Vistagen Therapeutics FY2026 Q3 Earnings Call - AI-led analysis targets placebo response to steer PALISADE-4

Lisa, Conference Call Operator: 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?

Mark McPartland, Senior Vice President, Investor Relations, Vistagen Therapeutics: 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 for a period ending December 31, 2025, 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 and 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.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: 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 3 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 3 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 covariates 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 involve 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-three and PALISADE-four 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 uncontrolled and exploratory, the OLE portion of the PALISADE-three phase three 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’s 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, if PALISADE-4 is successful, together with PALISADE-2 and 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 rafisolone. Rafisolone 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 rafisolone may also have therapeutic potential across other women’s health indications. We are currently preparing to submit our US investigational new drug application, or IND, for rafisolone to the US FDA, with a planned submission in the first half of 2026. This IND is intended to support further potential phase 2 clinical development of rafisolone in the US for the treatment of moderate to severe vasomotor symptoms due to menopause.

Building on a previously completed placebo-controlled exploratory Phase 2A clinical trial conducted in Mexico by Faran 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 rafisolone 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 31st, 2025, we had $61.2 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 varying pipeline.

We believe we are well positioned to complete PALISADE four and to advance preparations and planning for our varying pipeline. In closing, our mission remains unchanged: to deliver transformative treatments and improve 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, Sean. Operator, we would now like to open up the call for questions from the sell-side analysts joining us today.

Lisa, Conference Call Operator: Thank you. At this time, if you would like to ask a question, please press star one one on your telephone. You will then hear an automated message advising your hand is raised. If you would like to remove yourself from the queue, press star one one again. We also ask that you please wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. The first question today is coming from the line of Andrew Fein of Jefferies. Your line is open.

Andrew Fein, Analyst, Jefferies: Hi, good afternoon. Thanks for the updates. 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 five minutes? Was there a separation at all across any of those time points with fasedienol versus placebo?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Thanks for the question, Andrew. Josh?

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Hi, Andrew. At this point, you know, 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.

Andrew Fein, Analyst, Jefferies: Okay, thanks. And it sounds like you’re looking at ways for PALISADE-4 to tweak around the SAP plan, and 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?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Yeah, thank you.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: We would-

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Great question.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Oh, go ahead, Shawn.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: No, you go ahead, Josh. Sorry. It’s you.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Yeah, it’s a great question, and, you know, the SAP, just like with PALISADE three, you know, already been submitted and approved for 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 lock the database and got the top-line results.

Andrew Fein, Analyst, Jefferies: ... Understood. And then my last question, thank you, is, should you modify the plan, would you need to backfill to the original enrollment target of around 236 or 238, or are there no changes to the enrollment? Thank you.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Yeah, a change to the SAP would not change the enrollment or the planned enrollment for the study. You know, it’s the key there is that it’s whatever that SAP is locked in before you get to database lock, and then applied to the total population for the study.

Andrew Fein, Analyst, Jefferies: Understood. Okay. Thank you, guys.

Lisa, Conference Call Operator: Thank you. One moment for the next question. Next question is coming from the line of Emily Chetty of Stifel. Your line is open.

Emily Chetty, Analyst, Stifel: Hi, this is Emily on for Paul Matteis at Stifel. We just had a quick question. Maybe could you remind us where you guys are in terms of enrollment for PALISADE four? And if you like plan on telling, or plan on PRing when that has completed or like dosing has completed. And then also, could you maybe share, like, what details you saw on PALISADE three that kind of led you to refine to the refinements that you outlined in the PR? Thank you.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Thanks, Emily. Appreciate the question. So it’ll be consistent with the pattern for PALISADE three. Once we hit the last patient’s last visit and, and then proceed towards top line. So that’ll be... We’re on track with guidance that we’ve previously given, with respect to PALISADE four TLR, the randomized portion of PALISADE four. Josh, you can address the second part.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: I’m sorry, I missed the second part. Can you rephrase that?

Emily Chetty, Analyst, Stifel: 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?

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Yeah, I don’t think we can go into too much detail, given PALISADE-4 is ongoing. But, you know, at a high level, you know, one of the things that made PALISADE-3 different than PALISADE-2 was a higher placebo response. So, you know, 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, you know, chatting with the subjects as they come in. You know, anything that could potentially lend to, you know, a comfort for a subject or that could drive a higher placebo effect.

So it’s 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, gives us the opportunity, again, to be hyper-focused on feedback and any intervention where we see something deviating from the pre-script that we’ve put in place.

Emily Chetty, Analyst, Stifel: Great. Thank you guys so much.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: In addition to that, a focus on centralized recruitment and making sure that gets and stays completely tight and 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 the really experienced sites.

Lisa, Conference Call Operator: Thank you. One moment for the next question. Our next question is coming from the lines of Miles Minter of William Blair. Your line is open.

John, Analyst, William Blair: Hi, team. This is John on for Miles. Thanks so much for taking our question. 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? Alternatively, if PALISADE-4 misses, do you see any regulatory path forward with PALISADE-2 alone?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Thanks, John. Appreciate the question. So look, 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 as part of and factoring into the regulatory decision making. We 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 four, we’ll be able to look across the totality of the program. And the primary objective and the primary regulatory strategy remains, as we’ve said, which is complementing, if PAL four is successful, complementing PALISADE two with a broader base of information from the totality of the program for the acute treatment of social anxiety disorder. If PALISADE four doesn’t hit and separate from placebo, it’s still the same. It’s a totality of evidence focus. It’s a weight of evidence focus across the program and what we see from all data we can possibly see and analyze relating to the drug.

John, Analyst, William Blair: Helpful. Thanks. 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?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: We don’t comment on the blinded data, John.

John, Analyst, William Blair: All right. Thank you.

Lisa, Conference Call Operator: Thank you. As a reminder, if you would like to ask a question, please press star one one on your telephone. One moment for the next question. And the next question is coming from the line of Elemer Piros of Lucid. Your line is open.

Elemer Piros, Analyst, Lucid: Yes. Hi. Good afternoon. Shawn, have you noticed any impact on enrollment since the announcement on December seventeenth, enrollment patterns?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Josh, you can address that.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Sure. The quick answer is no, definitely have not. Enrollment has continued as planned and projected for PALISADE-4.

Elemer Piros, Analyst, Lucid: Okay. 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 two arms? If you could just help me conceptually understand this a little bit better.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Sure. Sure. I mean, part of what we’re doing with AI and machine learning, it’s potential. It’s not certainly not guaranteed. What you’re looking for is, are there any covariates that may have a potential fixed effect on the ANCOVA? And 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 PAL three 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.

Elemer Piros, Analyst, Lucid: Mm-hmm.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: So, that’s part of what we’re trying to find out. If there isn’t, then again, we’ve got operational, efficiencies and, and observations based on what we’ve seen across the studies that are being, implemented into the PALISADE-3 or PALISADE-4 execution. Josh, anything you want to add on that from the teams?

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: No, I think that, that captures it.

Elemer Piros, Analyst, Lucid: 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?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Yeah. It has to be whether-

Elemer Piros, Analyst, Lucid: Correct.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Not only whether it’s timely, it’s obviously got to be timely before you lock the database, but it’s also got to be appropriate. There may also be potential changes that wouldn’t be FDA regulatory appropriate. 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.

Elemer Piros, Analyst, Lucid: I understand.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: Shawn, I would just add that we’re actually, you know, we’re looking across all the PALISADE studies, so PALISADE one, two, and three-

Elemer Piros, Analyst, Lucid: Mm-hmm

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: ... to see what we can learn. You know, we’ve built... Now that we’ve had a third study complete, we’ve built, you know, continued size of data to examine, which gives you more power when you’re digging into different things.

Elemer Piros, Analyst, Lucid: Mm-hmm.

Josh Prince, Chief Operating Officer, Vistagen Therapeutics: But you’re 100% correct, that it’s essentially the covariates or the correction factors that you would apply in your statistical model.

Elemer Piros, Analyst, Lucid: 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. Can you help me to understand that?

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Nick, are you on?

John, Analyst, William Blair: Hi. Yes, I am. Yeah. So, it’s the shares outstanding at the end of the quarter, it’s how we measure our earnings per share.

Elemer Piros, Analyst, Lucid: Okay. So, but there are higher number of shares outstanding, because-

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: They-

Elemer Piros, Analyst, Lucid: The average is $42 million.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: It’s that includes the pre-funded warrants, Elemer.

Elemer Piros, Analyst, Lucid: Yeah. I got it.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Okay.

Elemer Piros, Analyst, Lucid: Mm-hmm. Mm-hmm. Yep. Thank you so much for clarifying that.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Not a silly question. 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 via email at [email protected], or through the Contact Us section of our website. We also encourage you to register for email 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. Mark, one more thing, real quick. I just want to clarify. I think I misspoke.

It’s, I think I said $61.2 million at the end of 2012, 12/31/2015 was $61.8 million, is reflected in our Q.

John, Analyst, William Blair: Understood.

Shawn Singh, President and Chief Executive Officer, Vistagen Therapeutics: Thanks, Sean.

John, Analyst, William Blair: Thank you.

Lisa, Conference Call Operator: This concludes today’s program. Thank you all for joining. You may now disconnect.