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Good day, everyone. Thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year 2026 Third 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, Lisa, and 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 third quarter, which ended December 31, 2025, and provided an update of our progress across our clinical stage neuroscience program. We encourage you to review the PR and 10-Q which are both available in the Investors section of our website. Before we begin, please note that we'll 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. 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 make today. Additional information concerning risks and factors that could affect our business and our financial results are included in our fiscal year 2026 third quarter Form 10-Q and for period ending December 31, '25, and in future filings that we make with the SEC from time to time. Again, all of which are available in the Investors section of our website or, of course, on the SEC's website. With the formalities completed, we warmly welcome our stockholders, sell-side analysts and others interested in our programs in progress. I'm joined on our call today by Shawn Singh, our President and Chief Executive Officer; Josh Prince, our Chief Operating Officer; and Nick Tressler, our Chief Financial Officer. Shawn will provide a brief business and clinical update, and Josh and Nick will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we'll take questions from the sell-side analysts participating on the call. A replay of the webcast will be available in the Events section of the Investor page of our website. With that taken care of, I'd now like to turn the call over to our President and CEO, Shawn Singh.

Thank you, Mark, and good afternoon, everyone. It's been an important quarter for our team with the completion of the randomized portion of our PALISADE-3 Phase III trial in social anxiety disorder, as guided, and focused efforts to learn from the study's results and drive high-quality and efficient execution of our ongoing PALISADE-4 Phase III trial. We have reviewed available data from PALISADE-3 and implemented moderate refinements, including retraining, site rationalization and operational enhancements to PALISADE-4. We've also been working with third-party collaborators on the implementation of innovative approaches to analyze the available data sets, not only from PALISADE-3, but also from the fasedienol studies across the PALISADE program, including both the randomized and the open-label trials. Our objective is to better understand the drivers of both fasedienol and placebo response using the substantial data collected from these studies to potentially inform optimized statistical models that consistently incorporate covariants and explanatory variables across all PALISADE studies, which could anchor future weight of evidence discussions with the FDA. The analyses are ongoing with our collaborators and involves the use of their proprietary artificial intelligence and machine learning technologies to identify nonspecific responses and understand and predict susceptibility to placebo response and likelihood of response to active drug in the context of the public speaking challenge study design. Overall, the full complement of ongoing work is focused on delivering practical operational understanding, predictors of response and enhanced statistical models with the potential to impact both PALISADE-4 and our regulatory strategy based on the totality of data from the PALISADE program. The open-label extension portion of PALISADE-3 and PALISADE-4 remains ongoing and is designed to evaluate the safety and tolerability of repeated as-needed intranasal administration of fasedienol in adults with social anxiety disorder, but in real-world daily life situations. In addition to safety assessments, the study includes exploratory longitudinal measures using validated instruments such as the clinician-administered Liebowitz Social Anxiety Scale, or LSAS, and the patient-reported Social Phobia Inventory, or SPIN. While open-label data are inherently in controlled and exploratory, the OLE portion of the PALISADE-3 Phase III study could provide important context on patient experience with repeated use over time in real-world anxiety-provoking situations the patients encounter. Together with our broader analytical work across the PALISADE program, insights from open-label studies should contribute to our enhanced understanding of fasedienol drug effect and usage patterns. Once again, we'd like to thank the patients who participated in our PALISADE studies as well as the clinical investigators, the site staff and our contract research organization for their ongoing dedication and professionalism as we complete PALISADE-4 and advance our broader analytical efforts. As we've previously stated, PALISADE-4 is successful, together with PALISADE-2. In the broader body of evidence generated across the PALISADE program, these data may support a potential new drug application submission to the U.S. Food and Drug Administration for the acute treatment of social anxiety disorder in adults. The significant unmet need in social anxiety disorder, where effective treatments are very limited, continues to guide our work and our long-term focus. Turning to our women's health program. We received an official USAN adoption statement, designating PH80 as refisolone. Refisolone is our hormone-free, nonsystemic intranasal product candidate with potential for the treatment of moderate to severe vasomotor symptoms, commonly referred to as hot flashes due to menopause. We believe refisolone may also have therapeutic potential across other women's health indications. We are currently preparing to submit our U.S. Investigational New Drug Application, or IND, for refisolone to the U.S. FDA and with a planned submission in the first half of 2026. This IND is intended to support further potential Phase II clinical development of refisolone in the U.S. for the treatment of moderate to severe vasomotor symptoms due to menopause. Building on a previously completed placebo-controlled exploratory Phase IIa clinical trial conducted in Mexico by Pherin Pharmaceuticals, which is now our wholly owned subsidiary, and that trial demonstrated clinical benefit in the vasomotor symptoms indication. We believe that indication in women's health represents a significant area of unmet need, and we remain committed to advancing refisolone as a nonsystemic, hormone-free product candidate with a disciplined data-driven approach as we prepare for the potential next phase of clinical development. Turning briefly to our financial position as of December 31, 2025, we had $61.2 million (sic) [ $61.8 million ] in cash, cash equivalents and marketable securities. During the quarter, we implemented company-wide cash preservation measures intended to enhance our operational efficiency, extend our runway and maintain strategic flexibility across our Pherin pipeline. We believe we are well positioned to complete PALISADE-4 and to advance preparations and planning for our Pherin pipeline. In closing, our mission remains unchanged, to deliver transformative treatments and improved lives. The path forward requires discipline, rigor and thoughtful analysis, and we believe the steps we have taken and are taking position Vistagen to make informed decisions and responsibly advance programs with the potential to deliver meaningful value to patients and to shareholders. So I want to thank you for your continued interest in the company and your support, and we look forward to updating you on our progress in the quarters ahead.

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

[Operator Instructions] The first question today is coming from the line of Andrew Tsai of Jefferies.

Thanks for the update. So maybe in the PALISADE-3 data, you had a chance to look at it maybe descriptively, how did the individual curves look at every interval out to 5 minutes? Was there a separation at all across any of those time points with fasedienol versus placebo?

Thanks for the question, Andrew. Josh?

Andrew, we -- at this point, what we've released publicly is the top line results. So we're still looking into a lot of that data. We haven't released the individual curves publicly. We do know that there's what really -- where we find information is looking into individual respondents and subgroups of respondents. And again, that analysis continues. So that's where we do see definite differences.

Okay. And it sounds like you're looking at ways for PALISADE-4 to tweak around the SAP planning, let's just say you did, would you need to notify and then talk to the FDA to potentially get an official buy-in from them that the changes can be done? Is there a risk to modifying the SAP plan, basically?

Yes, great question. Go ahead, Shawn.

No, you can go ahead. That's fine.

Great question. The SAP, just like with PALISADE-3, already been submitted and approved, no feedback from FDA. So that's set. So any future changes, to your point, would absolutely require a resubmission and alignment with the FDA before we locked the database and got the top line results.

Understood. And then my last question is, should you modify the plan, would you need to backfill back to the original enrollment target of around 236 or 238? Or are there no changes to the enrollment?

Yes. The change to the SAP would not change the enrollment or the planned enrollment for the study. The key there is that it's whatever that SAP in is, like I said, locked in before you get to database lock and then applied to the total population for the study.

Next question is coming from the line of Emily Chudy of Stifel.

This is Emily on for Paul Matteis from Stifel. We just had a quick question. Maybe could you remind us where you guys are in terms of enrollment for PALISADE-4? And if you like plan on telling -- or plan on PR-ing once that has completed or like dosing has completed? And then also, could you maybe share on like what details you saw in PALISADE-3 that kind of led you to refine -- to the refinements that you outlined in the PR?

Thanks, Emily. Appreciate the question. So it will be consistent with the pattern for PALISADE-3. Once we hit the last patient's last visit and then proceed towards top line. So that will be -- we're on track with guidance that we've previously given with respect to PALISADE-4 TOR, the randomized portion of PALISADE-4. Josh, you can address the second part.

I'm sorry, I missed the second part. Can you rephrase that?

For -- you guys discussed like refinements, including like retraining of some sites. Could you maybe provide any color on what details you saw from PALISADE-3 that kind of led to that decision?

Yes. I don't think -- we can't go into too much detail given PALISADE-4 is ongoing. But at a high level, one of the things that made PALISADE-3 different than PALISADE-2 was a higher placebo response. So as one example, making sure that our training is reinforced and up-to-date with sites in terms of potential ways to minimize that, in particular, kind of how the protocol is followed, the script is followed to the letter, making sure that there's no chatting with the subjects as they come in, anything that could potentially lend to a comfort for a subject that can drive a higher placebo effect. Those types of things that we're able to implement quickly based on what we see from PALISADE-3. And also because we're listening to what's happening at each site through the audio recordings that we've talked about previously, it gives us the opportunity, again, to be hyper-focused on feedback and any intervention where we see something deviating from the prescript that we've put in place.

In addition to that, some -- a focus on centralized recruitment and making sure that gets and stays completely tight or rationalized. So the kinds of things that can impact in stream execution especially, as Josh noted, with high focus on placebo mitigation strategies and best practices across -- especially from really experienced sites.

Our next question is coming from the line of Myles Minter of William Blair.

This is John on for Myles. I was wondering if you could talk a little bit more through your regulatory path forward and your confidence in it in the event that PALISADE-4 hits and you have a 50% program success? And alternatively, if PALISADE-4 misses, do you see any regulatory path forward with PALISADE-2 alone?

Thanks, John. Appreciate the question. So look, they -- fundamentally, we believe that the regulatory outcomes always depend not only on FDA regulations and guidance, but the totality of data, the weight of evidence, the risk benefit, the nature of the in-need population. So these kinds of assessments, this is what we align our regulatory strategies to accordingly. So we're not really in a position to speculate on any approval scenarios, but what we can tell you, of course, is we're very mindful not only of the evolving -- the way that AI is evolving within the agency and how that is emerging is part of and factoring into the regulatory decision-making be on top of that and very closely focused on that. But also just, again, the weight of evidence, once we see where we are with the randomized portion of PALISADE-4, we'll be able to look across the totality of the program. And the primary objective in the primary regulatory strategy remains, as we've said, which is complementing if PALISADE-4 is successful, complementing PALISADE-2 with a broader base of information from the totality of the program for the acute treatment of social anxiety disorder. If PALISADE-4 doesn't hit and separate from placebo, it's still the same. It's the totality of evidence focus. It's the weight of evidence focus across the program and what we see from all data, we can possibly see and analyze relating to the drug.

Helpful. And a quick follow-up. Is there anything that you're seeing in the blinded data of PALISADE-4 that gives you a little bit more confidence in that study over PALISADE-3?

No comment on the blinded data, John.

[Operator Instructions] And the next question is coming from the line of Elemer Piros of Lucid.

Shawn, have you noticed any impact on enrollment since the announcement on December 17? Enrollment patterns?

Josh, you can address that.

Sure. The quick answer is no, definitely have not. Enrollment has continued as planned and projected for PALISADE-4.

Okay. And so what I'm trying to understand is how could the PALISADE-3 outcome, and potentially PALISADE-4, be different by amending the SAP? Would that mean that you would include some covariates that may influence the separation between the 2 arms? If you could just help me conceptually understand this a little bit better.

Sure. I mean part of what we're doing with AI and the machine learning, it's potential, it's not -- certainly not guaranteed. And if they're -- what you're looking for are there any covariates that may have a potential fixed effect on the ANCOVA. And that's -- that may or may not evolve and emerge from the work that we're doing with our collaborators with their proprietary AI and ML. But it would be those kinds of things. Are there covariates that you notice when you look through the patient populations in each arm in prior studies in PALISADE-3, in particular, that may give you some sort of signal? So the answer is we don't know yet. And as noted earlier, if we do make a modification to the SAP that's already been signed off by the agency, then we'd have to go back to them and socialize it with them. So that's part of what we're trying to find out. If there isn't, then again, we've got operational efficiencies and observations based on what we've seen across the studies that are being implemented into the PAL-3 or PAL-4 execution. Josh, anything you want to add on that from the teams?

No, I think that captures it.

So just to summarize, you're looking at PALISADE-3 and maybe even PALISADE-2 for some covariates. If you find them, then you modify the SAP, take it to the FDA before you were to analyze PALISADE-4 hypothesizing that those same covariates will be applicable to PALISADE-4. Am I understanding it correctly?

Yes. It has to be whether -- not only whether it's timely, obviously, got to be timely before you lock the database, but it's also got to be appropriate. And there may also be potential changes that wouldn't be FDA regulatory appropriate. So it's got to be something that could be impactful, at the same time something that is reasonable with rigor and review from the FDA.

Shawn, I would just add that we're actually -- we're looking across all the PALISADE studies. So PALISADE-1, 2 and 3 to see what we can learn. We've built -- now that we've had a third study complete. We've built continued size of data to examine, which gives you more power when you're digging into different things. But you're 100% correct that it's essentially the covariates or the correction factors that you would apply in your statistical model.

I understand. And just a silly housekeeping question, if you may -- if I may. At the end of December, you had 39.7 million shares outstanding but the weighted average for the quarter was 42 million. Can you help me to understand that?

Nick, are you on?

Yes, I am. Yes. So it's shares are outstanding at the end of the quarter. It's how we measure our earnings per share.

Okay. So shares, I would say -- but there are higher number of shares outstanding because they have reduced 42 million?

That includes the prefunded warrants, Elemer.

Operator, I believe that's all the time we have for today. We can wrap up the call. So thank you, everyone, for joining today and for your continued interest and support in Vistagen. Again, with our diverse, innovative pipeline, we are encouraged about the future prospects of the company. If you have any additional questions, please don't hesitate to reach out to us at -- via e-mail, [email protected], or through the Contact Us section of our website. We also encourage you to register for e-mail updates and stay informed about the latest news and developments from Vistagen via our regular updates. We appreciate your time, engagement and ongoing support, and we look forward to keeping you updated on our continued progress. This concludes our call today. Have a great day.

Mark, one more thing, real quick. I just want to clarify. I think I misspoke. I think I said $61.2 million at the end of 12/31/25, it was $61.8 million as reflected in our Q.

Thanks, Shawn.

This concludes today's program. Thank you all for joining. You may now disconnect.

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 would 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 30, 2025. Providing an overview on the progress in our PALISADE 3 program for social anxiety disorder across our other lead medical neuroscience programs. I encourage you to review the press release and 10-Q, 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 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. Of course, forward-looking statements involve risks and uncertainties, and 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 30, 2025, and in future filings that we will make with the SEC from time to time. All of which are available in the Investors 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 am joined on our call today by Shawn Singh, our President and Chief Executive Officer, and Joshua S. Prince, our Chief Operating Officer. Shawn will provide a brief business update and clinical update, and Joshua will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we will take questions from the sell-side analysts participating on the call today. I remind you, a replay of the webcast will be made available in the Events section of our Investor page on our website. With that taken care of, I'll now turn the call over to our President and CEO, Shawn Singh.

Thank you, Mark, and good afternoon, everyone. We have built very strong momentum as we enter into what could be a potentially transformative period for VistaGen. Last week, we announced another major milestone in our PALISADE program. The last patient completed the randomized double-blind phase of our PALISADE 3 phase 3 trial, evaluating our most advanced intranasal ferrine product candidate, fascidinol, for the acute treatment of social anxiety disorder. We are now preparing for the release of top-line results from the PALISADE 3 study by the end of this calendar year. We extend our sincere gratitude to the patients who participated in the study, as well as the dedicated and experienced clinical investigators, the clinical site staff, and our contract research organization. Their enthusiasm, their focus on detail, and the collaboration throughout the study were notable and greatly appreciated and will remain so during the ongoing open-label extension of the study. Over the past several months, I have had the privilege of meeting in person with many of the dedicated teams conducting our PALISADE 3 and PALISADE 4 studies. The energy, the curiosity, the optimism that I have witnessed reaffirm just how great the need remains for new treatment options for individuals whose daily lives are affected by social anxiety disorder and how differentiated and innovative fascidinol could be in meeting their needs. Together, our teams remain deeply focused on fascidinol's potential to become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety disorder. Looking ahead, we remain on track to report top-line results from our 2026. Both PALISADE 3 and PALISADE 4 share a similar public speaking challenge design and the same primary efficacy endpoint as our previously successful PALISADE II phase 3 trial. In parallel, we are continuing preparations designed to advance our broader farine pipeline, including itravone for major depressive disorder, and PH80 for menopausal hot flashes. Both depression and women's health represent areas where far too many patients still struggle without adequate options. We are deeply motivated to bring forward the innovative non-systemic neurocircuitry-focused potential of Vitruvone and PH80 to help address these important and widespread needs. Turning now briefly to our financials. As of September 30, 2025, we had $77.2 million in cash, cash equivalents, and marketable securities. We believe current cash covers all known aspects of our ongoing US registration-directed PALISADE program for fascidinol for the acute treatment of SAD, including potential NDA submission if our PALISADE program is successful. Before I conclude the business update, I would like to welcome Mr. Paul Edick to our Board of Directors. Paul joins us at a pivotal time for VistaGen, bringing decades of experience leading successful FDA approvals, commercial launches, and strategic transactions. His leadership will be invaluable as we prepare for our next phase of growth. I would also like to extend our deep gratitude to Dr. Jerry Jin, who served on our board from 2016 until his retirement earlier in September. In closing, our mission remains clear and unwavering: to redefine what is possible in neuroscience, to restore emotional well-being, and improve quality of life for millions worldwide. With a diverse and innovative pipeline, an experienced team, and several key milestones approaching, we believe we are entering one of the most exciting and potentially transformative periods in our company's history with deep confidence in our ability to deliver meaningful value for patients and for our stockholders. I want to thank you all for your continued interest, your support, and your engagement with VistaGen. It makes a lot of difference, and we look forward to sharing our progress with you in the weeks and the months ahead.

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.

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

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

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

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

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

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

So we can unpack that later. But what I can tell you, Andrew, is the reason that we made enhancements to the PALISADE 3 and 4 studies, again, was to make sure that there is a very high-quality assessment for subject eligibility. And as a result of that, we had our own teams involved here with our CERT teams for subject eligibility review. We had other enhancements into the execution of the study, of course, throughout the duration of the study. So I think we have seen generally what we have expected to see, and as we have modeled forward for not only screen fail but also attrition rates throughout the course from enrollment through randomization through the end of the study. So I think we are comfortable with what we have typically seen and maybe more to come on that later. Okay. Important piece of the puzzle is we got to the last patient's last visit with the full complement that we had modeled for purposes of the studies we noted before, our end target was 236. So last patient's last visit reflects our original thoughts.

Perfect. Thanks again.

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

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

Sure, Matthew. Thanks for the question. So, you know, as you know, as we move closer toward completion of the Phase III development program, we always plan to interact with the agency, but we have said this before. Obviously, it is the pivotal program data. It is a repeat dose study. It is the open-label data from our long-term safety study. Human factor study, the typical preclinical safety-related studies, reprotox and CARC, all those are aspects that we expect to have wrapped up upfront, of course, of an NDA package. So we will, of course, be meeting with the FDA as we get closer to make sure that we are in line with what is necessary regarding submission package. So we estimate currently, you know, if everything goes according to plan that we have been executing on, we could see an NDA submission of PALISADE 3's positive sometime around 2026.

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

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

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

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

Sure. Yeah. Thanks, Myles. As we have gone through the course of these studies, for both PAL 3, PAL 4, you know, it is a constant evaluation of fit with sites. And so we have had a few sites that for whatever reason with regard to their ability to enroll the appropriate patients, whether it was their recruitment programs or other reasons. Just they were not able to enroll. And so at some point, it makes sense to terminate those sites. There have been one or two like that. And then also beyond that, you know, as we to your point, as we get towards the end of the study, we definitely, you know, take a wind-down approach for a soft landing for the study to make sure it is well controlled. We are controlling variability and then making sure that we will be able to get from that end of study last patient out to top-line results efficiently, in the timeline that Shawn mentioned. For us, it is kind of course of business as we have gone through the process of the studies.

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

Cool. Thanks for the questions.

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

Yes. Hi, Shawn. This is Alamir dialing in for Alamir.

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

Yeah. Most of the usage pattern data is going to come from the open label. So what we can talk about, of course, is related to the reported open label, the long-term safety study that we had before. And the patterns established in the context of that study, you know, give some pretty good guidance to us about what we see going forward in the real world. Remember, this is a disorder that is chronic, but it manifests acutely and episodically. And so a lot of it in terms of utilization depends on where people are in their particular phase of their journey. What is their job? What academic setting are they in? How frequently do they need to interact with people on a social basis? And you definitely see in that long-term safety study we reported on, more activity during the week especially after people are back to work, back to school, in the kind of rhythm of life that we are in now, you see more utilization during a week, especially during work kind of hours. Weekends tend to taper off, obviously, because people are not in similar stressful settings or maybe social situations, a barbecue with your friends, or you go to sporting events where, you know, there is worry about how you are looking, how you are whether you are being judged or not being judged, which is really what anchors this disorder, unfortunately. So more often during the week, less often during the weekend, and that is the pattern we saw early on in the open-label study we reported on. And it is reasonable to expect that sort of activity on a go-forward basis. At least that is what is anchoring a lot of our informed assumptions about how we could see the drug used in the real world.

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

Yeah. I can remark on the percentages, but I can tell you it is a high throughput rate. We have seen historically in any open-label activity that we have got. And that is to be expected. It is part of the reasons why people get interested in participating in a study in the first place. Is that they think if they complete it, there is an opportunity for the investigational agent to be part of their go-forward experiences. So I think the reasons people do not tend to go into an open-label historically are associated with a change in job, a change of living location. You know, something significant that is a life-changing event that allows them to or causes them to not be proximate to the site that they were involved in the randomized study.

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

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

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

Companies yeah. Well, certainly, you think about it all the time. Companies in positions like we are, if you have a contemplation for a first commercial launch, you have to have a lot of good reasons for that. And here as a company, we always position for optionality. There are many things that can happen. Key for us is to make sure we have the optimal opportunity to generate the value that could be associated with fascidinol if it gets approved. So there is certainly a very solid potential commercial plan. There are also opportunities should other strategic arrangements bring greater value potential. But, yes, as a company, we have the expertise. We have the planning. We have execution in certain cases already underway. To be able to bring this extremely innovative asset into the treatment paradigm where there is just nothing sitting there. That is interesting and exciting for patients to be able to recapture the agency that allows them to tailor the use of a medication to fit how these stressors are impacting their lives day to day. And yeah. In the world right now, it is a very interesting market out there in terms of the dynamics of telehealth and mental health. Digital psychiatry, consumer-generated influencer-based activity across the socials. What we see with anxiety, very similar to what people see and hear about weight in a GLP-1 drug. So there is a transformed market environment over just even the last couple of years. And now you are also looking at a population of patients and maybe practitioners too who really would prefer online engagement as opposed to in-person. There are some really unique opportunities, especially with what we would hope to be borne out as the target product profile. And the way to access not only practitioners but also raise awareness among consumers. So it is a really exciting opportunity for the company around this very unique asset. That fits in so many ways what we think are the clarion calls of not only practitioners but certainly patients.

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

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 do not hesitate to reach out to us at [email protected] or through the contact us section of our website. We also encourage you, of course, to register for email updates to stay informed about our latest news and developments from VistaGen. We truly appreciate your time, engagement, and ongoing support, and we look forward to keeping you updated on our continued progress. This concludes the call. Have a great day.

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