Social Wellness with Jonathan Leary

Doug. Doug Drysdale is a 30 year healthcare industry veteran. He is the CEO of cybin. They are a biopharmaceutical company focused on psychedelic therapies to address mental health challenges. Welcome to the show,

Doug Drysdale 0:14
Doug, Hey, George, good to see you. Thanks for having us on. Yeah. I

george grombacher 0:18
appreciate the time. Tell us a little about your personal life, smart about your work and why you do what you do.

Doug Drysdale 0:24
Yeah, thanks for that. Look, you’re right. I’ve been involved in drug development for 3035, years or so, in different roles, building companies to, sort of, building engines to to do that. And it’s been a it’s been a good career and a good experience. But, you know, it’s easy to become a little bit cynical about the whole pharma model. I think a lot of people are, and I have my own cynicisms with it too, in that when I look back at the sort of track record, and you realize that, in general, as drugs get developed, they’re just a little bit better than the one before. It Right? And incrementally better we that’s the way science is. It’s sort of incremental. We learn a little bit more the next drugs a little bit better than the last one. And it’s, it’s kind of rare that you make these big leaps forward. It happens, but it’s pretty unusual. And so that’s why I’m at cyber is because what we’re seeing is this opportunity to really leap forward and completely change the mental health treatment landscape. And these treatments we can talk about kind of act like pharmaceutical interventions. So instead of the daily kind of grind of trying to reduce someone’s depression symptom, for example, we can put people on a different, different path, very rapidly and for long periods of time, which is one or two doses of these, these treatments. So it’s a, for me, it’s a working once in a career, once in lifetime opportunity to really make a big, big difference. Well,

george grombacher 1:58
that’s certainly an exciting thing. So it

Doug Drysdale 2:01
is, it is. I mean, honestly, we can talk about it, but yeah, honestly, some of the results we’re seeing, I hate to say this as a biotech executive, but pretty close to being miraculous. That’s kind of, I’m reluctant to say it because it just sounds not credible. But, yeah, we’re really seeing life, life changing results. So,

george grombacher 2:25
so mental health is, is a great big term. So what is, what is the problem that Simon is working to solve?

Doug Drysdale 2:33
Yeah, so specifically, right now, we have a couple of programs. One’s focus on depression, major depressive disorder, which is a sort of formal term for depression, and the other is focused on anxiety disorders, specifically Generalized Anxiety Disorder. You know, in psychiatry, there’s a whole range of different syndromes all kind of merged together, but basically depression and anxiety in the future, these substances seem to have potential in other conditions too, bipolar disorder, potentially cluster headache, strangely, migraine, maybe chronic pain, alcohol use, opioid use. So there’s much broader potential in the future. But right now, anxiety disorders and depression

george grombacher 3:20
and when I research mental health problems, I get a lot of different different statistics, and I get a lot of different statistics on how many Americans, so I’m not sure people all over the world are are in treatment for mental health. What is, what is the landscape look like when it pertains to your work right now on depression and anxiety.

Doug Drysdale 3:45
So depression, if you look at the official numbers, as something like, well, mental health disorders, which includes depression, anxiety, eating disorders, all these something like a billion people around the world. To me, that sounds like a small proportion. I think we would all suspect the numbers bigger than that depression specifically, about 300 million people globally, 21 million people in the US. 40 million people in the US are taking SSRIs, drugs like Prozac and Lexapro. I suspect that there are a lot more people that are not diagnosed or not treated, choose not to be treated, in many cases because of either stigma or because of the side effects and various other things. So those numbers are big enough, but I suspect they’re under reported. And

george grombacher 4:33
how does what you’re doing differ from SSRIs?

Doug Drysdale 4:38
So like we’ve been we’ve been using SSRIs for 40 plus years. Prozac was the first one discovered in the early 80s, a big breakthrough, and no question, first time we actually had something the patient could take that was tolerable and could can impact their depression. Typically, with SSRIs, about a third of patients. Find themselves in remission, which means no depression, and then two thirds typically end up with some kind of blunting emotional blunting is the term. So it’ll blunt the depression, but not remove it, reduce the symptoms. Also tends to blunt all emotions, so there’s a kind of lack of joy as well, which is unfortunate that those daily they take four to six weeks to work, so it’s fairly slow process. Patients have to wait work through that, and then they can encounter some side effects, weight gain, sexual dysfunction, insomnia, some cognitive effects. So they work for some people, I think a lot of people we speak to on SSRIs wish they weren’t on them. Wish they were taking this daily thing that they that not addictive, per se, but they become an emotional crutch for people to be on. And what we’re seeing with our treatment is that we’re not treating daily. We we have a regimen which is two doses, three weeks apart, and after two doses, we see 75% of patients in remission, so free from their depression. And we followed up patients for a year in our phase two study, 70% of patients still in remission one year later after just two doses. So we see about 40, 50% of patients in remission after a single dose, about 75% after two doses. That a two dose measurement seems to be helpful, but the real benefits is that we see effects within a day of the first dose for a lot of people, and after two doses for most patients, benefits lasting for a year. So we can get rid of this daily dosing, we hope rid of daily side effects, and free up a heck of a lot of resources. Obviously, you can imagine depressed patients are quite resource intense in that they see their physician six or nine times a year. They’re tweaking their medication. They’re dealing with side effects, they may have other comorbidities like hypertension or diabetes, and it means that only about 18% of psychiatrists are available to see new patients. It’s pretty hard, if anyone’s tried to see a psychiatrist or a psychotherapist. It takes a while, 40 to 70 days for a first visit. So the system’s all jammed up. Lack of resources, high touch patients. So if we can, if we can give just patients just two doses, and have them out of the system for a year or so, at a time we’ve only tested for a year so far, that has ramifications, not just for patients, but for the entire mental health care system.

george grombacher 7:47
Seems like that’s a bad business model. Doug, you should have people using your product over and over again.

Doug Drysdale 7:53
Well, there are 21 million people. It may take us a while to get through all of those. I don’t think there’s going to be any shortage of patients. Unfortunately, it

george grombacher 8:01
was a that’s, that’s sort of a dark joke I made there, obviously.

Doug Drysdale 8:08
So you said, if we put ourselves in a business, George, that’d be, I could sleep. Well, that’s been okay, yeah,

george grombacher 8:13
there’s, there’s, there’s, there’s no doubt about that, I think that we talked about at the top, just people being cynical about maybe healthcare and pharma, and I think a lot of that is because we perceive much of it to be sort of the business model where I am the product, and you just want me as the person to be in your system and using not yours, but using these products forever. And I’m not interested in that. I’m interested in getting better, and I’m sure that that’s what everybody wants. So to hear this, that, with just two doses, 75% of people are in remission after the first year, and a large percentage of those remain there, is, is, is incredible. What’s, what’s, what’s the secret?

Doug Drysdale 8:59
Well, the secret is we have to get it approved still. So we’re in late stage trials now. We’ve been working with FDA. FDA has granted us Breakthrough Therapy status, which basically means they give us all this fast track resources to help us get to the finish line more more efficiently. So these results were in a fairly small phase to study 36 patients, and now our job is to repeat those results, or get close to that in about 500 patients now, which is what we’re doing now we’ve started that last phase of development.

george grombacher 9:35
And are you extremely confident? Are you cautiously confident? Are you? Are you stressing out?

Doug Drysdale 9:44
I’m, I’m, I’m confident. Yeah, absolutely I am. You know, this is three things that you have to worry about. I think with clinical trials, the first is always safety. And I think we’re confident in the safety profile. There’s a big benefit of not having to dose every day. A because you’re not having all these potential side effects daily. The second is, efficacy. Will it work? I think we’ve shown pretty spectacularly that it’ll work. Will it work as well in a much larger population? No. The numbers will come down, but they’ll still be dramatically. We expect better than anything else that’s been approved so far. And then the third issue is execution. You know, 500 patients, two studies, 40 dozen countries, 80 sites. It gets complex, but that’s where my focus is not so much on I’m not worried about safety and efficacy. We’re all focused on execution,

george grombacher 10:41
yeah. Well, that certainly does make sense. So wondering if it will work, I mentioned at the top it that this is a psychedelic therapy. So what? What is it?

Doug Drysdale 10:52
Yeah, that’s good question. So psilocybin is, is a well known molecule now is originally derived from magic mushrooms. That’s where most people have heard of it. That’s the psychedelic molecule. Psilocybin itself is not active. It’s a pro drug. So it’s an agent that when you ingest it, it has to be metabolized to silicon, which is the active agent in the body. So we ingest mushrooms, convert them to silicon. What we’ve done at Simon is we’ve created a synthetic version so we don’t have to go out and grow mushrooms. We don’t have to worry about the inevitable variability between species and between fungi. So we can repeat, repeatedly, synthesize this in a pure way, and by developing just the active agent sinusine, we remove the metabolic step, and we remove the inefficiency of that metabolism, so we make the whole thing more efficient. And then we’ve applied another technology called deuteration, and this is where we take selective hydrogen atoms on the molecule, we substitute those for heavy hydrogen or deuterium, and we change the way that the the molecule gets through the body to the site of action, the brain. So we’re not changing how it works. You don’t want to mess with that once you know something works. But we’re changing making it more efficient at getting into the brain, so we get better brain penetration, higher potency, so we can give lower doses. So it’s a modified version of of a natural compound you would find in magic mushrooms, refined, modified and synthesize. And we’re calling it CYB three, which is our code name for it. Very catchy. As I’m sure, absolutely agree, so that just that that’s that’s the the compound, and yes, it produces psychedelic effects. Patients will will be dosed in a in a clinical setting, under supervision, so safe environment. Typically, we have them wear an eye mask and we have them wear a headset, cutting out all external distractions. We don’t want them to be distracted by a light fitting or a picture on the wall that might lead to visual effects. We want them focused inwards. Focus inwards, and they spend four, four to six hours focused inwards and focus on doing the psychological work internally. The compound acts like a tool that enables them to rewire their negative patterns of thinking. So one of the challenges in depression and anxiety disorders that people get into these maladaptive, negative, spiraling patterns of thinking, rumination, like like ruts in the snow of your skiing, the they can’t get out of and and so the this tool, silicon generates what we call neuroplasticity, to new networks and connections being formed in the brain. But essentially, it’s just a way for them to think differently, and they spend this four to six hours realizing that or learning how to overcome some of those patterns that they’ve been stuck in for so long, sometimes decades, and they can think about things in a different way. And I think it’s this fact that there’s some structural change, where they are learning new patterns that leads to the durability. So this is not just a tablet that somebody takes, that deals with the symptoms, and then the symptoms come back, or you stop taking the tablet, they’ve fundamentally changed their way of thinking, which is quite remarkable.

george grombacher 14:47
That is absolutely remarkable. Alright, so first, how did, how did somebody figure out that psilocybin could potentially have this benefit of alleviating mental health challenge? Jizz. And then from there, how do you figure out how to synthesize it? And then, finally, isn’t it illegal?

Doug Drysdale 15:06
Well, it’s illegal to sell it. It’s not illegal to research it.

So look, I mean, we’ve been using as a species, sin psychedelic compounds for millennia, mushrooms, Ayahuasca, DMT, various other plants. DMT actually occurs naturally in our brain. So these are all naturally occurring compounds, and they’ve been using peyote is another one, as we’ve been using these ritualistically. You know, in the 60s and 70s, I think there’s a lot of studying of these, these compounds, we realized that it could have impacts on mental health disorders. Unfortunately, some of those activities got off track. And the whole thing kind of went off track, and led, frankly, all that behavior led to the creation of the DEA, the war on drugs, and kind of shut down psychedelic research for 5060, years or so, so, you know, now we’re back to it. These are fairly simple molecules to synthesize. What’s been what’s been occurring, though, in the last decade, is a better understanding of how they work. We still don’t know fully the whole downstream mechanisms, but we know which receptors they bind to in the brain. We know from studies using fMRI neuroimaging that when a patient is taking psilocybin or silicon, massive new networks and connections are being formed in the brain. Parts of the brain that don’t normally talk to each other start doing so it’s like the kind of the control center, which was called the default mode network. It’s like the control center the brain gets relaxed. So if you think about our brain, our brain is it protects us. We we have all these stimuli from all of our senses, our eyes, our ears, whatever, and like a fire hose coming in at us all the time, but our brain filters it all and creates a better word, a simulation that we can handle, but we don’t go crazy dealing with all of this stuff coming in, and our Brain also protects us by helping us create habits. So for example, when you learn to ride a bike, you don’t have to learn again every time, walking up the stairs, walking up a curb, you can walk up the stairs on your phone or reading a book, not even looking what you’re doing, because your body, your brain, has learned how to do that and and these, these habits, generally, one, they prevent us from having to relearn but two, they protect us from safety. But then downside of that is, when you get into negative habits, negative thinking that they’re also reinforced by the brain as well. So appears that the this default mode network, which is the control center, may be relaxed by this neuroplasticity and help us really get out of some of those negative patterns of thinking.

george grombacher 18:09
That’s also fascinating. It’s fascinating how the human brain works, and then how you’re able to identify that, that this, that this thing, all of a sudden starts activating our brains in a different way, and how it all connects. So super cool. And for the for the illegal thing, you said it’s, it’s illegal to sell, but not study. So how does, how is all that going to play into the success long term of the company? Yeah,

Doug Drysdale 18:33
that’s a good question. So you know, the these drugs are scheduled by the by the DEA schedule one is the category. It basically means that they can’t be commercially sold. It actually means that they’re not medically useful, which is kind of interesting. So each of the sites that touch compound study compound, but it was clinical manufacturing lab testing, they all have to have a DEA license. So it adds some complexity, it adds some time, add some costs to work we’re doing. But it’s not insurmountable. Clearly, we’ve been we’ve been doing this for a while, and once the once we get through the FDA process and the product is deemed to be safe and effective. It no longer meets that criteria of not medically useful, so DEA is enforced to reschedule, and then it’d be scheduled to something lower schedule two or schedule three. It doesn’t really matter too much, but anything below schedule one could be commercially sold within certain restrictions. So it would mean control distribution prescription only, of course, under medical supervision, but we have to go through this, this R D process, in order to sort of get to get a DEA to reschedule and and there’s lots of calls for these kind of compounds to be legalized. And I get that. I think that. It’s a little bit ahead of the science. What we’re doing here is trying to get it on a route where the science is unquestionable and there’s already a regulatory pathway to provide access to these treatments also improve.

george grombacher 20:14
Again, really, really exciting. So for people who are listening, who suffer from mental health, which is a lot of us, what is, what is the future look like for them and for Simon? And then for folks who are listening, who say, Well, this is a late stage company still looking for investment, I believe. And of course, there’s no guarantees. Anytime we invest money, we don’t know what’s going to happen, but for folks who are interested in potentially investing, how can they move forward as

Doug Drysdale 20:46
well? Sure. So you’re right. We’re late stage. We’re in the final stage of development, likely three years roughly, before we get to see an approval, something in that kind of ballpark. It just depends upon how quickly the trials finish up, and then hopefully, we expect then to be able to offer this to patients with depression. And our goal is to ensure that we have the data to make sure that these treatments are fully reimbursed by by healthcare companies. That’s that’s the ultimate goal, to maximize access. Beyond that, I mentioned that the achievements might work in a whole range of different conditions. And so once you’ve gotten through this first one, there are lots of other areas that we’ll be tackling as well. We’re a public company. We are traded on the New York Stock Exchange. The symbol is Cy bn, available through your brokerage, or through Robin Hood, or whatever it is tools that you use, and you can find more information about the company@cyb.com c, y, b, I n.com feel free to reach out with that, with any questions we are, as you say, in that late stage, and very excited about sort of how far We’ve come. Come this far from inception of the molecule to phase three, which is final stage in about three and a half years, which is two to three times faster than you typically see for a Big Pharma. Outstanding.

george grombacher 22:13
I love it. Well, Doug, thank you so much for coming on. If you enjoyed this as much as I did, show Doug your appreciation. Share today’s show the friend who also appreciates good ideas. Go to simon.com c, y, b, I n.com and dig deeper into what Doug has been sharing with us today. Educate yourself on it. And then, if you are interested, go to your favorite brokerage platform and type C, y, b, N, which is the ticker, and see if it’s a good opportunity for you to get involved from an investment standpoint as well. Thanks again. Doug,

Doug Drysdale 22:50
Thanks, George. Appreciate it

george grombacher 22:52
until next time, remember do your part by doing your best. You.

george grombacher 16:00
So if I want my iPhone, and my Tesla and my Bitcoin to work, we need to get the metal out of the ground.

Pierre Leveille 16:07
Absolutely. Without it, we cannot do it.

george grombacher 16:13
Why? Why is there a Why has production been going down.

Pierre Leveille 16:21
Because the large mines that are producing most of the copper in the world, the grades are going down slowly they’re going there, they’re arriving near the end of life. So and of life of mines in general means less production. And in the past, at least 15 years, the exploration expenditure for copper were pretty low, because the price of copper was low. And when the price is low, companies are tending to not invest more so much in exploration, which is what we see today. It’s it’s, it’s not the way to look at it. Because nobody 15 years ago was able to predict that there would be a so massive shortage, or it’s so massive demand coming. But in the past five years, or let’s say since the since 10 years, we have seen that more and more coming. And then the by the time you react start exploring and there’s more money than then ever that is putting in put it in expression at the moment for copper at least. And what we see is that the it takes time, it could take up to 2025 years between the time you find a deposit that it gets in production. So but but the year the time is counted. So it’s it’s very important to so you will see company reopening old mines, what it will push also, which is not bad, it will force to two, it will force to find a it will force to find ways of recalibrating customer, you know the metals, that will be more and more important.

george grombacher 18:07
So finding, okay, so for lack of a better term recycling metals that are just sitting around somewhere extremely important. Yeah. And then going and going back to historic minds that maybe for lack of technology, or just lack of will or reasons, but maybe now because there’s such a demand, there’s an appetite to go back to those.

Pierre Leveille 18:33
Yes, but there will be a lot of failures into that for many reasons. But the ones that will be in that will resume mining it’s just going to be a short term temporary solution. No it’s it’s not going to be you need to find deposit that will that will operate 50 years you know at least it’s 25 to 50 years at least and an old mind that you do in production in general it’s less than 10 years.

george grombacher 19:03
Got it. Oh there we go. Up here. People are ready for your difference making tip What do you have for them

Pierre Leveille 19:14
You mean an investment or

george grombacher 19:17
whatever you’re into, you’ve got so much life experience with raising a family and doing business all over the world and having your kids go to school in Africa so a tip on copper or whatever you’re into.

Pierre Leveille 19:34
But there’s two things I like to see and I was telling my children many times and I always said you know don’t focus on what will bring you specifically money don’t think of Getting Rich. Think of doing what you what you like, what you feel your your your your your, you know you have been born to do so use your most you skills, do what you like, do what you wet well, and good things will happen to you. And I can see them grow in their life. And I can tell you that this is what happens. And sometimes you have setback like I had recently. But if we do things properly, if we do things that we like, and we liked that project, we were very passionate about that project, not only me, all my team, and if we do things properly, if we do things correctly, good things will happen. And we will probably get the project back had to go forward or we will find another big project that will be the launch of a new era. So that’s my most important tip in life. Do what you like, do it with your best scale and do it well and good things will happen.

george grombacher 20:49
Pierre Leveille 21:03
Thank you. I was happy to be with you to today.

george grombacher 21:06
Damn, tell us the websites and where where people can connect and find you.

Pierre Leveille 21:13
The it’s Deep South resources.com. So pretty simple.

george grombacher 21:18
Perfect. Well, if you enjoyed this as much as I did show up here your appreciation and share today’s show with a friend who also appreciate good ideas, go to deep south resources, calm and learn all about what they’re working on and track their progress.

Pierre Leveille 21:32
Thanks. Thanks, have a nice day.

george grombacher 21:36
And until next time, keep fighting the good fight. We’re all in this together.