but then during the integration session with a qualified psychotherapist integrate those key learnings from the disassociated effect integrate the kid the coping mechanisms to really develop much more robust and dynamic coping mechanisms during that much more open part of the brain. That’s why ketamine is really good. So ketamine is a safe medicine, doesn’t interfere with the breathing system doesn’t interfere with the blood system does three things that are really important to us in the context of making psychotherapy more effective in the treatment of addiction. We don’t use enough ketamine we believe to develop any type of addiction or resistance and our approach has been proven to work in a phase two ab combined trial. Now and I’ll just add on that, you know, this is not take home therapy right so the opioid situation came up because you know, they were able to take it home and abuse it take too much of it in what awaken is doing. It is done in a clinic with only a certain amount of sessions. So
If not really a situation where people could take it home and take more than they should. That’s correct. We have a treatment protocol that has an initial medical assessment from a consultant level doctor. Then ketamine is prescribed if they pass the IMA administered by a nurse in a clinic with the psychotherapy prep session, active session integration session delivered in a clinic by a consultant level psychologist. So this is a medical grade assess psychedelic assisted psychotherapy. And so we’ll go to the next question from Adam T. In regards to ketamine, he says our patients coming in to get how often are patients coming in to get dosed in the study for a clinic visit? How long do the therapeutic benefits typically last? Yeah, so great, great question. So let’s just talk about the clinic, right, because that’s where the rubber hits the road. And that’s where we’re treating people. So we treat people were for addiction, but also anxiety, depression, PTSD, in our clinics. We’ve got different treatment protocols for addiction on the other mental health conditions, but just very, very high level. It’s, as I mentioned, for it’s about a it’s about 11 sessions, so an initial medical assessment, a prep session, Academy session and an integration session. And there’s three of those blocks. So prep, ketamine, integration, prep, ketamine, integration, prep, nine in total, and then a close out session. And that is typically over about two to two and a half months, just depending upon the individuals schedule.
Perfect. And then next question from Adrian Joe. Since AUD is may be comorbid. With other addiction indications, such as gambling, opioids, depression, what are considerations to keep in mind for patients with just AUD, Vers, AUD patients with comorbidities? And well, so we just put this in order context is 400 million people suffer from alcohol use disorder, and 14 million people suffer from opioid use disorder. So there’s 10x, with alcohol use disorder. So the comorbidity is not the biggest, biggest challenge. I think the comorbidity between alcohol use disorder and addiction in general and depression is, is more significant. And so part of the initial medical assessment is to determine, which is the drug, which is the which condition, if this is even the right term to use is in the driving seat. And then we make a determination as to which treatment track we put three people through or down, you know, in our clinics. For addiction, we have a treatment track that is CBT based, and it’s highly manualized. For anxiety, depression and PTSD. We have a treatment track that is act based, and is more formulation
made by a qualified qualified psychiatrist in each of our clinics. And if I recall correctly, Anthony, I think in your phase two trial with ketamine for AUD, I think you did look also at the comorbidity with depression. I know you reduce fatality, you know, obviously, suicidality is a big part of AUD, do you want to discuss any kind of of the, the the non AUD, other indications like any of your learnings from the research that you did in your phase two trial? Yeah, happy to do so. So the phase three trial, so the phase two be trying to make a plan, and there was the secondary endpoints were liver function. So people who would typically be sober 2% of the time, so said it’s over seven days a year, there’s typically a probability a one in eight probability of fatality, for people to consume that much alcohol in any in 12 months, and in the next 12 months, because we reduced that from 2%, or increased the sobriety from 2% to 86%, led through to a significant improvement in liver function, which is one of the secondary endpoints and lead through that conversion to a reduction in probability of fatality from one and eight to one an 80. In the 12 months post treatment, which is a significant improvement. We also saw a statistically significant improvement in depression. And a statistically significant and I always struggle to pronounce this word, so work with me on it in an had Dima, which is the ability to enjoy life. So there was positive results across primary endpoint and also the secondary endpoints. Great next question from your team. He’s wondering if you could treat ketamine addiction with ketamine.
Obviously, you’re within a mirror. We have not we are not currently looking at ketamine addiction. What we are looking at the primary indications that we are focused on his alcohol use disorder that affects 400 million people, and for which the current standard of care is poor, and behavioral addictions which affect over 800 million people and for which the current standard of care is most
Support. Awesome. And I think we are at the end of our questions and perfect. We think we’re at the end of our time as well. So, really appreciate everyone attending. Anthony, you did a great job. You made it through the investor hotseat?
No, thank you so much. Hope everyone has a great evening, Anthony. I’m sure we’ll be in touch. Thank you so much. We’ll have you on next time as well. Once you get a little bit of your face three results. absolutely happy to just it was just it was it was great fun. Thank you very much, Alison. Thanks for all the questions everyone keeps me on my toes. Really appreciate it. And yeah, look, just just just stay in touch with us. If anyone has any questions, just email me Anthony dark Tennyson at awakened life. sciences.com I’m happy to follow up with anyone on any questions. Thank you guys. Have a good evening. fares. Take care. Bye bye.