Vistagen Therapeutics, Inc.

Good day, everyone. Thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year 2026 Second Quarter Corporate Update Conference Call and Webcast. 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, Investor Relations at Vistagen.

Mark. Thank you, Operator. Good afternoon, everyone, and welcome to our conference call and webcast. Earlier this afternoon, we filed our quarterly report on Form 10-Q and issued a press release for our fiscal year 2026 second quarter, which ended on September 30th, 2025, providing an overview on the progress in our Palisade III program for FASA-DNL and social anxiety disorder across our other clinical neuroscience programs. We encourage you to review the PR and 10-Q, which are available in the investor section of our website. Now, before we begin, please note that we will be making forelooking statements regarding our business during today's call based on our current expectations and information. These forelooking statements speak only as of today. Except, as law requires, we do not assume any duty to update any forelooking statements made today or in the future. Of course, forelooking statements of all risks and uncertainties and other actual results could differ materially from those anticipated by any forward-looking statements we make today. Additional information concerning risks and factors that could affect our business and financial results are included in the fiscal year 2026 second quarter form 10-Q for the period ending September 30th, 2025 and in future filings that we'll make with the SEC from time to time, 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, we warmly welcome our stockholders, sell-side analysts, and others interested in our programs and our progress. I'm joined on our call today by Shawn Singh, our President and Chief Executive Officer, and Josh Prince, our Chief Operating Officer. Shawn will provide a brief business update, clinical update, and Josh will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we will take questions from the Southside 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, Sean Singh.

Thank you, Mark, and good afternoon, everyone. We've built a 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 portion of our Palisade 3 Phase 3 trial, evaluating our most advanced intranasal fairing product candidate, Fasodinol, 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've 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've witnessed reaffirms 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 Fasadionol could be in meeting their needs. Together, our teams remain deeply focused on Fasadionil'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 Palisade 4 Phase 3 trial 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. In parallel, we are continuing preparations designed to advance our broader farine pipeline, including itruvone 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're deeply motivated to bring forward the innovative, non-systemic, neurocircuitry-focused potential of iTruvone 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 financial U.S. registration-directed Palisade program for Fasodionol for the acute treatment of SAD, including potential NDA submission if our Palisade program is successful. 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. 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. 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, 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. We 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.

Thank you, Sean. 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 cell site analysts joining us today.

At this time, I would like to remind everyone, in order to ask a question, please press star followed by the number one on your telephone keypad. Your first question comes from the line of Andrew Say with Jefferies. Please go ahead.

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

Our guidance, I think we're just going to stick with it, Andrew. Thanks for asking the question. Thanks for coming on. But our guidance is that we'll see top line results released before the end of this calendar quarter, so by the end of this calendar year.

Okay. And for the top line analysis, how should we think about discontinuation rates, any protocol violations? Well, can we expect...

top line to be pretty close in terms of the number of patients you've enrolled in the study and then how should we also be thinking about the safety profile well you're going to hear as we did with palisade too right so we're going to give you obviously top line results on the primary uh the cgii the secondary and also the pgic is the secondary and obviously um pretty Customary information regarding the safety profile that we've seen throughout the course of the study through the randomized portion of the study 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? So any safety data that we have from that study similar to Palisade 2 will be reading that out as well Okay, and then last question is from what you can tell I

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? Thank you.

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, 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'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. I think we're comfortable with what we've typically seen, and maybe more to come on that later. Okay, thank you. The important piece of the puzzle is we... Yes, one more thing. Obviously, the important piece of the puzzle is that we got to the last patient class visit with the full complement that we had modeled for purposes of the studies we've noted before. Our end target was 236, so...

Last patient plus visit reflects our original thoughts. Perfect. Thanks again. Your next question comes from the line of Paul Matase with Stiefel.

Please go ahead.

Hi, this is Matthew on for Paul. Thanks for taking our question. I guess for us, you know, assuming one of palisade three or four 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.

Sure. Matthew, thanks for the question. So, you know, as you know, as we move closer toward completion of the Phase 3 development program, we always plan to interact with the agency. But we've said this before, obviously, it's the pivotal program data, the repeat dose study, the open label data from our long-term safety study. a human factor study, the typical preclinical safety-related studies, Reprotox and CARC. All those are aspects that we expect to have wrapped up up front, of course, of an NDA package. And 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. We estimate currently, you know, if everything goes according to plan that we've been executing on, we could see an NDA submission of Palcate 3 as positive sometime around the middle of 26.

Thank you. That's super helpful. And looking forward to the data soon. Thanks.

As a reminder, if you would like to ask a question, please press star followed by the number one on your telephone keypad. The next question comes from the line of Miles Minter with William Blair. Please go ahead.

Thanks for taking the questions. This is the first one. Is it your view that facidinol would be eligible for a commissioner's priority review voucher? It seems to me like that is potentially a public health crisis and it's certainly a massive unmet need with over 30 million patients out there. That's the first one. And second is just, I think in late October, you updated clinicaltrials.gov. You terminated a site in Arkansas and Kansas. 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. Was it something performance-related that you terminated those sites? Thanks very much.

Thanks, Miles. Thanks for the questions. Josh, why don't you go ahead and take that last question first?

Sure, yeah. Thanks, Miles. You know, as we've gone through the course of these studies for both PAL-3, PAL-4, you know, it's a constant evaluation of fit with sites. 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. 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, 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. We're 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 Sean mentioned. So for us, it's kind of course of business as we've gone through the process of the studies.

Thanks, Josh.

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 Fasadino 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. 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.

Cool. Thanks for the questions. You bet.

Your next question comes from the line of Elmer Pyros with Lucid Capital Markets. Please go ahead.

Yes. Hi, Sean. This is Elmer dialing in for Elmer. Hey, Elmer. What I'd like to ask you is if you have any indication on the usage patterns. This is coming from perhaps more likely from Talisaic 2.0. than maybe to a lesser extent from Palisade 3 at this point for those who went out to complete the OLE up to one year.

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. 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. 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've reported on more activity during the week, especially after, you know, after people are back to work, back to school, and the kind of rhythm of life that we're in now, you see more utilization during a week, especially during work kind of hours. Weekends tends to taper off, obviously, because people are and not in similar stressful settings. There may be social situations, a barbecue with your friends, or you go to a sporting event where there's worry about how you're looking, whether you're 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's the pattern we saw early on in the open-label study we reported on. 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.

Thank you, Sean. 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?

Yeah, I'm not going to remark on the percentages, but I can tell you it's a high throughput rate we've seen historically in any open-label activity that we've got, and that's to be expected. 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. So I think the 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, you know, 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 study. I see.

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 meaningful?

So we're going to try to, of course, replicate what we were able to accomplish in Palisades 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 PGII and PGIC. You get to clinical significance or clinical meaningfulness when you look at all three of those and we take a look at not only what happens with the SUDs but also with the secondaries. 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 PALS-A2 study.

I understand. And lastly, how do you think about commercialization at this stage? On your own, with a partner, have you thought about this recently?

Companies, yeah, certainly you think about it all the time. Companies in positions like we are, if you have a contemplation for commercialization, in 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's many things that can happen. The key for us is to make sure we have the optimal opportunity to generate the value that could be associated with fastidionol if it gets approved. 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, 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. In 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 in a GLP-1 drug. 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. 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. 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.

Yeah. Exciting times. Looking forward to the readout. Thank you very much, Sean.

You bet. Thanks again.

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.

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 don't hesitate to reach out to us at ir.vistagen.com 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.

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