Good day, everyone, and thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year-End 2025 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, please go ahead.

Thank you, Victor. Good afternoon, everyone, and welcome to Vistagen's Fiscal Year-end 2025 Corporate Update Conference Call and Webcast. Earlier this afternoon, we issued a press release for our fiscal year-end 2025, which ended on March 31, 2025, provided an overview of our progress across our lead clinical stage neuroscience programs. We encourage you to review the release and the 10- K, which can be found on our website's Investors section. Before we begin, please note that we will make forward-looking statements regarding our business during today's call based on 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. Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements we may make today. Additional information concerning risks and factors that could affect our business and financial results are included in our fiscal year-end 2025 Form 10-K for the period ending March 31, 2025 and in future filings, we'll make with the SEC from time to time, all of which are available in the Investors section of our website and on the SEC's website. Now with the formalities out of the way, we warmly welcome our stockholders, sell-side analysts and interested in our program and progress. I'm joined on our call today by Shawn Singh, our President and Chief Executive Officer; and Cindy Anderson, our Chief Financial Officer. Shawn will discuss recent highlights in our lead neuroscience program, and Cindy will discuss our fiscal year-end 2025 financial results. After our prepared remarks, there will be a brief opportunity for questions from the sell-side analysts on the call. As a reminder, this call is being webcast and will be available for replay upon completion. A replay link can also be found on our website's Investor Events section. I will now turn the call over to our President and Chief Executive Officer, Shawn Singh. Shawn, the floor is yours.

Thank you, Mark, and good afternoon, everyone. Thank you for joining us. As some of you know, our team here at Vistagen is at the leading edge of neuroscience that involves the therapeutic potential of nose-to-brain neurocircuitry to developing a new class of nonsystemic intranasal product candidates called pherines. We now have 5 clinical-stage pherine product candidates, each with a mechanism of action or MOA that is differentiated from all approved drugs and positive results in a controlled trial. Together, they cover a broad and diverse range of large market conditions and disorders where underserved patients have needed new and better treatment options for many years. Fiscal 2025 was another significant year of progress across our neuroscience pipeline with multiple pherine product candidates in Phase II or Phase III development we are advancing our mission to deliver transformative treatment options for patients and build value for our stockholders. Our lead pherine product candidate, fasedienol, is in Phase III development for the acute treatment of social anxiety disorder, or SAD. There is no FDA-approved acute treatment for SAD, a condition that now is estimated to affect over 31 million U.S. adults who struggle with the intense stress and debilitating anxiety and fear of embarrasment, humiliation and judgment in everyday social and performance situations. Our goal for fasedienol is for it to become the first FDA-approved acute treatment of SAD and help improve the millions of Americans whose lives are affected by the serious and potentially life-threatening disorder that often brings -- begins in adolescence and occurs for decades beyond. The ongoing Phase III trials in our U.S. registration-directed PALISADE program for fasedienol for the acute treatment of SAD, PALISADE-3 and PALISADE-4, are designed to complement our success in our PALISADE-2 Phase III trial that we reported during the second half of…

Thanks, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year March 31, 2025. Research and development expenses were $39.4 million for the fiscal year ended March 31, 2025 compared to $20 million for the same period last year. The increase in R&D expenses was primarily due to increases in research, clinical and nonclinical development, contract manufacturing expenses and headcount related to our U.S. registrational PALISADE program for fasedienol in SAD, and our U.S. IND enabling program for PH80 in women's health. General and administrative expenses were $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million for the same period last year. The increase in G&A expenses primarily due to increased headcount, consulting and professional fees. Our net loss attributable to common shareholders was $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million for the same period last year. As of March 31, 2025, we had $80.5 million in cash, cash equivalents and moderate securities. I will now hand the call back over to Shawn.

Thank you, Cindy. Once again, everyone, at Vistagen, our mission is to transform lives with pioneering neuroscience and an innovative pipeline of intranasal product candidates, nonsystemic intranasal product candidates that harness the power of nose-to-brain neurocircuitry, unlike any pharmaceutical product ever before them. With 5 promising clinical stage pherine product candidates and a U.S. registration-directed Phase III program advancing, not just developing innovative potential treatments but also working to restore hope, dignity and the quality of life for millions of people facing underserved conditions every day. We thank you for your continued support and your belief in our mission. And on behalf of the entire Vistagen team, we're honored to be on this journey with you, and we look forward to keeping you closely updated on our continuing progress.

Thank you, Shawn. Operator, we would now like to open up the call for questions from the sell-side analysts participating today.

[Operator Instructions] Our first question will come from the line of Paul Matteis from Stifel.

This is Julian on for Paul. You alluded to changes with FDA leadership and there's been reports of turnover of staff and medical review teams. I guess in your interactions with the agency, have you noticed any changes or anything that's worth highlighting to sell- side and investors? And then just with respect to PALISADE-4 quickly, you talked about patient demand being quite strong. What led to the modest slip back of timing for P4? Was it something operational? Or any color that you could provide on that would be super helpful.

Great. You bet, Julian. So to the first question, it was a very common line of inquiry by a handful of us at that CEO listening forum. It was quite -- actually, it was interesting because it was a bit opposite of the tone and tenor that we had heard a week before in the open form of the Jefferies conference, and it was very encouraging, especially on this particular point. Not only did Dr. Makary say this, but also Dr. Prasad said it from the CBER voice which is that no FDA reviewer or inspector was involved with the reduction in force, and that they are hiring additional reviewers and inspectors with domain expertise in the areas that they review. So we hope that will be the case. I think in our case, we haven't seen any changes in our review team, which is helpful. One of the things I mentioned to them is it'd be nice and helpful to industry if at this point, given the kind of questions you just asked that each company, each sponsor with an open IND or a program that's underway gets reconfirmed that the teams they have is the team that they have had, and especially as it relates to prior commitments and agreements. So we'll see if they act on that. But overall, I think we heard it not only at the Jefferies conference, but again, at our Listening forum, which is that in terms of the muscle, the reviewers and the inspectors, there hadn't been any change. Most of the change associated with centralizing resources, where there was tremendous overlap in fiefdoms and sort of a tribalism component where every aspect within the FDA had its own little universe, whereas none of us in the audience would really build the…

Our next question will come from the line of Andrew Tsai from Jefferies.

I appreciate the updates. So looking ahead, heading into the PALISADE-3 data readout, can we expect you to announce enrollment completion in that study? And if so, from there, how many weeks can we expect you to take before reporting the top line data?

Thanks for the question, Andrew. So yes, we will report when we -- remember, it's a 4-visit study paradigm. And so once the subjects have completed -- the randomized subjects have completed their safety follow-up, that's when we'll be announcing when the last patients completed that. And from that point forward, again, it always depends on the number of queries needed to get to DBL, but anywhere from us around 6 to top end would be 8 weeks, but typically somewhere around 6 weeks to get to the top line from database lock.

Understood. And then earlier speaking of variability back in the successful PALISADE-2 study, I think the placebo arm showed a SUDS reduction of 8 points absolute basis. Would you expect that to be the same case for PALISADE-3 and 4? Or with these more enhanced controls could the placebo be lower?

Well, what we've certainly done, Andrew, is intended to design PALISADE-3 and 4 in a manner to replicate the success we saw in PALISADE-2. Where that actually lands, we'll have to see how the cards flip but everything that we've done has been intended to limit variability. In any way, we can conceive of it after taking a look at PALISADE-1 and PALISADE-2 studies, which were the first 2 studies, as you know, with this design and this endpoint for the acute treatment of SAD. So a lot has been learned and the rigor matters, and so we'll see. The idea, obviously, is to increased visibility into all aspects of the study and its execution to ensure the highest impossible potential to reduce variability. So hopefully, that falls in the direction that we saw things land with PALISADE-2.

Great. And then my last question is in terms of psych conduct and as well as your overall surveillance, are you making sure these PIs are disqualifying patients appropriately when these patients are taking their SUDS tests? And are you looking at these SUDS rating somehow for each patient to make sure all time points make sense with the scoring?

Well, the last question, again, whether it makes sense, they are what they are in terms of the scoring. But what I can tell you in the first hand, I mean, the whole purpose of what we did majorly differently with PALISADE-3 and 4 was to develop and have internally what we call our secondary eligibility review team. This is a team, that internal Vistagen team, not a CRO team or a third-party team, but an internal team that consists of very experienced psychometricians who review eligibility of each subject, and they listen to screening assessments as well as each public speaking challenge to ensure in the proper execution. So we think, again, that those kinds of enhancements -- and those are some of the things that take a little bit more time, especially with obviously a hyperfocus on radar training upfront, across all the endpoints, not just the subs, but the CGI-I and the PGIC so that you have confidence that the study is being run the way it should be run and that we've done everything that we can through all the experience we've gained through the execution of 2 studies already to enhance the potential for success.

[Operator Instructions] Our next question will come from the line of Myles Minter from William Blair.

I've got one on the CEO forum and maybe conversations that you had with Marty Makary. It seems pretty clear to me that the FDA is driven to try and expedite approvals of products that are addressing a health crisis in the U.S., the innovative cures for American People, addressing unmet public health needs, given the voucher program announced today, seems like your work in social anxiety to sort of would point to matching those pillars there. But when we read the MAHA report that's coming from HHS, it paints a slightly different picture, at least in the preliminary stance there and the potentially want to restrict the use of mood stabilizer drugs. I know you're a different mechanism of action here. But did you get any sort of alignment from Marty or higher ups at the FDA that they're aligned with social anxiety disorder and fasedienol as meeting these pillars that the FDA has mandated towards? Or is there an alignment with the FDA here on that unmet need? Or is it more falling into that sort of HHS opinion in that MAHA report? I'd love your thoughts on that dynamic. And then secondly, it's a question on PAL-3 and 4. It seems clear to me that patient demand into the trial is not the issue here. Things are going well, but maybe it's the screening and the inclusion/exclusion criteria. I'm wondering whether that is to do with the Liebowitz Social Anxiety Scale? And if it's more to do with the independent raters that you've got here that you didn't have before and whether they're screening out more patients?

Well, thanks, Myles. It's quite a bit, and we could talk forever on that. But the first question, I think it's really important. I'd say, look, we got over 30 million people in this country that are affected by social anxiety. We've got a mechanism of action unlike anything that's ever been put out in the anxiety arena. It's not a drug candidate that we see causing addiction potential, sexual side effects, weight gain, requiring a REMS, things that are just completely different than what the universe has seen before. That said, in the forum, there was not -- one of the ground rules was no specific conversations about your particular program. Everybody got a minute to talk. Most people didn't adhere to the minute but most people did adhere to not talking about their specific programs. So I can't give you the answer directly on that one from that context. We do think, of course, have fast track designation from FDA. So we do know what they think of it from a regulatory standpoint, serious and life-threatening. The prevalence continues to increase yet there aren't any new options that don't seem to have a whole bunch of baggage. We certainly know about the benzo epidemic. So being able to deliver innovative MOAs certainly is on the mind of everybody in that room, FDA leadership, including some of the support teams that I spoke with during kind of the intro hour of that event. So I think we're confident for the place that we would be able to land in the universe associated with potential productivity people getting back into the rhythm of life that they aspire to achieve. There's ways to do that and we know a lot of people are on the sidelines with SAD struggling with it…

Operator, I believe that's all the time we have for questions today. If you have -- if those participated on the call have additional questions, please don't hesitate to contact us by e-mailing ir@vistagen.com or via the contact section of our website. We also encourage you to register for e-mail updates on our website to stay connected with our latest news. Thank you for participating on the call today. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing progress. This concludes our call. Have a tremendous day.

Thank you for your participation in today's conference. This concludes the program. You may now disconnect. Everyone, have a great day.