Q2 2026 VistaGen Therapeutics Inc Earnings Call
Speaker #1: Good day, everyone. Thank you now. for standing by. Welcome to the Vistagen Therapeutics, fiscal year 2026, second quarter, corporate update, conference call, and webcast.
Speaker #1: Please note that today's call is being recorded. At this time, I'd like to turn the call over to your host, Mark McPartland, Senior Vice President of Investor Relations at VistaGen.
Speaker #1: Mark.
Speaker #2: Thank you, Operator. Good afternoon, everyone, and welcome to our conference call and webcast. Earlier this afternoon, we filed our quarterly report on Form 10Q and issued a press release for our fiscal year 2026, second quarter, which ended on September 30th, 2025.
Speaker #2: Providing an overview on the progress in our Palisade 3 program for FASA DNR and social anxiety disorder across our other lead medical neuroscience programs.
Speaker #2: We encourage you to review the PR and 10Q, which are available in the investor section of our website. Now, before we begin, please note that we will be making forward-looking statements regarding our business during today's call.
Speaker #2: Based on our current expectations and information, these forward-looking statements speak only as of today. Except as law requires, we do not assume any duty to update any forward-looking statements made today or in the future.
Speaker #2: Of course, forward-looking statements involve risks and uncertainties and other actual results could differ materially from those anticipated by any forward-looking statements we make today.
Speaker #2: concerning risks and factors that could Additional information affect our business and financial results are included in the fiscal year 2026, second quarter, Form 10Q for the period ending September 30th, 2025, and in future filings that we'll make with the SEC from time to time.
Speaker #2: All of which are available in the investor section of our website or, of course, on the SEC's website. Now, with the formalities out of the way, analysts and others interested in our programs and our progress.
Speaker #2: I'm we warmly welcome our stockholders, sell-side joined on our call today by Shawn Singh, our Officer, and Josh Prince, President and Chief Executive Officer.
Speaker #2: Shawn will provide a update, and Josh will be available to provide additional feedback during the Q&A call. After our remarks, we'll take questions from brief business update, clinical today and remind you to replay the webcast will be made available in the sell-side analysts participating on the call the events section of our investor page on our website.
Speaker #2: portion of our
Speaker #2: With that taken care of, I'll now turn the call over to our President and CEO, Shawn
Speaker #2: Singh.
Speaker #3: Thank you, Mark,
Speaker #3: We've built a very strong
Speaker #3: double-blind portion of our Palisade 3 phase 3 trial. our Palisade program, the last intranasal pharyngeal product candidate, FASA DYNAL, for the acute treatment of social Evaluating our most advanced anxiety disorder.
Speaker #3: We are now preparing for the release of top-line results from the of this calendar year. We extend patients who participated in the study, as well as the dedicated and experienced clinical Palisade 3 study by the end investigators, the clinical site staff, and our contract research organization.
Speaker #3: Their enthusiasm, collaboration throughout the study, focus on detail, and the appreciated contributions will remain so during the ongoing open-label extension of the study.
Speaker #3: Over the past several months, of the dedicated teams conducting our Palisade 3 and Palisade 4 our sincere gratitude to the I've had the privilege of meeting in person with many studies.
Speaker #3: The energy, the notable and greatly curiosity, the optimism that I've witnessed remains for new treatment options reaffirm just how great the need for individuals whose daily lives are affected by social anxiety disorder.
Speaker #3: And how differentiated and innovative FASA DYNAL could needs. Together, our teams remain deeply be in meeting their become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety disorder.
Speaker #3: And how differentiated and innovative FASA DYNAL could needs. Together, our teams remain deeply be in meeting their become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety focused on FASA DYNAL's potential to Looking ahead, we remain on track to report top-line results from our Palisade 4 phase 3 trial.
Speaker #3: In the first half of 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 2 phase 3 trial.
Speaker #3: In parallel, we are continuing preparations designed to depressive disorder, and pipeline, including iTruvone for major flashes. Both depression and women's PH-80 for menopausal hot advance our broader pharyngeal health represent areas where far too many patients still struggle without adequate options.
Speaker #3: We're deeply motivated to bring forward the innovative nonsystemic neurocircuitry-focused potential of iTruvone and PH-80 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 in marketable securities.
Speaker #3: We believe current cash covers all known aspects of our ongoing U.S. registration-directed Palisade program for FASA DYNAL for the acute treatment of SAD, including potential NDA submission if our Palisade program is successful.
Speaker #3: Before I conclude the business update, I'd 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.
Speaker #3: His leadership will be invaluable as we prepare for our next phase of growth. I'd also like to extend our deep gratitude to Dr. Jerry Jin, who served on our board from 2016 until his retirement earlier in September of this year.
Speaker #3: In closing, our mission remains clear: end unwavering. To redefine what is possible in neuroscience, to restore, emotional well-being, and improve quality of life, for millions worldwide.
Speaker #3: 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.
Speaker #3: I want to thank you all for your continued interest, your support, and your engagement with Vistagen, and makes a lot of difference. And we look forward to sharing our progress with you in the weeks and the months ahead.
Speaker #1: 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.
Speaker #4: At this time, I would like to remind everyone that in order to ask a question, please press star, followed by the number one on your telephone keypad.
Speaker #4: Your first question comes from the line of Andrew Say with Jefferies. Please go ahead.
Speaker #5: Hey, guys. Thanks for taking my questions. Good afternoon. I look forward to the top-line data readout soon. I think you guys have mentioned before that we should expect six to eight weeks after the last visit for the top-line release.
Speaker #5: Is that still the case, or could it come earlier than that,
Speaker #5: actually? Our guidance, I think we're just going to
Speaker #1: stick with it, Andrew. Thanks for asking the question, and thanks for coming on. But our guidance is that we'll see top-line results released before the end of this calendar quarter.
Speaker #1: So by the end of this calendar year.
Speaker #5: Okay. And for the top-line analysis, how should we think about discontinuation rates? Any protocol violations? Will the can we expect the top-line to be pretty close in terms of the number of patients you've enrolled in the study?
Speaker #5: And then how should we also be thinking about the safety profile?
Speaker #1: Well, you're going to hear, as we did with Palisade 2, right? So we're going to give you, obviously, top-line results on the primary CGII, the secondary, and also the PGICs, the secondary and obviously pretty customary information regarding the safety profile that we've seen throughout the course of the study through the randomized portion of the study.
Speaker #1: So that's what we're printing out, and that's what we're reading out is are the top-line results from the randomized double-blind portion, which is the public speaking challenge.
Speaker #1: So, any safety data that we have from that study, similar to Palisade 2, we'll be reading that out as well.
Speaker #5: 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 2?
Speaker #5: Thank you.
Speaker #1: All right. 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 was very high-quality assessment for subject eligibility.
Speaker #1: 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.
Speaker #1: So I think we've seen generally what we've expected to see. And as we've modeled forward for not only screen fail but also attrition rates throughout the course from enrollment through randomization through the end of the study.
Speaker #1: So I think we're comfortable with what we've typically seen. And maybe more to come on that
Speaker #1: later. Important piece of the puzzle Okay. is we yeah. So one more thing. So obviously, the important piece of the puzzle is that we got to the last phase since last visit, with the full complement that we had modeled for purposes of the studies.
Speaker #1: We've noted before our end target was 236, so. Last phase since last visit reflects our original thoughts.
Speaker #5: Perfect. Thanks again.
Speaker #1: Mm-hmm. Your next question comes from
Speaker #4: the line of Paul Matteis with Stifel. Please go
Speaker #4: ahead.
Speaker #6: This is Matthew on for Paul. Thanks for taking our question. I guess for us, assuming one of Palisade 3 or 4 works, is there anything else gating registration gating filing?
Speaker #6: Is there anything else that you need to complete before then? How soon can you file? Thanks.
Speaker #1: Sure. Matthew, thanks for the question. So as you know, as we move closer toward completion of the phase 3 development program, we always plan to interact with the agency.
Speaker #1: But we've said this before. Obviously, it's the pivotal program data. So repeat those studies is the open label data from our long-term safety study.
Speaker #1: A 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.
Speaker #1: So then we'll, of course, be meeting with the FDA as we get closer to make sure that we're in line with what's necessary regarding submission package.
Speaker #1: So we estimate currently, if everything goes according to plan, that we've been executing on we could see an NDA submission of Palisade 3 is positive, sometime around the middle of
Speaker #1: '26. Thank you.
Speaker #6: That's super helpful. And looking forward to the data soon.
Speaker #4: As a reminder, if Thanks. you would like to ask a question, please press star, followed by the number one on your telephone keypad. Your next question comes from the line of Miles Minter with William Blair.
Speaker #4: Please go
Speaker #4: ahead. Thanks for taking the
Speaker #7: questions. This is the first one. Is it your view that Professor Dinal would be eligible for a commissioner's priority review voucher? Seems to me like SAD is potentially a public health crisis, and it's certainly a massive unmet need with over 30 million patients out there.
Speaker #7: That's 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.
Speaker #7: I'm just curious whether that was because you've completed enrollment and you didn't need those sites anymore, or just because of your site vigilance and you're going to see these sites in person.
Speaker #7: Was it something performance-related that you terminated those sites? Thanks very
Speaker #7: Was it something performance-related that you terminated those sites? Thanks very much. Thanks, Miles.
Speaker #1: Thanks for the questions. Josh, once you go ahead and take that last question first.
Speaker #8: Sure. Yeah. Thanks, Miles. As we've gone through the course of these studies, for both PAL3, PAL4, it's a constant evaluation of fit with sites.
Speaker #8: And so we've 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.
Speaker #8: And so, at some point, it makes sense to terminate those sites. There's been one or two like that. And then also, beyond that, as we— to your point— as we get towards the end of the study, we definitely take a wind-down approach for a soft landing for the study to make sure it's well controlled.
Speaker #8: We're controlling variability and ensuring that we are able to efficiently get from the end of the study, last patient out, to top-line results in the timeline that Shawn mentioned.
Speaker #8: So for us, it's kind of a course of business as we've gone through the process of the
Speaker #8: studies. Thanks, Josh.
Speaker #1: So Miles, on your first question related to the voucher program, the CMPV program, so we're certainly aware of it. And the criteria the FDA uses to evaluate eligibility I think right now, while we don't expect that Professor Dinal falls within the typical scope of the CMPV programs, we, of course, believe the magnitude of the unmet need and especially for a rapid situational treatment without the worrisome side effects and safety concerns, it's significant.
Speaker #1: But I think if the regulatory pathways evolve or additional guidance creates a relevant framework, then of course, we'll evaluate it at the appropriate time.
Speaker #7: Cool. Thanks for the
Speaker #7: questions. You
Speaker #1: You bet. Your next question
Speaker #4: comes from the line of Elmer Pyros with Lucid Capital Markets. Please go
Speaker #4: ahead. Yes.
Speaker #7: Hi, Shawn. This is Elmer dialing in for
Speaker #7: Elmer. Hey, What I'd like to ask you
Speaker #1: Elmer.
Speaker #7: is, if you have any indication on the usage patterns, this is coming from perhaps more likely from Palisade 2 than maybe to a lesser extent from Palisade 3 at this point.
Speaker #7: For those who went out to complete the OLE up to one year.
Speaker #1: Yeah. Most of the usage pattern data is going to come from the open labels. And so what we can talk about, of course, is related to the reported open label, the long-term safety study that we had before.
Speaker #1: And the patterns established in the context of that study give some pretty good guidance to us about what we see going forward in the real world.
Speaker #1: Remember, this is a disorder that is it's 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.
Speaker #1: 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've reported on more activity during the week, especially after people are back to work, back to school, into kind of rhythm of life that we're in now.
Speaker #1: You see more utilization during a week, especially during work kind of hours, weekends. It tends 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 a sporting event where there's worry about how you're looking, how you're whether you're being judged or not being judged, which is really the what anchors this disorder, unfortunately.
Speaker #1: So more often during the week, less often during the weekend. And that's the pattern we saw early on in the open label study we reported on.
Speaker #1: And it's reasonable to expect that sort of activity on a go-forward basis. At least that's what's anchoring a lot of our informed assumptions about how we could see the drug used in the real world.
Speaker #1: If it's approved.
Speaker #7: 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?
Speaker #7: And roughly what percentage is
Speaker #7: that? Yeah.
Speaker #1: I'm not going to remark on the percentages, but I can tell you it's a high-throughput rate we've seen historically. And any open label activity that we've got and that's to be expected.
Speaker #1: It's 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's an opportunity for the investigational agent to be part of their go-forward experiences.
Speaker #1: So I think the reasons people don't tend to go into an open label historically are associated with a change in job, a change of living location, something significant that's 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
Speaker #1: study. I see.
Speaker #7: I see. I just have two more if you're okay with that. What would be the minimal effect size in terms of the SODs or the CGI that would be deemed clinically
Speaker #1: So we're going to meaningful? 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.
Speaker #1: So you get the clinical significance or clinical meaningfulness when you look at all three of those. And we take a look not only at what happens with the SODs but also with the secondary.
Speaker #1: So and it's I think we're targeting to try to replicate what we already believe is not only statistically significant but a clinically meaningful outcome associated with the Palisade 2
Speaker #1: study. I understand.
Speaker #7: And lastly, how do you think about commercialization at this stage on your own? With a partner? Have you thought about this recently?
Speaker #1: Companies, yeah, certainly we think about it all the time. Companies in positions like we are, if you have a contemplation for in a first commercial launch, you have to have a lot of good reasons for that.
Speaker #1: And here, as a company, we always position for optionality. There's many things that can happen. E for us is to make sure we have the optimal opportunity to generate the value that could be associated with fasted INR if it gets approved.
Speaker #1: So there's certainly a very solid potential commercial plan. There's also opportunities should other strategic arrangements bring greater value potential. But yes, as a company, we have the expertise.
Speaker #1: 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's 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.
Speaker #1: And the world right now, it's 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 and a GLP-1 drug.
Speaker #1: So there's a transformed market environment over just even the last couple of years. And now you're also looking at a population of patients and maybe practitioners too who really would prefer online engagement as opposed to in-person.
Speaker #1: So there's 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.
Speaker #1: So it's a really exciting opportunity for the company around this very unique asset that fits in so many ways for what we think are the clarion calls of not only practitioners but certainly patients.
Speaker #7: Yeah. Exciting times looking forward to the readout. Thank you
Speaker #7: very much, Shawn. You bet.
Speaker #1: Thanks again.
Speaker #8: There are no further questions at this time. I would now like There to turn the call back over to Mark McPartland for closing remarks.
Speaker #8: Please go
Speaker #8: ahead. Thanks,
Speaker #1: operator. And thank you again, everyone, for joining us on the call today and for 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.
Speaker #1: If you have any additional questions, please don't hesitate irvistagen.com or through to reach out to us at the contact us section of our website.
Speaker #1: 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.
Speaker #1: And we look forward to keeping you updated on our continued progress. This concludes the call. Have a great day.