Everyone's dealt with anxiety and depression to some extent, at some point in their lives. It can be debilitating and can cause feelings of hopelessness and helplessness.
My guest, Shawn Singh wants to change that. Him and his company, Vistagen Therapeutics are taking on anxiety and depression with their unique bio technology that aims to leave the nasty side effects of anxiety and depression meds behind
Vistagen Therapeutics is a publicly traded company on the Nasdaq stock exchange under the ticket VTGN.
If you are someone who's dealt with either anxiety or depression this episode is for you.
Podcast notes and transcript available here: https://simplebiotechpodcast.com/shawn-singh-vistagen-therapeutics
-James Ruhle, SimpleBioTechPodcast.com
Stay up to date with the latest episodes and BioTech updates by following me on instagram @SimpleBioTech
If you want to know which BioTech companies I'm currently excited about, connect with me on Angel List at Angel.co/jamesruhle
Everyone's dealt with anxiety and depression to some extent, at some point in their lives. It can be debilitating and can cause feelings of hopelessness and helplessness.
My guest, Shawn Singh wants to change that. Him and his company, Vistagen Therapeutics are taking on anxiety and depression with their unique bio technology that aims to leave the nasty side effects of anxiety and depression meds behind
Vistagen Therapeutics is a publicly traded company on the Nasdaq stock exchange under the ticket VTGN.
If you are someone who's dealt with either anxiety or depression this episode is for you.
Podcast notes and transcript available here: https://simplebiotechpodcast.com/shawn-singh-vistagen-therapeutics
-James Ruhle, SimpleBioTechPodcast.com
Stay up to date with the latest episodes and BioTech updates by following me on instagram @SimpleBioTech
If you want to know which BioTech companies I'm currently excited about, connect with me on Angel List at Angel.co/jamesruhle
Feelings of anxiety and depression can be absolutely debilitating. And the side effects of the medication that's supposed to make you feel better. Can I Ronica often make things worse? It's amazing that in 2020, we haven't really figured out a consistent, reliable and side effect, free method of dealing with these issues. My guest today is the CEO of a company that is tackling these incredibly important issues. And they're doing it pretty successfully. Therapeutics is a publicly traded company on the NASDAQ stock exchange and has shown remarkable promise with their line of products. These products have so far been shown to drastically reduce feelings of depression and anxiety with little to no side effects. It's really some amazing stuff. As someone who has personally suffered from anxiety, this was an incredibly exciting interview. And if you're one of the millions of people suffering from anxiety or depression, your going to want to listen. So without further ado, CEO of VistaGen therapeutics, Sean sinch, the human experience is changing and it's going to happen a lot faster than you think the world is going to be a vastly different place in the next 10 to 20 years because of what's happening in the biotech industry right now. Welcome to the simple biotech podcast. My name is James rule, and I'm your host. The goal of the simple biotech podcast is to interview the researchers, founders, and investors that are working directly in the industry and to translate what they're working on into simple and easy to understand language. If that sounds like something you're interested in, let's get started. Shawn, thank you so much for joining me today. Hey James, my pleasure. Thanks for the opportunity to talk to you, Sean. You've been with Vista gin for a very long time, for more than 20 years first joining the board of directors back in 2000 and actually becoming CEO 11 years ago, back in 2009. That's a pretty long time to be involved with one company. So I imagine you miss really enjoy working there before we dive too much into that. I want to get to know you just a little bit better. What were you doing before this? Sujin what initially caused you to get involved in the biotech industry? Where did Sean singes career ambitions first start to take form? This is a very complicated business. There's an ecosystem that really has to be deployed to be effective, to develop a drug that's actually going to get, especially one that gets into a human brain and does some heavy lifting benefits people. But I think it started about 30. Wow,
Speaker 2:Almost 30 years ago. Now I was part of one big part of that ecosystem, which is the legal side. I started as a corporate finance lawyer at a big firm here in Silicon Valley called Morrison and Foerster. And my job at that time as a young attorney in my twenties was to be the one who wrote the perspectives, the business section. So I kind of split my time between what were high tech, booming, IPOs and biotech IPOs at the time. And you really developed an affinity for the biotechs aside. You have to ask a lot of questions when you don't really know much, and you're never the smartest guy in the room, or, you know, you're in the wrong room when you're writing these things. I learned a lot about the business of biotech and it just became clear in two fronts. One, I saw that in a very predictable future. My wife and I did my wife now 32 years early on in our marriage. We, it was pretty clear as a corporate lawyer, not a lot of time to see kids, lots of divorces just wasn't really the life cycle I'd envisioned. So I made a decision to really decide between the two different sectors at that time, high tech biotech, and it was clear choice to biotech. So I went in house at a company that I had just built as a lawyer about a million dollars. And I basically said, look, I can save you quite a bit of money by bringing me in house. And I made the move into a company called cycling pharmaceuticals. That time there was a focus on hepatitis and immunotherapy, and it just became fascinated by the entire process and the ability to actually make money and help people, which was, has been the driving mantra really from day one and wanting to be able to say that to my kids. They didn't have any at the time four kids later all now grown. I think it was probably the best move in my life. I was there through about 1999, 2000. At that time, it really, he hit me. I had a kind of a midlife crisis. This is at 36 and I got necrotizing fasciitis, the flesh eating bacteria while I was trying to scrape and tape for capital in New York. That was, that was really a close call hours away from dying. And a fabulous Navy seal surgeon came in and said, you got two choices. Either we operate in 30 minutes or you're done. He operated. And then it was just amazing medical treatment for the next several weeks. Totally changed my perspective. I left the company that we had rebuilt cyclone and recapitalized and decided to go to another part of the ecosystem, which was the venture capital arena. And then connected with that. What's called the contract service contract research organization sector. He's helped companies get through the hoops and hurdles of drug development and worked for both of those entities for about eight years. And during the course of running the venture fund, it became clear that this gin as a portfolio company was somewhere that I really wanted to focus timeline disproportionate to other companies in the portfolio. My thought at that time was there were a lot of drugs. I don't know if you remember Vioxx and Avandia, there were drugs that made it all the way to the market. And all of a sudden people started dying because of liver toxicity or heart toxicity. Well, this Jen had and still has the technology to be able in essentially in a test tube using human cells, derived from STEM cells, to tell whether a drug is going to be toxic to the human way before even animal studies. And that fascinated me, that technology we've since licensed it to Bayer or cardiac STEM cell applications. And then along the way it became clear, we could use that technology to also rescue drugs. Well, the same time I brought in a drug from the venture portfolio into Vista gin, and that was a CNS drug it's called[inaudible]. And that developed what is currently our focus and that's all exclusively on central nervous system, drug candidates and drugs that really are fundamentally different, not just a me too scenario, but drugs that act differently that work differently in the central nervous system, especially in the brain have a fundamentally different safety profile. I'm sure we'll talk about benzos today. Fundamentally different side effects and safety concerns eliminating those. So an ability to move in multiple different markets or indications as we call them a long road. And, but always surrounded by incredibly talented and smart people still are. I'm still doing that. And that's been really the biggest blessing of this career is to be able to work with just fabulously expertize people all around me and all the different disciplines needed to bring a program to near successful level where we are now with our lead truck.
Speaker 3:I got to say, that's a hell of a story, a corporate lawyer to a biotech CEO and sprinkle a little bit of flesh eating bacteria in there to inspire the change. I think that's a bit of a unique story
Speaker 2:Aspect, you know, and there's always a personal component. You have to have passions and real life experiences drive those passions and family members of mine. Also I've wrestled with mental health, especially depression. And, you know, it just became really clear that things had to change. We really had to, and I started even before COVID and I think one of the silver linings covert is starting to see this a lot more. I've always been the belief that we've just got to destigmatize mental health. You know, it used to be not that long ago when someone would get breast cancer or prostate cancer would be all hush, hush, and no one really wanted to tell anybody and saying, and now you hear that. And it's like, okay, fine, sorry to hear it. But here's the battle plan. Know it looks, go do this, this, this, and this. And really the same thing has to happen with mental illness, with anxiety, with depression. It's like, okay, this is something that we have to wrestle with. It's real. A lot of people have it and let's address it. Let's bring the resources to bear some of that's medication. A lot of that's talk therapy. That's actually been happening more and more as a result of COVID. That can be pretty clear that it's not surprising that we have a mental health pandemic on the other side of this COVID health pandemics. So far a little bit of progress made there. And I'm happy to hear that it's now the point in time where what we've got is even more relevant than ever before. We didn't just sneak up on these things takes a long time. As you said, to develop a drug and long before the world's anxiety, depression, and suicidality issues that we are all wrestling with today, we started these drugs on tracks that I think now are points to be ultimately hopefully very helpful to people.
Speaker 3:Yeah. I, 100% agree with you on that in general, as a society, we definitely need to not stigmatize mental health. And I think that we are making progress on that. I mean, you, you're seeing kind of tele mental health, especially nowadays growing even more sites like better health and Talkspace that allow you to do online conversations, online therapy. So I think in general, people are coming out more and more and talking about it, which is definitely a step in the right direction.
Speaker 2:And when you compare it to 10 years ago, yeah, no question. And we, even before COVID, when we had seen sharp increases in pressures from social media pressures, from rising team orientation in the workplace scenarios where there was just a lot more risk factors associated with anxiety disorders in particular, it just says become increasingly clear that now that has all been amplified by the verse impacts from the code pandemic, social unrest, these are real life issues that people wrestle with daily and they've appended a lot of lives. So it's no surprise when it's reported in the mass media that we have these issues universally, and that we have a system that needs to improve quite a bit. There are some advances, as you said with telehealth, and that allows a little bit more privacy. You don't have to tell your employer that you're going to go to a clinic and get your medication. But I think there's a lot of room for growth.
Speaker 3:Absolutely agree. So there are a few reasons why I'm really excited to talk to you. One of them being the, I personally suffer from social and generalized anxiety and to be able to talk to the CEO of a company that's at the forefront of basically replacing benzos is super exciting for me. Secondly, you are the only company I've talked to so far. This will be actually be the 10th episode that has a few let's call them assets that are through phase two trials. And I'm super interested to hear what that hope
Speaker 2:That's a whole podcast in itself. It's clearly the case that every season is not a harvest in biopharma. There are definitely seasons where got a water plant and we fertilize and all of that's important because you drive towards seasons where you get near the end of the line. And I think that's where we are with pH 94 B the first of the three assets. So we have three pH 94, B is for anxiety disorders. That's a neuroactive nasal spray with a completely unique pharmacology or the way that the drug works in the human body. And the second one is pH 10 that's for depression related disorders. Also a neuroactive nasal spray. And the third is 81 Oh one, which is an oral pill. That is for both what we call neuropsychiatric indications, depression, suicidal ideation, and neurological. So pain and movement disorders and potentially epilepsy and other indications. So two of those three have already been in human patients through what we call phase two studies and have generated very successful outcomes based on the statistics. So you look at the statistical probability that the result was due more to the drug than to any random chance and pinpoint Oh five is a really statistically significant value or the lead drug.[inaudible] that P value if you will, is 0.002. So highly statistically significant. And the study that was done in phase two, that is now leading us into phase three in the world of drug development, you really have an a four stages. The first is what we call preclinical development that's before a drug gets into a human, and then there are three phases of development in human, healthy volunteers and patients. So phase one is safety based. That's where healthy volunteers, people who don't have the problem you're trying to address are assessed for the safety of the drug. Then you move into phase two. If the phase one safety data are sufficient, then you have phase two development in patients. And in patients. Now you're trying to test both safety and efficacy. Does the drug work with pH 94, B and pH 10, both have had successful phase two studies and pH 94. B is the most advanced now moving into phase three, which replicates phase two on a larger basis, somewhat larger basis in many cases. And you do two of those studies, they're called adequate and well controlled studies. Those then support the total body of work that is under what's called a new drug application that you submit to the regulatory authorities. In our case here in the U S the FDA for approval to market the drug. So we're at that last stage with pH 94 B for anxiety disorders in particular social anxiety disorder, entering phase three, a early part of next year, and hopefully of successful. Then we will have for the first time a drug that can treat acutely on demand as needed the anxiety that adults with social anxiety disorder experience. And as I understand, you've experienced, so what's needed is what we don't have anywhere in the world. And that's exactly we're headed for is to try to become the first ever FDA approved on demand as needed treatment for that case where you can often predict, as you probably know, what's a trigger for you. What the anxiety provoking situation is. Is it giving a speech? Is it going on a date? You go into your neighbor's for a barbecue interviewing with your boss, knowing on a subway, getting an MRI. You know, there are many such a diverse range of experience that are triggers for those who suffer from social anxiety disorder.
Speaker 3:You said from preclinical trials until entering phase three trials, how long did that take?
Speaker 2:This is a different story, because this was initially invented by a brilliant doctor named dr. Lewis Monte based here in Silicon Valley at a company called Ferron pharmaceuticals. And they did a lot of the early developments funded by a family office and the team at Baron and the team at VistaGen have long standing relationships and one case going back about 20 years with our chief medical officer. So in 2016, I got my eye on these two assets, page 94 being pH 10. And we developed a business arrangement that made sense for us to acquire those two assets and bring them into Vista gin pH 94 B and pH 10. So there was a gap in time where is often the case cash strapped, private companies have a fits and starts type of a development program where you get to a phase. If you don't have the capital, you have to go find the capital and they had some gaps in development. So I guess I would say really the typical hall is about 15 years from bench to bedside. Sometimes it can be faster. Sometimes it can be even longer. I think that kind of will fit on that track here, although we've really accelerated quite a bit of the activity since we brought them in house two years ago,
Speaker 3:15 years, that's a long time to be working on one product. I mean, it must be exciting every step of the way. I'm sure it goes by in the blink of an eye when there's always new results coming out. And as you go through the phases,
Speaker 2:A lot of hoops and hurdles, there's no question you look for go, no go points all along the way. And patient endurance is certainly a necessary trait in this business. It's not a widget, it's not a fast and fleeting application that gets a new version every year or every six months. These are businesses that you build and you have protection commercially for quite a long time, once you're successful. And really they have to have a game changing impact. And even in cases in this business where there isn't as much white space, as there is here with anxiety, meaning there, isn't always a case where you just haven't seen anything new for many decades. And it's very clear the current standard of care falls short of what people need. And it's very clear that what you've got fundamentally changes, it has the potential to transform that standard of care. So when you get those opportunities and you have to throw vision into it, of course that's having vision and raising capital. Those are certainly among the top needs of any CEO in our business, but you have to have the ability to kind of see the fit and you have to look many steps ahead from wherever you are at a decision point to see if that fits going to still be there. What the potential return on the investment is all the different variables. At the end of the day, you've got the potential to help a lot of people in an area where the unmet need is tremendous. You'll find a way to get there and even helping a modest number of people affected with things. It mean there are 40 million people or things in the U S alone, probably more than that now with COVID. Can you imagine if we just, even if a million of those people, let's say even a hundred thousand of those people turn their lives to the point where they get to be the ideal version of themselves, tremendously innovative group of people now, creative, productive, and it becomes even more incredible. If that number is 2 million, 5 million, 10 million, 30 million, you know, start to add up global application. And it just becomes such a motivating factor, even on the tough days when you've got to grind through whatever the challenge of the day is that driving force, surely that helps all of us in this business keep going. And shareholder value comes on the other side of helping people in biotech. And that's what I always loved. Still do.
Speaker 3:Absolutely. On a global scale of how much you're going to be helping humans and raising, I guess let's call it happiness levels across the world. You're definitely, there's probably not a lot of companies out there that are going to have as much of an impact. So when does you said from something to bedside, when can we expect bedside? You guys are entering phase three trials. How long has that taken? And so when would phase three trials end and what would happen after phase three trials?
Speaker 2:We are really think about it in baseball parlance. If you looked at my office, you'd see it was filled with Willie Mays in baseball parlance. We're probably, we've rounded. Second, we're headed to third. And when you round third, when you've completed your phase three efficacy studies, your pivotal clinical trials, you still have other things you have to put together. And it's kind of like a college admissions application. You just have all kinds of information that you have to pull together from different perspectives and put that all into an application that hopefully it's a rolling admission process. And so with us, we have the very first fast track designation from the FDA for the development of pH 94 before social anxiety disorder. Sad. That helps a lot because it allows us to interact with the FDA. And it also eventually will allow us on a rolling basis to submit parts of our NDA. So the entire package doesn't have to be reviewed all at once at the very end things can be looked at along the way. And then, then when the final data are done, there's typically anywhere between eight and 12 months, once you submitted your application for the FDA and other regulatory authorities to get through. So we've got a couple more years left, at least in activity. I will start some of that around the middle of next year. We will do the two phase three studies. Those hopefully will be done by the end of 22 and maybe creep into a little bit of 23 with some of the other studies we want to do. We have to do, we don't have to, but we want to do, for example, a study in benzodiazepine addicts to find out for sure, as we suspect that people will not prefer from an addiction standpoint, the drug over a benzo, one of the key distinguishing features is we think there's absolutely no basis so far in any study to believe there's a potential for addiction. So that's a key distinguishing feature. We'll talk about in a bit, I would say, um, you know, we're looking at about three and a half years before we get to the point where we can see the daylight for approval. Hopefully sometime in 23 is when we can get concurrent approval in us. And ideally in China, we just landed a great partnership with the group for key markets in Asia.
Speaker 3:It's really exciting. And I mean, three years this year has gone by in the blink of an eye. So it doesn't seem like it's too far away. So let's get into the juicy stuff. You mentioned benzos. And for those that aren't super familiar with it, benzos typically Valium and Xanax, which do not have a great reputation are supposed to do the same thing as what you guys are working on your product works in a different way. Can you describe how it works differently? And yeah, let's just start off with that.
Speaker 2:The way benzos work is really well understood. The impact of benzos is understood. The benefits of benzos are understood and the side effects and safety concerns are really well understood as are issues associated with going off of them. And a lot of parallels are until the opioid epidemic. And people have seen a lot of media about that, but the benzo epidemic is certainly finally starting to get some traction. Although the covert pandemic is probably pushed back a little bit on that, given that there seems to be a, an upward, an alarming skyrocketing trend and prescription of benzos. So how do they work? Well, benzos worked very quickly and that's why people like that's why doctors prescribed them. And they work in about 30 minutes in most cases. And they go in and they are systemically absorbed trucks. That kind of means that means that they're oral and they go throughout your body throughout your blood. And they sort of go on this circulatory loop through the blood, through the liver, through the brain. And that can happen for many hours. Sometimes you can even affect more than a day or two. So there are systemically absorbed drugs that bind to receptors in what are called GABAergic neurons. These are neurons that produce a substance called Gabba located throughout the brain. And those produce widespread increases inhibition, inhibitory GABA function it's called. So the binding of these receptors throughout the brain results in their side effects, sedation, cognitive impairment, fuzziness, memory loss, eventually over a long period of time, tolerance builds up physical dependence. Do you need more to achieve the same benefit? These are the kinds of concerns and safety issues that are just completely different with pH 94 B because of the way it works. So think of the brain kind of like an electrical circuit court, the way it functions depends on which circuits are turned on and turned off, right? Which neurons neurotransmissions are inhibited or excited and pH 94 B is, is intra-nasal. It's not oral, it's a nasal spray. And it stimulates very short and fast neurocircuits. These are neurotransmissions that convey or send information to a part of the brain called the amygdala. And there, they turn on a switch that release these GABA neurons, which are again, the major inhibitory neurotransmitter in the brain that help to reduce fear and anxiety. The Magdala is the main fear and anxiety center of the brain. So unlike benzos, which are binding to these GABA receptors all throughout the brain, pH 94 B achieves its benefit from a distance, we call it action from a distance. And that is it's very specifically activates rapidly. These neuroconnections to the amygdala, that kinda modulator fine tune, the release of Gavin neurons that are in the amygdala, not everywhere else in the brain. And this specificity is really the key it's activating Gabba, specifically, that's in the amygdala and not throughout the entire brain that causes the cascade of side effects and safety concerns that are associated with benzos. So how does that happen? Well, all of us have in our nasal passages, these receptors that are called chemo, sensory receptors, and those when they're sprints with a microgram level, I mean, these are microgram doses of pH 94 B that are spreads, then a very fine nasal spray odorless. And once those receptors are occupied, they send a signal to what are called olfactory bulb neurons. These are inner neurons, think of inner neurons, kind of like relay stations. And when you again, go back to electrical circuit board suggestion, if you have too many intranet neurons, too many relay stations between say, when you stub your toe and you feel the pain, there's a lot of relays that occur between the pain and the brain here. We only have one relay station from that receptor in the nasal passage to the limbic amygdala, the part of the brain dealing with fear and anxiety. So we can achieve by activating that neurotransmitter, flipping that switch in the olfactory bulb neurons that are right at the base of the brain and real quick net of neurocircuitry that goes to the amygdala and sends out these calming signals to other parts of the brain really quickly like events. And to achieve that without having to take something that goes in your gut and your intestines is metabolized by your liver might bump into other drugs that you're taking for cholesterol or hypertension is a tremendous benefit. So when I say the pharmacology of page 94, B is fundamentally different from that of a benzo, well, there's just multiple reasons why that's the case nasal spray versus oral direct route to the brain versus having to be broken down and going into the flood acts quickly. That's the only similarity. And that's actually what we want, right? A new generation of drugs for mental health to be effective. They've even in depression and suicidality, they've got to act faster than the existing drugs. They've got to be more effective or at least as effective. And they've got to be phenomenally safer than what we're seeing these days. And people have to wrestle with, because often you may have experienced it yourself. You know, the side effects and the safety concerns affect compliance. They affect how frequently people will actually embrace a medication and whether or not it will work. And if the problems associated with taking the drug, you think of a commercial these days when you're watching a ball game, the first 10 minutes or 10 seconds of the commercial arm swing is enlightened. Great. And then the next 50 are all about the fears and those are what we've gotta do a lot better on people. I can't worry about the side effects more so than dealing with the underlying condition. The medicines intended to benefit. So lots of differences with pH 94 B versus benzos, again, because you're not going all over the brain like benzos do systemically. You're not going to trigger the kind of effects associated with tolerance with dependence, with addiction, with cognitive impairment, with memory loss, with all of the other issues associated with benzos. I mean, you know, they're scheduled for drugs. So what that means under DEA classifications is they definitely have a potential for misuse and abuse. We don't see that at all in the cards with pH 94 B. And that's because of the unique way they work
Speaker 3:The bit to unravel there. Quite a few questions I have about that. First of all, let's just start off with how long does it last?
Speaker 2:It takes about 15 minutes to work and it lasts for so far. What we've seen is about one to two hours in the data. So far people can take it up to four times a day that might become longer. We don't yet know on that one, but the key thing again, think about the rescue inhaler, right? For asthma or a migraine drug for migraine, you can tell when you need to take those. And when you right upfront, when you anticipate an asthma attack or the onset of a migraine episode, that's how we see 94 B fitting out of your briefcase out of your backpack, out of your purse, right up front of your particular anxiety, provoking stressor trigger. Typically we've found that once people get over that anticipatory phase, when they actually get into making their speech, executing their job interview, making a presentation to their colleagues at Google, they do fine at that point. It's that getting over that initial hump, that anticipatory phase where the needs, the greatest, especially in business and where we think the impact of 94 B will be the most profound.
Speaker 3:Yeah. It makes a lot of sense to kind of, I mean, one to two hours for sure. To use it even strategically, like you said, in business. I mean, when I first started this podcast, the very first interview I did, I was very nervous. I could have used some pH 94 B that's for sure. So yeah, I definitely see how there's a usage. I mean, two hours of a significant, well, let's talk about that. How significant is the anxiety dampening? I mean, let's compare it to a benzo to a Xanax. I mean, I've taken a Valium before 20 milligrams and it just knocks me out. So I'm curious how strong like one dose is when squeeze not totally sure how you would dose it, but how is it compared to, I guess you'd say one dose of value.
Speaker 2:Well, we don't have a comparison to that. There's not been the kind of direct head to head comparison or do we really need to do it, but experientially, I think if that's what you're saying, that you see, like how long would you say you, it takes for the impact of value to be notable for you? So it is about 30 minutes. Typically we have heard that and that effect can last for three hours. You're going to last for 10 hours. 15 hours really depends on which benzo you're taking. They are in the same class, but they are a little bit different. I think with pH 94 B we see the onset within 10 to 15 minutes in the phase two studies, and it's significant, it's profound. And it's not accompanied with the sedate of effect that you see with the benzos. That's one of the most significant attributes of the drug. And it's ultimately its product profile is, you know, if you're a broker booking trades, if you're a manager going to give a meeting to your team, if you've got to give a speech or whatever you've got to do functionally, right? You don't want to fall asleep and you don't want to become fuzzy. You don't want to have things get cloudy. And really that's the major difference with pH 94 B. And again, the reason is because it's acting from a distance, it doesn't even have to get into the brain. It acts by activating neurotransmissions that are associated with the calming effects of the GABA neurons. And so I think they will it'll work faster than benzos and faster. If it's 15 minutes versus 30 minutes, that's still significant. But even if it was 30 minutes, we haven't seen that it takes 30 minutes, but it's a quick spreads of a nasal spray. It's from a standard Amber vial. It's a normal pump. That's a very fine mist. And it doesn't take a lot. As I said, it's microgram doses, not milligrams. You know, a typical Advil for example, is 200 milligrams. This is 3.2 micrograms. And so it doesn't take much to get the activity that you're desiring in play. The other side of it is you don't have to worry that you're going to fall asleep shortly after you take. And that's key too, because it's performance that you're trying to improve, right? It's not only calming the anxiety, but at that anxiety is what impairs the functionality, whatever scenario you're in, doesn't have to be just professional. It certainly could be social or athletic or you're given a recital. It could be so many things in your right, even participating. There's a whole performance component. It's not just, we call it social anxiety disorder, but it's really anything with an answer, personable or any situation where you would fear judgment or embarrassment or humiliation. That's really the hallmark of, of sad is those fears, which me, even many people realize are irrational to have because they've experienced them and nothing's happened many times over, but it still doesn't go away. And it takes time. I mean the mean duration of social anxiety disorder. It's about 20 years and the onset is often from adolescents. So we're really focusing not only on adults, but ultimately on youth as well. And we're seeing just alarming increases in young people with anxiety it's now I think it's now the leading mental health condition among American youth. One in eight adolescents have issues with anxiety. So it's to compliment like every other medication really effective psychotherapy or talk therapy from a mental health professional. There's never a one size fits all patients. There's not a one size fits all solution either. So it really has to be an integrated effort of talk therapy combined with proper medication. We just don't think pencils are the proper medication or even close to it for the needs that people have these days in particular.
Speaker 3:I think what you said earlier is really quite a gem when you're describing, I mean, some of the benefits that[inaudible] will have over benzos, it's just the fact that you don't get tired from it overall. It seems like just a performance enhancing addition to your life. So I don't think, yeah, it doesn't really seem like there'd be any reason. It almost sounds like kind of a benzo light, I guess you'd say maybe that's the worst way to describe it, but something that's not going to be as so taxing on your nervous system, but just kind of give you the good parts without the bad parts. Would that be a fair way to explain it?
Speaker 2:I never liked to compare them at all because they're just so different, but I guess you could put it that way. We don't see the baggage of the benzos associated with pH 94 B the benefit of the benzo. And look, I'm not saying that people haven't been helped by benzos. They certainly do help some people and they've been around for 50 years, but it's just that they can be dangerous and they can be scary and we need better alternatives. So they're not designed for the longterm use that people seem to be falling into the trap of, and just like with opioids, you know, they're short term monitored use that can have an impact. I mean, they're certainly helpful with seizures are helpful with insomnia, but the problem is that they're just getting handed out like candy and the prescriptions that we've been seeing increasing 34% increase in scripts just in recent months. And I don't see that changing. I actually, I see it going the other way, unfortunately for quite awhile. So we're laying a foundation for an even greater number of people that are going to need a better alternative down the road and think what's most alarming to me at least is how frequently when we see opioid deaths, benzos are on board as well. And you can have real scary consequences related to the press respiration. And it's about, I think 30% is the latest data I've seen of opioid related deaths have also had benzos on. So that's a concern of the FDA. It's a concern of the industry. It's a concern, you know, certainly one of the things we're trying to knock back, it just doesn't need to be the case. We need to get something that can give the benzo benefit, but without the benzo baggage, that's page 94, B
Speaker 3:A lot of baggage when it comes to benzos has there, you've obviously you're coming up to phase three trials now. So there's quite a bit of human testing at this point. Have you seen any side effects, short term longterm with patients?
Speaker 2:Yeah, really minimal. There's never been a single serious adverse event. That's been drug related or otherwise in the studies. And that's the key thing you look for. You also look at adverse events and adverse events, really. They haven't been that different from what had been experienced in the placebo group. So a little bit of nasal irritation, a little bit of nausea, but we're talking like four or five out of 220, not that much different from the placebo side. So, and it's not surprising again, you're not having to mess around with all kinds of human systems. If your drug is very specifically going to where you want it to go and not going to other places, especially in the brain, you avoid a lot of the psychological side effects and you avoid a lot of the motor side effects that are associated with many CNS drugs and drugs in general. So especially if you don't have to have the gastrointestinal system involved and the drug doesn't get into the blood. I mean, one of the benefits we see beyond social anxiety disorder is potential in postpartum anxiety. So 17 to 20% of new moms within the first three months experienced anxiety. And they're for all kinds of reasons associated with the birth of their child, but to lean on a drug that like a benzo that will get in your blood and pass through to your child when you're breastfeeding, not a great option. Page 94 B doesn't get into the blood. It's not at all detectable in the blood. So that is because it's not systemically delivered. It's directly affecting the action from a distance started in the nasal passage and doesn't get into the blood. So non-systemic, non-addictive, non-sedating, those are the, really the key features on the safety side and side effects side. The efficacy is that it works fast. That's something that we want to go into beyond social anxiety disorder, many other disorders. So postpartum anxiety is one. We've seen some, there could be some potential in PTSD. We have a study, we'll do an adjustment disorder. This is especially related to experiences from COVID nurses. First responders, healthcare providers, all kinds of people who have never experienced anxiety, but for the diverse impacts of the coed pandemic, some trauma, and the definition is something that's occurred within the last three months. That's impaired their functioning in a way it never had before. Well, think about that. That's a lot of people's lives have been up ended. So adjustment disorder, or a lot of people who fear certain kinds of tests like closed MRIs. There are surgeons who don't want to drop IB Adavan for an hour before a surgery. They'd rather have some option that's non-systemic so preoperative, anxiety, pre-testing anxiety. There are a lot of panic, a lot of other indications that we will be exploring beyond social anxiety disorder. That's just the very first stop and it's the most advanced program. So I'm excited about that because each one of our three assets has multiple column verticals. If you want, or other indications that it's not just one drug for one thing, it's each drug for many things. And that's what makes it so exciting. And you have a pipeline.
Speaker 3:It does seem like, I think anxiety just affects so much of performance in general. So when you cut out the anxiety factor of things, it really just seems like just a performance enhancing addition to your life. Yeah,
Speaker 2:Anxiety is not all bad and we need anxiety. It's evolved as a human trait over times, and you need it to heighten your senses. If you've got a dog that's baring his teeth and you're suspecting from everything, you know, from movies and books and TV, that that means he's going to possibly attack well and heightened your awareness. And your sense is that anxiety and you get that. It's when anxiety on a persistent basis impedes or interferes with the way you want to live your life. That's when it becomes an anxiety disorder. And that's when you need to really find some help, start to talk with a mental health professional, and then seeing if there's a medication that can compliment that work. But you're right. There are so many different anxiety related disorders that could benefit from a drug like pH 94 B, which is why we're so excited about it.
Speaker 3:You jump into the business side of things. I know that a lot of the listeners here are curious about the business side. A lot of them are potential investors, a fairly large audience of investors that email me advice, et cetera. So let's just jump into a little bit, just a few questions if you don't mind. And for anyone that's listening, the stock is VistaGen VTG N and that's on the NASDAQ, by the way, currently trading about 62 cents at a$40 million market cap. As of September 11th, 2020, first of all, are, do you guys have any type of money-making? Are you earning any money? Right now?
Speaker 2:We just signed a partnering arrangement that brought in$5 million of non-dilutive capital or a, an arrangement with a partner covering multiple key Asian markets, especially greater China, South Korea, and Southeast Asia. And there we have in the past, as I said, we did a deal with the company that was acquired by Bayer on the STEM cell side. So the revenues we generate at this point, aren't product sales, they're revenues associated with collaborations, with grants, with grant awards, from what we've received, a lot of money from the NIH and a little bit from the veterans administration. So grants and licensing revenue, yes.
Speaker 3:Going through trials is quite capital intensive. How has your guys's runway? Will you be raising more?
Speaker 2:We just raised, uh, another 12 and a half million net. So about not quite a month ago, we bought in 17 and a half million in cash net to us. Some of that was from the partnering arrangement. And some of that was from common stock offering. And, uh, yeah, this, of course you have to raise money to develop these drugs. I think one of the most amazing things for us, probably the most remarkable meetings I've had in my 30 year career with the FDA we had in the middle of June. And we announced the results of that in the middle of July, after we got the official meeting minutes in our hands, the results of that meeting set the stage for what will really be a very, I think, efficiently executed and very cost effective phase three program. The way that meeting came about and the consensus that's reached on the study design, we essentially get to replicate identically the P 0.02 phase two study that I mentioned to you earlier, the highly statistically significant study and the design from that study is very simple. It doesn't require a lot of involvement over time with patients and sites. The study itself is remarkably less expensive than most phase three studies that I've seen in my career by a lot. So we're excited by the economies associated with that meeting and really the simplicity of the study design to be able to assess the efficacy and safety of peach 94 being phase three, whether we will partner and generate additional revenues from partnering arrangements around the world remains to be seen, but I'm confident we can replicate some of the activity that we've seen recently. We want to keep all of these assets for ourselves in what is the world's largest pharmaceutical market currently the United States, but we will also leverage the expertise locally of partners like our partner ever insight in key regions around the world where we see tremendous promise for each of these drugs. So we will partner each drug regionally ultimately, and we will keep rights in the United States where we will drive the commercial efforts associated with each of these drugs. So it's revenue from those arrangements combined with properly timed capital raised from long biased, fundamental investors that see the world the way we do. And no challenge that we have had previously, I think has been knocked down. There has been some uncertainty as to whether the FDA even knew how to deal with a drug like this and how to assess it. There hasn't been anything new in social anxiety disorders for decades, and those are even antidepressants. So once it was clear that really we're looking at acute treatments, think about the rescue inhaler comparison or the migraine drug comparison. It became very clear the development path that is most appropriate for a drug with the pharmacology or the way that pH 94 B works. And now that is at a mode where when we have meetings with fundamental institutional investors, the way they look at assets and programs and expenses, it just becomes increasingly clearer that this is the roadmap forward. And so we will, we'll raise some additional capital at the right time with the right investors that have a long view and see the potential commercial benefits of the assets we're developing when the time's right for that. But right now we're fine. We don't need any cash for the foreseeable future. And we are in the pregame mode where we're setting everything up for the launch of the phase three study and some phase two work on pH 10 for depression,
Speaker 3:Very exciting time to be a Vista gin investor. And I have a very quick question. Is this something that will be OTC? Is this something that we licensed? I mean, are we going to see this available on Amazon?
Speaker 2:Ultimately we see it as having potential as an OTC. Again, you know, the safety and the market performance market experience with the drug goes a lot towards that equation and whether or not something ultimately becomes OTC when a commercial exclusivity of whatever flavor that is expires the safety profile of pH 94 B and pH 10, any you want to one, all of those lend towards a reasonable projection downstream that they will be suitable for OTC. And if that's the way that actual patient experiences play out, as we've seen things go in clinical development, if that's how it also goes in the real world in the market, you know, we're confident, that's absolutely potential. It seems like everything will be on Amazon. Ultimately.
Speaker 3:Yeah, they're going to have their own pharmacy anyways. It doesn't matter if it's OTC or not.
Speaker 2:We want as many people to benefit as possible. We certainly don't want it in any way, shape or form where there's harm to people. So science and medicine sound science and medicine is driven us all the way to this point. There'll be heavy clinical scrutiny and regulatory scrutiny on every aspect of the program, as there should be, especially for a drug for mental health. And we like our chances. I mean, I stack up what we've got against anything. Anyone is developing anywhere. There is nothing we see in the anxiety arena. That's even close to what we're doing with pH 94 B and its potential. And the same thing, really with pH 10, you've got to look for something that's totally different mechanistically than what's out there supporting the current standard of care. And I can confidently say, that's the case with each of our assets,
Speaker 3:The, on the fence investors out there, what should they be on the lookout with VistaGen what news should they be looking for? That is a big deal. What gate will you guys have crossed where people should really start paying attention? And most importantly, how can they stay up to date, I guess, on the website subscribe there?
Speaker 2:Yeah. This agenda.com V I S T a G n.com is our website. And you can always contact us through the website with any questions. Any investor has, it's a common occurrence, but, you know, look, as I said, every, season's not a harvest and there are seasons with every drug you go through different seasons of planting and weeding and fertilizing the ground. So each of these drugs, as at different stages and different indications, we're constantly planning new studies and the results of those studies. That's the harvest phase, whether it's a preclinical study or a clinical study, no, they're all a big deal in their own way. As our partnerships, as our intellectual property achievements, regulatory achievements, fast track designations, the kinds of things that are all part of the, as I mentioned earlier, the ecosystem that needs to be deployed to move along. We will certainly keep people up to speed on social media, on any developments in the clinic or with the FDA or with partners. And again, having three different drugs, multiple shots on goal, if you will end up multiple different targets, I'm in, I'm excited by the potential to have, you know, a nice constant flow of progress and news impacting each of the different programs as we go forward. So we will be, um, the next clinical study that we see starting will be in New York city in adjustment disorder during the first quarter of 21 and a small open label study results from that study will likely be in hand before the results of the first phase three study for nine for me. Um, but you know, we're entering into a really exciting phase where we start to get results and we start to start studies with results that really should have the potential to, uh, to show the value that we're developing here as a company, whether or not the market sees it. That's, that's a constant frustration of a CEO because there's often a significant difference between what clinicians know and scientists know and regulators know and partners know and what the market's able to absorb. So we'll do our best to connect the dots and make sure people keep informed on our progress.
Speaker 3:Everybody can agree that the markets don't really stand for what a good company is at all. I like to end every interview with just a few fun questions. I know that for sure people are going to be interested in pH 94 B, how does one sign up for trials if they wanted to be involved in that
Speaker 2:Typically in a clinical trial, once it's at the point where you've cleared all the internal control issues and requirements, you have to go through a separate internal review board IRB that assesses the study and its potential safety and efficacy benefits as well as risks. And once that's occurred and the sites are on board, they will advertise locally the study at hand. And in our case, we'll have 15 different sites throughout North America, mostly in the U S one Canada, one in Mexico city, the rest in the U S that will be participating in the study. This is the phase three study for PhD for me. So it's that way. Then you contact patients, contact the sites directly, their site coordinators. Each of them work under the auspices of our team and the principal investigator. One of the key benefits we've got is the people we work. Dr. Michael Liebowitz is arguably the godfather of social anxiety disorder. He created the Liebowitz social anxiety scale, which the FDA is used for the drugs that have been approved. Dr. Liebowitz conducted the phase two study, and he will be the principal investigator working with our team for phase three. So it's important really to have the best and the brightest involved in your studies. We certainly think we have that with Michael and the sites that Michael will involve or manage throughout the course of the study also are very familiar to him. So the way you sign up to a study is to look for a particular site in your area that is participating in the study, and then your screen people, not everybody who signs up, gets to go in, you have to meet really specific criteria. Qualify. Cool.
Speaker 3:Then for the final question, I imagine that running a NAS tech related company in the world of anxiety and stress relief can be quite stressful all in its own. Do you have some tips for those out there to relieve your own stress?
Speaker 2:Uh, well, fortunately I have a fabulous family with four, no longer kids, but between 21 and 26 enjoying their lives and the events of their lives is really key. My wife and I, we walk a lot. I read a lot, you have to step away and give herself a mental break from time to time. Now there's not a lot of time for that. And these are especially these days, but walking and reading are probably my two key breakaway opportunities, so that, and enjoying my family,
Speaker 3:Reading and enjoying the family. Well, Sean, thank you so much for joining me today. I learned a lot and I'm personally really excited about all of the, I guess we'll call them assets that VistaGen is working on in particular pH 94, B sounds really exciting, still three years away, but I think a lot of people listening to this are going to be anxious
Speaker 2:W awaiting, well, thanks, James. Again. I really appreciate it. And again, if people are struggling with social anxiety or any mental health illness, we have a terrific page on our website called finding help@vistage.com and you can find real nice connections to resources to help you out. Please do seek that help, especially if you're in a crisis mode because it's there and help can really guide you through some troubled waters. And we certainly don't want to see anybody, any traumatic outcome. So encourage you to look there as well.
Speaker 1:If you got this far, I just want to say thank you so much for listening. If this was all interesting to you, I'd love to connect on Instagram and hear your feedback. I'll also be posting clips from the latest episodes as well as anything else. I find interesting about the biotech industry. You can find me on Instagram at simple biotech, and if you're interested in the companies that I'm looking at and the companies that I'm excited about, connect with me on angel list at angel.co/james rule. That's James R U H L E. Thank you so much and be safe out there.