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DATE

Thursday, November 13, 2025 at 5:00 p.m. ET

CALL PARTICIPANTS

  • President and Chief Executive Officer — Shawn K. Singh
  • Chief Operating Officer — Joshua S. Prince
  • Vice President, Corporate Development and Investor Relations — Mark McPartland

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TAKEAWAYS

  • PALISADE 3 Phase 3 Study Completion -- Last patient for the randomized double-blind portion completed the study; top-line results are expected by year-end.
  • PALISADE Enrollment Target -- Enrollment met the original end target of 236 patients for PALISADE 3, as planned.
  • Cash Position -- $77.2 million in cash, cash equivalents, and marketable securities as of September 30, 2025, stated as sufficient to fund current U.S. registration-directed PALISADE activities through potential NDA submission.
  • Clinical Readout Guidance -- CEO Singh said, "guidance is that we will see top-line results released before the end of this calendar quarter, so by the end of this calendar year."
  • Pivotal Efficacy Endpoints -- Top-line readout for PALISADE 3 will report on the primary efficacy endpoint (CGII), secondary endpoint (PGIC), and randomized study safety data, replicating the same design used in PALISADE II.
  • Trial Enhancements -- Enhanced subject eligibility assessments and CERT team involvement cited as reasons for greater control of screen fail and attrition rates.
  • Pipeline Progress -- Preparations are underway to advance itravone for major depressive disorder and PH80 for menopausal hot flashes into further development.
  • Board Expansion -- Paul Edick joins the Board of Directors, bringing prior experience in FDA approvals, commercial launches, and strategic transactions.
  • Clinical Site Termination -- COO Prince stated site terminations in Arkansas and Kansas were due to enrollment issues and controlled study wind-down, described as "course of business."
  • Commercialization Optionality -- CEO Singh described commercial launch planning as underway, with ongoing evaluation of internal commercialization versus potential partnerships.
  • Open-Label Study Utilization Patterns -- Higher usage observed mid-week and workdays; decreased usage on weekends, based on open-label long-term safety data.
  • Regulatory Timeline -- If PALISADE 3 is positive, NDA submission may occur in 2026 after completion of required studies and FDA interactions.
  • CMPV Program Eligibility -- CEO Singh said, "we do not expect that fascidinol falls within the typical scope of the CMPB programs," but will re-evaluate if FDA guidance changes.

SUMMARY

The completion of the randomized double-blind phase for PALISADE 3 and meeting of the original patient enrollment target signal imminent top-line data release and alignment with stated operational benchmarks. Management confirmed all required study elements and pre-NDA activities—including repeat dose, long-term safety, and preclinical studies—remain on track for timely integration into a regulatory submission package. Expansion of the board with expertise in commercial execution aligns with preparations for a potential first-in-class acute anxiety treatment launch. No clinical or operational setbacks were cited in the transcript.

  • CEO Singh confirmed top-line results from PALISADE 3 will provide data for primary and secondary efficacy endpoints, plus detailed safety information specific to the randomized portion.
  • Ongoing site attrition and terminations at select clinical centers were attributed solely to enrollment and fit, with COO Prince calling these moves "course of business."
  • Company stated existing cash resources are sufficient for all planned registration activities, including a prospective NDA filing.
  • CEO Singh stated, "we have the expertise. We have the planning. We have execution in certain cases already underway. To be able to bring this extremely innovative asset into the treatment paradigm where there is just nothing sitting there," and described evaluation of both independent launch and partnership models as active and ongoing.

INDUSTRY GLOSSARY

  • PALISADE Program: VistaGen's late-stage clinical trials evaluating fascidinol for acute treatment of social anxiety disorder, including randomized double-blind and open-label extension phases.
  • CGII: Clinical Global Impression of Improvement; a standard measure of treatment efficacy in clinical trials for psychiatric disorders.
  • PGIC: Patient Global Impression of Change; a patient-reported assessment of perceived change since the start of treatment.
  • CERT Team: Specialized internal group at VistaGen overseeing subject eligibility review to enhance protocol compliance and study data integrity.
  • CMPV (Commission's Priority Review Voucher) Program: FDA initiative to incentivize development of treatments for unmet medical needs by awarding vouchers to qualifying sponsors; cited as not currently applicable to fascidinol.
  • NDA: New Drug Application, the regulatory filing submitted to the U.S. FDA to seek approval for commercial distribution of a new pharmaceutical.

Full Conference Call Transcript

Now with the formalities out of the way, we warmly welcome our stockholders, sell-side analysts, and others interested in our programs and our progress. I am joined on our call today by Shawn Singh, our President and Chief Executive Officer, and Joshua S. Prince, our Chief Operating Officer. Shawn will provide a brief business update and clinical update, and Joshua will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we will take questions from the sell-side analysts participating on the call today. I remind you, a replay of the webcast will be made available in the Events section of our Investor page on our website.

With that taken care of, I'll now turn the call over to our President and CEO, Shawn Singh.

Shawn K. Singh: Thank you, Mark, and good afternoon, everyone. We have built very strong momentum as we enter into what could be a potentially transformative period for VistaGen. Last week, we announced another major milestone in our PALISADE program. The last patient completed the randomized double-blind phase of our PALISADE 3 phase 3 trial, evaluating our most advanced intranasal ferrine product candidate, fascidinol, for the acute treatment of social anxiety disorder. We are now preparing for the release of top-line results from the PALISADE 3 study by the end of this calendar year.

We extend our sincere gratitude to the patients who participated in the study, as well as the dedicated and experienced clinical investigators, the clinical site staff, and our contract research organization. Their enthusiasm, their focus on detail, and the collaboration throughout the study were notable and greatly appreciated and will remain so during the ongoing open-label extension of the study. Over the past several months, I have had the privilege of meeting in person with many of the dedicated teams conducting our PALISADE 3 and PALISADE 4 studies.

The energy, the curiosity, the optimism that I have witnessed reaffirm just how great the need remains for new treatment options for individuals whose daily lives are affected by social anxiety disorder and how differentiated and innovative fascidinol could be in meeting their needs. Together, our teams remain deeply focused on fascidinol's potential to become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety disorder. Looking ahead, we remain on track to report top-line results from our 2026. Both PALISADE 3 and PALISADE 4 share a similar public speaking challenge design and the same primary efficacy endpoint as our previously successful PALISADE II phase 3 trial.

In parallel, we are continuing preparations designed to advance our broader farine pipeline, including itravone for major depressive disorder, and PH80 for menopausal hot flashes. Both depression and women's health represent areas where far too many patients still struggle without adequate options. We are deeply motivated to bring forward the innovative non-systemic neurocircuitry-focused potential of Vitruvone and PH80 to help address these important and widespread needs. Turning now briefly to our financials. As of September 30, 2025, we had $77.2 million in cash, cash equivalents, and marketable securities.

We believe current cash covers all known aspects of our ongoing US registration-directed PALISADE program for fascidinol for the acute treatment of SAD, including potential NDA submission if our PALISADE program is successful. Before I conclude the business update, I would like to welcome Mr. Paul Edick to our Board of Directors. Paul joins us at a pivotal time for VistaGen, bringing decades of experience leading successful FDA approvals, commercial launches, and strategic transactions. His leadership will be invaluable as we prepare for our next phase of growth. I would also like to extend our deep gratitude to Dr. Jerry Jin, who served on our board from 2016 until his retirement earlier in September.

In closing, our mission remains clear and unwavering: to redefine what is possible in neuroscience, to restore emotional well-being, and improve quality of life for millions worldwide. With a diverse and innovative pipeline, an experienced team, and several key milestones approaching, we believe we are entering one of the most exciting and potentially transformative periods in our company's history with deep confidence in our ability to deliver meaningful value for patients and for our stockholders. I want to thank you all for your continued interest, your support, and your engagement with VistaGen. It makes a lot of difference, and we look forward to sharing our progress with you in the weeks and the months ahead.

Mark McPartland: Thank you, Shawn. These are definitely exciting times at VistaGen as we continue to build momentum across our programs. Operator, we would now like to open up the call for questions from the sell-side analysts joining us today.

Operator: At this time, I would like to remind everyone the first question comes from the line of Andrew Tsai with Jefferies. Please go ahead.

Andrew Tsai: Hey, guys. Thanks for taking my questions. Good afternoon. I look forward to the top-line data readout soon. So, I think you guys have mentioned before that we should expect six to eight weeks after the last visit for the top-line release. Is that still the case, or could it come earlier than that, actually?

Shawn K. Singh: Our guidance, I think we are just going to stick with it, Andrew. Thanks for asking the question. Thanks for coming on. But our guidance is that we will see top-line results released before the end of this calendar quarter, so by the end of this calendar year.

Andrew Tsai: Okay. And for the top-line analysis, how should we think about discontinuation rates, any protocol violations? Can we expect the top-line to be pretty close in terms of the number of patients you have enrolled in the study? Then how should we also be thinking about the safety profile?

Shawn K. Singh: You are going to hear, as we did with PALISADE II. Right? So we are going to give you, obviously, top-line results on the primary, the CGII, secondary, and also the PGIC is the secondary. And obviously, pretty customary information regarding the safety profile that we had seen throughout the course of the study through the randomized portion of the study. So that is what we are printing out, and that is what we are reading out, are the top-line results from the randomized double-blind portion, which is the public speaking challenge. So any safety data that we have from that study, similar to PALISADE II, we will be reading that out as well.

Andrew Tsai: Okay. And then last question is from what you can tell, what have been the top reasons why patients screen failed in PALISADE 3, and are the top reasons different from what we saw in PALISADE II? Thank you.

Shawn K. Singh: So we can unpack that later. But what I can tell you, Andrew, is the reason that we made enhancements to the PALISADE 3 and 4 studies, again, was to make sure that there is a very high-quality assessment for subject eligibility. And as a result of that, we had our own teams involved here with our CERT teams for subject eligibility review. We had other enhancements into the execution of the study, of course, throughout the duration of the study.

So I think we have seen generally what we have expected to see, and as we have modeled forward for not only screen fail but also attrition rates throughout the course from enrollment through randomization through the end of the study. So I think we are comfortable with what we have typically seen and maybe more to come on that later. Okay. Important piece of the puzzle is we got to the last patient's last visit with the full complement that we had modeled for purposes of the studies we noted before, our end target was 236. So last patient's last visit reflects our original thoughts.

Andrew Tsai: Perfect. Thanks again.

Operator: Your next question comes from the line of Paul Matteis with Stifel. Please go ahead.

Matthew: Hi. This is Matthew on for Paul. Thanks for taking our question. I guess, assuming one of PALISADE 3 or 4 works, is there anything else gating registration, gating filing? Is there anything else that you need to complete before then? How soon can you file? Thanks.

Shawn K. Singh: Sure, Matthew. Thanks for the question. So, you know, as you know, as we move closer toward completion of the Phase III development program, we always plan to interact with the agency, but we have said this before. Obviously, it is the pivotal program data. It is a repeat dose study. It is the open-label data from our long-term safety study. Human factor study, the typical preclinical safety-related studies, reprotox and CARC, all those are aspects that we expect to have wrapped up upfront, of course, of an NDA package. So we will, of course, be meeting with the FDA as we get closer to make sure that we are in line with what is necessary regarding submission package.

So we estimate currently, you know, if everything goes according to plan that we have been executing on, we could see an NDA submission of PALISADE 3's positive sometime around 2026.

Matthew: Thank you. That is super helpful, and looking forward to the data soon. Thanks.

Operator: Next question comes from the line of Myles Minter with William Blair. Please go ahead.

Myles Robert Minter: Hi. Thanks for taking the questions. Just the first one, is it your view that tasadionol would be eligible for a commission's priority review voucher? It seems to me like that is potentially a public health crisis. And it is certainly a massive unmet need with over 30 million patients out there. That is the first one. And then second is just, I think, in late October, you updated clinicaltrials.gov. You terminated a site in Arkansas and Kansas. I am just curious whether that was because you have enrollment and you did not need those sites anymore or just because of your site visit.

Vigilance and you are going to see these sites in person it was a something performance-related that you terminated those sites. Thanks very much.

Shawn K. Singh: Thanks, Myles. Thanks for the questions. Josh, why do not you go ahead and take that last question first.

Joshua S. Prince: Sure. Yeah. Thanks, Myles. As we have gone through the course of these studies, for both PAL 3, PAL 4, you know, it is a constant evaluation of fit with sites. And so we have had a few sites that for whatever reason with regard to their ability to enroll the appropriate patients, whether it was their recruitment programs or other reasons. Just they were not able to enroll. And so at some point, it makes sense to terminate those sites. There have been one or two like that.

And then also beyond that, you know, as we to your point, as we get towards the end of the study, we definitely, you know, take a wind-down approach for a soft landing for the study to make sure it is well controlled. We are controlling variability and then making sure that we will be able to get from that end of study last patient out to top-line results efficiently, in the timeline that Shawn mentioned. For us, it is kind of course of business as we have gone through the process of the studies.

Shawn K. Singh: Thanks, Josh. So Myles, on your first question related to the voucher program, the CMPV program. So we are certainly aware of it, and the criteria the FDA uses to evaluate eligibility. I think right now, while we do not expect that fascidinol falls within the typical scope of the CMPB programs, we, of course, believe the magnitude of unmet need and especially for a rapid situational treatment without the worrisome side effects and safety concerns is significant. But I think if the regulatory pathways evolve or additional guidance creates a relevant framework, of course, we will evaluate it at the appropriate time.

Myles Robert Minter: Cool. Thanks for the questions.

Operator: You bet. Your next question comes from the line of Alimair Piras with Lucid Capital Markets. Please go ahead.

Alimair Piras: Yes. Hi, Shawn. This is Alamir dialing in for Alamir.

Shawn K. Singh: Hey, Alamir. What I would like to ask you is if you have any indication on the usage patterns. This is coming from perhaps more likely from Talisade 2 than maybe to a lesser extent from Talisade 3 at this point. For those who went out to complete the OLE, up to one year.

Shawn K. Singh: Yeah. Most of the usage pattern data is going to come from the open label. So what we can talk about, of course, is related to the reported open label, the long-term safety study that we had before. And the patterns established in the context of that study, you know, give some pretty good guidance to us about what we see going forward in the real world. Remember, this is a disorder that is chronic, but it manifests acutely and episodically. And so a lot of it in terms of utilization depends on where people are in their particular phase of their journey. What is their job? What academic setting are they in?

How frequently do they need to interact with people on a social basis? And you definitely see in that long-term safety study we reported on, more activity during the week especially after people are back to work, back to school, in the kind of rhythm of life that we are in now, you see more utilization during a week, especially during work kind of hours.

Weekends tend to taper off, obviously, because people are not in similar stressful settings or maybe social situations, a barbecue with your friends, or you go to sporting events where, you know, there is worry about how you are looking, how you are whether you are being judged or not being judged, which is really what anchors this disorder, unfortunately. So more often during the week, less often during the weekend, and that is the pattern we saw early on in the open-label study we reported on. And it is reasonable to expect that sort of activity on a go-forward basis.

At least that is what is anchoring a lot of our informed assumptions about how we could see the drug used in the real world.

Alimair Piras: Thank you, Shawn. And do you see any difference between the number of people entering the open-label phase between PALISADE 2 and PALISADE 3? And roughly what percentage is that?

Shawn K. Singh: Yeah. I can remark on the percentages, but I can tell you it is a high throughput rate. We have seen historically in any open-label activity that we have got. And that is to be expected. It is part of the reasons why people get interested in participating in a study in the first place. Is that they think if they complete it, there is an opportunity for the investigational agent to be part of their go-forward experiences. So I think the reasons people do not tend to go into an open-label historically are associated with a change in job, a change of living location.

You know, something significant that is a life-changing event that allows them to or causes them to not be proximate to the site that they were involved in the randomized study.

Alimair Piras: I see. I see. I just have two more if you are okay with that. What would be the minimal effect size in terms of the SODS or the CGI that would be deemed clinically meaningful?

Shawn K. Singh: So we are going to try to, of course, replicate what we were able to accomplish in PALISADE 2. Right? So you always have to contextualize whatever your primary is with the outcomes that are from the other endpoints, especially in this case, the cross-association with CGII and PGIC. So you get to clinical significance or clinical meaningfulness when you look at all three of those. And we take a look, not only what happens with the subs, but also with the secondary. So and it is I think we are targeting to try to replicate what we already believe is not only statistically significant but a clinically meaningful outcome associated with the PALISADE 2 study.

Alimair Piras: Understand. And lastly, how do you think about commercialization at this stage? On your own, be it a partner, have you thought about this recently?

Shawn K. Singh: Companies yeah. Well, certainly, you think about it all the time. Companies in positions like we are, if you have a contemplation for a first commercial launch, you have to have a lot of good reasons for that. And here as a company, we always position for optionality. There are many things that can happen. Key for us is to make sure we have the optimal opportunity to generate the value that could be associated with fascidinol if it gets approved. So there is certainly a very solid potential commercial plan. There are also opportunities should other strategic arrangements bring greater value potential. But, yes, as a company, we have the expertise. We have the planning.

We have execution in certain cases already underway. To be able to bring this extremely innovative asset into the treatment paradigm where there is just nothing sitting there. That is interesting and exciting for patients to be able to recapture the agency that allows them to tailor the use of a medication to fit how these stressors are impacting their lives day to day. And yeah. In the world right now, it is a very interesting market out there in terms of the dynamics of telehealth and mental health. Digital psychiatry, consumer-generated influencer-based activity across the socials. What we see with anxiety, very similar to what people see and hear about weight in a GLP-1 drug.

So there is a transformed market environment over just even the last couple of years. And now you are also looking at a population of patients and maybe practitioners too who really would prefer online engagement as opposed to in-person. There are some really unique opportunities, especially with what we would hope to be borne out as the target product profile. And the way to access not only practitioners but also raise awareness among consumers. So it is a really exciting opportunity for the company around this very unique asset. That fits in so many ways what we think are the clarion calls of not only practitioners but certainly patients.

Alimair Piras: Yeah. Exciting times. Looking forward to the readout. Thank you very much, Shawn.

Shawn K. Singh: You bet. Thanks again.

Operator: There are no further questions at this time. I would now like to turn the call back over to Mark McPartland for closing remarks. Please go ahead.

Mark McPartland: Thanks, operator, and thank you again, everyone, for joining us on the call today and for your continued interest and support. With a diverse and innovative pipeline and several key major milestones on the horizon, we believe VistaGen is entering one of the most exciting and potentially transformative chapters in our company's history. If you have any additional questions, please do not hesitate to reach out to us at [email protected] or through the contact us section of our website. We also encourage you, of course, to register for email updates to stay informed about our latest news and developments from VistaGen.

We truly appreciate your time, engagement, and ongoing support, and we look forward to keeping you updated on our continued progress. This concludes the call. Have a great day.

Operator: Ladies and gentlemen, this concludes today's call. Thank you all for joining, and you may now disconnect.