Episode Transcript
[00:00:00] Speaker A: When I first started looking at psilocybin data, I thought it was B's. Honestly, the first few studies I read, I thought this is just too good to be true.
[00:00:19] Speaker B: Well, Doug, hey, thank you so much for taking the time to have this conversation. I've been so looking forward to it. For the folks who are listening, Doug is the CEO of an innovative company called Saibin. Saibin is developing really exciting research that is psychedelic or psychedelic adjacent for neuroscience indications. Doug also has a storied history in building and scaling companies across pharma, having built, I think, four companies at this point, completing 16 acquisitions in total and raising over a billion dollars in capital. So, Doug, thank you so much for taking the time to have this conversation.
[00:00:52] Speaker A: Hey, Brandon, thanks for having me. Looking forward to the conversation.
[00:00:55] Speaker B: Tell us a little bit about your background, your history, the kind of career you've had thus far.
[00:01:00] Speaker A: You can probably tell from my accent. I grew up in the UK and spent the first part of my career there. I actually started working in a lab, a biochemistry lab for the national Health service. Interesting. Working for the government in that you can see your salary, what it's going to be for the next 30 years, all laid out despite your capabilities. And that wasn't very attractive. So I moved into pharmaceutical spend. The first half of my career, I think it's now 35 years. The first half building drug development companies. But through business development, R and D licensing, product licensing, m and A. As you said, I've been involved in a lot of acquisitions at one point for a company I was head of M and A at, we completed 15 acquisitions over a four year period, which is kind of insane. That's closing an acquisition every quarter for four years across Europe, Asia and the US. So I spent a lot of time, as you can imagine. And then the second half, yeah, I've been. I've run four different companies now as CEO. The first was a generics company I co founded in 2008. And we took that from inception. It's about half a billion dollars in revenues and in 35 countries in about five years. So that was a great first stop as a CEO. I then took over for a turnaround, a spec pharma company, a Nasdaq listed company as chairman, CEO. Then I ran a CDMO contract development, manufacturing organization, and then Cybin, which is obviously more biotech. So I've been very fortunate to have really quite broad exposure, kind of across the spectrum, many facets of drug development that really helps with anticipation. Driving a company forward is like driving a car, you know, where you're going to go. So getting from a to b is sort of the simple part of the equation, but the hard part is anticipating what's going to hit you along the way. And so I think that experience helps a lot. With that anticipation, what drives you?
[00:03:05] Speaker B: I could imagine you built your first company, you're an executive for a long time, then you built your first company to $500 million in revenue. Where did the passion, the energy, the drive to go to act two, act three, and then now act four? Where'd that all come from?
[00:03:19] Speaker A: I just love building things, frankly. I always have done, and I love being in the cutting edge of things. I started back in college. I was studying biology and then ended up specializing in molecular biology, genetics, because it was leading edge. And every week or month it seemed like there was a new paper that was taking the field forward that was much more interesting than other parts of biology I could have been studying. And so each time I moved to something different. So the generics company that we did very well at scaling, by the time we got to five or five and a half years in, and we had scaled to 35 countries, the sort of exciting growth part of it was done for me. So it was time to move to something else. And the next thing I moved to was very broken. It really was a company in a mess that had made a few acquisitions, overpaid for one of them, and then found itself in trouble. And so that required a lot of cleaning up. So it was a completely different mission than the first one. But I just love building things and being in areas that are novel and interesting. Psychedelics is definitely that. In that there's so much that's still unknown. There's so much stigma and controversy around these treatments. So an interesting and exciting area to be in.
[00:04:34] Speaker B: Talk to us about that. So we're now on act four, your fourth company here. Why now? What convinced you to jump into this.
[00:04:41] Speaker A: Side of the world? Well, I think a couple of things. The first is that I spend a lot of time being involved with drug development, and what you learn is that it is slow and it is generally incremental. So each drug we develop is maybe a little bit better than the one before it. It's rare that we see massive leaps forward. We do, of course, from time to time, but for the most part, you're seeing a slightly better drug coming along than the one before.
But what we see with psychedelics is a once in a career opportunity to make a massive impact, because these treatments just have huge effect sizes. It's interesting when I first started looking at the psilocybin data, I thought it was B's. Honestly, the first few studies I read, I thought, this is just too good to be true. I've been involved in CN's drugs for quite a while, and there is nothing in our history that has an effect size like, we've seen some of these early academic studies out of Johns Hopkins at NYU. And the more I looked at them and the more that we saw more studies being published, it was clear that this was real. There was really something, really something there to be a part of that was exciting. And also, as I said, as you get older, you get to choose what you want to do. And I was kind of also, aside from being able to help a lot of patients, I was also a little bit attracted by the controversial nature of it all.
Having been in pharma a long time, which is quite conservative, it's a refreshing change.
[00:06:15] Speaker B: Now, obviously, the early papers are coming out. The effect sizes are astounding, but still there's regulatory risk, there's stigma, like you've said. How did you triangulate these things to get enough confidence to go all in here?
[00:06:28] Speaker A: Yeah, it's interesting. So when I. When I first leapt into the space, there really wasn't anyone else from pharma in the space. There are a lot of psychedelics companies that were starting around that time, and compasses had started maybe a year or two before, but even the compass leadership at that time were not from pharma. More of a mission, you know, by some, a pair of clinicians.
And so I think a lot of the mindset was exactly as you say, oh, how do we make this work? How do we get through these challenges? I saw it very differently, actually. I saw these molecules like any other drug development program, like any other molecule. I mean, I think there's a lot of questions at the beginning of this field as to, like, how these treatments would come to market. Would they be legalized? Would they be natural mushrooms? Would they be synthetic?
Are they going to be like retail stores? Like, there is this cannabis? And I think it became very clear to me quite early that the fastest and safest and most likely route to an approval was going to be down the FDA pathway, because it gives cover to every other agency. I mean, there's no reason for DEA to suddenly reschedule these molecules while there are drug trials going on. May as well wait for the data. There's no reason for politicians, policymakers to suddenly make these scheduled compounds broadly legal while there are drug trials going on. So why not just let FDA do their job and companies do their jobs and prove that these treatments are safe and effective? So I think it's been fairly clear from the beginning what the pathway is. And we've been really quite fortunate actually. FDA has been very proactive. They've handed out four or five breakthrough therapy designations in this sector, which is remarkable. They've issued draft clinical trial guidelines for psychedelics fairly early on in the growth of this sector. So I've seen FDA being quite proactive and I'd say quite supportive. Despite some of the news and some of the media coverage around the Glycos situation, that's not really reality. The reality is I think FDA is being quite interested in the potential for these compounds and what they can do for patients.
[00:08:50] Speaker B: Now I want to get into that in your programs in a minute here, but before we get there, I'd love to know how you thought about which psychedelics to pursue for which indications in what order. Is there like a framework in your mind?
As I dig in and I learn more, I'm seeing MDMA for PTSD, psilocybin for depression. You have a DMT program for Gad, LSD for Gad. There's s ketamine for depression. How have you thought about where to kind of place your bets here?
[00:09:17] Speaker A: When you're leaping into developing something new, you've got to rely on some existing data. So there's been a fair number of studies performed in psychedelics, but primarily they're around psilocybin and LSD. If you look back through the last several decades, psilocybin is about half the duration of LSD. So much more practical and scalable. LSD also has a certain stigma around it that we thought was maybe one step too far. Psilocybin hard enough to overcome some of the stigma and also the safety profile of psilocybin, zillow better than LSD. So we started there. But as we got more into this and looking at how do we want to expand the portfolio? When you look at the whole space, there's really two categories of psychedelics being developed right now. You've got these already bioavailable mystical experience, longer acting psychedelics like psilocybin and LSD. And then you've got the non orally bioavailable, fast acting, highly immersive molecules like DMT and five MEO DMT. So our goal was to create the best in class in each of those categories. We've done that with a psilocin compound and with a DMT compound each of which we've generated.
So we started out with psilocin in depression because that's where the most data was. And we also believe that MDD, major depression, not TRD, treatment of resistant depression, is a very large population with massive unmet need. Why did we choose Gad for DMT? Well, first of all, it's likely that both compounds would work in both indications, but each of these compounds creates some level of anxiety in patients. The beauty of DMT, in particular our deuterated version, is that effects begin very quickly with regular psilocybin, you might be waiting an hour for effects to kick in. With our deuterated psilocinous, we see effects in about 15 minutes. With our deuterated DMT, we see effects in about two to three minutes. So it works really quickly. And then people are in this very intense DMT experience that there's no thinking about anxiety when they're in there. They're already in that space, and then it lasts about 90 minutes. So, very scalable. So we think that deuterated DMT is more suited for anxiety disorders than, say, psilocybin. But I think they would both likely both work for both indications.
[00:11:34] Speaker B: Why are they both likely to work for both indications? How should we be thinking about cross indication kind of applicability?
[00:11:39] Speaker A: I think that's the most exciting thing about these compounds, actually, is that we've seen evidence of them working in many, many different indications, and that's rare. And it's fantastic for investment to be able to take one compound and get multiple different indications out of it. So we've seen evidence now, outside of MDD and anxiety, we've seen evidence PTSD, postpartum depression, opioid use disorder, alcohol use disorder, these might even work, and there's still work to be done, but it may even work in schizophrenia or bipolar disorder. I mean, collectively, that's hundreds of millions of people in the US alone that we could help. So that's really interesting.
[00:12:20] Speaker B: I want to dig into the science.
[00:12:21] Speaker A: A little bit here.
[00:12:22] Speaker B: So you've mentioned your unique formulations, deuterized versions of these compounds. What does that mean? How should patients think about that versus maybe the traditional forms of these compounds?
[00:12:33] Speaker A: Yeah, so there's a couple of changes that we've made with psilocybin. Psilocybin is not an active agent. It's metabolized to psilocin in the body, and psilocin is what's creating the psychedelic effects. So we've removed that metabolic step and we've deuterated psilocin the actin agent. And then with DMT, we've applied deuteration to that as well. What that is, is it means that we've taken selected hydrogen atoms on each of these molecules and we've replaced them with heavy hydrogen or deuterium, hence deuteration. What that does is it changes the pharmacokinetics without changing the pharmacology. So what does that mean? It means it changes the way that the compounds get into the body and to the site of action in the brain, but it doesn't change how they work.
We don't want to mess with the receptor binding profiles because that leads to either changes in efficacy or changes in safety. So we wanted to keep the pharmacology intact, but make them more efficient at getting to the side of action.
[00:13:35] Speaker B: For the folks at home who are hearing all this exciting news and maybe seeing other people pursuing research that look similar on the surface, how should people be thinking about your programs versus other programs? What are the key kind of markets that people should be looking at that you really understand?
[00:13:52] Speaker A: I think the main difference with what cyben is working on compared to other companies in the space is that we've taken the time to modify these molecules. Other compounds that are being developed are well known, what I call generic versions. So psilocybin, LSD, five, MEo, DMT, DMT have all been around for decades. We didn't simply take those pre existing molecules, we created new ones and we created new ones in order to make them more druggable, if you like, more suitable as therapeutics and at the same time creating ip protection for the company as well and for its shareholders.
[00:14:29] Speaker B: Pharmaceutically optimized, one might say.
[00:14:32] Speaker A: Exactly.
[00:14:33] Speaker B: So I've been seeing a lot of really exciting news about your phase two study for cyb zero zero three. Upcoming phase three. Tell me a little bit more, what do you have on the horizon? How are you thinking about that?
[00:14:44] Speaker A: Yeah, so our generated citizen read out a phase two study in depression at the end of last year. And really very, it's hard to put into words just how the data was what we saw. 75% of patients having remission from their depression, so no longer met the clinical criteria for depression. 75% of them after just two doses of CYv three. Not two doses a day or two weeks of dosing, but just two doses. And then we still saw 75% of patients in remission four months later after just two doses. So that's remarkable. It's a real game changer. So it means that we can, we have the potential to move away from the current standard of care, which is SSRI's, which don't work for the majority of people. They're taken every day. They take six or eight weeks to work. So people are waiting that long while they're depressed for the drug to actually have some effect. And then they come with these chronic daily side effects, some of them pretty awful. Weight gain, insomnia, some cognitive effects, sexual dysfunction. There's a lot of evidence now that SSRI's cause sexual dysfunction in men and women, and sometimes this can persist for life after. After patients stop taking the drug. So there's a lot that we're learning about SSRI's now that they've been around for 40 years. Suicidality. I mean, depressed patients have a 20 times higher risk of suicidality, but SSRI's actually increase suicidality by at least twofold, and in some studies, much, much more than that. So there's a really big need for these treatments. And now we've got an opportunity, I think, to, instead of just daily dosing, to intervene. And we see rapid and very large effects on depression symptoms that seem to be highly sustainable. Later this year, we'll have twelve month data from that phase two study. We'll be able to see how many patients are still in remission twelve months later. So based on that, those results, we're about to begin a phase three study. We've met with the FDA a couple of times around the program design. Great alignment with them. The first study will start around the end of the summer, and we've already recruited 30 sites across the US and about seven other european countries as well. So looking forward to kicking that off.
[00:17:05] Speaker B: What is top of mind for you as you go from phase two to phase three? Is there anything at all that you're thinking about changing now that you're kind of at this critical inflection point?
[00:17:14] Speaker A: Definitely. Front of mind is scaling, quite honestly. So it's a very different organization that you need for phase one, phase two than you need for phase three, and then kind of pre commercialization. So we have about 55 members on our team today. Our peers that are at the same kind of stage have about 200 on their team. So we are significantly leaner and actively expanding. I mentioned 30 sites to set up for the first phase three study, another 40 sites for the second phase three study, and several hundred facilitators that we need to train for those studies as well. So we have a lot of work to do. And thankfully, because of the results, because of the mission, because many people in pharma know someone that is depressed or anxious or has a, you know, a mental health condition. We have been very fortunate to be able to attract really high quality folks from big pharma, senior people with strong CN's and phase three experience. And that's, I think that's going to help us move this forward in a very robust and rigorous way. And I think that's really important as you think about moving from phase one, phase two where you're looking for proof of concept, to phase three where you're looking to optimize your results, because that's the data you'll be marketing with in the future. So we go from speed as the primary focus to quality obviously being the primary focus. As we, as we get into phase three.
[00:18:40] Speaker B: Talking about optimizing results, given the really dramatic effects that you've already, already measured, how much more optimization of the results are you looking for here?
[00:18:49] Speaker A: You know, we thought about that long and hard. So there's a few things that we have designed into the studies to optimize outcomes.
The first is the molecule itself. So as I mentioned, we've optimized the PK through deuteration, but we've also done quite a bit of work on dose ranging to find a dose that we think is going to get more people across the line into the psychedelic space without running into unwanted side effects. So the molecule and the strength. The second is we are studying an MDD population. So major depressive disorder, not treatment, assistant depression, TRD. That group is going to contain folks that are highly refractory to all treatments, including likely psychedelics. So selecting an MDD population, which is, you know, 80% of the depressed population, is going to provide, I think, you know, obviously better outcomes than in the TRD population. We're also dosing CyV three as an adjunctive treatment. So that's one very convenient. It means the patients don't have to immediately come off of their background medications, but it's just practical as well. You think that patients are on stable doses of SSRI's and you're asking them to come off of those scary, scary and challenging. Scary for the patient, challenging for the physician as well, so they can get started right away. And then the last thing we've done is created a two dose protocol. The reason we did that is we saw in some of the early academic studies there's really impressive results from two doses. What we see with psilocybin. Psilocybin is that it is a bit of a wavy experience. There's peaks and troughs of intensity throughout the session. And some patients who are anxious or skeptical or just not willing to fully immerse themselves and let themselves go, don't want to necessarily trust the process.
They can resist, to some extent, the experience. But what we found is that by the time they have a second dose, they're diving right in. And in the phase two study, the facilitators reported to us that the second experience for everyone was more intense. They've gotten past that initial anxiety or apprehension and diving right in. Other studies. With psilocybin, single doses, we've seen effects begin to wear off after six, Orlando, or eight weeks or so. And yet with two doses, we're seeing robust effects out to four months so far. So there's a number of things there, you know, the molecule, the strength, the indication in a dosing protocol that we think are going to optimize the data.
[00:21:28] Speaker B: What do we have to look forward to in terms of this twelve month readout?
[00:21:32] Speaker A: Can you say, you know, first thing I say is that if you have just even one patient that was still in remission twelve months after just two doses, you'd be pretty impressed with that. I think just because just in my mind just doesn't seem possible. It doesn't happen really, does it, very often, whatever diseased state you're talking about. So what we're looking for is trying to understand what portion of patients remain in remission. It's a fairly small study and a fairly small number of patients, but we'll get some kind of signal from that, and I think that's going to be really exciting. I don't think any other company has read out twelve month data yet, but to be able to show that level of durability is important for, obviously for patients, but also important for payers as they're thinking about this new model, moving away from your chronic dosing to this intermittent dosing.
And then, of course, in phase three, we'll also follow patients up for a year. So we'll have a really good sense on a much larger scale of what the typical kind of relapse time is.
I'd be surprised if you weren't seeing at least maybe on average eight or nine months or something like that. Some people may go for much longer, others may be a little shorter, but on average it might be in that sort of eight or nine month range, which would be remarkable. Yeah.
[00:22:52] Speaker B: Do we know anything yet about developing treatment resistance to psychedelics?
[00:22:57] Speaker A: We don't. We know a little about it, I should say, in that we know that these work on a threshold effect. So these are serotonin receptor agonists and they're activating these receptors on the surface of nerve cells. And when they become flooded with these drugs, then you get to a threshold point where then the receptors internalize. And that's the point we're trying to reach with dosing. We don't want a little bit of activity like you might get with microdosing. We want a full on psychedelic experience and internalizing these receptors. Of course, once those receptors are internalized, they're no longer available to be agonized. So if you were giving repeat doses quite close together, you get to a point where there really wasn't any effect. And you see that with folks recreationally that tried magic mushrooms or even MGMA, that there's no incremental benefit of rapid repeat repeat doses. So in our study we're dosing twice, but it's three weeks apart. So there's plenty of time for the receptors to all reset. And if we're thinking about redosing every eight or nine months, it's not likely because of that infrequency that we're going to see tolerance building up. Not from what we're seeing so far anyway.
[00:24:19] Speaker B: I want to go back to something you mentioned earlier, which is that the FDA has been really collaborative, designating these as breakthroughs. I'd love to hear from you what it's been like to spearhead a breakthrough therapy in a net new, let's call it like therapeutic asset class around psychedelics and psychedelic adjacent therapies.
[00:24:36] Speaker A: So it has pros and cons, doesn't it? Being at the tip of the spear. Obviously it means that sometimes we are walking into the unknown and we're having to make a intelligent judgment calls. There's certainly been situations where FDA has looked to us for expertise, where it's lacking at the agency. This is a new area. And what we're trying to figure out with the agency in some cases is how do we design studies to solve for these unknowns that we're learning?
But you know, it's not just sabin, it's other companies out there as well. So we're learning collectively from everyone activity too, including when things go wrong. We mentioned Glycos, obviously unfortunate for patients, the Glycos outcome, but that's a learning opportunity for us and an important one to have that feedback, that information ahead of initiating phase three. So I think for the most part, the bulk of the drug development here, because it's not all just clinical, it's not all clinical. Studies. There's all the other things you have to do, toxicology, drug interactions, clinical pharmacology, all the background studies that nobody ever talks about, but it's probably 20 of those that we're having today. Those things are all standard drug development.
And then the challenging part is working with, on the clinical side, with the obvious unblinding nature of these treatments. And I think that's where Lycos, in terms of including in other areas, but that's one area where I think they were tripped up by their study design. And so we spent a lot of time thinking about that and the way we are dealing with this, functional unblinding is working with the FDA on study design. So, functional unblinding is when a patient is taking the psychedelic agent, they're having an experience. And because they're having an experience, they know they're taking the active drug, they're in a clinical study, so they're in there to get better. So they have an expectation that the drug will work. So the unbinding leads to expectancy. What the agency has asked us to do is to run a three arm study. So three groups of patients, one group will receive a high therapeutic dose, the second group will receive a mid dose, a sub therapeutic dose, and then the third group is going to receive placebo for a safety control. What it means is with these psychedelic naive patients that are receiving active, either the high or the mid dose is they won't know which one that they've received, but both groups will feel something, and so they'll both have expectancy, right. And so if you see separation of the high therapeutic dose from placebo and you don't see separation of the mid therapeutic dose from placebo, then you know it's the drug that's working because there's expectancy in both groups of. So it's quite simple to do. It's not a surprise or anything new to FDA. Every single CN's drug has functional unblinding. If you're in a clinical trial and you're taking a benzodiazepine, you know you're taking a benzo. If you're taking an antipsychotic, you know, even SSRI's patients know they can guess. So unblinding isn't new, and how to deal with it isn't particularly new.
[00:27:45] Speaker B: How do you think about setting this mid dose? Like, how do you, how do you know that you're not going to accidentally provide a therapeutic dose?
[00:27:52] Speaker A: Well, first of all, we've done a lot of PKPD modeling. And so, you know, the goal is to select a dose that is going to generate some sensations or effects so the patient can feel something. You definitely don't want it to be so low that they're feeling nothing. But. But assuming that because this is a threshold effect and you need to flood the receptors that for most people they won't get there, you may well have some people where the mid dose is therapeutic. For sure, we're all quite variable, right. But the chances are statistically across the whole group that it won't be therapeutic. Now, let's say it is therapeutic. Statistically. Great. We've got another dose.
So there's no real downside for doing it.
[00:28:34] Speaker B: It's interesting to hear you say this challenge of functional and blinding is not new, and yet ostensibly it's caused a challenge in the Lipos program. Where do you think that came from?
[00:28:45] Speaker A: First of all, a lot of the noise around functional unblinding came from the ADCoM, the advisory committee meeting. The AdCoM members are not FDA.
Their points of view and the huge amount of time they spent talking about functional unblinding does not necessarily represent the FDA's viewpoint. So we have to separate the two things. I think it's important for people to understand that the Adcoms decision or perspective is not the FDA. That said, FDA has clearly been asking for a dose ranging study like this. We talked about to deal with functional and blinding, and Lycos didn't perform one. I know they've given reasons as to why they didn't perform one, but my suspicion is I don't know. I haven't seen the CRL. But my suspicion is that's probably what they're going to have to do in the phase three study. They have to repeat.
[00:29:31] Speaker B: I want to switch gears a little bit here. We've been talking about cyb three. I want to talk about cyb four. Now tell me a little bit more about that.
[00:29:39] Speaker A: Cyp four is deuterated DMT. DMT is an interesting compound. We run five studies now around DMT and deuterated DMT in order to understand the pharmacokinetics, the pharmacodynamics, and it's an interesting molecule. It's not orally bioavailable. So you have to give it through some other route. You can inhale it, which is quite variable. You can provide it through an intravenous fusion. You can inject it intramuscularly, maybe subcutaneously. And so we've done a lot of work to try and understand the best route of administration and the best way to dose this. So over those five studies, we've now identified a dose that we're going to get, that we're giving in our phase two. We also did a lot of work at different routes of administration. And while inhalation is great and rapid, we found it was highly variable and comes with all the complexity of having to study hormonal toxicology and developing a device and all this other stuff. So we stepped away from that. We looked at intravenous and we found that when you infuse this over time intravenously, it takes a long time for patients to get up into the DMT space, and some don't even get there. And that's a long time of period of anxiety, basically, that you're creating for the patient. So what we found is the ideal situation is to get patients up into the DMT space rapidly, and you want that peak to also be short and then develop a tail period, which is the therapeutic window. That's where the psychological work is being done. So what we've ended up with, with Cyb four is an intramuscular injection. So really simple to give. We've all had plenty of shots at our arm in the last several years. So just a simple shot in the arm and we see effects in two to three minutes, and then about 90 minutes, or a little less than 90 minutes, patients are in that therapeutic window in the tail of the DMT experience. So we think we found the ideal pk we'll see as we get through the study. We're in a phase two study in patients with generalized anxiety disorder. Now 36 patients, so quite small and efficient, but enough for proof of concept. We already have plenty of safety data from the phase ones, and we should expect data, top line efficacy, safety data right around year end, maybe early January.
Wow.
[00:32:00] Speaker B: How have you thought about prioritizing Cyb three versus Cyb four? As a startup biotech? Naturally you've got constrained resources. How do you think about that?
[00:32:10] Speaker A: Yeah, so obviously we're ahead with Cyb three. We started with our psilocin asset. Again, as I mentioned, based on the data that was out, there is lower risk to go with psilocybin as a startup rather than DMT, which was less understood. So we're naturally ahead with that. Right now we have phase two proof of concept data of cyb three. We did not yet have it with cyb four. So again, cyb three is the priority. Once we have proof of concept for both, and we think about additional indications going forward.
My view is that for many people, a shorter 90 minutes experience, and certainly for clinics, is going to be potentially more attractive than a four to six hour experience with psilocybin. So I think naturally, the market might trend towards shorter acting treatments over the long term. So we'll look at adding new indications on that basis. On the flip side of that, DMT is quite an intense and immersive experience, and maybe not for everyone, and others might prefer the more kind of gentle, mystical experience of. Of psilocybin. Psilocybin. So I think there's room for both. As I said, our goal was to create options for physicians and for patients, and to create best in class and both of that, longer acting and shorter acting treatments. Sure.
[00:33:31] Speaker B: It strikes me that you're developing kind of this capability. I don't know if you want to call it a platform for taking psychedelics, applying it to CN's indications. How do you think about that? Like, the kind of broader vision of the science and the capability you're developing here?
[00:33:44] Speaker A: You know, it's an interesting discussion that we have internally quite a lot. We've generated a lot of IP over the last several years. So we have, I think, 60 or 70 granted patents and 200 plus that are still pending. So a lot of IP. But that IP covers a tremendous number of molecules, maybe ten to 15 trillion molecules or something crazy like that. And there are a number that we've advanced to clinical, to become clinical candidates. We've done particularly a good amount of work around phenethylamines, which is the same category of drug that MDMA falls into.
But we've been looking for treatments that are less amphetamine like. Like MDMA is, and more tryptamine like. Like psilocin and LSD. And the question is, okay, well, what do we do with these? What indications can we pursue? And it's kind of. We're spoiled by riches, really, in that looking at these other early stage molecules, looking at those in terms of investment opportunities. But we have these two advanced compounds where we know they're safe, we know the doses, we know the risk of administration, done all this work, several years of work, and, of course, adding another indication there just makes a lot more sense than maybe starting from scratch with other molecules. So, certainly for psychiatry, I think we've got two great assets that have plenty of vindications to go after. It might be that some of these other compounds could be suitable for CN's disorders, neurological disorders, maybe neuropathic pain or Ms, maybe Parkinson's, maybe Alzheimer's. But those are long paths to market at high risk, large populations that needed in the studies, at a very different budget needed for those. So we'll continue, we're continuing to work on those in the background. And who knows, maybe at some point we'll generate enough data, something interesting that could be partnered with a company that's more focused on CN's rather than psychiatry as we are.
[00:35:47] Speaker B: Any hints as to what's next?
[00:35:50] Speaker A: We are looking at other indications for our current clinical assets. So I'm sure we'll make an announcement when we're certain what we're going to.
[00:35:58] Speaker B: Do next, we'll hold our breath. So I want to talk about this most recent $150 million rates in the current kind of biotech environment feels like doom and gloom everywhere, but 150 million is nothing to sneeze at. What was that like?
[00:36:11] Speaker A: Well, it's been a tough three or four years in biotech. I mean, this is the longest biotech bear market in history, I think certainly the longest bear market in my career. Good news is that in general, when biotech bounces back, it bounces back hard. But yeah, it's been a tough few years raising capital. And of course, the only option you really have as an early stage company is to raise equity. There aren't many other options available. You know, maybe later as you get phase three data, there might be debt or partnerships or royalty streams or other things, but early on equity is really kind of the only option. And so we've had to continue raising capital despite that sort of tough pricing environment. So it's been hard on the employees and it's been hard on the founders as it's been hard on shareholders, frankly.
But we're making great progress. This $150 billion raise back in March, I think was just massive validation. Not only the quantum, but the quality of the investors that came in the realm was led by Deeptrak. So deeprack and the other investors in that round, long, fundamental, highly intelligent biotech funds that really do their diligence, really do their work. And, you know, it's clear from that group coming in that they believe in the programs. I think there's strong confidence in the science. I think it's called strong confidence in the science across the board, really. I think there is increasing confidence in the commercial model. It's taken a bit of time to get that confidence and it's really come about because of the success of esketamine spravato. And they've managed to help encourage the creation of a network of 4500 centers now across the US and those are all centers where psychedelics could be dosed as well. So I think investors can see that there's a platform and infrastructure for these compounds. But I will say that the science isn't enough. It's important and we're very fortunate to have compounds with really large effect sizes. So the likelihood of success here I think is unusually high, but it's not enough. And I think Lycos is an example that success is not just based on the science. You need execution. We started out three, four years ago here with maybe 50, 60 companies in this sector and we're down to a handful. And I think the companies that will succeed are going to be the ones that are best managed, the ones that have the best teams. And of course I think seismic has the best team in this sector.
[00:38:41] Speaker B: Maybe last horizon for us to talk about here. Competitive landscape post approval. Let's fast forward two years from now. Like you've mentioned, we've gone from 60 companies down to a handful. But knock on wood, two years from now a few of them will be in market. How do you think about competing post marketing? Given similarity, probably promising effect sizes across the board.
[00:39:01] Speaker A: You know, for the most part, we've seen each of these companies select a different molecule and each of them select a different indication. So while there are a handful of companies working on these treatments, they're all kind of adjacent, at least in the beginning. Here you've got treatment resistant depression, major depressive disorder, PTSD, for example. But as we've talked about these, these molecules ultimately will probably get used from multiple indications. So over time there will be direct competition in different indications. And we're nothing concerned about that because we spend time at the outset trying to optimize the molecules. For example, LSD has breakthrough therapy designation for GAD, generalized anxiety disorder. That's terrific for us. One, I think it shows proof of concept that psychedelics work in anxiety disorders. Two, it shows that generalized anxiety disorder can be granted both in therapy designation. So that's awesome. We've got a 90 minutes treatment versus LSD, which is about 12 hours. So from the outset we know we're competitive there. And then we talked about how we're creating data in phase three to optimize the data set. All with that in mind, that war. But I've been in pharmaceutical sales and you have a few minutes with the doctor and you're able to show him one or two charts. That's about it, right? You want some really great charts from your studies to say, hey, doctor, this one has 25% remission. This one has 75. Which one you want to choose. So it's important to get that right from the outset. And that's why we didn't just rush into the generic molecules.
[00:40:38] Speaker B: Let's bring it right back to where we started. M and a. Two years from now, five years from now, what do you think the m and a landscape looks like? Are these compounds being acquired by some of the behemoths, or are they merging and creating a super psychedelic, super psychiatric entity? How do you think about that?
[00:40:54] Speaker A: Yeah, I mean, at this stage, it's hard to see merging between pre revenue companies because it just adds to the burn, right? Because you're adding more programs.
But as we go forward and there's more phase three data being generated, I have no doubt there'll be transactions with big pharma. There's been no innovation in psychiatry for the last 40 years. Prozac was the last big innovation, and, of course, we had a number of other SSRI's after that. But this is the biggest breakthrough in psychiatry in 40 years. And so many companies have moved away from psychiatry and focused on CN's because psychiatry is difficult. Also. We fall into this trap sometimes. Big pharma falls into this trap in that we develop drugs that are effective, and then maybe there are half a dozen versions, different brands, and they all do really quite well. Each of the SSRI's were some multi billion dollar drugs. Then they go off patent, and then, of course, you've got a problem where you got a drugs that are perceived to be effective and safe and simple, but they're cheap, and so the next drug you develop has to be much, much better because you're competing with generics. Same thing happened in hypertension. ACE inhibitors came along and suddenly there were half a dozen of those. Then when they went generic. How do you compete against generic hypertensives? With something much, much better. So the innovation stops. But this is different. I think first time in 40 years, we're actually changing the course of disease now, and not just treating the signs and symptoms every day. And for me, that is an opportunity that big pharma can't miss out on. So I'm confident they're watching, they're waiting, they're doing their homework, they're watching the trials, they're watching the IP landscape. We'll see if something happened at some point.
[00:42:35] Speaker B: My traditional closing question for you, Doug. Is there anything I haven't asked about that I should have?
[00:42:40] Speaker A: I think you covered it for the most part. I think there have been a lot of unknowns in the sector over the last few years.
The field is becoming clearer all the time. You have more companies entering phase three, more data, more robust studies happening and so I think some of those unknowns are becoming clearer. This last one with the situation with Lycos and the functional unblinding I think that's another big myth that's now I think expelled by FDA. So I think we're in a really exciting phase. You know you've got not just saiphin but other companies with good proof of concept data heading into phase three, good safety profiles. We're going to see these treatments be approved in the not too distant future and that's quite exciting for them.
[00:43:26] Speaker B: Well Doug, thank you so much for spending the time with me today. I really appreciate it. I feel like I've learned a lot and we've covered a lot of really interesting topics. So again really appreciate you taking this time.
[00:43:34] Speaker A: I really enjoyed it. Thanks Brian and fan.
