VistaGen at Jefferies: Expanding Horizons in Social Anxiety Treatment

On Thursday, 05 June 2025, VistaGen Therapeutics (NASDAQ:VTGN) presented at the Jefferies Global Healthcare Conference 2025, outlining its strategic initiatives and progress in developing treatments for social anxiety disorder (SAD) and other health conditions. The company highlighted its lead candidate, fasidionol, as a potential game-changer in the SAD market, while also acknowledging the challenges of bringing a new treatment to market.

Key Takeaways

• VistaGen’s lead drug candidate, fasidionol, targets over 30 million adults in the US with SAD, with potential peak revenue of $1-2 billion.
• PALISADE Phase III program is underway, with results expected in Q4 2025 for PALISADE III and the first half of 2026 for PALISADE IV.
• The company is shifting towards a digitally-driven commercialization strategy, requiring a couple hundred sales reps.
• VistaGen plans to file for FDA approval of fasidionol in the first half of 2026, with ongoing conversations with the FDA.
• The company is also advancing other pipeline assets, including PH80 for vasomotor symptoms.

Financial Results

• Over 30 million adults in the US are affected by SAD, but only 4-5 million are currently treated.
• Fasidionol is expected to generate $1-2 billion in peak revenue in the US alone.

Operational Updates

• PALISADE Phase III Program:

- PALISADE III data is anticipated in Q4 2025, with PALISADE IV results expected in the first half of 2026.

- Enhanced screening processes aim to improve the probability of success.

- The trials involve a public speaking challenge to assess efficacy.

• Additional Clinical Trials:

- A small human factor study and a repro tox study are ongoing, with the CARC study nearing completion.

- A re-dosing study is being conducted to evaluate safety concerns from double dosing.

• Commercialization Strategy:

- The shift towards a digitally-driven strategy is in response to high consumer engagement online.

- VistaGen plans to employ a couple hundred sales reps to support leadership.

Future Outlook

• Regulatory Filing:

- VistaGen aims to file for FDA approval in the first half of 2026, with a pre-NDA meeting planned to discuss the program’s status.

• Commitment to PALISADE IV:

- The company will continue with PALISADE IV, even if PALISADE III results are not favorable.

• Safety Data:

- VistaGen anticipates having sufficient one-year open-label follow-up data to meet ICH guidelines by the time of filing.

• Commercialization:

- The company considers direct-to-consumer advertising due to fasidionol’s favorable safety profile.

Q&A Highlights

• PALISADE III and IV: Data expected in Q4 2025 for P3 and the first half of 2026 for P4.
• Screening: Rigorous safety checks and toll gates are in place to ensure proper investigator qualification.
• FDA Communication: VistaGen maintains ongoing conversations with the FDA, aligned on study design since 2020.
• Re-dosing Study: Focuses on safety, not powered to inform efficacy but may impact labeling.
• Afamed: VistaGen adopts a wait-and-see approach with its Chinese partner.

For more detailed insights, please refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Andrew Tsai, Senior Biotech Analyst, Jefferies: All right, we’re going to get started with our next session. I’m Andrew Tsai, senior biotech analyst at Jefferies. Thanks for tuning in and it’s my pleasure to have Sean Singh, CEO of Vistagen joining me today. Welcome Sean.

Sean Singh, CEO, Vistagen: Thanks Andrew. Great to see you again.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. So maybe a brief introduction about Vistagen, what you’re working on and what you’re trying to achieve and milestones over the next six to twelve months would be very helpful.

Sean Singh, CEO, Vistagen: Great. Really exciting time for us. We are certainly at an exciting transition point given that we’ve got one positive Phase III study and an indication that no one’s really ever got anything approved for. And no one’s ever had a positive success for, as you know, the acute treatment of social anxiety disorder. We are advancing a extremely differentiated pipeline across a broad range of indications, Five assets, each has achieved at least phase two in the one case, phase three positive data in the patient populations where we see significant need from social anxiety disorder through depression, several women’s health disorders, cognitive impairment, and all the way down to cancer supportive care.

So it’s an exciting time where we are advancing what we hope could be a complement to replicate the positive phase three study that we’ve achieved already in an NDA enabling program called the PALISADE phase three program.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Wonderful. And help us frame into context the market opportunity for fascidional for social anxiety. How many patients in The US, should this be approved, where would it be used?

Sean Singh, CEO, Vistagen: The need is phenomenal. As we reported at a recent conference, we’ve seen an increasing prevalence of social anxiety across all demographics. Pre COVID was certainly troubling, post COVID more so. This is a disorder where the onset’s typically in adolescence. The mean duration’s about two decades.

And so this is not something that goes away pretty quickly. But what would people stress and struggle with are their stressors in their everyday life where they fear humiliation, embarrassment. And as a result, they avoid a lot of things that could enrich their lives. They don’t engage to a level that would be optimal. We see over thirty million people in The US, Thirty Million adults affected by the disorder.

You look at the national health and wellness data that we see, and that’s about ten percent of the population. And that prevalence is pretty similar globally if you bring in Japan, EU, and other markets. So we see even if a modestly treated population, currently treated maybe about four to five million people, That alone puts this as a product candidate with a billion to $2,000,000,000 peak potential in The US alone. And again, with the type of profile, what people seem to want when we get feedback from practitioners, from patients, is something that will work rapidly, something that doesn’t have abuse liability potential. There’s no requirement for this type of drug have systemic absorption or to even chemically bind to receptors in the brain, especially abuse liability receptors, which we’ve seen as problematic for a lot of neuropsychiatric drugs over time, as you’ve seen.

So that’s really the hallmark mechanistically we see sea change in the way that we’re able to address this disorder in a tailored to fit manner. People want, with this disorder, something that they can use on demand because it’s an episodic indication. It’s not an all day every day, but there are stressors that are multiple times in certain days and other days none. So not having medications, you heard this probably last night from the commissioner of the FDA, that having medicines on board in bodies that don’t need them at the moment is something we’d really like to avoid.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Very good point. And I see you’ve brought Fazodone as an example of it. And so what would be some real world examples where you use this drug?

Sean Singh, CEO, Vistagen: It’s an incredible diversity of stressors. We look at patient diaries from an open label context, for example. One of the things we’re really encouraged in the PALSID program and the ongoing studies is a really high throughput rate to the open label. So that allows us to assess utilization. What we never have seen is any kind of a hockey stick inflection for utilization.

That goes to the abuse liability question. We know with this disorder that we’re seeing more engagement talk therapy is online, not in person. To have a drug that hopefully is ultimately not scheduled. When we went to the FDA, you might recall a couple years ago, and the question was do we have to do a human abuse liability study? And the answer was no, not at this time.

And we’ve since had tens of thousands of doses and now well over 1,100 subjects exposed. So every day you can think of a stressor. We’ve seen people afraid to eat alone in a food court, to go to a public restroom, go to the neighbors next door for a barbecue, sit in the classroom worried about getting called upon, presenting in a team context in the workplace, going on a date, talking to your boss, going on the job interview. I mean, it is a broad, broad range of stressors, unfortunately, in the day to day lives. It really depends on the lifestyle of the person.

We see this sometimes in the open label as well, where you see maybe a drop of use on weekends when people are reading a book or going on a hike during the work week or school week. You see a lot more utilization as it goes through different stressors associated with daily life. Because again, ultimately, what drives this disorder and over such a long duration is the fear of being judged or humiliated or embarrassed when you’re with other people. And even that fear sets in when you’re not even with other people. And that’s what’s challenging because that brings a large group of people in that simply don’t want to use alcohol.

They don’t want to use benzos. They don’t want to use opportunities that are out there today. There really is no good available treatment for the acute treatment of SAD, social anxiety disorder. And we would certainly have as our primary goal to be the first company ever to get an approved treatment for the acute treatment of SAD.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Wonderful. So like you said earlier, you succeeded in one study, so all you need is one out of two in the upcoming studies. When do those studies read out, to be clear? And then secondly, why will those studies look different or similar to the study that succeeded?

Sean Singh, CEO, Vistagen: I’ll take it in reverse order. So our whole goal has been to replicate the historic success we had with the PALISADE II study. So everything that we’ve done in the PALISADE III and IV studies right now is with the objective of replicating that outcome. So for PALISADE III, our guidance is Q4 of this year. And for Palisade IV, it’s the first half of next year.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Okay. And what are you doing differently this time to ensure success?

Sean Singh, CEO, Vistagen: You always want to do whatever you can do to control variability, right, when you try to scale across a large number of sites. So a few things. There’s been a lot more rigor and a lot of additional scrutiny from pre screening mode, right? So making sure that subjects that we think have the potential to respond to the drug, better potential than not, to respond to the drug are the ones that are ultimately randomized. So there’s a lot of scrutiny and a lot of rigor between lead generation and that visit, one that first visit.

So a lot, some stricter criteria associated with comorbid psychiatric disorders, for example, THC levels. The subject might have lab testing associated with that. So the ability to make sure everywhere we can we’re enriching the population to improve the probability of success. There’s no guarantee ever, obviously, as you know. But what we have learned, we really have the most experience in a phase three setting with the public speaking challenge design and this endpoint.

A lot of subjects now that we have run through this in a lot of sites and a lot of PIs. So the ability to execute in an environment right now where the masks are no longer part of the program, we’re able to surveil to a greater degree during the course of the study whether people are rigorously following the protocol. But most of the enhancement has been associated with, once that lead is generated from a centralized recruitment campaign, making sure that the right subjects who should be eligible to be randomized in the study are the ones that are making it through visit one, two and through visit one. Since once it is at visit one, the rates we’ve seen on throughput have been pretty similar to what we saw on PALSAT two.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. And is it fair to say that you’re placing a lot of confidence in these investigators to make sure the trials do right? Are there checks and balances going on just to make sure they’re truly disqualifying patients if they don’t qualify for visit one, visit two?

Sean Singh, CEO, Vistagen: Yeah, there’s a lot of safety checks and toll gates in the whole process from the top of the funnel all the way through the randomization point. So as you know, in the study design, the first speech is intended to ensure that there’s sufficiently provoked with the public speaking challenge. And the reason we use that design is because you can provoke anxiety consistently with that challenge. So it’s the same stressor that you’re measuring the acute benefit of the drug in that context, right? Because that’s the endpoint we’re striving for here is just to make people, it’s only one dose in a treatment context, show that we can drive down their symptoms very rapidly.

So yeah, the answer is we’ve got an expanded internal team that surveils not only eligibility, but also rigorous training, rigorous adherence to the protocol. That is intense. It’s all day, every day, and across all sites. Fortunately, we have a lot of sites that have been involved already, so the learning curve was not very steep. And the quality, given the aggregate lessons learned through all experiences all the way from Phase II till now, really puts us at the leading edge of expertise on how to execute this trial design.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And can you give us a sense of how screen failure rates are trending relative to the prior two studies?

Sean Singh, CEO, Vistagen: Well we are definitely seeing in terms of subject selection, the intention again was to ensure that we have a high quality patient population that gets through visit one, right? Always emphasizing quality over speed. So I think the impact of the enhancements that are associated with that subject selection, specificity and rigor, that’s caused there to be fewer subjects through the phase one or to the phase one. But once they’re through the phase one, again like we said, the throughput to the end of the study has been pretty consistent with what we’ve seen historically.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. And any discontinuation rates so far?

Sean Singh, CEO, Vistagen: If you’re talking about once people are from visit one through, no, nothing appreciable, nor have we seen that really in any of the studies. Again, it’s a four week study paradigm. So what’s helpful now as opposed to prior times when you might have seen out of scope in terms of with the pandemic and other times where you’d see site turnover or you’d see patients coming in possibly broader periods of time than in the rigorous one week. That’s just not the case. It hasn’t been, what we’ve seen since PALISADE II has been exactly what we saw in phase II, and what we’re seeing also now in PALISADE III and So having a normalized clinical study environment has been really helpful.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And speaking of the clinical trial design, this was previously blessed by the FDA a few years ago. Given FDA changes recently, have you spoken to the FDA recently to just make sure one more time maybe that they’re on board in a sense?

Sean Singh, CEO, Vistagen: Well, you can rely on the FDA making agreements with you early on. So we’ve been aligned with them on this study design since early twenty twenty. And that’s important because that’s how you have predictable investment in studies and why you want to be able to hit the end based on the beginning you agreed to. So no, we’re always in an ongoing conversation with the agency across all real aspects, even in the context of NDA prep now, whether it’s CMC, non clinical, clinical. So we aligned early on that people with this disorder are afraid of talking to people, fundamentally.

And that we can, as a study design, consistently provoke anxiety with the public speaking challenge, right? And you can apply that across sites. So you’re not having to assess a broad diversity of stressors, as you would maybe say in a real world study. Although as you know we had positive real world data in phase two. So it just made it and when you think about scaling a study across sites in a phase three context, you want to do what you can do to control variability, always.

So having the same stressor as the provocation in a clinical setting with very rigorous recipe that you give to each site of how to execute it, that’s been very helpful. So we haven’t seen a departure from that at all.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Okay. And for your studies to be stat sick, will they fundamentally be clinically meaningful? Can you describe what kind of change in suds would be clinically meaningful?

Sean Singh, CEO, Vistagen: We can take a look at PALISADE II, right? We’re replicating PALISADE II, which we think is not only stat sigma clinically meaningful. So that’s been the objective. And you have a situation, again, where unfortunately there’s nothing else out there that in a benzo epidemic laden society that we have right now, it’s problematic. We see tremendous safety benefits again, which separate from the pack.

So it’s not just, it’s obviously you have to achieve efficacy and stat seg separation on your endpoint. But the safety card comes into the mix as well, considerably into the mix. And we constantly hear from practitioners and patients, they want something that works quickly, that they can again tailor it to fit on demand for their lifestyle, that has no abuse liability potential, has no weight gain potential, has no sedation potential and cognitive impairment, no sexual side effects. So we see that up and down the pipeline with this mechanism that each of these distinct pharynx that we’re advancing, again, hallmarks have been associated with time to onset and then the what we’ve seen in completed studies to date in terms of safety, especially as the weight gain, sedation, sexual side effects.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Male Right. Efficacy is only one part of the equation here. Okay, so we’ve been mentioning the successful PALISADE II study. When can we expect a publication on that to maybe help propel awareness of fazodone within the doctor community?

Sean Singh, CEO, Vistagen: You mean beyond what you write? Yes. Later this year, I think is what we’re targeting for the publication. We’ll potential, when you’re running studies too that are similar to what you’d be publishing on, there’s some strategic components associated with that. So again, especially with this particular study design, there’s strategic reasons to do some of the things in terms of the timing.

And

Andrew Tsai, Senior Biotech Analyst, Jefferies: in the meantime, you’re running peripheral studies, maybe one of them, the redosing study. Are there any other studies you need to run at this juncture before you file?

Sean Singh, CEO, Vistagen: Well we’d run a small human factor study based on use of this device, pretty similar to what people have done before, the approved products that use the same vial and the same actuator. We’d have a small repro tox study. We’ll finish up our CARC study even though the drug doesn’t systemically absorb and you can’t detect it in plasma. We’re still doing check the box. So that’s basically about it.

Small human factor, repro and finish the cart.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. And so once the data reads out in Q4, fingers crossed it’s positive, when could you file?

Sean Singh, CEO, Vistagen: We think we could file in the first half of twenty six, right? And so we’d go to the FDA for a pre NDA meeting, clearly show where we are at that point, especially as where we are with the perspective safety. We can certainly provide additional safety on the other side of the submission. But that would be the timeframe, the first half of twenty six.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And if, unfortunately the first one doesn’t read out positively, you’re still committed to finishing the Palisade IV.

Sean Singh, CEO, Vistagen: Sure, absolutely. It was always a sort of a safety net study, but at the same time, we want the safety bodies from that. And yeah, absolutely, that was we definitely will.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And to file in first half twenty twenty six, do you need do you have enough one year open label follow-up data to help meet ICH guidelines, if that’s even relevant?

Sean Singh, CEO, Vistagen: Yeah, we should by that time have what we need on the 100 for the twelve months. Three hundred for the six months, not quite sure. But again, we’re always allowed to supplement with safety from all the other studies as well as from PALSID III. But we already have, we’ve already got a few notches on our belt already on the twelve month. And same thing with the six month, a decent population moving forward.

So by the time we’ve fully randomized two thirty six in PALISADE III, and not even if it’s the full complement in PALISADE IV by that time. There’s a really substantial safety database, safety database already created and in process. So that’ll just keep building strength on strength.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see. And then there’s a, you’re working on a re dosing study. What’s the purpose of that? And could that data set read out before PALISADE III?

Sean Singh, CEO, Vistagen: Not before PALISADE III. The purpose of that study, we started just at the beginning of this year, it’s a small study, exploratory study. FDA wanted primarily to focus on safety. People’s human nature saying, well, one’s good, maybe two’s better. And within a short period of time, the way that study is designed in the repeat dose oriented arm, it’s two doses within ten minutes.

So we know passediol activates the chemo sensory neurons in about twenty five milliseconds. And that’s with a three point two microgram dose. The reason is we’re dropping it directly on the receptors to the neurons that we want to activate. It’s about three hundred milliseconds to get to the olfactory bulb neurons. So activating, further activating more receptors in the nose to achieve what we know we’ve already achieved with one likely may not change the outcome from an efficacy perspective.

But at the end of the day, safety wise, there’s no concern either.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Male I see. I see. And on the it’d be interesting to see because I think there’s three arms, drug, drug, drug plus drug, drug plus placebo, or maybe vice versa.

Sean Singh, CEO, Vistagen: Placebo, placebo, drug, placebo, drug, drug.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Male Right.

Sean Singh, CEO, Vistagen: Three arms, 20 each.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Male And basically, like you said, it’s more of a safety check the box kind of thing. But drug plus drug, your point is we might not see an improved benefit on

Sean Singh, CEO, Vistagen: No, no. I mean, it’s a small study. It’s really designed more from the safety perspective. It could inform labeling, if that’s better. That there’s not a worry to practitioners if people do do that.

But again, it’s a pretty small study with 20 subjects per arm. We’re not really powered for the kind of outcome we’re looking to see in the registrational trials.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. And that data set would come after PALAS A3, but still this year, or could it be early twenty twenty six?

Sean Singh, CEO, Vistagen: It’d be right around with PAL four

Andrew Tsai, Senior Biotech Analyst, Jefferies: in the first half of ’twenty six. Okay. Okay. Very clear. And years ago, you did partner with Afamed, a Chinese partner, to develop this in China.

How has that relationship been? There is a plan to do a global study. Where are we there?

Sean Singh, CEO, Vistagen: I think it’s mostly on a wait and see mode from their perspective to see how we roll out the Palisade program so that they can leverage The U. S. NDA with the PMDA. So at this point, they’re sort of in that wait and see mode, which is fine for us. Right.

We we think the strength of our NDA is going to be leverageable in a lot of different markets, not just China. And, you know, we, as our strategy, was is the ex US partner as well in other markets. So we’ll see how that goes.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And what is your current thinking about commercialization? How many sales reps do you need once this is approved to maximize the sales growth?

Sean Singh, CEO, Vistagen: Yeah, it’s really interesting the way that’s developed. I think the answer is that’s still in flux, right? Because what we’re seeing, especially and we’re not even trying with the centralized campaigns is we see the interest from folks hitting the website, it’s a substantial number without even targeting patients as you would in the digital ramp in a commercial mode. So there’s a unique benefit there, especially because what we see is the interaction with the practitioners is online. Practitioners don’t really want these days psychiatrists to see subjects in person.

They don’t also, the patients with SCD typically won’t want to see. We’ve heard from several academic centers that 10 out of their last 10 have been all online. And compliance is increasing in the follow-up visits. So the digital impact, especially across the socials and things that we’ve seen as we’ve been in this recruitment campaign for Palisade III and IV in the environment we’re in right now, we see a lot of the narrative sort of like with the GLP-one drugs. That there’s a conversation out there from consumers and influencers about anxiety similar to about weight.

And so pre COVID, post COVID, we’ve substantially reduced the headcount that we think is needed from a commercialization perspective, given the leverage now that exists from the digital side. So it’s still not going to be zero, but somewhere in a couple hundred level with the sales reps, leadership 50 or so. But we do that. That builds also on a kind of a toll gated basis, right? A little bit now more on the other side of the next pivotal study to complement PALISADE II as we move to a launch environment where it’s also the case to just think about the commercials, right?

So this is a case where the direct to consumer advertising, it’s a completely different commercial, where you’re not spending thirty seconds talking about all of the worrisome side effects, safety concerns, risk of stroke, coma, all the things that take a lot of that buy up. So the cost and the impact of what we’re able to deliver based on this target product profile, there’s a lot of economies there. So it’s very doable, anxiety disorder. We’re maintaining that optionality, of course, and we’ll see how things go.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. And ultimately, your sales reps would be targeting not only psychiatrists, but PCPs moving all the way to the front ends.

Sean Singh, CEO, Vistagen: Yeah. The specialists as well as primary care physicians, nurse practitioners. There’s folks all in the ecosystem that are very motivated to see something different. We hear this from PIs at our sites in the study. We hear this from people on the open label.

There’s a dramatic interest in having a paradigm shift in the kind of medication support to complement talk therapy in today’s world. With the number of stressors, and the way that people are affected by them, and how they want to be able to tailor to fit support. And again, with this drug, what we see, and we’ve seen this in one of the open label studies that we commented on, we think the more people use it, the more success they have in an acute setting. The more frequently that success is repeated, confidence is built, resilience is built, avoidance goes down, engagement goes up. Things that really are enriching lives in kind of game changing ways that the patients and practitioners and advocacy groups haven’t seen, have not seen and are not seeing other than what we think we’re bringing to the table in SAD for the acute treatment of SAD.

Andrew Tsai, Senior Biotech Analyst, Jefferies: I see, I see. And you mentioned going back in one of the peripheral studies, a human factor study. Is that design like?

Sean Singh, CEO, Vistagen: Pretty simple. Just to make sure people know how to take it out of the package, unscrew it, put it together, have it, you know Got it. That they know how to use it. It’s pretty simple, straightforward. Understood.

Not a lot of risk factor there. A couple dozen subjects.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Male Got it. And speaking of disruptive therapies like what Fazodone could become, there are, totally understood, it could differentiate over current treatments. There are other drugs in the pipeline. When we think about competitions, maybe even psychedelics come into play for social anxiety, what are your thoughts on competition and why that’s irrelevant to Fazodone?

Sean Singh, CEO, Vistagen: Competition’s not irrelevant in any way. But as you and I have talked about for a long time, our perspective as a company has been we’re rooting for everybody. There is no one size fits all. There’s plenty of room. Perhaps the impact of psychedelics may be more so in depression than in the acute treatment of anxiety disorders, especially given where we see differentiation, obviously, is the fact that we don’t require systemic absorption.

We don’t require chemical activation or receptors in the brain. We’re not seeing psychotomimetic side effects. We’re not seeing any of those things that typically have been associated with a lot of neuropsych drugs. So from a competitive standpoint, the target product profile we’ve got for fascidinol is very differentiated in all ways. But the numbers are enormous.

And again, even if we’re talking about a ten percent penetration rate on the currently treated population, let alone the folks who will come into play when they say, look, I know I didn’t want to take alcohol. I know I didn’t want to engage in marijuana smoking. I know I didn’t want to take a benzo. But now this, and I only have SAD. So why do I need to take an antidepressant from my SAD?

So there’s reasons to believe, a lot of reasons, especially from what we’re seeing at the top of the funnel in recruitment, to believe that the patient universe is expanding as awareness is expanding. And what’s needed is an approved acute treatment that doesn’t cause them to say, wait a second, I’m not sure if the cost benefit here with the risk of abuse liability or weight gain or sexual side effects or whatever it is or all of those that cause compliance to really be problematic with existing meds. Even with existing meds, if they’re taken as they should be, you have a decent opportunity to complement talk therapy. But obviously when they’re not taking them, it’s not getting better. Especially if they’re taking something worse that causes another problem like alcohol.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right, right. So today we talked a lot about, or all about, phasidinol, but you do have a faring portfolio. Is it safe to assume you’re putting all your resources to ensuring phase three success or are you making progress with other farings as well?

Sean Singh, CEO, Vistagen: Well, we certainly optimize capital allocation to and the Palisade program. No question about that. That said, we’re making considerable progress up and down the pipeline. We now, as you know, have five pharynx clinical stage with positive phase 2A or later data. That’s a tremendous pipeline with a broad diversity of potential indications.

So we’re staging the PH80 program for US IND in the fourth quarter. Hopefully with that we can progress forward with vasomotor symptoms, hot flashes. There is a tremendous interest and need for a new drug for dysmenorrhea for PMDD in the women’s health arena. We’ve got the depression program ready to go, capital enabled, we would move that forward. So a lot of excitement up and down even with some of the earlier stage assets that we haven’t talked much about yet.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. So I think that’s all the time we had, but thanks for the update and best of luck in your Phase III data coming Thank

Sean Singh, CEO, Vistagen: you. Appreciate the interest. Thanks for having me.

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