Episode Transcript
[00:00:00] Speaker A: The clarion call in the mental health arena is something that works rapidly without weight gain, without sexual side effects, and without abuse liability.
[00:00:15] Speaker B: Well, Sean, thank you so much for having the time to have this conversation and having us in your office for this podcast. Really appreciate it.
[00:00:22] Speaker A: Well, mutual, I appreciate it as well. It's great to spend time with you, Brandon, and your listeners. So I always enjoy talking about vistagen and all the exciting things we've got going down the hall and in the various clinics across the country. So thanks again.
[00:00:35] Speaker B: Yeah, absolutely. Now for the audience, Sean is the CEO of VistaGen. They're pioneering some really interesting work that we're about to get into. But before we do that, Sean, maybe just give us a thumbnail sketch of your career.
[00:00:47] Speaker A: It's quite a sketch, actually. It goes back about three decades. I started down the Peninsula, Silicon Valley, started as a corporate finance lawyer, did a lot of IPOs, high techs, biotechs. Made my way up the Peninsula to where we are here today in the birthplace of biotech, right. South San Francisco. In between, ran in house at a biotech company and then a venture fund and then a contract research organization. So it's really all the different aspects of the ecosystem that many companies our size and with our focus need to lean into. So unique perspective from multiple different angles, especially capital side and bringing together the augmentation through the CROs and that support that's needed and to be force extenders. And then as well, also obviously running our own internal team the way we do now.
[00:01:33] Speaker B: We speak with a lot of biotech executive leaders, founders, CEOs on this show. And one common theme is that they feel compelled to come do the work that they're doing today. And I'm curious what compelled you to kind of go from the contract research side over to leading VistaGen.
[00:01:49] Speaker A: I'm not surprised you hear that answer a lot. And that that's an essential component of doing what we all do. And that's really the case with a lot of leaders throughout the whole industry. Naj To CEOs, it's really the passion for human health and in our case, especially mental health. And for my personal case, that begins with family and friends. Throughout all the seasons of my life, where depression in particular and to a greater extent more recently, anxiety has really disrupted people's lives that I've seen. Whether it's when I was a coach of high school softball players, whether it was when I was in college, whether it's at law firms and service sectors. People struggle, and they struggle a lot with the way that mental health gets in the way of who they really would love to be. And so vistagen's offered that really interesting marriage between what I would like to do on the personal level for those who are close to me, as well as what I think we have an opportunity to do for millions of people beyond ourselves. So the passion really has to be personal. It also has to be well beyond any one particular person in the company. And that's the case where we're at now, unfortunately.
We've got a country and a world to a greater degree that's sick from a mental health perspective. And it was a conversation once with the Surgeon General and I said, you're the doctor we need for helping with that. And it is the case that you don't often in a career have opportunities to make once in a generation changes. And so the opportunity here at VistaGen, which I saw and still see every day I come into this office, is to really be among change makers, people who really do have a heartfelt interest going into it with very clear eyes. We know there's risk and there's challenges and there's a lot of effort that's needed. But at the end of the day, if we're successful, it has far reaching potential to impact people in their daily lives. And you start to think about, well, what if it was a thousand people, what if it was 5,000 people? How about a million people? Or 5 million people who no longer have to, in the case of social anxiety, for example, worry about being judged or humiliated or embarrassed in everyday social and performance situations, or people who are, who are not able to perform at their full ability because depression's holding them back. It's just amazing to think about what the world could be like. Even here in Silicon Valley you unlock that kind of productivity and that's change.
[00:04:26] Speaker B: Making now, once in a generation impact. Powerful statement. Maybe let's start from just at the highest level. How would you articulate kind of the work that you're doing at VistaGen and maybe the kind of generational opportunity that you kind of see there?
[00:04:40] Speaker A: Yeah, mental health in particular focused mostly on that today. Probably in the time we've got together there just have not been sea changes, differences in the way that people impacted by mental health disorders, especially anxiety and depression, have been able to deal with those conditions with medication combined with talk therapy. So the talk therapy, all that, we think it's improved considerably, especially with telehealth and mental health. It's a very nice marriage there. But in terms of the medications available, they really fall far short for a lot of reasons. They don't work fast enough or, or you don't know whether they won't work fast enough. In the meantime, you've got to deal with side effects no matter whether they work or not. There may be risks of abuse, potential liabilities. There are significant. So that it focuses, our company focuses on areas within major high prevalent indications or disorders where we haven't seen the standard of care change for a long time, years, even decades in many cases, where there really hasn't been a fundamentally differentiated change in the way the medication is capable of addressing these problems. Right. And so in the case of social anxiety disorder, in the case of depression in particular, there really has not been a fundamentally new mechanistic approach to social anxiety disorder really ever. So we have these opportunities based on, and that comes from a lot of angles, the ability to affect that kind of once in a generational change. Of course, it's people and it's strategy and it's capital and it's all those things. But initially it's got to be drug candidate, a product candidate that really does have differences, right? Differences in the way that it achieves the outcome you're trying to achieve therapeutically. We think we've got that here at Visigen. We've got a whole new class of drug candidates, product candidates called farnes, that the way they work is unlike any other approved drugs. And we've seen it now in late stage clinical studies across 4 of the farrines, that we've got either phase 2 or positive phase 3 studies, but with fundamentally different mechanistic approaches and fundamentally different safety profiles, product profiles at the end of the day too, which matters. The clarion call from most people, whether it's psychiatrists, general practitioners, patients in the mental health arena, at least for anxiety and depression, is something that works rapidly or that, you know, won't work. You know, today with the antidepressants, for example, you're waiting six weeks to know whether it even is possible. You're the one out of three that might benefit, but along the way you have side effects. So rapid onset works quickly, but without weight gain, without sexual side effects, and without abuse liability.
Those are really the major things that we're not seeing in today's treatment alternatives, FDA approved treatment alternatives, especially in social anxiety disorder and major depressive disorder.
[00:07:40] Speaker B: So to ask me the naive question, what is a farrine?
[00:07:44] Speaker A: A Farrinine is a new. It represents a whole new class of medications that rely essentially on the nose being a portal to different regions of the brain that affects different therapeutic outcomes. In the case of mental health for a social anxiety disorder, what we've studied through one historic and positive phase three study, we're the first company to ever have a positive phase 3 study using a public speaking challenge for the acute treatment of social anxiety disorder. So I'll tell you more about that disorder in a bit. But a farrin, it relies on neural circuitry, nose to brain neural circuitry. And we humans have in our noses receptors for neurons that are only there. And so all of our farrines are formulated as nasal sprays. They're designed that way intentionally because at very low doses, microgram level doses, typical ibuprofen is 200 milligrams, right? So we're talking about 3.2 to 6.4 micrograms administered self administered directly onto those receptors for peripheral chemosensory neurons that are located in the nose that then project neural circuitry to what's called the olfactory bulb at the base of the brain that then propagates forward further to different regions of the brain depending on what we're trying to achieve. So in the case of social anxiety disorder, what we're trying to do there is really regulate our fear and anxiety center of the brain called the limbic amygdala. So we are trying to, in a very rapid manner, bring people from a very heightened level of anxiety down to the point where they have a normal level of anxiety. It's good to have some anxiety. You have to be energized, you have to be focused. But it's difficult to live at a very, very high level of anxiety when stressors. In the case of social anxiety disorder, people are worried about being judged or humiliated or embarrassed in everyday social and performance situations. And so we're trying to help people engage and not avoid those kinds of life enriching experiences. Could be academic, could be social, could be professional by engaging in them. And so with the ability to go basically a few inches from the nose to the limbic amygdala through neural circuitry in a 1, 2, 3 manner, what we do is have the ability at the end of the day for the anxiety level neurons within the amygdala to calm down very rapidly within minutes. And that allows the kind of engagement we think that can allow people to perform and engage in their lives for depression, it's the opposite. What we're trying to do there is stimulate activity, right? So we're trying to, again, it's the same first kind of one, two punch, right? The left jab Is the spray into the nose right on top of the receptors for the neurons that we activate with all these pharines within about 350 milliseconds, very, very rapidly that then projects forward again to the olfactory bulb neuron and then to different parts of the brain. So let's say the objective is hot flashes associated with menopause, right? That's a different part of the brain, the hypothalamus, it's associated with your body temperature. What we've seen in studies is the ability to reduce the number of hot flashes and the severity of those hot flashes by neural circuitry that connects via neural circuits that ends up at the point in your brain that's associated with your body temperature. So depending upon what the objective is, we're doing this in a way with the class of drugs that don't go through your whole body. A normal pill, it's going to be broken down and your liver is going to have issues, maybe your kidney. You may see drug, drug interaction. It may affect the way your drug works or other drugs work. These are non systemic, they don't go through your whole body. You cannot detect pharynges in plasma. So a very, very unique aspect compared to just about any drug that we know of in neuropsychiatry and also in the case of hot flashes, we don't know of a single asset out there, product, candidate or product that has the ability to achieve these therapeutic outcomes in a non systemic manner. Also what's very important about the class is they don't need to act directly on neurons in the brain. Why that's important is really especially as to abuse liability. Because with many neuropsychiatric drugs, while they'll achieve what you want, they may also have off target binding. So opiate, nicotine, dopamine, steroidal hormonal receptors, all those could be problem. Off target binding activities. Well we have with farrines we rely on the neurocircuitry. So we don't really need a drug to go through the body and we don't need a drug to go into the brain and act directly on neurons in the brain. Because the power of the nose to brain neurocircuitry is you achieve the therapeutic outcomes by the neurological benefit associated with neurotransmitters in the brain.
[00:12:49] Speaker B: So let me make sure I understand this properly. It's a nasal spray.
[00:12:51] Speaker A: Every one of them is they're nasal.
[00:12:53] Speaker B: Sprays and they get transmitted directly from your nose to the brain. In you said 350.
[00:13:01] Speaker A: So it's not that the drug does. The drug's important to activate the neurocircuits so the neural circuits that achieve the therapeutic outcomes. The starting gate is right there in the nasal cavity. You could drink a bottle of these drugs. Not going to do anything. The receptors for our drugs, the catcher's mitt for our drug to fall into is only in the nose.
So that's why they're intentionally delivered. And part of the rapid onset effect is, if you think about it, it's going directly on the receptors in the nasal cavity. It's not going in your mouth, down to your gut, through your liver, into your bloodstream, up to your brain, over the blood brain barrier, figuring out where to go and then not going where it shouldn't go.
So the whole focus of the Faring platform is around that neural circuitry. We have many elegant ways here in our labs to be able to assess whether that neurocircuitry is kicked into gear. We have what we call EGNR studies. So they're very elegant studies where subjects will come in and will put electrodes in and on top of their nasal cavity and we'll be able to assess whether we see a depolarizing effect, unlike an EKG would for a heart condition. You're looking at whether or not there's electrophysical activity to give you a signal of whether a drug's active. We also will take cells from the nose, we'll do tissue culture work, we'll see if there's calcium flux. So there's many ways to assess, and these are human species specific receptors. So many things that you typically would want to study first in non human models. You study in human tissue in a laboratory setting, but then also in human volunteers, as we have over many studies now, or what we're often able to see too.
And this is part of the remarkable part of it, because you really need differentiated safety in the neuropsychiatric arena as well as others. For example, having a non hormonal approach and a non systemic approach to the acute treatment of hot flashes associated with menopause. It's a big deal. Having a non hormonal therapy for women that are 75% of women at, and the age groups that we are focused on here to help, they have to deal with hot flashes. But doing it with a hormone based therapy has its own risks, even oral therapies. There's a new one that's recently approved. It may have its own issues associated with liver liabilities or whatever the issues might be. So we like the fact that these farrines are non systemic. They do not have to go through your whole body to achieve their effect. And we also are happy with the fact that you are going right onto the receptors of the neurons we need to activate. That helps with the rapid onset effect because with social anxiety, and maybe you think about even with menopausal hot flashes, having the ability to take something out of your pocket or out of your purse or your backpack right up front of a very stressful, often predictable social or performance related stressor is incredibly important. These are patient tailored to fit solutions. If someone is about, if a woman's about ready to have a dinner party and she doesn't want to deal with hot flashes during the dinner, the ability to knock that down acutely is a big deal in the way that you get to live your life. And so we're trying to do overall pretty simple. Everybody in our business is trying to improve lives. We are trying to do it in a way that we haven't seen anybody ever do it before.
And it isn't just theoretical at this point. It's the fact that we've got human patient clinical data across four of these farrines in phase two or in the case of social anxiety disorder, phase three now. And we're in a US Registration directed phase three program for what could be the very first ever approved acute treatment for social anxiety disorder. And we're very proud of that.
[00:17:05] Speaker B: And I want to dig into each of these avenues independently. But before we get there, I'm just so curious, how did the team stumble upon this in the first place? Because as you say, this is an entirely novel way to think about it. So what's the story?
[00:17:20] Speaker A: Well, there's often serendipity. I wouldn't say it's a stumble. I would say at least it was an educated approach. And a lot of this in our industry, as you probably know, I've certainly learned over the years, it's networking. It's the people that you know within the industry that have good ideas and good accomplishments. So I met Dr. Louis Monti, who is our senior VP of Translational Medicine. He's really the one who should get the Nobel Prize because he is really the innovator of this class and he's really the one who stuck with it. And he was at a company called Farron Pharmaceuticals before joining us. And we acquired Ferrin pharmaceuticals in early 2023. We licensed in global rights, however, to our two lead programs, social anxiety disorder and depression depression back in 2019. So earlier than that, Dr. Monti and I, on the basis of some input from some of the folks we had internally here who had known really the godfather of social anxiety disorder, Dr. Michael Leibowitz, back out of Columbia and he innovated the Leibowitz Social Anxiety Scale. He had done some work with Lewis and the team at Farren in phase two. Some members on our team learned of that. And for about a year and a half, Starting with the J.P. morgan Conference in 2017, Louis and I had many, many lunches and many dinners and got to the point where you reach this mutual state of trust. And we developed a really solid entity to entity relationship. So when we licensed those in, it became pretty clear to us that we were onto something unique and different based on what had already been done at that time. And then we built on top of that. So they had gone through phase two with the social anxiety program and we were very impressed with the data. And as I unpacked it more and more and learned more about this mechanism, had many KOLs around us looking at it and understanding that it takes a while for people to understand new mechanisms. People have old friend ways of thinking about ways that drugs should work to treat certain types of disorders. And certainly this was not one at the time that anybody really recognized broadly. So fortunately, we had a really solid team. We had insight, it gave us confidence to bring those two assets in and we got more and more confident with them and decided to then acquire the remainder of the pipeline and did that in the early part of 2023. That's how we brought in pH80 for menopausal hot flashes, pH15 for cognitive impairment due to mental fatigue, and then pH284 which is associated with wasting syndrome and cachexia and late cancer stage patients and many others that we have yet to, to even talk about in the pre clinical mode. So it really did make sense for what we wanted to do as a company and really what needed to happen with this pipeline.
[00:20:09] Speaker B: And I sense there must be like an interesting story underneath some of these challenges and winning over maybe some of the traditional ways of thinking. How did you go about doing that?
[00:20:20] Speaker A: It's very interesting because sometimes it's skeptical eyes that focus first on safety. So if you have a neuropsychiatric drug, if you look at just about anyone that's out there, especially ones that approved, if you watch a commercial, half the commercial is going to be telling you all the things you need to worry about, right? Maybe worse than the thing you're trying to address.
And so what really caught my eye first was differentiated safety. And what I meant by that or what I saw into that was we weren't seeing the kinds of things that typically affect compliance, which if you don't have rigorous compliance, I don't care how great your medication and your talk therapy are together, you probably won't achieve the outcome. So when you see things that absence of sedation, absence of weight gain, absence of hallucinations, dissociation, absence of sexual side effects, things that just have been essential givens that you've got to deal with no matter what, whether you get the benefit on the efficacy side, then the other side of it was, well, we did see efficacy in placebo controlled studies today. When the conversations occur, sometimes it's really drug for social anxiety, drug for depression. You don't have abuse liability potential, you don't have sexual side effects, you don't have weight gain. But then we start to talk about the mechanism and when it becomes clear, oh, we don't have to go through the full body, we're not cruising through the liver, the kidney, the bloodstream into the brain, you do have the ability with direct access to activate the neurons that are associated with key neural circuits that everybody knows about. They've been around forever.
Then I get these kind of epiphany eyes that are like, oh, okay, now it starts to make a little more sense. Why when we have 30,000 doses in our open label safety study administered to about 500 patients, the most common treatment emerging adverse effect was headache at 8.7%. Nothing other than Covid, which is not drug related, but no other treatment emergent adverse effect, over 5% prevalent. That's just remarkable. It's absolutely phenomenal compared to what we've typically seen over decades. And that's where if you don't understand the mechanism, it's very logical to have that initial thought. We had it initially as well, way back when. So I'm not surprised. But what's very encouraging and very, it builds a lot of confidence is when we start to see the crowds that are at our poster presentations at scientific conferences, the KOLs that focus on the clinical meetings, the outcomes of the studies, the embrace of neurocircuitry, being involved in really important changes needed where there are treatment gaps in major disorders, highly prevalent disorders. Social anxiety affects just more than 30 million people the US alone. Depression, we know is high prevalent, not as prevalent as social anxiety disorder, believe it or not, but way up there. And yet when you look at what people today have to help them, it's inadequate they fall short. And so people don't take what's out there. They don't lean into the benzodiazepines.
The drugs that people have come to know have issues. Even the fda, they don't want to lean into the current generation of antidepressants. So you don't have good compliance and so you don't also have good outcomes. So safety matters. Efficacy, of course, matters. But I really do like the ability going into these studies and even dialogues with regulatory agencies and others that safety isn't just a profound worry when we move in. That's not to say that there may not be issues downstream that we haven't seen. But so far to date in all completed studies, been very pleased to see a very favorable safety profile. One we think there'd be a high conversion rate for physicians and others that are associated with the care of people with these disorders.
[00:24:33] Speaker B: And certainly the differentiated safety profile is fascinating. Talk to me a little bit about some of the really promising efficacy data you were looking at to kind of complement that.
[00:24:43] Speaker A: Sure. Social anxiety soar. That's the lead program. Right. We're in a US Registration directed phase three program. So we've had one positive phase three study and we used a public speaking challenge with an endpoint called the subjective units of distress scale. That's a patient reported outcome. Very important for us that we have patient related feedback and patient rated outcome scores associated with the studies. So with fastidional the lead asset, that's the lead faring asset. What we had is this public speaking challenge where people would come into a clinical setting and after establishing a baseline, they would then have a speech where we would be able to assess in a double blind, placebo controlled manner whether or not the speech with those in the treatment group versus those in the placebo group benefited from the treatment. Were they less anxious using a patient reported outcome when they gave the speech the second time versus when they gave it in the baseline setting time. So it's very important for us to see the acute benefit of our drug candidate and its ability right up front of a challenge. A stressor that many people face in the world. Right. Speaking to people, we've aligned with many that that's the most common effect of social anxiety disorder, whether it's socially or in a work or academic setting. So the ability to be able to engage in that activity without the stress and perform well without the typical stress that's associated with that fear and anxiety, being judged and humiliated. That's really what we're trying to get to. And in that phase three study, when we also ask patients themselves at the end, do you think you did better the second time when you were on drug or placebo versus the first time when you weren't on drug or placebo? And more than two times the number of people who are on drugs said yeah, much better, very less anxious or much less anxious. So that's what we're trying to achieve. What you're ultimately trying to do is to allow people to engage in these activities that they've been avoiding self, avoiding self, isolating. And over time, what we think happens too is that we've seen this in some of our other studies is that people build confidence, they build resilience. It's almost like having a little therapist on your shoulder saying, see, you got through that, you didn't get embarrassed, you didn't get humiliated or judged. And the more and more that happens over time, the better really we think it is for the patient to improve their lives and enrich them with broader base of activities that we think they've, they really would love to engage in but for their fear. Yeah. In depression. What we've seen over time in a phase two, a study, exploratory study, was that people, the scale that's standardized, The Hamilton Scale, MD17 after eight weeks, people who took 6.4 micrograms of our antidepressant drug called Itruvone twice a day over that eight week period did much better than the people on placebo, statistically significantly better than the group that was only on placebo through that eight week period.
In menopausal hot flashes, we studied there whether or not women who took our drug pH80, our drug candidate pH80 had a reduction in the number of hot flashes they had over a four week period and whether the severity of the ones that they did have was reduced, those on drug versus those on placebo in a double blinded manner. So we've been able to clinically assess, especially in cases where acute benefits needed. So the acute management of menopausal hot flashes, the acute treatment of social anxiety disorder, compared to what's out there for those two disorders, there's really nothing that's been FDA approved, certainly nothing that's non hormonal and non systemic in the hot flashes area and certainly nothing in the social anxiety arena.
[00:28:44] Speaker B: I'm curious if you've got any hints so far as to groups of people or types of individuals for which this works better.
[00:28:54] Speaker A: It's not going to work on you if you are not stressed. Right. So but as beyond that Criterion, there really is no group that is not affected by social anxiety disorder in one way or another. It's usually a disorder. The onset's typically in adolescence. We see a lot of the reason for that being social media. We see a lot related to team orientation requirements in the workplace, in school settings. Especially since we've re engaged again after Covid, we've seen the prevalence rise back again. It was already high pre Covid. And the duration, the mean duration tends to be about two decades. So it's unfortunately the case where it's onset early. And even as people go through different seasons in their life, different aspects of their journey, you're not the same as an adolescent, of course, as you are in high school, as you are in college, and as you are as a young professional, maybe as a young parent. So the challenge though is that fear, it's irrational in many ways because even when people have gone through a stressor and nothing did happen, they still are equally stressed by the same provocation without something in between. That's saying you have this success. Cognitive behavioral therapy is very important. So that's why I say it's almost like having a therapist on your shoulder right after the incident to say, see, this didn't happen to you, this thing you were worried about. And the medication we believe helps with that.
[00:30:26] Speaker B: Now I want to broaden the aperture a little bit. We've been talking about this phase three program. You're also doing some remarkable work in other spaces. Maybe give us just an overview as to where else you are hoping to see applications of variance.
[00:30:40] Speaker A: Yeah. As I noted earlier, the second program we have is we're planning for a phase 2B program with our drug Itruvone, which is a faring product candidate for the treatment of major depressive disorder. So based on a positive exploratory phase 2 a study, now it makes sense to move into a larger US based phase 2b study for our drug candidate. Ph 80 is a farrine intranasal farrin for vasomotor symptoms. Fancy way of saying hot flashes associated with menopause. That too. We have a US IND enabling program there to do further phase two research in the US with that product candidate at the lower end of the pipeline. We have two other farrines, pH15, which we've seen in a pilot study, improve cognition, reaction time associated with mental fatigue. So that's been important for psychomotor improvement associated with mental fatigue, sleep deprivation, chip workers and sleep apnea and narcolepsy. So the ability to not have to lean into Say high dose caffeine and then Ph 284. We haven't announced any data on that one yet. The study there is associated with trying to increase appetite in late stage cancer patients who typically have a hard time with wasting syndrome or cachexia associated with that with their comorbidity. So again, different parts of the brain, all with non systemic, ideally rapid onset, patient tailored ability to use a drug when you need it and not have to have a drug in your body when you don't need it. And that's very important for social anxiety in particular. Right? Again, there's three drugs approved, none of them for the acute treatment, but the old school antidepressants that are approved, they're in your body whether you're provoked or not. So if you're fishing one day or if you're at home reading a book, you don't really want that in your body because you're going to get the side effects regardless of whether you get the benefits. We really think like a rescue inhaler would work for asthma, we think for social anxiety and for hot flashes. That's what we think the market needs, we think is a giant treatment gap that's associated with an increasing need, increasingly prevalent need, but to have it also with a go to opportunity that does not cause you to worry about abuse, liability in particular. It's a big deal. Of course it's a big deal. That's the once in a generation component, that's the game changer component, is to really make sure there are clear differentiations in the way that people are able to accomplish the therapeutic effect. And what are the consequences of trying to achieve that effect?
Because the unintended consequences of many current medications are not great.
[00:33:30] Speaker B: As I listen to you outline the different indications, condition areas, you're looking at this, I, I'm struck by the fact that they're all rather different. What is the maybe unifying theory, unifying framework that helps you see where the applications could be on your roadmap?
[00:33:47] Speaker A: Neurocircuitry.
We definitely know through lots of work, especially Dr. Monti's work over many, many decades that key neural circuits are involved in achieving different therapeutic outcomes. Very broad and diverse set of potential therapeutic outcomes. Right now already we're talking about anxiety, depression, hot flashes, psychomotor improvement, appetite enhancement. So those are all different activities and states of mind associated with neural circuitry in the brain.
So being able to get the brain to help do the job is accomplished with current medications through things that you take and go through your whole body. And have to get into your brain and go where they need to go, but not where you don't want them to go for off target binding. That's how you get opioid addiction, that's how you get benzo addiction. The brain neurons in the brain are saying, give me more, give me more. When you have to occupy those receptors, it creates a whole different dynamic that you have to worry against and mitigate against. It's different with a drug that is only intended to activate neural circuits to achieve outcomes that our brain mediated or brain regulated. And we believe in the tremendous power of the brain to create these therapeutic benefits based on not just what we've theorized and seen in dishes, but what we've actually seen with psychometric standardized outcomes and scales that tell us we're achieving these behavioral effects. That's really the best proof. Right? You can't always tell everything with things that are associated with the brain because of what you need to do to assess the human brain. But when you marry it with human behavioral outcomes in placebo controlled studies, that's where the confidence really starts to get very robust.
[00:35:43] Speaker B: Neurocircuitry sounds pretty broadly applicable for folks who are excited about what you're doing. How can they think about what might be coming down the down the road for you?
[00:35:54] Speaker A: Well, what we hope is coming down the road for us it is next year. We have two phase three studies that we'll read out and intended to complement the historic study that we announced at the end of 2023. And that is the US Registration Directive Program for acute treatment of social anxiety disorders. So that is, that's a potentially life changing outcome in so many ways, obviously not only for our shareholders, but for what I call stakeholders, which is everybody associated with the care of people affected by social anxiety disorder in particular.
We think that could have also very helpful read through to the potential of the depression drug and the other drugs, the farrines in our pipeline. But that alone really is hopefully a new beginning for a lot of people that are struggling day to day even now, and even more so now that we've had Covid kind of get under control. The silver lining from the pandemic was we've seen really an increase in the destigmatization of mental illness. It's okay to not be okay. It's okay to talk about not being okay. There's many more resources now for accessing care online, especially like through telehealth that we talked about. But we still need differences. We still need significantly different medications to complement Talk therapy. You always have to have talk therapy and there's never one size fits all. So having I root for every company that's involved in the mental health universe, different medications have different potential lanes that they can be in at the end of the day. So I think if we can do this and accomplish it with the type of safety profile that we've been able to accomplish so far, that's really. It's an exciting potential outcome. It really is. And then to see that trickle through to a platform that in many other indications where there's a big need to see something different that encourages all parts of the ecosystem.
[00:37:57] Speaker B: Absolutely. And maybe an interesting jumping off point to talk about the future. There's a lot of conversation happening today about precision psychiatry. A lot of buzz around applications of psychedelics in some of the condition areas. You're doing research as well. What do you think the next five, 10 years look like? And what role do you want VistaGen to play in the way that this kind of progresses into clinic and into everyday lives?
[00:38:22] Speaker A: I want vistagen to play the role we're already playing, which is that we are pioneering neuroscience, really based on nose to brain neurocircuitry, but still neuroscience, and in a way that has a power that we've not seen.
And that really is important to remember too. We've seen a renaissance in neuroscience in the recent years and I expect that to continue to grow, to tremendously grow beyond where we even are today, which relative to where the industry was even three, four years ago, is markedly different than where it had been for the prior 20 years. So I think as we continue to be able to unpack the different ways, especially with neurocircuitry, that we can affect therapeutic outcomes with different approaches. It's very important to have different. They really have to be different than what we've seen before. Right. I know we're at a spot where we are really at a leading edge and a lot of times it takes the rest of the market and other things to catch up to where things are in the lab and in the clinic. Fine. Our job is to continue to stay focused and laser focused, not only on innovation at the front end with new product candidates, but also the marshaling forward with efficient execution of the clinical opportunities that we've already created, that we've already got ongoing. You can never take your eye off any one of the balls. Ours is an industry that's got 20 balls up in the air at any one time and two hands to catch them. But we all really have key Roles to play here. We have to do things as an industry, and a lot of us are small companies.
These are not the large, large companies that are really driving the innovation. It's really energetic, focused, passionate companies like ours, where you really have got to live and work beyond yourself. You've got to have reasons why you're doing what you're doing. Because there's risk. We can never eliminate risk. That's not an objective here. You have to manage risk as best as possible. In any given scenario, whether it's executing a study or deciding what research to invest in, which people to hire, which vendors to work with, those are always. There's risks associated with all those. But managing risk is really. It's key. It's where you have incredibly phenomenal people are needed. We have phenomenal people. All the others that you've talked about, they have phenomenal people. And it's that collective courage and that collective confidence to really continue to charge and know there's challenges, but then to be energized, to really embrace the challenges and figure out what's the way forward. When any challenge gets. Not every clinical trial succeeds. We've seen drugs approved that have had five failed phase three studies that are now actually helping people. You need two these days. And so regulatory strategy is important. Capital market support is important. Third parties with sites, the invigorated research community is helpful to see in neuroscience in particular, and also even within the CRO universe to see some more boutique expertise that's really neuroscience, only focused, like the groups we work with. It's encouraging to see. We haven't seen that for 30 years. I don't think I could say I've seen that more than maybe five, and it's the recent five. So that's why it's encouraging.
[00:41:51] Speaker B: This language, this theme around. It's a renaissance in neuroscience has come up a few times, and we're certainly excited to be following along the journey. So, Sean, maybe in closing, I'd love to hear, as we think and reflect on this renaissance in neuroscience and in particular, the innovative work you're doing, if you had a magic wand and you could change anything about the way that research is done in the space and potentially it's brought into practice, what would you change?
[00:42:13] Speaker A: Well, I'm very pleased with the way it's going now. So I would say that what we're talking about now would be incremental benefits onto an already solid situation. So I'm very encouraged by that. And the reason for that being I think that neuroscience is top of Mind, I think people do understand the need and I think they do engage in that effort. It's not just companies that are sponsors of studies, it's all the others that need to be involved, especially if it's a small or medium sized company to get the job done. I think there's always opportunities to improve systematic engagement across sites and have sites help talk to each other and amplify best practices that emerge during the course of studies. A lot of times you will stagger studies just because you want to see if there's anything out of the gate with one that you might want to enhance in another.
But having that constant feedback loop is really key. Like I said, it's a Golden Gate bridge painting exercise. Right. As soon as you get done, you start over again.
And I think that the general awareness out in the market helps too, to the extent that that could be surprisingly changing, even more so than it has because these are very large markets with substantial unmet needs that even modest incremental benefits are tremendously valuable. And yes, there's risk always associated with clinical research and clinical development, but also the rewards on the other side of some of these potential wins that many of us are trying to accomplish on our peer group. In neuroscience, these are big things that you've got to have a new way to get at them because the ways that have been done so far, they're not getting it done. Even though there's blockbuster products that have historically established incredible revenue lines for companies, you still see things that really shouldn't have to be in human care. And so I guess I would just say every additional bit of motivation and awareness that we could drive around what's possible with neuroscience and pioneering neuroscience would be my one ask, because awareness always helps. People are drinking water through a fire hose of opportunities out there, especially in the capital markets. So to be able to narrow the focus on truly innovative neuroscience is important. So we can do this helps when we do things like this with you. But there's a lot out there that's to be excited about.
[00:44:44] Speaker B: Absolutely. Well, we're going to keep our eyes peeled and we're excited to hear more about how things are progressing over at VistaGen. Sean, thank you for taking the time to have this conversation. I really appreciated it.
[00:44:53] Speaker A: You bet. Thank you.
