BTI 53 | Social Anxiety Disorder

 

Social anxiety disorder is the third most common mental health disorder. Over 23 million Americans alone are affected by it. This disorder can continue to grow into depression and drug abuse, so it’s very important to catch it early so it can be stopped.

But how can it be stopped? Shawn Singh, the CEO and Director of VistaGen Therapeutics, and his team are creating a nasal spray to help people with social anxiety disorder. Just like an inhaler for asthma, this nasal spray can do for social anxiety. Join Ammon Rivera as he talks to Shawn Singh about the PH94B nasal spray. Find out how it works and how far along they are in the process. If they get approved, VistaGen has the opportunity to be the first FDA-approved acute treatment for adults with social anxiety disorder. Discover how VistaGen is going beyond the current standard of care for anxiety, depression, and CNS disorders.

Listen to the podcast here

Going Beyond The Current Standard Of Care For Anxiety, Depression, And CNS Disorders With Shawn Singh

I’m glad that you are here with us. If it’s your first time stopping by, thank you for doing so. Don’t forget to go back and check out some of the previous episodes that we have put out. We’ve had some great conversations with individuals talking about strategy, the projects that they are working on, their backgrounds, and how the company was structured. If you are a frequent or long-term reader, I want to say thank you so much. I appreciate you making the show what it is. I appreciate you being here and spending some time. I’m glad that you are getting value out of these shows.

That being said, let me jump in to tell you a little bit about our guest. That is Shawn Singh, the CEO, and Director at VistaGen Therapeutics, which is a publicly-traded company on the NASDAQ as VTGN. Sean has an extensive history here in the background. He has been with VistaGen since 2009. This is not a new thing that he’s working on with him.

He has been through it with them and working through this. A couple of things that we talk about in Sean’s background is how he entered into the industry. He has been in different executive-level roles with other BioTech companies. We talked a little bit about some of that. A little bit about VistaGen, they are publicly traded. They are a clinical-stage biopharmaceutical company.

They have multiple assets in the clinical trial stages. If you want the most up-to-date information on that, you would probably want to look at the company’s website so that you could look at what their pipeline states. Shawn gets into explaining to us a little bit about the excitement around some of these assets that they are working on. They are addressing the mental health space, taking on things like anxiety, depression, and other CNS disorders. One thing I want to tell you about before we jump into the interview briefly is a pretty interesting asset that they have.

It’s a first-in-class rapid-onset CNS pherine nasal spray with the potential to be the first FDA-approved, fast-acting on-demand acute treatment of anxiety for millions of Americans who suffer from social anxiety disorders. It’s a pretty interesting thing. Shawn explains that a little bit to us but what’s so cool about it is, basically think of it like this.

Somebody has a social activity that they need to attend, perhaps it’s a business meeting, a family function or going to the grocery store for that. Maybe that’s something that they struggle with. This nasal spray would allow them to use the spray and, within fifteen minutes, already have direct action, a treatment to the social anxiety they are feeling, and it would allow them to get out and accomplish what needs to be done.

Without further ado, I will go ahead and roll the intro on this and say thank you. Don’t forget to leave us a review. I do my best to read all those reviews. Also, reach out to me on LinkedIn. That’s one thing I always say as well because I mean it. Find me on LinkedIn, @AmmonRivera. Also, find my page on LinkedIn, which is BioTech IQ. I post different types of videos and updates there. Sometimes I do a direct video of me talking, sharing something, and putting it out there, and a number of other things as well. Thank you.

Welcome to the show, Shawn Singh, CEO of VistaGen.

Ammon, thanks a lot. I appreciate the chance to speak with you and your readers. I’m looking forward to it.

The topic of mental health and depression and those types of disorders is something that affects everyone, whether they have it or they know somebody that has it. This will be a great topic to cover. Let’s get started talking about your background. I would love to know why you went the route you did with your career. Looking at your educational background and then looking at where you are in your career seems interesting. I would love to find out maybe what drove you in the direction you did.

Things are not ever a straight 45-degree angle up. There are a lot of curving lines along the way. I’ve always had a passion for justice and fairness and the puzzle building associated with business transactions. That’s what drove me to the law initially. I started my career in Big Law out in Silicon Valley, working at Morrison & Foerster, a giant law firm back in the early ‘90s, billing five years’ worth of time at about two years. In the context of that effort, I had a good opportunity. There were a lot of IPOs back then. High tech and BioTech IPOs were all over the place. I added a lot of due diligence and prospectuses trying for each of those sectors.

It became clear early on, especially when I got to surround myself with scientists and doctors. There were a lot of MDs and PhDs in the companies that I had to do the diligence on, write prospectuses, and lay language. These are complicated things. It fascinated me. I had a mindset that I wanted to ultimately not only have a career but have a life. At the same time, a life that I thought could make a difference to other people. That made it clear that BioTech was the way to go back then. It’s one of the unique opportunities and industries out there where you can do that. You can make a good living. At the same time, you can have a good life and live beyond yourself with all kinds of opportunities to do that.

I ended up going to the CEO of a company I had helped take public and build that company about a million dollars in my 25-year-old self and said, “I could save you 10X on that if you bring me into your company.” He did. It was business development for a while. Many years later, I rose to the ranks. I became Chief Business Officer and then ended up leaving that when I had a midlife health crisis.

I was in the ICU for a few weeks with necrotizing fasciitis, which is a flesh-eating bacteria that made it abundantly clear at 36 what the healthcare system, medicine, doctors, and surgeons could do. The miracle on the other side of all that was emerging with a totally new perspective. That’s what moving into the venture capital arena and trying to help young startup companies with their visions and their dreams leveraging the work I had done the prior decade. I also worked in the contract research sector.

BTI 53 | Social Anxiety Disorder

Social Anxiety Disorder: One of the silver linings of the pandemic is that it has destigmatized mental illness and allowed people to speak more freely than ever.

 

I got a solid appreciation of what it takes for companies to go through all the hoops and hurdles needed to get a new medicine through early testing, clinical testing, all the way through to the point where you have FDA blessing, which is a rarity. That process also energized me. The deal always was to be able to leave. If there was a company that I thought had a unique note in the portfolio, VistaGen was one of those companies. That opportunity presented, and here I am now.

That’s an interesting transition. I interestingly interviewed another individual a while back that is a Chief Business Officer at his organization. He was working in the investment banking space. It was doing the mergers and acquisitions that opened him up to the BioTech space, which I find interesting because it was your law work that you were doing for these individuals or these companies that opened it up. Do you mind if maybe I stepped back with you a moment and zero in on that experience that you had where you ended up in the ICU? That’s a pretty tough thing I would imagine going through. How does something like that happen? How does somebody get exposed to that?

A lot of what you have to do when you are working with startups, whether you are advising them, funding them, or working within them, is you’ve got to have patience and endurance. You’ve got to be willing to scrape and tape by sometimes but hang on to that vision and faith. It’s hard. This was back in the late ‘90s in the winter of ’98 going into ‘99 when I was out scrambling for money to keep this company going. I was fortunate at the time to get a New York Life to make a million-dollar investment, which then led to another few million, which led to a total rebound of the company.

I totally recapitalized and re-energized it over time. In the midst of that, I got the flu. These were the days you could fly back on the airplane and lay across the seats with your trench coat over you if you were feeling too well. When I got back home, I had three young kids at the time, and fortunately, thankfully, they are all grown and productive adults. Still working on the prosperous part but they are at least productive.

I got a spider bite. It was strep A combined with being immunocompromised from having the flu. What I ended up having to deal with was 9 surgeries over the course of almost 20 days in the ICU and a lot of miraculous behavior by amazing nurses and doctors and antibiotics. It was amazing, the way the whole thing worked out. I’m lucky to be sitting here. That’s framed a lot. It’s framed the way I have coached youth in softball and Little League over the years for my kids. It frames the way I lead this company. Things happen.

You have to keep an open mind in leadership roles. It’s critical. Things change over time. A little spark led to an amazing comeback because a lot of setbacks or setups were comebacks in our space. It’s unpredictable. Everything relies on how studies go. You do your best to set up studies and build on what you know from the past, giving them the best chance to work and apply whatever tradecraft is current and successful over time but you can never always predict clinical outcomes. You have to be ready. Be flexible.

I personally find it interesting to hear people’s stories and things that they’ve gone through and how that’s shaped them and led them to where they are going. With that being said, let’s talk a little bit about VistaGen. You mentioned as you were sharing your story that you took on the project of VistaGen. First off, tell me what’s the genesis of VistaGen and the real vision of the company.

The biotech industry is one of those rare careers where you can make a good living while having a good life. Share on X

It’s a classic case of how things change. Originally, VistaGen, back in the late ‘90s, before I joined full-time as CEO, I was on the board. The company was focused on stem cell technology and using stem cell technology to assess liabilities and drugs early on and see if they could be re-engineered. Some of it was licensed out to bear but the company shifted right around the time that we went up onto NASDAQ in 2016, where the focus became exclusively around central nervous system disorders, especially depression, and then later anxiety and depression. Generally, now, mental health disorders are on both wheels, all the spokes on the depression disorder wheel and all of those on the anxiety disorder wheel that have acute triggers.

Since we’ve acquired several assets over time and personnel related to the invention of those assets and some of the earlier work, our focus, and it has been this way for a while now, is trying to dramatically change the trajectory of mental health globally but also one mind at a time. The first focus is on anxiety disorders. The lead asset is social anxiety disorder-focused, a drug called PH94B, second on depression. We are at a spot now where things have changed in swirled. The pandemic didn’t bring on this crisis but it’s magnified it. The awareness of it and the need for changes has risen dramatically since over the last couple of years. We are trying to knock that part down.

What the pandemic did was highlight some of the areas that we’ve glossed over the moment you took away a lot of the stigma. Many people began to realize, once you took away a lot of that distraction, the way of life that they were so used to living, everything stopped. People started to all of a sudden manifest these things and realize, “I have been dealing with this or suppressing it.” It became, “We can talk about this now.”

If there is a silver lining of the pandemic tragedy as it has been is that it has this stigmatized mental illness. It didn’t cause the crisis but it allowed people to speak more freely than ever before. We’ve got a lot of reasons, unfortunately, to be impacted by the diverse effects of the pandemic, self-isolation, loss of job, loss of life, loss of friends, a loss of opportunity, disruption in routine, and uncertainty.

Those two things are the match set that are major triggers for persistent anxiety and persistent depression. One leads to the other, anxiety to depression, to suicidality, to substance abuse. Intervening early is key. Now not only are people feeling more comfortable talking about mental illness and their needs because of the reasons created by the pandemic.

There’s also better access to that talk therapy that’s an essential component. As good as drugs ever are, you always need that talk therapy component at the foundation. These are not one-size-fits-all, one-and-done type solutions that you have in this space but we need medicine that gives you that signal faster. We need medicine that will allow you to undertake that therapeutic approach without worrying that there are side effects and safety concerns downstream worse than what you are trying to knock down in the first place. In the last couple of decades, we haven’t seen anything that has provided that combination, rapid onset without a lot of side effects and safety concerns. That’s the track we are on. It’s exciting.

That’s what you are looking for. You are looking for that balance of the effectiveness of the treatment but also that safety profile. That’s awesome. Your lead asset, PH94B, of which you have a fast-track designation on, Phase 3 at that social anxiety disorder that you are talking about. It’s got that nasal spray. It looks like you are potentially looking at this asset tackling more than one indication. You’ve got a couple of other assets that are tackling other indications as well. Maybe give us a simple overview of the mechanism of action with PH94B in social anxiety disorder.

BTI 53 | Social Anxiety Disorder

Social Anxiety Disorder: Social anxiety disorder is the fear of being judged, humiliated, or embarrassed in predictable scenarios. So PH94B is similar to an inhaler for asthma, except that it’s for social anxiety disorder.

 

It might help to start with the latter first. A bit overview of social anxiety disorder, it’s the third most common mental health disorder. This is not a small thing. It’s a big deal. Over 23 million Americans alone are affected by it. This is also an accretive scenario where, unfortunately, that number was much lower, although still high pre-pandemic. As we continue to have uncertainty and disruption of routines, you start to see even a further expansion of this. What is it? It’s a profound fear that makes life almost impossible for people affected by it. Fear of being judged, humiliated or embarrassed in what is for them, predictable scenarios but a broad variety of different triggering situations that are performance or social.

It could be based on some of the diaries that we’ve got from patients in our Phase 2 program. It’s everything from sitting in a classroom and being afraid to be called on, going on a date, speaking with your employer for a raise, going to your neighbors for a ballgame and a barbecue, and eating alone in a food court. There are many different scenarios where that anxiety-provoking trigger puts someone in a situation where there’s a tremendous opportunity cost.

They don’t pursue relationships and academic or professional aspirations. There’s often self-isolation. It’s a situation where we need, and people need is, the ability, flexibly, on-demand, right upfront of these predictable triggers or even if it’s an unpredictable trigger that’s anxiety-provoking to be able to use something similar maybe to what you would think of a rescue inhaler doing for asthma when an asthma attack is coming on or a migraine drug right up front of the onset of the migraine.PH94B is focused on that particular dynamic around social anxiety disorder initially but everything with an acute trigger, a phobia, a situation where you don’t want to have a drug that goes through your whole body like in postpartum anxiety we have up there, maybe a breastfeeding mom doesn’t want medicine to pass through to her baby, those are some of the unique aspects of PH94B’s pharmacology or the way it works that we are so excited about.

A typical drug for anxiety, maybe you’ve heard of Benzodiazepines, these drugs, unfortunately, there’s a significant risk of abuse associated with them. They cause cognitive impairment and sedation but are often a go-to for anxiety-related disorders. It has never been approved for the acute treatment of anxiety for adults with social anxiety. That’s what we’ve got in our sites, that on demand, take it out of your pocket, your purse, your backpack, right up front of these anxiety-provoking triggers, where you need to be brought down to what we would say is a normal level of anxiety.

We all need some anxiety. We need the ability to be focused and energized. We need the ability to not make reckless decisions but someone with a social anxiety disorder is living at a normal level of anxiety that is more than a little uncomfortable and often causes their perspective of themselves and their way to live that make it impossible.PH94B is unique in that it’s got rapid onset potential based on Phase 2 completed study within about 10 to 15 minutes. This nasal spray that we’ve got is a nasal spray because the neurons that we need to trigger, the chemical messengers, the neurotransmitters that ultimately lead to the part of the brain associated with fear and anxiety, the amygdala, the main part of the brain. These receptors to these neurons are only in your nose.

With a small amount of spray, we occupy or bind to these receptors. That triggers some neurocircuitry, a cause and effect consequence that ultimately leads through one interneuron or one relay station that then broadcast to the amygdala, the part of the brain that’s associated with fear and anxiety. In there, there are inhibitory neurotransmitters, GABA, that’s what it’s called here, which is what a benzo does, but benzo increases GABA all over your CNS.

What we are finding with PH94B is we have with this drug the opportunity to deal with what are these peripheral neurons. They are just in the nose, not in the brain. The drug doesn’t even have to get into the brain and act directly on top of CNS neurons. When drugs go into the brain, you know it’s a long road. If you take an oral drug, it’s got to be metabolized in your liver and kidney and gets in your blood and crosses the blood-brain barrier. When it gets in your brain, you want to make sure it goes where you want to go and not where you don’t want it to go. You don’t want to go to opiate receptors, for example, if you are worried about treating something else.

You have to keep an open mind in leadership roles. A lot of setbacks are setups for comebacks. Share on X

This drug doesn’t bind to opiates, nicotine, dopamine or steroidal hormonal receptors. None of those abuse liability-related receptors in the brain. As a result of it not having to be going through your entire body, it doesn’t require systemic uptake. You also avoid other issues. The drug won’t bump into other drugs you are taking for cholesterol or hypertension that get metabolized in your liver, given that we are using the nose to put simply as a portal to the brain. It’s a short distance. There is not much in between that causes delay.

We get that rapid onset but we also seem to be avoiding the drug, the typical off-target activity that you worry about. Haven’t seen sedation, dissociation, hallucinations, things that are red flags that what you are trying to manage down also increases the risk that other things might happen, insomnia, sexual dysfunction or addiction. It’s that unique rapid onset activity with what we’ve seen so far is a comfortable safety profile. These are the hallmarks of this new class of compounds that we are developing here at VistaGen.

It’s easily deployable in this situation that is needed. It reduces the risk of some of these side effects that you were talking about. You are fast-track-designated into Phase 3. Perhaps I could have looked at this or maybe there was a note on there but at what part of Phase 3 are we on with this? Phase 3 was initiated in Q3 2021. We are already on track with this. I will leave it at that. No one knows exactly what the results are going to be. Everyone is expecting to be good results but how much longer do you anticipate the trial running?

There should never be any CEO who tells you confidently what he or she thinks will be the clinical outcome because you don’t know. These are blinded studies, double-blinded both to the patient and to the investigator, the doctor who’s administering the medicine. We have what’s called the PALISADE Phase 3 program underway now. This study started in 2021. We are in the home stretch.

For both, you need two adequate and well-controlled pivotal studies, which will be considered pivotal studies if they are successful to anchor your new drug application with the FDA. Both of those Phase 3 studies, we call PALISADE-1 and PALISADE-2. They are replicated. Both of those studies will report out in 2022, one in the 3rd quarter and one in the 4th quarter. Late stage of late stage. We are hopefully at a spot as a company where we are migrating that.

The objective of many companies in our space is to move from clinical to commercial and then have both a robust R&D operation at the same time, developing a commercial operation that generates a whole bunch of value to the patients. Ultimately, that falls back to the company and its investors. You have to have a patient-focused perspective because if you have that and keep that, it works out. All the rest of it works out. Here, we know what people need. What they need is what isn’t available now.

There is no FDA-approved acute treatment of anxiety in adults with social anxiety disorder. We have the opportunity to have the first FDA approval in that space if this Phase 3 program is successful. We have been advancing it with the support of some amazingly long-biased and successful investors in the public market, as well as a team internally that’s done this development work in this space for a long time.

BTI 53 | Social Anxiety Disorder

Social Anxiety Disorder: Not every season is a harvest. You may think it’s harvest time, but it’s time for fertilizing and getting ready for harvest. That’s especially the case with biotech.

 

That’s important to have solid financial backing at the same time and have an amazing team internally to be able to drive the programs forward, not just Phase 3 but also some Phase 2 programs that you mentioned, exploratory programs. We want to be able to cover as much territory with what this drug potentially can do for patients as possible.

We will be looking at procedural anxiety. That’s where you say you don’t want to get an MRI or go to the dentist. There’s sleep anxiety, for example, associated with people affected by PTSD and postpartum anxiety. We are giving this drug at microgram doses, not even a milligram, let alone stay 200 milligrams like ibuprofen, a microgram level dose that can have potential neuropsychiatric benefits within a rapid period of time.

We think that’s what patients need. With this indication, while it might not be all day every day, there are days when you have distinct but multiple triggers within that same day. You may have to present to your colleagues in the morning. You may have a business development meeting at lunch, and you may have a date that night. All of those could be anxiety-provoking to people suffering from ADD in a single day or you may have a conference, let’s say that you are on a panel for five hours. Fortunately, the duration of effect that we’ve seen so far is about an hour.

The number of times per day we see so far supported by studies is up to about four times a day. It’s possible, unlike benzo, that if you take a benzodiazepine, it will act in about 30 minutes or so. It will sedate you, and the effect will last for half a day. Sometimes that will impair your ability to function in the job that you have that day. It’s not so bad if you are going to sleep but again, if you are trying to deal with the things that come up commonly in everyday social and performance settings, we think PH94B has some exciting potential.

Not to diminish the seriousness of what some people deal with but sometimes, doing stuff like this, you are all self-conscious about everything. You mentioned something in your last explanation, you talked about having solid financial backing and also having a good, strong internal team. That’s something that I wanted to zero in on here as we can move towards the latter half of our episode here.

Your approach to building a team is when you’ve got an early-stage company that’s moving into a late stage. You’ve got a late stage going on but you are also in Phase 2. What would be your approach to telling a young early startup? What type of advice or how would you approach building a company with the theme of the company?

I’ve had to do it many times. You have to be patient. You have to focus on the multiple work streams that you are going to need to get to your objective as you lay them out. You have to be multiple chess moves ahead of wherever you are at the moment with your vision because you are focusing on what’s down the road but what are the unintended consequences potentially along the way?

As good as drugs are for dealing with mental health, you always need that talk therapy component at the foundation. Share on X

What’s key is that there are always multiple work streams that intersect and that what one group does affects what another group has to do and so on throughout multiple different disciplines and functions within your company. You have to foster a culture of cross-functional collaboration. You must also identify early where those different functions will fall and when those needs will arise.

You may not need massive IT infrastructure build-out when you are trying to focus on finding a vendor with the $1 million you have to do a preclinical study to see if your drug is toxic. Your development plan is always about planning but it’s also about keeping an open mind when things change because they change. This is where patient endurance comes into play. It’s key to find people with that same underlying and passionate perspective of whatever is driving you as the leader.

Here, it’s pretty easy. Many people, I would submit, most of our employees and their extended families, every audience I speak to, and every investor group I meet with either indirectly or unfortunately, if it’s directly, there’s experience with a mental health disorder, in some events many family offices that have come in to invest.

That’s a key source of funding, especially in our sector, our family offices that, in many cases, have financial resources that are well beyond conventional funds. What you are doing might impact the hearts and the minds of the people that you are speaking with, whether it’s your employee, whether it’s a partner you want to develop or whether it’s an investor that you want to come into play. That connection is key.

If you don’t have it pretty early on, it won’t work out in the employment setting and the investment setting. Be careful about the relationships that you build but make sure you do build them and that you let them have time to build themselves beyond your initial idea of bringing people together. There’s no simple answer. There’s never a one-size-fits-all for management as there isn’t for neuropsychiatric disorders.

Those are some things I’ve learned. Hall of Famers in baseball bat 300, and they fail 7 out of 10 times. You will have to be able to deal with no, without letting your ego get in your way. When ego and insecurity are a matching set, it’s trouble. It doesn’t work out so well. If you know what you are doing and what you want to do and why you want to do it, and others see the same thing, eventually, it works out.

You make a lot of great, interesting points. Every time I ask a question, I think to myself that I almost want to explain the question away because I know that there’s no one size fits all. There are so many different factors that could affect each situation. You yourself could be in a certain situation, and something happens in that leads you to take a different decision than what you might generally think would be the right course of action. I understand that.

BTI 53 | Social Anxiety Disorder

Social Anxiety Disorder: When it comes to mental health, you have to be smarter about the potential triggers and risks. You need to get in and deal with them early.

 

In many ways and times, it’s all about the timing, the environment, what’s in vogue, and many perspectives that are out there that you think you have to conquer or that you can slide in with. Those things are important too. That’s why you have to be willing to understand that not every season is a harvest. You may think it’s harvest time but that’s the time for seeding, watering, fertilizing, and getting ready for the time that that harvest comes up again.

That’s especially the case with BioTech. There have been so many different cycles over the last few decades that I’ve seen in a couple even before that, that they surprise you, something that is totally irrelevant and no one thinks about. For the longest time, large pharmaceutical companies wouldn’t be involved with CNS disorders.

There were a lot of late-stage failures. There weren’t a lot of patient advocacy groups around these disorders because of the stigma and the lack of discussion about them. There were a lot of reasons why Big Pharma stayed out. That’s also swung back now. We’ve seen multiple different players come back into the space. It was a big deal between Pfizer and Biohaven at almost $12 billion in that transaction.

There’s some interest. What happens in the market is always important. Are there transactions that show investors that there are multiple exit opportunities beyond just a price appreciation with an equity position they take? Is there M&A? Is there partnering? Are there other things that give them some comfort that they are not going to be stuck? There are lots of different perspectives out there you have to fold in.

What you said earlier on to the setbacks are setups for a comeback. What’s happening now in the BioTech world? This is my first round at watching this happen. As a professional recruiter, I started working in the medical space, recruiting physicians for hospitals and things like that. Back in 2018, it was when I got into the BioTech space. It’s pretty much by chance. I saw a boutique recruiting firm locally that was hiring for something. I read the description and thought, “I have had a great time at this startup where I’m at. I worked for a billion-dollar company before that. Maybe I should look and see what’s out there. I wanted to establish myself.

They happen to have two different areas they were hiring for. They said, “We have this established recruiting practice in banking.” It was previously established. You must rebuild it in the BioTech industry, recruiting and pharmacovigilance, drug safety. I remember going, “I have been recruiting in the medical world for a few years. There’s no way I’m going into banking.

I did not want to recruit banking, no offense to any bankers out there. I have a colleague to this day who has been successful in that. I have been recruiting far longer than myself, and he has been in banking. I got into the BioTech world. That was back in 2018. You know what’s happened since 2018. Now with all the turbulence happening, it’s interesting for me to watch that. I’m experiencing it for the first time.

When building your company, you have to focus on the multiple work streams you will need to get to your objective. Share on X

It sounds like you’ve tapped into multiple aspects of the ecosystem. The ecosystem in BioTech is pretty broad. You have many different players, especially companies that are in the earlier stage that doesn’t have the head count internally. It has also been helpful over time where you don’t need that health, that internal headcount. You don’t need to manufacture, for example. There are a lot of CFOs out there that will do drug substance and drug product work. You don’t always need full-blown internal clinical teams, and regulatory teams are given the contract research organization support that’s out there.

You have alumni from large pharmaceutical companies all over the place now that are looking for shifts in culture and work environments. COVID certainly changed that dynamic with hybrid work orientation and remote working options. All of it’s still fundamentally driven by people wanting to be together to try to make a big difference in the lives of other people in this particular industry.

It seems to be the common and constant driver, which I love the fact that that’s the case. It’s the case for sure that if you are able to impact and improve the lives of patients, the rest of the whole entire corporate life works. You have to be focused on why you are doing what you are doing. What’s the end game that you are trying to affect here? We’ve got many people. We didn’t just sneak up on this.

You don’t get into Phase 3 by responding to the pandemic and the increase in mental health disorders at alarming rates. Fortunately, I’m grateful that we have this opportunity for something to be in the late stage when it seems to be needed more now than ever that we make some changes in the standard of care for mental health that we continue to benefit from the silver lining if anything from the pandemic has been de-stigmatizing mental illness.

People have lots of reasons to seek help. We have to put it on par dealing with mental health with the way we deal with physical ailments. It used to be the case you might remember in the early days when someone had breast cancer. Years ago, it was treated somewhat how mental illness was before the pandemic, which was Hush Hush, then talk about it, as opposed to now, which is okay, “That’s the challenge. Here’s the game plan. Let’s go execute on it. These are the options.”

That should be the same thing for mental health. Someone identifies the need. It should be, “This is the game plan. This is the combination of talk therapy. These are the medications that could augment the potential of talk therapy. These are the risk factors we’ve got to look out for along the way because there’s such a progression trend from anxiety to depression, to suicidality, to PTSD.”

We have to be aware of all that. In nowadays world, it’s much different. There are a lot of things we have had to figure out now how the rewiring of our minds back to engagement with people is going to occur while we have, through the pandemic, rewired for tactics of avoidance for self-protection. It’s complicated. Usually, social anxiety disorder onset is in adolescents between, say, 8 and 15 but it lasts for decades. The mean duration is about twenty years. Sometimes it’s learned when you are trying to deal with what are the downstream consequences.

BTI 53 | Social Anxiety Disorder

Coach Wooden’s Leadership Game Plan for Success: 12 Lessons for Extraordinary Performance and Personal Excellence

We see substance abuse and depression, and then the dots are connected backward to, “It’s when I was in middle school. It was when I was in high school. It was the impact of social media. It was team orientation in the classroom or workplace.” We have to be smarter about what are the potential triggers and risks, and then what are the signs, and then deal from get in early, especially with talk therapy.

I appreciate that. I appreciate you coming to the show. I wanted to ask a couple of more questions that I like to ask the guests that come on the show. The first one is about advice. If you were to go back in time, is there any advice you would give yourself? It’s more of what you have learned.

I’m never a shortage of advice, especially if you ask my four kids, who are no longer kids. You have to be bold, hopeful, and positive because there’s so much power in that positivity and hope but you have to be patient. Not every season is a harvest. You can’t give up, and you have to look for things. If I were talking to myself back in my mid-twenties, I would say, “You did a pretty good job of looking for opportunities to live and work beyond yourself.” That has been a driving force. Unfortunately, it has not been exactly what I thought along the way but it’s been amplified by other real-life come on me.

It’s important. Positive, hopeful, patient, and keeping an open mind and listening because it’s that listening piece that’s going to let your mind go in directions where you can execute the amazing ideas that have the power to change people’s lives. That’s the best thing here. I have been surrounded by some amazing people for many years. I know where I would be anywhere near where I am now without what I’ve learned from the doctors, the lawyers, the accountants, the scientists, the regulators, and the patients. It’s awesome. It’s a wonderful privilege to be in this spot where I get to have all that talk to me.

Are there any books over the course of your life or career that you’ve read that stuck with you?

I’m a voracious reader. I have John Wooden’s book on leadership meant a lot to me. Coach Wooden. I’m a major sports fan. If you were to have me remove my background, you would see a mini Hall of Fame behind me. In depression, there are two important books, The Noonday Demon by Andrew Solomon, whose dad Howard Solomon, founded Forest Labs. They were involved with some of the early antidepressants. It’s a harrowing perspective from the patient’s perspective of their journey with depression.

William Styron’s book, Darkness Visible, is another one on depression. Triumph Over Fear is a book on panic and anxiety by Jerilyn Ross. The Alchemist, that’s always stuck with me by Paul Coelho. Shoe Dog, Phil Knight’s book. Leadership and then books that give me insight into what people struggle with when they are dealing with these disorders that’s helpful.

You need to be able to listen because that is what will lead your mind to amazing ideas that have the power to change people's lives. Share on X

When I go back and read these episodes, sometimes I used to try and write everything down like a note, and I would get halfway through. I will go back and listen to that list of books. I did read Shoe Dog. That was good for me.

That’s a perfect book on the patient endurance and that taking a chance to believe that what you’ve got is something people need to pay attention to. Those concepts transcend that shoe industry and Phil Knight’s experience. Many different industries and journeys that professionals have. It’s critical. There are always days where you have every temptation to say, “Forget it. I don’t need this.” There’s no way it’s going to work out. A little something happens, then it builds and builds, and now you are back. He’s hanging in there, which he started.

There were a couple parts throughout when he was telling the story of how this all happened. They were well, and the business was well into this. It was functioning, and they were literally floating payroll. They were like, “We don’t know how we are going to pay everybody. How are we going to do this?” It’s a cool, good story.

There are many chapters of life so far without pay, with paying energy bills for a company on a credit card. Those days happen, especially early on. Again, if you were with something that you think is worth it, stick with it.

Maybe in the future, we could reconnect to have ideas for other episodes around BioTech. It was the nature of BioTech IQ and the nature of how I get my guests and things like that. Some of the discussions that I would like to have are not suited for this type of a conversation. I have ideas for another episode that could be set up to address some of the nitty gritty, ups and downside of being an entrepreneur in a business that has science and all that involved.

That’s a tough one to tackle because I could teach a course, and it would have a different chapter every week. It would be full of things that you didn’t think they are there but there’s always the conventional but there’s more unconventional than conventional if you start off early stage. There’s one roadmap that everybody thinks is the way to go. That roadmap may not be the fit for other opportunities.

It’s not always the case that you route through venture firms. It’s not always the case that you avoid partners or get partners early. A lot of it depends on what you’ve got and what you want to deal with it and how you get there, then fills in between if you have that vision in the first instance. There are a lot of ways to get to the goal line but you have to understand what you are playing with and who’s on your team.

BTI 53 | Social Anxiety Disorder

The Noonday Demon: An Atlas Of Depression

Speaking of team, you mentioned that you are an avid sports fan. What sports do you follow?

Mainly baseball but everything, baseball, basketball, football. We are out here in south San Francisco. I’m a Giants fan through and through. If I opened up this thing, you would see Willie Mays everywhere.

I’m not a big sports follower. I’ve got buddies and friends that are big-time sports fans. I never grew up following. I grew up playing a lot of sports but my dad never followed sports either. My mom, either. It wasn’t a big thing but I do like sports. I can’t quote all the players and their stats and the memorabilia and all that but I love to watch it. In fact, I went to a local baseball game here. That was fun. I hadn’t been to a baseball game in a long time. It was cool watching them get up to the plate, and they had their stance and have their little way of doing things. It was good.

There are many ways of connecting, especially from baseball into life and coaching. I coached all my kids in Little League and softball. There are many life lessons that you can bring out of this sporting experience, especially team orientation and bringing it into the workplace. It has been fun doing that over the years. Too many dad jokes, probably along the way but they resonate. They stay there.

It has been great having you on the show. We covered mostly. There’s a third question I usually ask, and that’s about where the industry is headed but we are up at end of our time here. I feel like we probably answered that to some of our discussions throughout the episode. I appreciate your input. I loved having you on the show. Again, we will see how VistaGen is doing. It would be great to reconnect to the future and see what the conversation brings in.

Thanks again, Ammon. Thanks to all your readers for spending time with us. I appreciate that.

For all of you out there on YouTube, don’t forget to like, share and subscribe. If you are listening to a traditional podcast, you can leave a review and share it. We really appreciate it. Thank you.

 

Important Links