Q4 2025 VistaGen Therapeutics Inc Earnings Call and Business Update

Operator: Thanks everyone and thank you for standing by.

Good day, everyone and thank you for standing by woke up to the Vista Gen 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 more.

Operator: Welcome to the VistaGen Therapeutics Fiscal Year End 2025 Corporate Update Conference Call and Webinar. Please note that today's call is being recorded at this time.

Mark McPartland: I'd like to turn the call over to your host, Mark McPartland, Senior Vice President, Investor Relations at VistaGen.

Mcpartland: Mcpartland Senior Vice President Investor Relations, Mr. Jim <unk>. Please go ahead.

Mark McPartland: Mark, please go ahead. Thank you, Victor.

Mark McPartland: Good afternoon, everyone, and welcome to VistaGen's Fiscal Year End 2025 Corporate Update Conference Call and Webinar. Earlier this afternoon, we issued a press release for our fiscal year-end 2025, which ended on March 31st, 2025, providing 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 in our website's investor section. Before we begin, please note that we will be making 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.

Speaker Change: Thank you Victor good afternoon, everyone and welcome to the basic James fiscal year end 2025, corporate update conference call and webcast.

Speaker Change: Earlier this afternoon, we issued a press release.

Speaker Change: For our fiscal year end 2025, which ended on March 31, 2025, providing an overview of our progress across our lead critical stage neuroscience programs. We encourage you to review the release and the 10-K, which can be found in our websites investors section.

Speaker Change: Okay.

Speaker Change: Before we begin please note that we will make forward looking statements regarding our business. During today's call are based on current expectations and information.

Speaker Change: 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.

Mark McPartland: 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 investor section of our website and on the SEC's website.

Speaker Change: 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.

Speaker Change: For the period, ending March 31, 2025, and in future filings will 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.

Mark McPartland: Now with the formalities out of the way. We warmly welcome our stockholders, sell-side analysts, and interested in our program and progress.

Speaker Change: Now with the formalities out of the way.

Speaker Change: We warmly welcome our stockholders sell side analysts and interested in our program and progress I'm joined on our call today by Sean Zhang Our President and Chief Executive Officer, and Cindy Anderson, our Chief Financial Officer.

Mark McPartland: I'm joined on our call today by Shawn Singh, our President, Chief Executive Officer, and Cindy Anderson, our Chief Financial Officer.

Mark McPartland: 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 Southside analysts. on the call. As a reminder, this call is being webcast and will be available for replay upon completion. The replay link can also be found on our website's Investor Events section.

Speaker Change: Sean will discuss recent highlights and 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.

Speaker Change: On the call as a reminder, this call is being webcast and will be available for replay upon completion.

Speaker Change: <unk> can also be found in our web site's investor events section.

Shawn Singh: I will now turn the call over to our President and Chief Executive Officer, Shawn Singh. Shawn, the field is yours. Thank you, Mark, and good afternoon, everyone. Thank you for joining us.

Speaker Change: I will now turn the call over to our President and Chief Executive Officer, Sean thing, Sean failed as yours.

Speaker Change: Thank you Mark and good afternoon, everyone. Thank you for joining us as some of you know our team here at Vista Gen is at the leading edge of neuroscience.

Shawn Singh: 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. Developing a new class of non-systemic intranasal product candidates called FAERI. We now have five clinical stage ferrying 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.

Speaker Change: It involves the therapeutic potential of noticed the brain neural circuitry.

Speaker Change: Eloping, a new class of non systemic intranasal product candidates called fairings.

Speaker Change: We now have five clinical stage product candidates each with a mechanism of action or M. A way that is differentiated from all approved drugs.

Speaker Change: And positive results in a controlled trial.

Speaker Change: 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.

Shawn Singh: Fiscal 2025 was another significant year of progress across our neuroscience pipeline. With multiple fairing product candidates in phase two or phase three development, we are advancing our mission to deliver transformative treatment options for patients and build value for our stockholders. Our lead Farin product candidate, Fasadienol, is in Phase 3 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 embarrassment, humiliation, and judgment in everyday social and performance situations.

Speaker Change: Fiscal 2025 was another significant year of progress across our neuroscience pipeline with multiple ferring 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.

Speaker Change: Our lead Ferring product candidate fast the die and all was in phase III development for the acute treatment of social anxiety disorder or S. A D.

Speaker Change: There is no FDA approved acute treatment for C. D. 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 embarrassment humiliation and judgment in everyday social and performance situations.

Shawn Singh: Our goal for Fasadienol 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 this serious and potentially life-threatening disorder that often begins in adolescence and occurs for decades beyond. The ongoing Phase III trials in our U.S. Registration-Directed Palisade Program for Fascidinol for the Acute Treatment of SED, Palisade III and Palisade IV, are designed to complement our success in our Palisade II Phase III trial that we reported during the second half of 2023. Our Palisade 3 trial is on track for a top-line data readout in the fourth quarter of this year, and we anticipate top-line results from Palisade 4 in the first half of 2026.

Speaker Change: Our goal for faster Dino is for it to become the first FDA approved acute treatment of S. A D 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 of course for decades beyond.

Speaker Change: The ongoing phase III trials in our U S registration directed Palisade program Professor Dino for the acute treatment of S. C. D. Palisade three in palisade for are designed to complement our success in our policy to phase III trial that we reported during the second half of 2023.

Speaker Change: Our Palisades III trial is on track for topline data readout in the fourth quarter of this year and we anticipate topline results from palisade for in the first half of 2026.

Shawn Singh: The enthusiasm of patients and physicians participating in the Palisade program continues to be very strong, and we remain committed to rigorous operational execution. If successful, we believe either Palisade 3 or Palisade 4, in combination with the positive results from Palisade 2, could provide the substantial evidence of effectiveness needed to support a new drug application for facetidinol and its potential to be the first FDA-approved acute treatment for SAD.

Speaker Change: The enthusiasm of patients and physicians participating in the palisade program continues to be very strong.

Speaker Change: We remain committed to a rigorous operational execution. If successful we believe either policy three or palisade four in combination with the positive results from policy too.

Speaker Change: Could provide substantial evidence of effectiveness needed to support a new drug application for faster Dino and its potential to be the first FDA approved acute treatment for S. E D.

Shawn Singh: We are also advancing iTruvone, our variant product candidate for standalone treatment of major depressive disorder, or MDD. Following the promising results from a controlled exploratory phase IIa study, we are encouraged by its differentiated, non-systemic MOA and potential to treat MDD without the weight gain, sexual side effects, or systemic safety concerns commonly seen with traditional antidepressants. Our fairing product candidate focused on women's health indications, PH80, also continues to generate interest as we advance its development as a potential hormone-free treatment for menopausal hot flashes. PHAD also demonstrated positive signals in a controlled exploratory phase 2A study in premenstrual dysphoric disorder, or PMDD, further validating its broad utility in women's health.

Speaker Change: We're also advancing <unk>, our ferring product candidate for Standalone treatment of major depressive disorder or M. D D <unk>.

Speaker Change: Following the promising results from our controlled exploratory phase Iia study, we are encouraged by its differentiated non systemic M away and potential to treat M. D D without the weight gain sexual side effects or systemic safety concerns commonly.

Speaker Change: Commonly seen with traditional antidepressants.

Speaker Change: Our ferring product candidate focused on women's health indications P. J D. Also continues to generate interest as we advance its development as a potential hormone free treatment for menopausal Hot flashes PHA D. Also demonstrated positive signals in a controlled exploratory phase Iia study and premenstrual This fourth disorder.

Speaker Change: Or P. M D D. Further validating its broad utility in women's health.

Shawn Singh: We are also encouraged by PHAD's potential to treat the disruptive and painful effects of dysmenorrhea.

Speaker Change: We're also encouraged by <unk> potential to treat the disruptive and painful effects of dysmenorrhea.

Shawn Singh: We've made substantial progress preparing our US IND for PHAD to support additional phase 2 clinical development in women's health, and we anticipate submitting the IND in the second half of this year. Beyond these three LEAD programs, our diversified pharyngeal pipeline has potential for future development to improve cognitive and psychomotor impairment due to mental fatigue, as well as appetite-enhancing effects in patients with cancer cachexia, often overlooked conditions with limited treatment options. So across all five of our clinical stage ferrying product candidates. Potential therapeutic benefit has been observed with favorable safety. a testament to the power and the promise of nose-to-brain neurocircuitry.

Speaker Change: We've made substantial progress preparing our U S. IDE for PHA D to support additional phase II clinical development and women's health.

Speaker Change: And we anticipate submitting the IND in the second half of this year.

Speaker Change: Beyond these three lead programs, our diversified bearing pipeline has potential for frito development to improve cognitive and Psycho motor impairment due to mental fatigue, as well as appetite enhancing effects in patients with cancer cachexia, often overlooked conditions with limited treatment options.

Speaker Change: So across all five of our clinical stage <unk> product candidates the potential therapeutic benefit benefit has been observed with favorable safety.

Speaker Change: A testament to the power and the promise of noticed the brain neuropsychiatry.

Shawn Singh: On the U.S. regulatory front, which is on most of our minds these days, we are encouraged by the evolving regulatory landscape. Last week I was privileged to participate in the FDA's CEO Listening Tour. It was hosted at the Stanford Medical School. This CEO-only forum was led by FDA Commissioner Dr. Marty MacCary and CBER Director Dr. Vinay Prasad and their supported staff members. The forum was impressive and very productive, was allowed for essential direct interface between the new FDA leadership and my fellow industry CEOs to drive FDA initiatives that are designed to improve the ease and frequency of communication with the agency and provide clear and early guidance to support optimal capital allocation and enhance market confidence and predictability.

Speaker Change: On the U S regulatory front, which is on most of our minds. These days, we are encouraged by the evolving regulatory landscape.

Speaker Change: Last week I was privileged to participate in the Fda's CEO listening tour. It was hosted at the Stanford Medical School.

Speaker Change: The CEO only four of them was led by FDA Commissioner, Dr. Marty Macquarrie, and Zebra director, Dr. VNA Prasad and they are supported.

Speaker Change: <unk> members.

Speaker Change: One was impressive and very productive was allowed for essential direct interface between the new FDA leadership and my fellow industry Ceos.

Speaker Change: To drive FDA initiatives that are designed to improve the ease and frequency of communication with the agency and provide clear an early guidance to support optimal capital allocation enhance market confidence and predictability.

Shawn Singh: while also modernizing the agency's regulatory framework and leveraging AI to bring innovative, safe, and effective medications to underserved patient populations, both large and small. So I applaud Commissioner McCary for holding this unique forum in several cities across the country where industry expertise and perspectives can and will be openly shared with FDA leadership. It's a meaningful step toward fostering a far more collaborative, transparent, and innovation-friendly regulatory environment where, very importantly to us, new mechanisms of action and emerging technologies require re-evaluation of legacy registrational pathways. At VistaGen, we welcome conversations with the FDA, as always, about policies that speed up innovation, that make drug development more efficient and affordable, and most importantly, improve patient outcomes.

Speaker Change: While also modernizing the agency's regulatory framework and leveraging AI to bring innovative safe and effective medications to underserved patient populations, both large and small.

Speaker Change: So I applaud Commissioner macquarrie for holding this unique for them in several cities across the country, where industry expertise and perspectives.

Speaker Change: And we'll be openly shared with FDA leadership, it's a meaningful step toward fostering far more collaborative transparent and innovation friendly regulatory environment, where very importantly to us new mechanisms of action and emerging technologies require reevaluation of legacy Registrational.

Speaker Change: <unk> and <unk>.

Speaker Change: Jen we welcome the conversations with the FDA is always about policies at speed up innovation to make drug development more efficient and affordable and most importantly improve patient outcomes.

Shawn Singh: Overall, we are energized by the potential of all five of our clinical stage fairing product candidates. and with our primary focus on delivering top-line data from Palisade III in the fourth quarter of this year. Doing so has the near-term potential to transform lives and produce remarkable shareholder value.

Speaker Change: Overall, we are energized by the potential of all five of our clinical stage product candidates and with our primary focus on delivering top line data from palisade three in the fourth quarter of this year.

Speaker Change: Doing so has the near term potential to transform lives and produce remarkable shareholder value.

Cindy Anderson: So I'll now turn the call over to our Chief Financial Officer, Cindy Anderson, to highlight some of our financial results for the year. Thank you, 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 non-clinical development, contract manufacturing expenses, and headcount related to our U.S. Registrational Palisade Program for Fasinidol and SID and our U.S.

Speaker Change: So I'll now turn the call over to our Chief Financial Officer, Cindy Anderson to highlight some of our financial results for the year Sydney.

Speaker Change: Sean as Sean mentioned I will highlight a few financial results.

Speaker Change: Fiscal year March 31, 2025 research and development expenses were $39 4 million.

Speaker Change: So year ending March 31 2025.

Speaker Change: <unk> 20 million for the same period last year.

Speaker Change: The increase in R&D expenses was primarily due to increases in research clinical and non clinical development contract manufacturing expenses and head count related to our U S. Registrational palisade program for patina at all.

Cindy Anderson: IND Enabling Program for PHAD and Women's Health. General and administrative expenses were $17.1 million for the fiscal year ending March 31, 2025, compared to $14.1 million for the same period last year. The increase in GINA expenses, primarily due to increased headcount, consulting and professional Our net loss attributed 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.

Speaker Change: And our U S R&D, enabling program for ph Adrian Let me talk.

Speaker Change: General and administrative expenses were $17 1 million for the fiscal year ended March 31 2025.

Speaker Change: Compared to $14 1 million for the same period last year.

Speaker Change: The increase in G&A expenses, primarily due to increased head count consulting and professional fees are.

Speaker Change: Net loss attributable to common shareholders was $51 4 million for the fiscal.

Cindy Anderson: You ended March 31, 2025, compared to $29 4 million for same period last year.

Cindy Anderson: As of March 31, 2025, we had $80.5 million in cash, cash equivalents, and monetary securities.

Sean: As of March 31, 2025, we had $80 5 million cash cash equivalents and marketable securities I will now hand, the call back over to Sean.

Shawn Singh: 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, non-systemic intranasal product candidates that harness the power of nose-to-brain neurocircuitry unlike any pharmaceutical product ever before. With five promising clinical stage fair end product candidates and a U.S. registration directed Phase III program advancing, we're 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.

Sean: Thank you Cindy and once again, everyone that Fisher and our mission is to transform lives with pioneering neuroscience and an innovative pipeline of intranasal product candidates non systemic intranasal product candidates that harness the power of knows the brain neuropsychiatry, Unlike any pharmacy.

Speaker Change: Critical product ever before them.

Speaker Change: With five promising clinical stage ferring product candidates in the U S registration directed phase III program, advancing where not just developing innovative potential treatment, but also working to restore hope dignity and the quality of life for millions of people facing underserve conditions every day.

Sean: Thank you for your continued support and your belief in our mission and on behalf of the entire Vista team. We're honored to be on this journey with you and we look forward to keeping you closely updated on our continuing progress.

Shawn Singh: 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.

Operator: Thank you, Shawn.

Operator: Operator, we would now like to open up the call for questions from the cell side analysts participating. Thank you.

Sean: Thank you Sean operator, we would now like to open up the call for questions from the sell side analysts participate.

Operator: To ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by. We'll compile the Q&A roster.

Sean: Thank you to ask a question you will need to press star one on one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again please.

Sean: Please standby, we compile the Q&A roster.

Operator: One moment for our first question.

Greg: One moment for our first question Greg.

Greg: Okay.

Julian Pino: First question will come from the line of Paul Matisse from Stiefel, your line is open. Hey there, this is Julian on for Paul. Thanks so much for taking our questions.

Speaker Change: Our first question comes from the line of Palmer <unk> from Stifel. Your line is open.

Julian: Hey, there this is Julian entre Paul Thanks, so much for taking our questions.

Shawn Singh: You alluded to changes with FDA leadership and there's been reports of turnover of staff in medical review teams. I guess in your interactions with the agency, have you noticed any changes or anything that's worth highlighting to cell side and investors? And then just with respect to Palisade 4 quickly, you talk about patient demand being quite strong. You know, what led to the modest slip back of timing? 4P4, was it something operational or any color that you could provide on that would be super helpful. Thanks so much. Great, you bet, Julian. So, to the first question, you know, it was a very common line of inquiry by a handful of us at that CEO listening forum.

Julian: You alluded to changes with FDA leadership, and there's been reports of a turnover of staff.

Julian: In medical review teams.

Julian: I guess in your interactions with the agency have you noticed any changes.

Julian: Or anything that's worth highlighting two sell side and investors and then just with respect to palisade for quickly.

Julian: You're talking about patient demand being being quite strong.

Julian: What led to the modest slip back of timing.

Julian: Hum.

Julian: <unk> four was there something operational or any color that you could provide on that would be super helpful. Thanks. So much.

Julien: All right you bet Julien so far to the first question.

Julian: It was a very common line of inquiry by a handful of us at CEO listening for them. 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 and the open forum at the Jefferies Conference.

Shawn Singh: It was quite actually, it was interesting because it was a bit opposite of the tone and tenor that we'd heard a week before in the open forum at the Jeffries Conference. And it was very encouraging, especially on this particular point. Not only did Dr. McKerry say this, but also Dr. Fassad said it from the CBER voice, which is that no FDA reviewer or inspector was involved with the reduction of force. and that they are hiring additional reviewers and inspectors with domain expertise in the areas that they review. So we hope that'll be the case. I think in our case, we haven't seen any changes in our review team, which is helpful.

Julian: And it was very encouraging, especially on this particular point not only the doctor.

Speaker Change: <unk> say this but also Dr. Saad said it from the <unk> voice, which is that no no FDA review or Inspector.

Julian: He 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.

Julian: 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 as it would be nice and helpful to industry. If at this point given the kind of questions you just asked.

Shawn Singh: 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 team that 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 Jeffries Conference, but again at our listening forum, which is that, in terms of the muscle, the reviewers and the inspectors.

Julian: At each.

Julian: Each company each sponsor with an open IND or a program that's underway.

Julian: Gets reconfirmed that the team. 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 inspectors.

Shawn Singh: 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 FDA or build a company like the FDA has been built today. So I think they appreciate that and recognize that. And I think we can expect some changes, so that's encouraging.

Julian: <unk>.

Julian: 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.

Julian: There is.

Julian: None of us in the audience would really build the FDA.

Julian: The company like the FDA has been built today, so I think they appreciate that and recognize it.

Julian: And I think we can expect some changes so that's encouraging on that side so back to the <unk>.

Shawn Singh: So back to the Palisade IV, I think overall... We, as I think we've talked to you and Paul about in the past and others, the enhancements that we brought to the table related to Palisade 3, Palisade 4, from lessons learned and improvements that could be implemented to limit variability, to enhance subject selection, to improve study execution efficiency, those kinds of things, in addition to the mask obviously coming off and eliminating some of the COVID-related disorders, we really have been focused on very stringent subject eligibility requirements. And some of the original projections that we had were based on observations from Palisade 2 and the recruitment rates in those studies, which steadily increased through the end of the study, especially when the world got a little bit more normal at the end of Palisade 2.

Julian: Palisade for I think overall.

Julian: We as I think we've talked to you and Paul about in the past and others.

Julian: The enhancements that we brought to the table related to palisade III palisade for from lessons learned and improvements that could be implemented to limit variability to enhanced subject selection to.

Julian: To improve study execution efficiency those kinds of things in addition to.

Julian: The mask, obviously coming off and eliminating some COVID-19 related disorders, we really haven't been focused on very stringent subject eligibility requirements in some of the original projections that we had were based on observations from policy too in the recruitment rates in those studies switch.

Julian: Steadily increase through the end of the study, especially when the world got a little bit more normal at the end of palisade too.

Shawn Singh: and the impact of Those positive enhancements that we made to PALC 3 and 4 wasn't really fully understood at the beginning, but it's now very apparent. And screening visits have continued to increase. And the more stringent subject eligibility requirements and secondary subject eligibility review that we integrated with developing our own internal team in addition to increasing training and remediation. So bottom line, we've been very, very picky in the way that the study can be executed, the stringent. inclusion exclusion criteria all in an effort to of course replicate the success from Palisade 2. So I think we've got a pretty good rhythm now, and we've been able to eliminate subjects who we think may be less likely to demonstrate a benefit through that more rigorous eligibility criteria that we've applied, and the secondary review of subject eligibility and site conduct that's ongoing and very specific.

Julian: And the impact of.

Julian: Those positive enhancements that we made the palisade three and four it wasn't really fully understood at the beginning but it's now very apparent and screening visits have continued to increase.

Julian: And the more stringent subject eligibility requirements in secondary subject eligibility review that we integrated with developing our own internal team.

Julian: In addition to increasing training and remediation so bottom line, we have been very very picky.

Julian: In the way that the study can be executed the stringent inclusion.

Julian: The exclusion criteria.

Julian: All in an effort to of course replicate the success from palisade too.

Julian: So I think we've got a pretty good rhythm now and we've been able to eliminate subjects, who we think may be less likely to demonstrate a benefit through that more rigorous eligibility criteria that we've applied and the secondary review of subject eligibility insight conduct its ongoing.

Shawn Singh: Overall, all that together is caused a little bit of an adjustment in timing, but I think that benefits the overall potential outcome. Great. Thanks, Shawn. One moment for our next question.

Julian: Very specific so.

Julian: Overall all of that together has caused a little bit of an adjustment in timing, but we think that benefits. The overall potential outcome of the study.

Speaker Change: Great. Thanks, Sean.

Speaker Change: One moment our next question.

Andrew Tsai: Our next question will come from the line of Andrew Tsai from Jefferies. Hey, good afternoon. Thanks for taking my question. Appreciate the updates.

Speaker Change: Our next question comes from the line of Andrew Tsai from Jefferies. Your line is open.

Andrew Tsai: Hey, good afternoon. Thanks for taking my question I appreciate the update.

Shawn Singh: 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, yeah, we will report when we have – remember, it's a four-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 patient's completed that. And from that point forward, again, it always depends on the number of queries needed to get to DBL, but anywhere from around six to – top end would be eight weeks, but typically somewhere around six weeks to get to the top line from database lock.

Andrew Tsai: So looking ahead heading into the palisade III data readout can we expect you to announce enrollment and completion and that study and if so from there how many weeks can we expect you to take before reporting the topline data.

Julian: Okay.

Julian: Thanks for the question Andrew So yes, we will report when we have remember it's a four visit.

Julian: <unk> paradigm and so once the subjects have completed the randomized subjects have completed their safety follow up.

Julian: We'll be announcing when the last patient has completed that and from that point forward again, it always depends on sort of the number of queries needed to get to <unk>, but anywhere from us around six to top end would be eight weeks, but typically somewhere around six weeks to get to the top line from database lock.

Shawn Singh: Understood.

Shawn Singh: 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, you know, 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 the Palisade 1 and Palisade 2 studies, which were the first two studies, as you know, with this design and this endpoint for the acute treatment of SAD.

Speaker Change: Understood and then earlier speaking of variability.

Julian: Back in the successful palisade study I think the placebo arm showed asides reduction of eight points absolute basis would you expect that to be the same case for palisade, three and four or with these more enhanced controls could the placebo would be lower.

Julian: Well, what we've certainly done Andrew is intended to design palisade, three and four in a manner to replicate.

Julian: The success, we saw in palisade to where that actually lands.

Julian: I 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 one in palisade two studies, which were the first two studies as you know with this design in this endpoint.

Shawn Singh: So a lot has been learned, and the rigor matters, and so we'll see. The idea, obviously, is to increase visibility into all aspects of the study and its execution to ensure the highest possible potential to reduce variability. So hopefully that... It falls in the direction that we saw things land with Palisades.

Julian: <unk> for the acute treatment of <unk>. So a lot has been learned.

Julian: And the rigor matters and so we will see the idea obviously is to.

Julian: Increased visibility into all aspects of the study and its execution to ensure the highest possible.

Julian: Potential to reduce variability so hopefully that.

Julian: That falls in the direction that we saw things land with policy too.

Shawn Singh: Great.

Shawn Singh: And then my last question is in terms of site 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 test? And are you looking at these SUDS ratings 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.

Julian: Great and then my last question is in terms of cycle conduct.

Julian: And as well as your overall surveillance argue.

Julian: Making sure. These pis are disqualifying patients appropriately when these patients are taking their sites test and are you looking at these sides rating somehow for each patient to make sure all time points.

Julian: Makes sense with the scoring.

Julian: 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 firsthand I mean, the whole purpose.

Julian: What we did majorly differently with palisade, three and four was to develop and have internally what we call. Our secondary eligibility review team. This is a team that internal <unk> team not a CRO team or a third party team.

Shawn Singh: 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 hyper-focus on rater training up front across all the endpoints, not just the SUDs, but the CGII and the PGIC. So that...

Julian: Internal team that consists of very experienced cycle nutrition, who review eligibility of each subject and they listened 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.

Julian: A little bit more time, especially with obviously, a hyper focus on radar training upfront across all the endpoints not just the sides, but the CGI in the Pgi C. So that.

Shawn Singh: 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 two studies already to enhance the potential for success. Thanks, Shawn. Thank you. One moment for our next question. And once again, that's star 11 for questions.

Julian: And you have confidence that the study is being run the way it should be run and that.

Julian: We've done everything that we can through all the experience we've gained through the execution of two studies already.

Shawn Singh: To enhance the potential for success.

Sean: Thanks, Sean.

Julian: You bet.

Julian: Thank you one moment for our next question.

Julian: And once again Thats star one one for questions.

Myles Minter: Our next question will come from Myles Minter from William Blair. Hey, thanks for the question. I've got one on the CEO forum and... conversations that you had with with Marty Macri. It seems pretty clear to me that, you know, 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 the voucher program announced today. Seems like your work in social anxiety disorder would point to, you know, 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.

Julian: Our next question comes from the line of Myles Minter from William Blair. Your line is open.

Myles Minter: Hi, Thanks for the question.

Myles Minter: I've got one on the <unk> and then maybe conversations that you had with commodity macro area. It seems pretty clear to me that either.

Myles Minter: <unk> is driven.

Myles Minter: Try and expedite approvals are products that are addressing the health crisis in the U S that innovative cures for American payable addressing unmet public health needs.

Myles Minter: Given the voucher program announced today, it seems like Youll work and social anxiety disorder would point to matching those pillars there.

Myles Minter: When we rate the Maha report that's coming from HHS.

Myles Minter: Slightly different picture at list in that preliminary stats there.

Shawn Singh: 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 facadienol as... you know, meeting these pillars the FDA is mandated towards, or, you know, is there a 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 panel 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 screen and the inclusion exclusion criteria.

Myles Minter: Potentially want to restrict the use of a mood stabilizer drugs I know you're a different mechanism of action here, but did you get any sort of alignment for Marty or higher opposite the FDA that they are aligned with social anxiety disorder and faster dot all as.

Myles Minter: Canadian pillar Fda's, Matt guided towards or is there a lineup with the FDA here on that unmet aid or is it more falling into that sort of HHS.

Myles Minter: Opinion in that mall Hot report I'd Love your thoughts on that dynamic and then secondly, a question on <unk> three and four seems clear to me that pace of demand into the trial. That's not the issue here things are going well, but it might be at the screening.

Shawn Singh: I'm wondering whether that is to do with the Leibowitz 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 you know screening out more patients. Thanks very much. Well, thanks, Myles. That's quite a bit, and we could talk forever on that.

Myles Minter: And the English next question criteria I'm wondering whether that is to do with the labor with social anxiety scale and if it has more to do with the independent writers that you've got here that you didn't have before and whether theyre screening that more patients. Thanks very much.

Andrew Tsai: Well, thanks, Myles, it's quite a bit.

Shawn Singh: 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, one of the ground rules was no specific conversations about your particular program. Everybody got a minute to talk.

Myles Minter: We could talk forever.

Myles Minter: First the first question I think it's really important I'd say look we've got 30 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.

Myles Minter: Addiction potential sexual side effects weight gain requiring a rems things that are just completely different than what.

Myles Minter: The universe is seen before that said.

Myles Minter: 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.

Shawn Singh: Most people didn't adhere to the minute, but most people did adhere to not talking about their specific program. So I can't give you the answer directly on that one from that context. We do think, of course, we 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 FDA.

Myles Minter: But most people did it here to not talking about their specific program. So.

Myles Minter: So I can't give you the answer directly on that one from that context, we do think of course, we have fast track.

Myles Minter: Designation from FDA. So we do know what they think of it from a regulatory standpoint serious and life threatening.

Myles Minter: <unk> continues to increase yes, there arent 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.

Myles Minter: Innovative <unk> certainly is on the mind of everybody in that room FDA leadership, including.

Shawn Singh: Some of the support team that I spoke with during the 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 mightily, but yet simply saying, look, we don't want to delve into any of the other things that people might use to try to manage the disorder.

Myles Minter: Some of the support team that I spoke with during the kind of the intro hour of that event.

Myles Minter: I think we're confident for the place that we would be able to land in the universe associated with potential productivity.

Myles Minter: People getting back into.

Myles Minter: 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 us struggling with it mildly but yet simply saying look we don't want to do.

Myles Minter: <unk> any of the other things that people might use to try to manage the disorder. So.

Shawn Singh: So I think, again, anything that's going to provide a beneficial patient outcome with a... Negligible risk on the safety side is something that the FDA is going to be open to looking at and we've seen that consistently regardless of who's the commissioner.

Myles Minter: I think again anything thats going to provide a beneficial patient outcome with with <unk>.

Myles Minter: Negligible risk on the safety side is something thats. The fda's can be open to looking at and we've seen that consistently regardless of who's the commissioner.

Shawn Singh: I don't think that In terms of your question about PAL-SAIT 3 and 4, really what's different is, it's not at the top of the funnel at all. We've seen incredible interest in our recruitment vehicles, but where we have seen things slow is the visit one, the screening up front of a visit one. The throughput rates from the screening visit through the end of the study have been very much what we saw in prior studies. We also have seen a remarkably good throughput rate from visit four into the open label. Those are the kinds of things that we like.

Myles Minter: Think that changes.

Myles Minter: In terms of your question about <unk>, three and four really what's different is it's not the top of the funnel at all we've seen incredible interest in <unk>.

Myles Minter: Our recruitment vehicles.

Myles Minter: Where we have seen things slow as the visit one the screening upfront of a visit one the throughput rates from from the screening visit through the end of the study and then very much what we saw in prior studies.

Myles Minter: We also have seen.

Myles Minter: Remarkably good throughput rate from visit for into the open label those are the kinds of things we like to see.

Shawn Singh: And we tend to not see any of the kind of hockey stick utilization that worries folks about abuse liability either. Remember, FDA in 22 said we didn't have to do a human abuse liability study at that time and all we've seen since is concordant safety data and studies completed. So it's really more about the scrutiny associated with eligibility, inclusion, exclusion, and eligibility criteria at the very front end of the study to make sure that we've got folks that are sufficiently affected by the disorder, aren't associated with any other comorbidities that would be exclusions associated with enrollment, and obviously making sure that they're screened out very rigorously for any conment.

Myles Minter: And we tend to not see any of the kind of hockey stick utilization that worries folks about abuse liability either remember FDA. In 22 said, we didn't have to do a human abuse liability study at that time and always seen.

Myles Minter: Is it concordance safety data and studies completed.

Shawn Singh: It's really more about the scrutiny associated with eligibility.

Myles Minter: Inclusion exclusion and the eligibility criteria at the very front end of the study to make sure that we've got folks that are sufficiently affected by the disorder arent associated with any other comorbidities that would be exclusions associated with enrollment.

Myles Minter: And obviously, making sure that they are screened out very rigorously for any.

Myles Minter: So it's mostly, again, from at the pre-Visit One screening where we've seen a little bit of a slowdown, but that itself is also starting. Makes sense. Apologies for the long-winded question. Thanks.

Myles Minter: Con meds.

Myles Minter: So it's mostly again from.

Myles Minter: At the pre pre visit one screening where we've seen a little bit of a slowdown but that itself is also starting to pick up.

Myles Minter: Makes sense apologize for the long winded question.

Myles Minter: Alright.

Myles Minter: Okay.

Operator: Operator, I believe that's all the time we have for questions today. If those participating on the call have additional questions, please don't hesitate to contact us by emailing IR at VistaGen.com or via the contact section of our website. We also encourage you to register for email updates on our website to stay connected with our latest news. Thank you for participating on the call day. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing progress.

Myles Minter: Operator, I believe that's all the time, we have for questions today.

Myles Minter: If you have it.

Myles Minter: Those participating on the call with additional questions. Please don't hesitate to contact us by E mailing IR at <unk> dot com or via the contact section of our website.

Myles Minter: We also encourage you to register for E Mail updates on our website to stay connected with our latest news. Thanks.

Myles Minter: Thank you for participating on the call today, we appreciate everyone's interest and support and look forward to keeping you updated on our ongoing progress. This concludes our call have a tremendous day.

Operator: This concludes our call. Have a tremendous day. for your participation in today's conference.

Myles Minter: Thank you for your participation in today's conference. This concludes the program you may now disconnect everyone have a great day.

Operator: This concludes the program. You may now disconnect. Everyone.

Myles Minter: Okay.

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Operator: Yes.