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Transcript Disclaimer: This transcript is generated using speech-to-text technology and is intended to capture the essence of the conversation. However, please note that it may contain multiple spelling errors and inaccuracies. It should not be relied upon as an exact or comprehensive record of the discussion.
Mike Koelzer, Host: [00:00:00] Well, hello, Sean. Hi Mike, for our listeners that haven't come across you online, introduce yourself and tell our listeners what's
Shawn Singh, CEO, VistaGen: hot. Well, thanks. Um, so I'm Shawn Singh. I'm the CEO of VistaGen therapeutics. We're uh, a NASDAQ listed public company, tickers VT, G N. And, uh, we are really in tough times to state the obvious.
So, uh, what we're finding, and this is not an area we've just snuck up into, but, um, we have been focused on trying to bring some solutions to mental health and from the, the medication standpoint, the current standard of care, in our opinion, and just fall short of what people need, especially now. In the midst of COVID in the midst of social unrest, uh, we're seeing skyrocketing rates of anxiety of depression, suicidality.
So I think what we've got, uh, across our pipeline, three different assets, each of which has just a real unique way. Uh, of working. And I know from a pharmacology standpoint and your audience, uh, the likes of which I've just not seen in my 30 year career. So we're excited to talk about that, uh, why they're different, how they fundamentally are different and how they might transform the standard of
Mike Koelzer, Host: care.
We're gonna focus on the business stuff here, but what's the drug? What are the drug differences in what you guys are putting out?
Shawn Singh, CEO, VistaGen: Yeah, well, let's, let's back up a step, as you said. So if you take a look at the landscape, what are the drug related treatment options? Right. All of these medicines in mental health really have to complement psychotherapy talk therapy.
Gotcha. So it's, it's really a, a complimentary scenario where it's an antidepressant and an anxiolytic or anti-anxiety. Could be a beta blocker, but let's take social anxiety disorder in particular. Yeah. Right. And this is, uh, this is a real intense fear of judgment, uh, humiliation, embarrassment that people have persistently really over what many would consider everyday situations and circumstances, whether they're social or performance.
A job interview date, uh, a presentation to your colleagues in mm-hmm in a work or an academic setting. Uh, and these anxiety provoking triggers are just, uh, they're really debilitating. Yeah. And they impair the function of someone's life. It affects the opportunities in the workplace and yeah, and, uh, socially.
So for that indication, there's only three drugs approved. There are only three drugs approved. Um, Two SSRIs and one Sri. So these are old school antidepressants that focus on neurotransmission, be, uh, serotonin, uh, no epinephrine. And as you said, there's a very long onset of time for depression or for any other indication.
Yeah. That they're being used for weeks, six weeks, seven weeks, 10 weeks. And there's also a very low hit rate. Right? There's a very. Low percentage of people that actually get a benefit in depression. If, if you were to try, um, you know, pick one of them, um, yeah, any one of them, they will have about a 33% effectiveness rate.
So two out of three people, when they first try an antidepressant, whether it's for depression or something else, it is not gonna work. So that long onset of activity, especially for someone who's wrestling with social anxiety, more episodic, You can typically anticipate, uh, a particular event is going to cause you a lot of stress.
Yeah. A lot of fear, a lot of anxiety, you know, when you have an interview, you know, when you have to go to the doctor, You know, when you have to give a presentation or a speech. Yeah. Uh, and it's, and so something that ha is, comes upon you acutely almost like an asthma attack would, or a migraine. Right. You need to slip something right.
In, in front of that. Right. That can knock, knock that down, not take something that, you know, you have side effects for a long time and they may or may not work. Yeah. So, so chronic. Everyday use of antidepressants for social anxiety, particular, and many anxiety disorders just isn't cutting it. Yeah. So then, then you move to the, what we call off-label prescriptions, right?
So these are, as you know, doctors in our country can prescribe whatever he or she wants to prescribe. If they think it's safe, whether or not it's FDA approved for that. So benzodiazepines. Um, drugs like Xanax and Valium and Ativan and, uh, Klonopin. They're not approved for social anxiety disorder, but they're very often prescribed off label [00:05:00] as our beta blockers.
So why, right. Why do they use them? Well, they act quickly. So in that pocket of time, right up front of a particular anxiety provoking scenario, about 30 minutes, it takes for a benzo to. The challenge is you get some baggage on the other side of the benefit and you have a lot of different side effects, um, because the drug lasts in your body for hours and hours and hours.
So sedation, cognitive impairment, um, memory, um, fuzziness, right? There's also nausea. There's, there's a lot of different side effects. So when we say that, um, The market needs something better, what the market needs for depression and anxiety are drugs that can work quickly. Right. But you don't have to wait around to figure out if you're the lucky winner.
Yeah. Right. That, and that doesn't cause as many problems in terms of side effects and safety concerns for benzos, for example, that's a big deal. And I would
Mike Koelzer, Host: Say the third that does know they work, it comes on. So gradually yeah, that's it. It's not like, okay, my, my, uh, adrenaline switch was on an hour ago and now it feels like it's off.
It's like, ah, I might feel better now than I did two months ago. I'm not sure, you
Shawn Singh, CEO, VistaGen: now. Yeah. Good point. Really good point. Because all along the way, you're still wrestling with the risk of tolerance and your, and physical dependence. Yeah. The more that you take it, the more you need to get the same effect.
And ultimately you end up in, in sort of an opioid like scenario where we do have a benzo epidemic for the same reasons. So short term, great longer term, not so great. And what we need is, and this is what we think we're charging towards, uh, is something that can act quickly 15 minutes, but not cause sedation not required.
Systemic distribution to achieve that effect, right? That these drugs don't have to be the ones we're developing. They don't have to be carried through the blood after they're broken down, right metabolically into the brain. It's a straight shot. And that's the uniqueness of, of the nasal spray formulations that we've got.
Very exciting.
Mike Koelzer, Host: The chicken or the egg, was the company formed around a chemical formulation or did you have, did, did the company have this idea and say, let's go out and create the best thing we can. I mean, how does that, how does the mission come or, you know, do you, yeah, I know you don't stumble upon it, but what comes first in.
In that company.
Shawn Singh, CEO, VistaGen: Yeah. Well, it's never really a straight line from idea to success. Right, right. Um, and so the, we went public in, in may of, uh, went on to NASDAQ in may of 2016. And even before that, the focus, um, was around a, one of our three assets called AV 1 0 1, which had. Uh, a lot of features and benefits we saw and may still, uh, have like ketamine in the context of depression.
So the benefit ketamine brings to the table is, its rapid onset, you know, quickly, you're not waiting six, 10 weeks to figure out if it's going to work. Yeah. Um, but ketamine has its own set of safety issues and concerns. So that drug worked on the NMDA receptor. And it allowed us to focus both on neuropsychiatry indications and neurology indications, the pH 94, B and pH 10 came into the company through a paradigm we had set up, which was.
Look, we want drugs in CNS that work quickly. They have to have a totally different innovative mechanism of action. They have to have a way they work in the brain and in the CNS, that's completely different from what we at the time, um, saw out there and still see out
Mike Koelzer, Host: there because of two reasons. One is you knew those didn't work so well, but also you had to be far enough away for a patent or not.
Shawn Singh, CEO, VistaGen: No patents are always important. Sure. You have to get patents, uh, along the way. And you have to know that what you have at the end of the day will commercially be protectable. Yeah. Yeah. Uh, we have that with every one of the drugs. There's no way to go in our business really with innovation, you get that kind of protection, so, right.
But, it helped us to say, look, what we're looking for out. There are drugs that will work quickly. In a fundamentally different way and have an exceptional safety profile. And then the final piece is the business part, which is they've got to work on more than just one thing. They've got to work for multiple different diseases, multiple shots on goals.
So. We have three drugs, they all fit that profile. Um, and they all have, um, promise in multiple different vertical disease states within a particular therapeutic [00:10:00] area, pH 94 being pH 10. We acquired and we looked, uh, we're doing work from about 2016 till middle of 2018. Um, our own homework, our own due diligence, working with, uh, what is a, a terrific little company.
That, um, we acquired these two assets from a company called fair and pharmaceuticals nearby here on the peninsula. And they did some real groundbreaking work early on Dr. Lewis, Monty who's the inventor. And, um, and they took it to the point where we took the handoff. And so we're now at a spot where we can execute the later stage clinical studies, the commercial component, the regulatory.
But they fit so nicely, pH 94 B for anxiety disorders and pH 10. Uh, for depression disorders, the pH stands for faring. So it's a, it's a type of neuroactive, uh, molecule, a fear, not, not really a neurosteroid, but, uh, it acts in similar ways in the brain. Um, but not some of the negative connotations associated with steroids.
So not like anabolic steroids. Even, um, endocrine issues with the neurosteroid.
Mike Koelzer, Host: So Sean, your three drug differences. What are the drug differences?
Shawn Singh, CEO, VistaGen: pH 94. B is for multiple anxiety disorders. The lead is social anxiety. Following that the other verticals within that anxiety disorder arena are. Postpartum anxiety, for example, the drug, because it doesn't get into the bloodstream.
There's, it's not systemically, uh, taken up to achieve its effects. It's a waste, it's an ideal drug candidate for, uh, a breastfeeding mom who has a lot of anxiety in the few months after birth. But they don't want to pass any of that to their child, you know, through breast milk. So it's got a really interesting spot there.
Uh, posttraumatic stress disorder is another potential place where after exposure therapy, we see a potential opportunity for pH 94 B preoperative anxiety. So when you go into surgery, often, a doctor. We'll drip IV out Avan for an hour before that procedure. Well, that's systemic again. If you can avoid systemic involvement before any of these types of procedures, all the better you go get a closed MRI.
A lot of people have trouble right up front during that MRI experience. If you, if you can, 15 minutes before. Take pH 94 B. You're gonna have a different experience. So those are the kinds of verticals
Mike Koelzer, Host: and the PTSD might be like 4th of July coming up or something. You don't have to start planning for this in April.
You know, you plan on it at noon on that day or something. You're
Shawn Singh, CEO, VistaGen: right on track. That's number one. The second one is pH 10 and that is for depression disorders. So pH 10, uh, whereas pH 94, B will. Neuro transmissions to generate calming effects. pH 10 is the opposite. It works through the amygdala and it will stimulate neural transmission activity to generate antidepressant effects.
That is for major depressive disorder, treatment resistant depression, suicidal ideation. So there's postpartum depression. Again, a big opportunity. So these are, these are ways that you can pivot with really safe drugs. That's what we've seen so far in all clinical development. And when you have that benefit, which is unusual in drug development, especially CNS, it really allows us to, to get patient experiences in open label studies in multiple different disease and disorder states.
And, and that's why you, you ultimately can build, you know, a universe of vindications around a particular drug. And the third vertical is neurology. So AV 1 0 1 is our oral drug. It's got some potential, we believe in depression and suicide. And, but also in neurological indication. So if you have Parkinson's disease, for example, you have to take Levo.
Do. Right for your dopaminergic neurons that you're not producing as a result of your disease, but when you take levodopa, it will cause a movement disorder called dyskinesia. The drug itself causes another problem. So we see that as an opportunity with our drug. We've done some terrific work in monkey studies to show that we can reduce dyskinesia without affecting the benefit of the levodopa.
So. It's an opportunity to, to fix one thing and not cause another right? Yes, exactly. In pain, for example, we have some studies where we put the drug up against pregabalin, which is Lyrica. Um, yeah. And in a case like that, you know, or in a case where you have an opioid, you, you may be dealing with the pain.
But you're either [00:15:00] causing sedation or grogginess or addiction. So again, there, we see, we have fast track designation from FDA, for depression and, and, um, pain for this oral drug of virus. So again, that's a third vertical where you have multiple different, um, a third. Business set. That's associated with each drug and that's the way you gotta look at it.
Cause you wanna get the best return for investors on the opportunities that we're investing in when you have
Mike Koelzer, Host: a vertical. And let's say that for diagnoses are. Better than one, is that because you can market to a bigger crowd, basically. I mean, there's four. Now there's four groups of people who are maybe interested in this, the groups being doctors, the sales people, the, you know, investors, the patients versus just one, or is there some other reason I missed why you would want more indications for one
Shawn Singh, CEO, VistaGen: drug?
The biggest reason Mike is you get to help more people. Uh, and that's a fundamental driver. There's a lot of people suffering with CNS disorders where current therapies just are falling short, they're inadequate. And so the more you can develop your drugs, safety and efficacy profile through adequate and well controlled studies.
Just the, the better it is. The commercial side takes care of itself. Quite honestly, if you're helping people, um, who are. Who are just not making it with the current alternatives. That's where you find that's what drives us. We've got a unique opportunity at this crossroads in time to make amazing changes in this country alone.
I mean, imagine, you know yeah. Tens of millions of people affected by these disease states, right? Anxiety, depression did. Take 5 million of them, take 1 million of them. And imagine those people now are functioning without any impairment from anxiety or depression, they're productive. They're going to take their kids to soccer practice.
When this COVID is over, they're going to work. They're innovating something. That's the human side of it. And we've got a mental health pandemic. There's no question about that. And it's gonna just get, unfortunately, a little bit worse. Before it gets a lot better. And these, there's a lot of people in the context of COVID, there's an indication called adjustment disorder and we've filed with the FDA to do a phase two, a study for adjustment disorder.
And that's a case where really people often who have had no preexisting history with anxiety, um, yeah. Find themselves in a situation. Lot of nurses, a lot of first responders, a lot of doctors. That they're not, they've never experienced before. So the clinical requirement is that it's a trauma that's occurred within three months and that, uh, that may persist for much longer, but it's a brand new traumatic or anxiety provoking stressor.
That's caused them to be impaired in the way they function. And so we'll be, we'll be studying the drug not only in phase three. Uh, for social anxiety disorder, but also starting some phase two studies. And that's where you start to develop these other indications. Yeah. Is by, um, small studies, usually 25 or 30 subjects where you get some experience with the drug in that unique new population.
Right. And you do it on an open label basis. So there's, um, there's not a double blind placebo controlled scenario, but it helps you design your phase two B study. So that gotcha. When you're, you have a lot more education and knowledge into the specific needs of that group and how the drug works in that group.
So for social anxiety, it may be that it works just acutely and you can like a rescue inhaler. That's it, you know, one right. One spray and you're done. It may be a different dosing regimen for a different disorder. So it's a lot of trial and error.
Mike Koelzer, Host: So you could have a vertical that's only one disease and then someone could argue, well, it can be written off label for everything else.
Yeah. But the problem with that is that it doesn't help. As many people. That's gonna be a slower process. You can't test it as well. The world's not gonna get out. You can get those early. Diagnoses faster. You are gonna help more people with that
Shawn Singh, CEO, VistaGen: drug. Yeah. And you want good science in medicine to drive any decision.
So E let's say we cannot promote it unless it's FDA approved for a particular indication, but doctors will look at white papers. They'll look at study results from one indication versus another, [00:20:00] um, quite often, right? That's part of the reason why benzodiazepines are used for social anxiety disorder.
Is that a lot of times there's nothing else? And they are approved for different anxiety related disorders, but not social anxiety disorders. So there's some, uh, a reasonable basis for a medical professional to make that decision. It's just, patients need more options. Doctors need more options. They need newer, different treatment options.
So like in depression, there has been nothing new for decades. And just last year there was a new drug approved, the nasal spray formulation of ketamine. I saw that that was a sea change, because again, it helped us all believe, look, FDA is, FDA is very focused on providing patients with as many possible safe and effective options as they can, right.
Patients need the benefits that are available. And, so it was nice to see a new mechanism. Totally different from everything else. Come into play under an approval paradigm, give a lot of hope to people developing drugs, like our teams that, uh, the old ways don't necessarily have to apply to the new generations of drugs.
So we just had a meeting with the FDA on our lead drugs. pH 94 B we've talked about for S a D and the study design that we were able to reach consensus with FDA on is, is just a fabulous consensus. Very perfectly fit to the far unique pharmacology of pH 94 B a drug that acts quickly that you need to be able to use acutely on demand.
Not in a mode where you take it in the morning, and then you have your, uh, you have an interview with your boss at 5:00 PM. Not gonna do much for you. um, so you need a study design that fits the way that a particular drug works and takes into account. All, obviously all the safety issues, because you wanna be able to assess the efficacy of a drug in a pivotal way.
Um, and to reduce potential variability and, and outcomes. Um, we were just excited because our phase two study was a highly statistically significant study P 0.002 was the P value. And you know, a lot of drugs in my career have been, you know, P 0.05 is statistical significance. Oh, oh two is a whole different level.
right. So to be able to have that study design, it's a public speaking challenge. In, uh, in a laboratory simulated public speaking challenge. And to be able to do that in phase three, especially in the midst of, uh, of COVID. So we don't have to send people out into the real world to experience a broad diversity of stressors.
Everybody will get the same challenge in the same setting, and that really simplified, uh, the effort associated with the forthcoming phase three studies. Reduced a lot of costs reduced a lot of time, but it really was showing FDA's, uh, very progressive mindset and, and really unique care in assessing the specifics of this particular drug and how it fits into a study.
And it didn't need to be studied like the older drugs,
Mike Koelzer, Host: VI ketamine, nasal spray. I read that mm-hmm and I thought it was fascinating because, um, you know, you just think about all the help that could give. You know, suicide hotline, things, you know, stuff like that. I mean, they're not together, but yeah.
What was that? Biggest shift that you saw with that drug? Was it the speed? Was it, was it the mechanism of action? Was it the, uh, the distribution route? Did all those things kind of open up a little bit of a, a light bulb or was it one of those things in
Shawn Singh, CEO, VistaGen: particular? Well, the most, uh, most significant thing, and there are many things that were significant, but clearly I think the most significant to the industry was the NM D receptor.
Is a totally different neurotransmitter. It's a totally different mechanism compared to every drug you've ever heard of in depression. Gotcha. And, and that, uh, that allowed the, it, it just allowed a different perspective into how to study the drug and the NMD, a receptor, uh, that's a drug that blocks the ion channel of the NMD, a receptor.
So it's like a cork in a bottle. And, uh, it causes, unfortunately there's safety concerns that the FDA set up a REMS program as a result of those safety concerns. Uh, we don't think we'll see those with any of our drugs and that's always a good thing. Um, but. For treatment resistant depression. These are for people who have had unfortunate RINs and repeat scenarios with multiple antidepressants, there [00:25:00] had, there was nothing for them to go to.
And so to provide a whole new horizon of hope and yes, there are definitely things to consider. Right? You have to take it into the clinic. You have to take it, uh, come back and get maintenance treatments. You have to watch blood pressure. You know, there's still some hoops and hurdles, but. For someone who's who's suicidal and nothing else has worked.
Boy. I mean, it's, it's, it's an, it's an option. And I think specifically, you know, of veterans and, uh, communities where we know there's a high prevalence and now COVID, um, because. Your benefit from antidepressants is reduced as time goes on. So some people have taken 6, 7, 8, 10 different antidepressants.
They've taken them for 10, 15, 20 years and there is still no benefit. And I remember going to the FDA advisory committee meeting, and I was just impressed with the mindset that says, yes, there's some safety concerns here. You get hallucinations. You have to, that's why you have to stay in the doctor's office for a while, and it only can take it in the clinical setting.
Ketamine is still a scheduled drug. Uh, so there are precautions, but again, it's, let's provide options to patients, especially in the case where in this case, even with safety concerns, Options provided. That's what people need. And you know, that was hopeful.
Mike Koelzer, Host: God bless you guys for moving on this, cuz it really sucks that the one indication that you don't wanna have a drug that takes three weeks to start helping and then you gotta see how it's going, then you gotta taper off.
And if there could be any indication that that would. Terrible way to move forward. It would be for depression. Yeah. You know, that's all you need to give a depressed person their ninth different drug. Yeah. In the meantime, they've put on, you know, 40 pounds and, and they don't know if it's gonna work for three weeks.
I mean, that's just a bad, you know, it's a bad
Shawn Singh, CEO, VistaGen: combination. No, you're right. And, and typically the scenario is, is there's an add-on, uh, dynamic. For, for mental health professionals and doctors. Right? So if you're taking an antidepressant, it's not working, you're either gonna add an atypical antipsychotic on top of that, or try another antidepressant or both of those.
And so you're still depressed. You've just washed out. You might have probably had anxiety in the first place when you took it. The comorbidity of anxiety and depression is staggering. Uh, it's, it's, it's difficult, but you're right. This, this whole idea, especially. With Esketamine though the gap that seems to still be there with bravado is between visits.
You might, it will help kind of clear the hard drive if you will, for someone who's treatment resistant, but, but what do you do in between? And so what we think people need, and we have this thought in mind with debut 1 0 1 and the same thing with pH 10 is you need to have something. In between those visits to maintain the benefit, because we know the effect of Esketamine ketamine WANs over time.
Yeah. That's why you have Deb maintenance visits. So, yeah, ideally, uh, that's just one indication for our depression assets. I think what we really need is a new standalone earlier in the, in the lineup treatment option. So that you may still want to take your original old school. Antidepressant payers may require that.
Uh, yeah, but then right after that one doesn't work, the new generation of antidepressants must work faster. They must work within days at most days, sometimes even hours. And, the new mechanisms can achieve that. Just like the SSRIs replaced the tricyclics back from the fifties and sixties, there's a whole new generation, a foot that got mechanistic benefits that are just phenomenally different from the current generation of drugs.
So we hope to prove that out with, with pH 10 and, um, that's certainly the road's been. Been tapped onto a little bit with Esketamine and that came after IV ketamine, the nasal spray as a treatment option for a real significant disorder, like depression. It's nice to know. Because it'll change some perceptions out there.
And when we come along with pH 94, B and pH 10, both our nasal spray formulated, the reason their nasal spray formulated is the receptors, um, that they activate and the neuronal activity they activate. Those are in the nasal passage only really. So you could, you could drink a bottle of each of the drugs, not gonna do anything to you, but you've.
And these are Mike. These are microgram doses, not milligrams. [00:30:00] And so if you spritz just even a little on the receptor and you set in motion, a sequence of, uh, of neuro transmitted transmissions that are mediated via the amygdala, ultimately. You've got a direct shot. That's why it's rapid onset, but you don't have to go through, uh, the whole systemic route is typically the case.
So, well,
Mike Koelzer, Host: That's fascinating because yeah, I mean, like with Narcan, the opioid antagonist, it's like, Hey, if I'm dying of a. Morphing overdose. I want someone to stick me like a three inch needle into the heart. I don't want just this sissy nasal spray you know, but like you say, this sort of paves the way to say, Hey,
Shawn Singh, CEO, VistaGen: this works.
Yeah, these are transformative.
Mike Koelzer, Host: You're a smart guy, but you are not classically medically trained. How many people are there from scientists to you? Or do you like it? Directly talking to them.
Shawn Singh, CEO, VistaGen: Oh, that's a good question. It's an elastic number, right. And it's also the major benefit of what I do. And as you go on the website, you'll see some of the incredibly smart people that I have the benefit of being surrounded by.
And there's many there that aren't. Aren't even listed and it is the case. You're right. If I'm ever the smartest guy in the room, then I'm in the wrong room because my job is to be sure I don't get the benefit of detachment and, and my passion and my interest doesn't allow me to do that anyway, because I'm fascinated.
By the way these drugs work, I'm fascinated by the potential to absolutely transform lives. I mean, everywhere I go, every presentation, there are people in the audience, people come up to me afterward, you know, they're struggling. They have some family member, their child, their parents, uh, in one way or another with some mental health complication that.
Fortunately, um, or a neurological condition that I think we've got some potential to touch at some point, um, down the road, but I don't have, um, I don't really ever want to be disconnected. And so fortunately that's kind of the lawyer in me early on in my career. I've. First few years, I was a corporate finance lawyer at a big law firm in Silicon valley.
And my whole job was to do IPOs with high tech and biotech companies. And my job was to write to prospectus and I'm, you know, a mid twenties guy coming outta law school. I don't know anything about these industries. So I learned really well fast and bill 3,500 hours a year to ask really good questions of a lot of people.
And that's how I do it. I mean, that's, you just have to dig in and put the time in to understand what you're doing. I have to shepherd a lot of resources and people and time, uh, and the investors have trusted me at the top to make sure we're deploying the right people to the programs in the right way and the right resources.
So it's an ongoing thing. And at any given time, I mean, I'd say right now, the brain trust consists of maybe about 40 people. Overall, uh, some inside the company, some outside the company, we have some of the most amazing clinical and regulatory advisors. We have a former director of the FDA's division of psychiatry.
He's on our advisory board, um, depression expert. Number one depression expert at Harvard. Number one, depression expert at Yale. Number one at Baylor, the godfather of social anxiety disorder. Michael Leitz Dr. Leitz outta Columbia. He's uh, he's our guide on social anxiety. So it's important to build that ecosystem.
And that's an ongoing thing. You constantly wanna add layers of, uh, of expertise as you move through the different indications. And we don't always have it all right up front. So. There are new discoveries from time to time where we'll be able to see an opportunity related to that discovery. And we'll have to bring that expertise into the current fold.
And that's part of the fun as well. You build relationships and it's actually a relatively small community of experts. If you think about it, given what's at stake, uh, they've all been doing these kinds of things for decades. And for example, the NMDA, a receptor at the time, the serotonin drugs were being developed.
People gave complete short shrift to the NM D a and they were like, no, there's no shot for that in depression. And there were, but there were people at NIH, for example, studying it. And they're now having their day. Right. The, yeah. Right. The science and medicine has evolved to the point where, what might have not been regarded so highly before.
Has come into the forefront and, and that's, it's good because the time for that is now more than ever.
Mike Koelzer, Host: Like If I'm building a computer program or something, I probably don't know all my programmers. I might have a programmer that's on the other side of the world doing a part of this and I might [00:35:00] have someone else doing some other research.
It is the. Industry is, is your company like that or are these like scientists, like in your physical building?
Shawn Singh, CEO, VistaGen: It's a combination. Uh, it's a combination of those. So there are certain disciplines that in the world today, it depends on your business model and your approach. Mine is, uh, and I ran a contract resource organization for eight years as chief business officer.
So I've got a little bit of, uh, sense of what happens under the hood. And there's a lot of resources, especially for smaller companies that you just don't need to own. You need to use them on a flexible, real time basis. So for example, contract manufacturers, um, or wet lab preclinical work, right? We don't need to own the capability to do animal studies.
So we don't need to own the ability to manufacture our own. As our company's model, because there's a, there's a lot of resources out there, especially alumni of large pharmaceutical companies that are now working in these other industries. So those are the people I don't know directly. Right. I will know them vicariously through those on our team who have the primary responsibilities of dealing with those disciplines and those contract manufacturing relationships or, or contract, uh, preclinical studies.
Um, there're various aspects of the drug development process that you just don't have to own the core disciplines you do, and you need competency in all of them, but you don't need, um, you don't need to spread teams across all those areas.
Mike Koelzer, Host: Well, it's just like in the podcast now I'm renting this capability.
Yeah. To talk to you. I didn't build it. You know, that kinda stuff. Good point. You just don't need all
Shawn Singh, CEO, VistaGen: that. No, you don't. Somebody does, but, but we don't know. Yes.
Mike Koelzer, Host: Someone does. So during your day, typical day, how many people are you? Talking to like, how many people do you run into and say, Hey Bob, Hey, Fred.
And you talk a little bit about stuff. How many is that
Shawn Singh, CEO, VistaGen: per day? Each day is pretty long, because we're, we're like we just had a partnership that we put in place a really great partnership with, a group over in, uh, in Shanghai, uh, for key Asian markets. So, yeah, there's there's on the one hand there's there's Japan.
There's China. There's Korea. And then on the other hand, there's Europe, and then in the middle of all that, we've got the east coast and then finishing off the day with the west coast before the far east starts. So 24 hours a day, I, you know, on a daily basis it fluctuates. Um, but it's probably. Just a specific context through email and through phone, uh, couple dozen minimum.
And, and, and if I'm, if I am in pre COVID times when you're presenting to audiences, then it's a heck of a lot more than that, but yeah.
Mike Koelzer, Host: Then it's a lot
Shawn Singh, CEO, VistaGen: more than that. The pressures on the right. The anxiety of working at home is a real thing for a lot of people. You know, it's, we're all more productive.
I think we've passed the test that says we can be productive working remotely. And a lot of CEOs were skeptical of that. And we got forced into this experi. But I don't think, um, that's going to change much. I think the way our business in particular is run. I think there's gonna be a lot less business travel and you know, there's not gonna be travel across the country for one meeting kinda thing anymore.
And we have a lot of benefits as a result of remote activity and. Uh, especially no commutes in the bay area, especially.
Mike Koelzer, Host: Right. Did you say the pressure of on, do you mean that you're always on because your office is only a step away, right?
Shawn Singh, CEO, VistaGen: It is that, that is that right. And with texts and with emails and with now these, it is different because, um, you don't get that, that separation.
You have to force. And it, and, and that is something that you can achieve sometimes, but, you know, there's a lot of important things that have to be done and, um, it's not easy to develop a drug that gets in the brain to do really amazing things. So there's usually something somewhere that has to have some sort of attention and decision making yeah.
Associated with it. And, uh, you know, but you know what that is. That's great. That's I would much rather do that than be sitting on my hands all day. So we get the benefit here of really doing some amazing things for a lot of people. And that's our
Mike Koelzer, Host: job. Yeah. My dad, God rest his soul. I was his junior partner at the pharmacy and you know, back then, You know, there was nothing, there was a telephone, but you'd get mail.
I think they might have done it twice a day, but you get mail once a day. So one time a day, you're getting a surge of adrenaline, like what the hell's in the mail, you know, and you get that. But now I've been on some school boards and it used to be that school [00:40:00] board meetings were monthly meetings.
You'd meet. And then a month later you'd meet. And now it's like, even something as relatively small as a school board. it's like
Shawn Singh, CEO, VistaGen: every day, it's like, it's like every
Mike Koelzer, Host: day you're on it, you know, it's crazy
Shawn Singh, CEO, VistaGen: with it. Always on, you gotta call your shots. No question about it. And you still have to try to maintain the same things that kept you on balance before.
Right. And even more so, because it takes a little more care and feeding. With kids with parents, I've got a, a heroic wife or I've been married for 32 years and, you know, ah, nice. She keeps everything really together. We've got four, four grown kids that help. Okay.
Mike Koelzer, Host: As a CEO, I guess they would say that your main job description is for the shareholders.
You know, I mean that, that's the cliche, I guess, at least. So with that said, do you know, like every second I've never talked to a public shareholder. CEO before. Not that I recall. Mm-hmm do you know, like every second of the day, what your stock price is at? Who's the Berkshire guy laughing? Warren buffet buffet.
Like every morning he wakes up and if the stock is up, his wife gives him like $2 and 42 cents to get this. And if the stock is down, he only gets a dollar for 85 just spent at McDonald's, you know, or something like that. How much pressure, how tied in are you to that? I have no idea about that world. Just stuff I imagine.
Tell me a little bit about that.
Shawn Singh, CEO, VistaGen: Yeah, it's a challenge. Uh, you know, it's, I, I wouldn't say that I don't see it because I do, and we have resources internally. That's their focus, investor relations, public relations. Um, but you know, I've got, uh, a multitude of things that I have to attend to each day. And being laser focused on the stock price and, and each moment of the day, the stock prices movement isn't in the best interest of anything to do with this company.
We're building a business. And it's a very complicated business that has tremendous rewards potential, um, and hopefully the not too distant future. So I have to have a vision. I have to have the hope that drives the leadership, um, effort. That's necessary to keep everybody focused, motivated.
Uh, that requires a lot of interaction with a lot of people. And it, my looking at the stock price every day, isn't going to continue to add the benefits. It's not gonna get a new partnering deal done. It's not going to get a decision that advances a clinical trial protocol. It's not going to be a key strategic decision that's necessary to generate the value that ultimately hopefully makes its way into the stock price.
Where I gain the confidence for the company and its future is to discuss. With the scientists, with the doctors, uh, with the regulators, with the partners, all the people who have spent incredible amounts of time looking at and scrubbing what we're doing and why we're doing it and how we're doing it.
And, and, and how given thumbs up really? So you, you don't get a partnering arrangement without a lot. Due diligence by the prospective partner and you don't get positive FDA meetings without actually getting the win and putting the time in necessary to educate the FDA about your particular drug and negotiate and discuss.
So they're really, it's, it's not the best use of my time in, in, in the skill set for the benefit of the company. To be hyper focused on the stock price. Now, again, I'm not derelict in disregarding that on a daily basis, but it's not often. That you see the perfect connection between potential and a stock price.
Uh, and it's just not possible. We do as much of this as we can, and we try to do it as often as we can, but it's really never possible for any investor except those large fundamental institutions that will go under a confidentiality agreement. To really have the time and dig in to know everything there is to know that might help with, with evaluation efforts.
I imagine
Mike Koelzer, Host: I'm just throwing this out there. There's probably a lot of different things that people can talk about to maybe get the stock to move around. But is it still fair to say that if you really try to get a good product. And you're trying to, you know, get good people and you're trying to solve a problem.
And this and that, that in general, not all the time, but in general, it's naturally gonna raise the value of the stock or the company.
Shawn Singh, CEO, VistaGen: Well, you hope, and you can't be passive about it. You have to educate people, just like when a new drug comes out. You never want a patient. To walk into a doctor's office and be educating the doctor about the drug.
The doctor needs to know how to prescribe that drug before a patient even walks in the door. Otherwise you won't have what's called a good conversion rate, right. Uh, [00:45:00] request to, to prescription. And, and so educating your investor base and prospective investor base. It is an everyday event and you're always getting new people in every day, uh, that weren't investors and see things for the first time and you also have longer term investors.
So it's very important for us to break things down to their essence. It's important for us to be able to clearly communicate where we are. Some things we can communicate, some things are proprietary. Uh, people always want to know more than you can actually tell from a strategy. There are certain things that if you do, you just still have to be mindful.
Normal business, strategic, um, conditions and, and circumstances. And so you do the best you can to, to, uh, to execute in a way I call it the mom test. And if my mom doesn't understand it, then we're not doing a great job. And sure. And so that's typically the area where. We at least want to hit that.
Mike Koelzer, Host: If people understand it better, then they might say, Hey, that's something that I believe in and I might wanna invest in.
Correct. Yeah.
Shawn Singh, CEO, VistaGen: And social media has really helped, um, everything digital has helped. The virtual environment is actually going to help. I think more people are staying home or are accessing podcast and, and videocasts and the web. But that's something that we really, we have a concerted focus on. We need to do it, you can always do better than whatever you're doing.
Yeah. In that regard. And communication's a priority. And you know, it may seem sometimes to people that we're not saying, oh, we can say, and if that's the case, then there's a really good business reason. For their benefit that we're not, but most of the time, most of the time it's, it's, it's simpler than that, you know?
What do you have? Why do you like it? What's the next step ahead? Um, those are important things to know a vortex will fill itself. Right? So if, if we don't, if we don't fill it with the right information, Someone else is gonna plug it in.
Mike Koelzer, Host: That's for sure. Out of your week, what's the 5% of your week that you have to take your deep breath and say, oh, when you wake up that day, you're like, I gotta do that today.
what's, what's something
Shawn Singh, CEO, VistaGen: you don't like it. Uh, the fact that I have to ponder this is actually a good signal. I think. That's a good thing. I don't know. I get more, mostly frustrated about manufacturing related, um, complexities and the little bit of all the rules and regulations that are associated with some of those things and supply chain, not
Mike Koelzer, Host: all the creation and stuff, but actually like trying to make enough for all the tests and things like that.
Shawn Singh, CEO, VistaGen: Yeah. There's all kinds of requirements that are, you know, they're, they're there and there are guidelines and just have to. Go through all the hoops and hurdles, but oh yeah. Uh, there's a lot of, um, components on the manufacturing train, if you will, right. You're, you're making a drug substance and then you've gotta formulate that into a drug product.
And then there's all things along that supply chain. So I don't know, I guess, I guess maybe that, um, Uh, but for the most part, you know, there isn't really anything that's causing me to not open the computer. Yeah. And, and not engage. That's a great way to put it. And that's, that's a really important thing because I made a decision early on.
I knew we were gonna have, we were gonna try to be blessed with kids and yeah. That worked out well. I just wanted to be able to say, you know, you have to make it. Right. But you, you wanna be able to make money and help people. And this was the industry that I saw as possible. Uh, I remember that every day and I know how medicine can really help . I've had my own traumas over time and, um, you know, I've learned a lot to be thankful for.
So are there
Mike Koelzer, Host: a few hours of the week that you particularly like about the job?
Shawn Singh, CEO, VistaGen: Yeah, most of the week, I like about the job, uh, honestly, and when we talked, I love talking to the clinicians. I love talking to scientists who really know. Uh, how to lay out why, what we have has a real great chance of working and actually helping people.
Uh, I love learning, you know, I love figuring out what's the standard of care. What's the state of play out there? Um, how can we make an impact? Where do we fit? Um, I love that. And, and I, the more that you see problems in the media, and we've been seeing this for now, you know, seven months, right. Um, What more, what we're doing makes me happy that we're doing it.
We didn't just start this, you know, seven months ago we've been on this track and it hasn't always been okay to talk about mental health disorders. And I think that's one of the best silver linings of this pandemic is that there's a stigmatization that's occurring for sure. And people, people realize people are gonna need help [00:50:00] walking through some of this stuff.
And, and that's good because we should be treating. Depression and anxiety. Like we think of when someone's told they have breast cancer or prostate cancer, it's like, all right, here's the deal. Let's go do this, this, this, and this. Yeah. That wasn't the case that many years ago with those two indications, they were quiet.
And now I think that's where we're moving. That's really where I hope we end up as, as one silver lining from this, this COVID, uh, trauma is. People's feeling it's okay to reach out for help. We have a whole section of our website dedicated to finding help and, and I want there to be a day where that's normal to do and it's okay to do.
And whether it's our drugs or anybody else's drug, or just talking to somebody about that. You have to get engaged and, and we have all kinds of ways on the website, on our finding help page for people that need that kind of guidance. What's the address? www.vistagen.com V I S. T a G E N vistagen.com. I heard
Mike Koelzer, Host: Someone said one time, we all have a big potential for having a mental illness.
It's just like blowing up a raft. And at some point the seam is gonna crack somewhere. And, uh, in this case, the RAF just got blown up a little bit quicker than usual.
These
Shawn Singh, CEO, VistaGen: numbers are staggering. I mean, it's, it's, we've got 10% of America based on CDC data just done in June 10% considered suicide in June, June.
Geez. That's almost 40 million people. We've got 39% of Californian, 39% of our 38 million people just in California reported having symptoms of anxiety. Last month. I mean, these are staggering numbers, man. These are not, these are not jokes.
Mike Koelzer, Host: And then on top of that, the help's not there. You know, they can't travel, they can't get to the doctor and all that kind of stuff.
So, yeah. There's never been a better time. Well, Sean, thank you so much for joining us. This has been really enlightening to me. I didn't know a lot about it. This stuff. I've got like one shareholder. It used to be my dad. Now it's probably my dog or something, but I don't know. But, uh, but that's been very enlightening for me.
So I, I wish you guys all the best, those are fascinating drugs and so important. So I'll be, I'll be watching closely.
Shawn Singh, CEO, VistaGen: Well, great. I really appreciate the time too. Have a chance to talk to you about what we're doing and, and thanks for the focus and thanks to your listeners for paying attention for all this time.
So, uh, I wish the best to everybody.
Mike Koelzer, Host: Well, Sean, thank you so much. We'll talk to you again soon. All right, Mike. Thanks again. Bye.
