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Date
Feb. 12, 2026, 5 p.m. ET
Call participants
- President and Chief Executive Officer — Shawn K. Singh
- Chief Operating Officer — Joshua S. Prince
- Chief Financial Officer — Nick Tressler
- Vice President, Corporate Development & Investor Relations — Mark McPartland
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Takeaways
- Cash, cash equivalents, and marketable securities -- $61.8 million as of Dec. 31, 2025, clarified by Singh at call's end.
- PALISADE III Phase 3 trial -- Randomized portion completed; Singh stated, "We have reviewed available data from PALISADE III and implemented moderate refinements."
- Operational enhancements -- Implementation of retraining, site rationalization, and refined placebo mitigation strategies based on data from PALISADE III.
- AI and machine learning analytics -- Company collaborating with third parties using "proprietary artificial intelligence and machine learning technologies to identify nonspecific responses and understand and predict susceptibility to placebo response."
- PALISADE IV Phase 3 trial -- Enrollment "continued as planned and projected," according to Prince, with ongoing application of operational and analytical learnings.
- Open-label extensions -- Both PALISADE III and IV open-label portions remain ongoing for real-world safety and exploratory efficacy assessments using LSAS and SPIN scales.
- Regulatory strategy -- Potential New Drug Application submission to the FDA "if PALISADE IV is successful, together with PALISADE II and the broader body of evidence," per Singh.
- PH80 (rifasalone) development -- USAN adoption for the hormone-free intranasal product; planned U.S. Investigational New Drug application in 2026 for vasomotor symptoms of menopause.
- Cash preservation -- "company-wide cash preservation measures" executed during the quarter, aiming to extend operating runway and maintain flexibility.
- Shares outstanding -- Singh clarified the higher weighted average share count "includes the prefunded warrants."
Summary
VistaGen Therapeutics (VTGN 1.76%) highlighted completion of the randomized portion of the PALISADE III Phase 3 trial and its influence on operational and statistical refinements implemented for PALISADE IV. Management is leveraging advanced analytics, including artificial intelligence and machine learning, across all PALISADE studies to address placebo response and optimize regulatory submission strategy. The company confirmed that open-label extensions of its key trials are ongoing, designed to collect real-world safety and usage data. During the quarter, VistaGen advanced its women's health portfolio by obtaining the USAN designation for rifasalone and outlined plans for a 2026 IND submission in the U.S.
- Management reiterated its reliance on the "weight-of-evidence" approach and close regulatory dialogue, explicitly declining to speculate on approval scenarios before PALISADE IV results.
- Enrollment has continued as planned and projected for PALISADE IV, according to Prince, with no reported enrollment impact since prior public disclosures.
- Modifications to the statistical analysis plan (SAP) for ongoing trials would require FDA resubmission and prior approval, as confirmed by Prince.
- AI-driven identification of statistical covariates is in progress, though Singh said, "It is not certainly not guaranteed" that actionable covariates will be identified for SAP adjustment.
Industry glossary
- PALISADE: VistaGen's multi-study clinical trial program evaluating fasedienol in social anxiety disorder.
- Fasedienol: Company product candidate, a rapid-onset neuroactive nasal spray for acute treatment of anxiety.
- LSAS: Liebowitz Social Anxiety Scale; a clinician-administered measure of social anxiety severity.
- SPIN: Social Phobia Inventory; a patient-reported questionnaire measuring social anxiety symptoms.
- Usan: United States Adopted Name; generic drug name designation.
- SAP: Statistical Analysis Plan; formal plan for statistical evaluation of clinical trial data.
Full Conference Call Transcript
I am joined on our call today by Shawn K. Singh, our President and Chief Executive Officer; Joshua S. 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 will 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 would now like to turn the call over to our President and CEO, Shawn K. Singh.
Thank you, Mark, and good afternoon, everyone. It has been an important quarter for our team with the completion
Shawn K. Singh: of the randomized portion of our PALISADE III 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 IV Phase 3 trial. We have reviewed available data from PALISADE III and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to PALISADE IV. We have also been working with third-party collaborators on the implementation of innovative approaches to analyze the available datasets, not only from PALISADE III, but also from the fasedienol studies across the PALISADE program, including both the randomized and the open-label trials.
The 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 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 IV and our regulatory strategy based on the totality of data from the PALISADE program. The open-label extension portion of PALISADE III and PALISADE IV 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 (LSAS) and the patient-reported Social Phobia Inventory (SPIN).
While open-label data are inherently uncontrolled and exploratory, the OLE portion of the PALISADE III Phase 3 study could provide important context on patient experience with repeated use over time in real-world anxiety-provoking situations 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 would 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 IV and advance our broader analytical efforts.
As we have previously stated, if PALISADE IV is successful, together with PALISADE II 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 rifasalone. Rifasalone 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 rifasalone may also have therapeutic potential across other women's health indications. We are currently preparing to submit our U.S. Investigational New Drug application (IND) for rifasalone to the U.S. FDA with a planned submission in 2026. This IND is intended to support further potential Phase 2 clinical development of rifasalone 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 2a clinical trial conducted in Mexico by Ferreon 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 rifasalone 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 12/31/2025, we had $61,200,000 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 PH80 pipeline. We believe we are well positioned to complete PALISADE IV and to advance preparations and planning for our PH80 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 Therapeutics, Inc. to make informed decisions and responsibly advance programs with the potential to deliver meaningful value to patients and to shareholders. 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.
Mark McPartland: Thank you, Shawn. Operator, we would now like to open up the call for questions from the sell-side analysts joining us today. Thank you.
Operator: At this time, if you would like to ask a question, please press 11 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 11 again. We also ask that you please wait for your name and company to be announced before proceeding with your question. The first question today is coming from the line of Andrew Tsai of Jefferies. Your line is open.
Shawn K. Singh: Hi. Good afternoon. Thanks for the updates. So maybe in the PALISADE III 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? Thanks for the question, Andrew. Josh?
Mark McPartland: Hi, Andrew.
Shawn K. Singh: We at this point,
Mark McPartland: you know, what we have released
Shawn K. Singh: publicly is the top-line results. So we are still looking into a lot of that data. We have not released the individual curves publicly. We do know that there is
Mark McPartland: what really where we find information is looking into individual
Shawn K. Singh: respondents and subgroups of respondents. And again, that analysis continues, so that is where we do see definite differences. Okay. Thanks. And it sounds like you are looking at ways for PALISADE IV to tweak around the SAP plan. And let us 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? Yeah. Thank you. That is great. Great question. Oh, go ahead. Sorry. No. You go ahead. Sorry.
Joshua S. Prince: That is you. Yeah. It is a great question and, you know, the SAP, just like with PALISADE III, has already been submitted and approved or no feedback from FDA. So that is 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, thank you, is should you modify the plan, would you need to backfill
Shawn K. Singh: back to the original enrollment target of around 236 or 238 or are there no changes to the enrollment
Mark McPartland: Thank you.
Joshua S. Prince: Yeah. A change to the SAP would not change the enrollment or the planned enrollment for the study. You know, the key there is that whatever that SAP is, is, like I said, locked in before you get to database lock and then applied to the total population for the study.
Shawn K. Singh: Understood. Okay. Thank you, guys.
Operator: Thank you. One moment for the next question. Next question is coming from the line of Emily of Stifel. Your line is open. Hi. This is Emily on for Paul at Stifel.
Emily: We just had a quick question. Maybe could you remind us where you guys are in with in terms of enrollment for PALISADE IV? And if you, like, plan on telling if or plan on PRing when that has completed or, like, dosing has completed? And then also, could you maybe share in, like, what detail you saw on PALISADE III that kind of led you to refine to the refinement that you outlined in the press release? Thank you.
Shawn K. Singh: Thanks, Emily. Appreciate the question. So it will be consistent with the pattern for PALISADE III once we hit the last patient's last visit and then proceed towards top line. So that will be we are on track with guidance that we have previously given. With respect to PALISADE IV TLR, the randomized portion of PALISADE IV. Josh, you can address the second part.
Joshua S. Prince: I am sorry. I missed the second part. Can you rephrase that?
Emily: For you guys discussed, like, refinements, and including, like, retraining of some sites. Could you maybe provide any color on what details you saw from PALISADE III that kind of led to that decision?
Joshua S. Prince: Yeah. I do not think we can go into too much detail given PALISADE IV is ongoing. But, you know, at a high level, you know, one of the things that made PALISADE III different than PALISADE II 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 is no, you know, chatting with the subjects as they come in, you know, anything that could potentially lend to a comfort for a subject or that could drive a higher placebo effect. So it is those types of things that we are able to implement quickly based on what we see from PALISADE III. And, also, because we are listening to what is happening at each site through the audio recordings that we have talked about previously, it gives us the opportunity, again, to be hyperfocused with feedback and any intervention where we see something deviating from the prescript that we have put in place.
Emily: Great. Thank you guys so much.
Shawn K. Singh: In addition to that, some focus on centralized recruitment and making sure that gets and stays completely tight and rationalized. So 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.
Operator: Thank you. One moment for the next question. Our next question is coming from the line of Myles Robert Minter of William Blair. Your line is
Mark McPartland: open.
Joshua S. Prince: Hi, team. This is John on for Myles. Thanks so much for taking our question. 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 IV hits and you have a 50% program success? Alternatively, if PALISADE IV misses, do you see any regulatory paths forward with PALISADE II alone?
Shawn K. Singh: Thanks, John. Appreciate the question. So 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, nature of the in-need population, so these kinds of assessments, this is what we align our regulatory strategies to accordingly. So we are not really in a position to speculate on any approval scenarios, but what we can tell you, of course, is we are 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 regulatory decision-making.
We, on top of that, are 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 IV, we will be able to look across the totality of the program, and the primary objective and the primary regulatory strategy remains, as we have said, which is complementing, if PALISADE IV is successful, complementing PALISADE II with a broader base of information from the totality of the program for the acute treatment of social anxiety disorder. If PALISADE IV does not hit and separate from placebo, it is still the same. It is a totality of evidence focus.
It is 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.
Joshua S. Prince: Helpful. Thanks. And a quick follow-up. Is there anything that you are seeing in the blinded data of PAL that gives you a little bit more confidence in that study over PALISADE III?
Shawn K. Singh: We do not comment on the blinded data, John.
Joshua S. Prince: Alright. Thank you.
Emily: Thank you.
Mark McPartland: As a reminder, if you would like to ask a question, please press 11 on your telephone.
Operator: One moment for the next question. And the next question is coming from the line of Alimair Piras of Lucid. Your line is open.
Joshua S. Prince: Yes. Hi. Good afternoon.
Mark McPartland: Shawn, have you noticed any impact on enrollment
Alimair Piras: since the announcement on December 17? The enrollment patterns. Josh, you can address that.
Joshua S. Prince: Sure. The quick answer is no. Definitely have not. Enrollment has continued as planned and projected for PALISADE IV. Okay. And so
Alimair Piras: what I am trying to understand is how could PALISADE III outcome and potentially PALISADE IV 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. Sure. Sure. I mean, part of what we are doing with AI and the
Shawn K. Singh: machine learning, it is potential. It is not certainly not guaranteed. And if what you are looking for is are there any covariates that may have a potential fixed effect on ANCOVA, and
Joshua S. Prince: that is
Shawn K. Singh: that may or may not evolve and emerge from the work that we are 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 patient populations in each arm in prior studies, in PALISADE III in particular, that may give you some sort of signal. So the answer is we do not know yet. And as noted earlier, if we do make a modification to the SAP that has already been signed off by the agency, then we would have to go back to them and socialize it with them. So
Alimair Piras: Mhmm. That is
Shawn K. Singh: part of what we are trying to find out. If there is not, then, again, we have operational efficiencies and observations based on what we have seen across the studies that are being implemented into the PALISADE III or PALISADE IV execution. Josh, anything you want to add on that from the teams?
Joshua S. Prince: No. I think that captures it.
Alimair Piras: So just to summarize, you are looking at PALISADE III and maybe even PALISADE II for some covariates. If you find them, then you modify the SAP, take it to the FDA before you were to analyze, I would say, four, hypothesizing that those same covariates will be applicable to PALISADE IV. Am I understanding it correctly?
Shawn K. Singh: Yeah. It has to be whether correct. Not only whether it is timely. It has, like, obviously got to be timely before you lock the database. But it has also got to be appropriate. And there may also be potential changes that would not be FDA regulatory appropriate. So it has got to be something that could be impactful, at the same time, something that is reasonable with rigor and review from the FDA.
Joshua S. Prince: Shawn, I would just add that we are actually, you know, we are looking across all the PALISADE studies. So PALISADE I, II, and III to see what we can learn. You know, we have built, now that we have had a third study complete, we have built, you know, continued size of data to examine, which gives you more power when you are digging into different things. But you are 100% correct that it is essentially the covariates or the correction factors that you would apply in your statistical model.
Alimair Piras: I understand. And just a silly housekeeping question, if you may, if I may. At the December, you had 39,700,000 shares outstanding, but the weighted average for the quarter was 42. Can you help me to understand that?
Shawn K. Singh: Nick, are you on? Hi.
Joshua S. Prince: Yes. I am. Yeah. So it is the shares outstanding at the end of the quarter. It is how we measure our earnings per share.
Alimair Piras: Okay.
Mark McPartland: So
Alimair Piras: shares out today. But so, but there are higher number of shares outstanding, because the average is 42,000,000.
Shawn K. Singh: That includes the prefunded warrants, Alimair.
Alimair Piras: Yeah. Alright. Got it. Okay. Mhmm. Mhmm. Yep. Thank you so much for clarifying that.
Shawn K. Singh: Not a silly question.
Mark McPartland: Operator, I believe that is all the time we have for today. We can wrap up the call. Thank you everyone for joining today and for your continued interest and support in VistaGen Therapeutics, Inc. Again, with our diverse, innovative pipeline, we are encouraged about the future prospects of the company. If you have any additional questions, please do not 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 Therapeutics, Inc. 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.
Shawn K. Singh: Have a good day. One more thing. Real quick. I just want to clarify. I think I misspoke. I think I said $61,200,000 at the end of 12/31/25. It was $61.8 million as reflected in our 10-Q.
Joshua S. Prince: Understood.
Alimair Piras: Thanks, Shawn. Thank you.
Operator: This concludes today’s program. Thank you all for joining. You may now disconnect.
