Q3 2026 VistaGen Therapeutics Inc Earnings Call

February 12, 2026

Operator: Good day, everyone. Thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year 2026 Q3 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?

Speaker #1: 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.

Speaker #1: Mark?

Speaker #2: 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 10Q and issued a press release for our fiscal year 2026 third quarter, which ended December 31st, 2025.

Mark McPartland: 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 Q3, which ended 31 December 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.

Speaker #2: And provided an update of our progress across our clinical stage neuroscience program. We encourage you to review the PR and 10Q, which are both available in the investor section of our website.

Speaker #2: 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.

Speaker #2: 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 are actual results could differ materially from those anticipated by any forward-looking statements we make today.

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 make today. Additional information concerning risks and factors that could affect our business and our financial results are included in our fiscal year 2026, Q3 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.

Speaker #2: 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 10Q and for periods ending December 31st, 2025, and in future filings that we make with the SEC from time to time.

Speaker #2: Again, all of which are available in the investor 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.

Speaker #2: 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.

Mark McPartland: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: With that taken care of, I'd now like to turn the call over to our president and CEO, Shawn Singh.

Speaker #3: 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.

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 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 datasets, not only from PALISADE-3, but also from the fasedienol studies across the PALISADE program, including both the randomized and the open label trials.

Speaker #3: 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 facet eye and all studies across the Palisade program, including both the randomized and the open-label trials.

Speaker #3: Our objective is to better understand the drivers of both facet eye and all 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.

Shawn Singh: 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.

Speaker #3: 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.

Speaker #3: Overall, the full complement of ongoing work has focused on delivering practical operational understanding predictors of a 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.

Speaker #3: 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 facet eye and all in adults with social anxiety disorder.

Shawn Singh: 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 uncontrolled and exploratory, the OLE portion of the PALISADE-3 Phase 3 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.

Speaker #3: 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.

Speaker #3: While open-label data are inherently in control and exploratory, the OLE portion of the Palisade 3 Phase 3 study could provide important context on patient experience with repeated use over time in real-world anxiety-provoking situations the patients encounter.

Speaker #3: Together with our broader analytical work across the Palisade program, insights from open-label studies should contribute to our enhanced understanding of fasedienol's effect and usage patterns.

Speaker #3: 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.

Shawn Singh: 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.

Speaker #3: 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 US Food and Drug Administration for the acute treatment of social anxiety disorder in adults.

Speaker #3: 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 PH 80 as Rifisolone.

Speaker #3: Rifisolone 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.

Shawn Singh: Rafisolone is our hormone-free, non-systemic, 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 Ferring Pharmaceuticals, which is now our wholly owned subsidiary. That trial demonstrated clinical benefit in the vasomotor symptoms indication.

Speaker #3: We believe Rifisolone 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 Rifisolone to the US FDA with a planned submission in the first half of 2026.

Speaker #3: This IND is intended to support further potential Phase 2 clinical development of Rifisolone in the U.S. for the treatment of moderate to severe vasomotor symptoms due to menopause.

Speaker #3: Building on a previously completed placebo-controlled exploratory Phase 2A clinical trial conducted in Mexico by Ferrin Pharmaceuticals, which is now our wholly owned subsidiary, and that trial demonstrated clinical benefit in the vasomotor symptoms indication.

Speaker #3: We believe that indication in women's health represents a significant area of unmet need, and we remain committed to advancing Rifisolone as a nonsystemic hormone-free product candidate with a disciplined data-driven approach as we prepare for the potential next phase of clinical development.

Shawn Singh: We believe that indication in women's health represents a significant area of unmet need, and we remain committed to advancing rafisolone as a non-systemic, 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 31 December 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 Ferring pipeline. We believe we are well positioned to complete PALISADE-4 and to advance preparations and planning for our Ferring pipeline. In closing, our mission remains unchanged: to deliver transformative treatments and improve lives.

Speaker #3: Turning briefly to our financial position as of December 31st, 2025, we had 61.2 million in cash, cash equivalents in 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 Ferrin pipeline.

Speaker #3: We believe we are well positioned to complete Palisade 4 and to advance preparations and planning for our Ferrin pipeline. In closing, our mission remains unchanged.

Speaker #3: 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.

Shawn Singh: 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.

Speaker #3: 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.

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.

Speaker #4: Thank you, Shawn. Operator, we would now like to open up the call for questions from the South Side analysts joining us today.

Speaker #5: Thank you. At this time, if you would like to ask a question, please press star 11 on your telephone. You will then hear an automated message advising your hand is raised.

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.

Speaker #5: If you would like to remove yourself from the queue, press star 11 again. We also ask that you please wait for your name and company to be announced before proceeding with your question.

Speaker #5: One moment while we compile the Q&A roster. The first question today is coming from the line of Andrew Fay of Jefferies. Your line is open.

Andrew Fein: 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?

Andrew Tsai: 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?

Speaker #6: 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?

Speaker #6: Was there a separation at all across any of those time points with facetidal versus placebo?

Speaker #4: Thanks for the question, Andrew. Josh?

Shawn Singh: Thanks for the question, Andrew. Josh?

Josh Prince: ... Hi, Andrew. We 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.

Speaker #7: Hi, Andrew. 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.

Speaker #7: 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.

Speaker #6: 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.

Andrew Fein: Okay, thanks. And if 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?

Andrew Tsai: Okay, thanks. And if 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?

Speaker #6: 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?

Speaker #6: Is there a risk to modifying the SAP plan, basically?

Speaker #4: Yeah, thank you. Great question. Oh, go ahead, Shawn.

Shawn Singh: Yeah, thank you.

Josh Prince: We would-

Shawn Singh: Great question.

Josh Prince: Oh, go ahead, Shawn.

Speaker #7: No, you go ahead. Sorry. That's you.

Shawn Singh: No, you go ahead, Josh. Sorry. It's you.

Josh Prince: Yeah, it's a great question, and you know, the, the SAP, just like with PALISADE 3, you know, already been submitted and approved for no feedback from FDA. So that's, 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.

Speaker #4: Yeah, great question. And the SAP—just like with Palisade 3—has already been submitted and approved, with no feedback from the 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 go to top-line results.

Speaker #6: Understood. And then my last question. Thank you. Should you modify the plan, would you need to backfill back to the original enrollment target of around 236 or 238?

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

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

Speaker #6: Or are there no changes to the enrollment? Thank you.

Speaker #7: Yeah. 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.

Josh 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 it's whatever that SAP is, like I said, locked in before you get to database lock, and then applied to the total population for the study.

Speaker #7: And then applied to the total population for the study.

Speaker #6: Understood. Okay. Thank you, guys.

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

Andrew Tsai: Understood. Okay. Thank you, guys.

Speaker #5: Thank you. One moment for the next question. Next question is coming from the line of Emily Chetty. Of Stifel, your line is open.

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 Chudy: 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, with, in terms of enrollment for PALISADE-4? And if you, like, plan on PRing when that has completed or, like, dosing has completed. And then also, could you maybe share on, like, what details you saw on PALISADE-3 that kind of led you to refine to the refinements that you outlined in the PR? Thank you.

Speaker #8: Hi. This is Emily on for Paul McKee at Stifel. We just had a quick question. Maybe could you remind us where you guys are in terms of enrollment for Palisade 4?

Speaker #8: And if you plan on telling if, or plan on PRing when that has completed or dosing has completed. And then also, could you maybe share what details you saw on Palisade-3 that kind of led you to the refinements that you outlined in the PR?

Speaker #8: Thank you.

Speaker #4: Thanks, Emily. Appreciate the question. So it'll be consistent with the pattern for Palisade 3. Once we hit the last patient's last visit, and then proceed towards top line.

Shawn Singh: Thanks, Emily. Appreciate the question. So it'll 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'll be... We're on track with guidance that we've previously given, with respect to PALISADE-4 TLR, the randomized portion of PALISADE-4. Josh, you can address the second part.

Speaker #4: So, that'll be—we're on track with the guidance that we previously gave with respect to Palisade 4 TLR, the randomized portion of Palisade 4. Josh, you can address the second part.

Speaker #7: I'm sorry. I missed the second part. Can you rephrase that?

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

Emily Chudy: 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?

Speaker #8: For you guys discussed refinements including 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?

Speaker #4: Yeah. 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.

Josh Prince: 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.

Speaker #4: 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.

Speaker #4: 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 or that could drive a higher placebo effect.

Josh Prince: 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.

Speaker #4: 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, it 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.

Speaker #8: Great. Thank you guys so much.

Emily Chudy: Great. Thank you guys so much.

Speaker #4: In addition to that, some 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 really experienced sites.

Shawn Singh: 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.

Speaker #5: Thank you. One moment for the next question. Our next question is coming from the lines of Miles Mentor of William Blair. Your line is open.

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.

Myles Minter: 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 four hits and you have a 50% program success. And alternatively, if PAL four misses, do you see any regulatory path forward with PALISADE two alone?

John Boyle: 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 four hits and you have a 50% program success. And alternatively, if PAL four misses, do you see any regulatory path forward with PALISADE two alone?

Speaker #6: Hi, team. This is John on from 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.

Speaker #6: And alternatively, if PALISADE-4 misses, do you see any regulatory path forward with PALISADE-2 alone?

Speaker #4: 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.

Shawn Singh: 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.

Speaker #4: 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 way that AI is evolving within the agency and how that is emerging as part of and factoring into the regulatory decision-making.

Speaker #4: We are 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. The primary objective and 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.

Shawn Singh: 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 and the primary regulatory strategy remains, as we've said, which is complementing, if PAL-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 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.

Speaker #4: If Palisade 4 doesn't, 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.

Speaker #4: And what we see from all data we can possibly see and analyze relating to the drug.

Myles Minter: 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?

John Boyle: 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?

Speaker #6: Helpful things. 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?

Speaker #4: You don't comment on the blinded data, John.

Shawn Singh: We don't comment on the blinded data, John.

Speaker #6: All right. Thank you.

Myles Minter: All right, thank you.

John Boyle: All right, thank you.

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.

Speaker #5: Thank you. As a reminder, if you would like to ask a question, please press star 11 on your telephone. One moment for the next question.

Speaker #5: And the next question. It's coming from the line of Elimer Pyros of Lucid. Your line is open.

Speaker #9: Yes. Hi. Good afternoon. Sean, have you noticed any impact on enrollment since the announcement on December 17th? Enrollment patterns.

Elemér Piros: Yes. Hi, good afternoon. Shawn, have you noticed any impact on enrollment since the announcement on 17 December, the enrollment patterns?

Speaker #4: Josh, you can address that.

Shawn Singh: Josh, you can address that.

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

Speaker #9: 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 Palisade 3 outcome and potentially Palisade 4 be different by amending the SAP?

Elemér Piros: 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, 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.

Speaker #9: 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.

Speaker #4: Sure, 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 there—what you're looking for is, are there any covariates that may have a potential fixed effect on the ANCOVA?

Shawn Singh: 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.

Speaker #4: 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.

Speaker #4: But it would be those kinds of things. Are there covariates that you notice when you look through the patient populations at each arm in prior studies in Palisade 3 in particular that may give you some sort of signal?

Speaker #4: 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.

Shawn Singh: 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,

Speaker #4: So that’s part of what we’re trying to find out. If there isn’t, then again, we’ve got operational efficiencies in observations based on what we’ve seen across the studies that are being implemented into the Palisade 3 or Palisade 4 execution.

Elemér Piros: Mm-hmm.

Shawn Singh: 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 PAL three or PAL four execution. Josh, anything you want to add on that from the teams?

Speaker #4: Josh, anything you want to add on that from the teams?

Josh Prince: No, I think that captures it.

Speaker #9: 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.

Elemér Piros: 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?

Speaker #9: A hypothesizing that those same covariates will be applicable to Palisade 4. Am I understanding it correctly?

Speaker #4: Yeah. It has to be whether 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 and there may also be potential changes that wouldn't be FDA regulatory appropriate.

Shawn Singh: Yeah, it has to be whether-

Elemér Piros: Correct.

Josh Prince: Correct.

Shawn Singh: 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. 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.

Speaker #4: 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.

Josh Prince: And 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.

Speaker #9: Thanks, Sean. I'll 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.

Elemér Piros: Mm-hmm

Josh Prince: ... to see what we can learn. You know, 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.

Speaker #9: We've built now that we've had a third study complete, we've built continued size 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.

Elemér Piros: Mm-hmm.

Josh Prince: But you're 100% correct that it's essentially the covariates or the correction factors that you would apply in your statistical model.

Elemér Piros: ... 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?

Speaker #9: I understand. And just a silly housekeeping question, if I may: At the end of December, you had 39.7 million shares outstanding.

Speaker #9: But the weighted average for the quarter was 42. Can you help me to understand that?

Mark McPartland: Nick, are you on?

Speaker #4: Nick, are you on?

Nick Tressler: 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.

Speaker #10: 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.

Nick Tressler: 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.

Speaker #9: Okay. So shares outstanding. But there are higher number of shares outstanding. Because the average is 42 million.

Elemér Piros: Okay. So shares, but so, but there are higher number of shares outstanding, because the average is 42 million.

Mark McPartland: It's that includes the pre-funded warrants, Elemer.

Shawn Singh: It's that includes the pre-funded warrants, Elemer.

Speaker #4: That includes the pre-funded warrants, Elimer.

Elemér Piros: Yeah. I got it. Okay. Mm-hmm, mm-hmm. Yep. Thank you so much for clarifying that.

Speaker #9: Right. That's right. Okay. Yep. Thank you so much for clarifying that.

Speaker #4: Not a silly question.

Mark McPartland: 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, ir@vistagen.com, 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. Have a great-

Mark McPartland: Not a silly question.

Mark McPartland: 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, ir@vistagen.com, 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. Have a great-

Speaker #10: Operator, I believe that's all the time we have for today. We can wrap up the call. So thank you, everyone, for joining us today.

Speaker #10: 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.

Speaker #10: If you have any additional questions, please don't hesitate to reach out to us via email at ir@vistagen.com, or through the Contact Us section of our website.

Speaker #10: 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.

Speaker #10: And we look forward to keeping you updated on our continued progress. This concludes our call today. Have a great day.

Nick Tressler: Mark, one more thing, real quick. I just wanna clarify. I think I misspoke. It's... I think I said $61.2 million at the end of December, 31 December 2025. It was $61.8 million, as reflected in our Q.

Shawn Singh: Mark, one more thing, real quick. I just wanna clarify. I think I misspoke. It's... I think I said $61.2 million at the end of December, 31 December 2025. It was $61.8 million, as reflected in our Q.

Speaker #4: 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.

Speaker #4: Was 61.8 is reflected in our queue.

Mark McPartland: Understood. Thanks, Shawn.

Speaker #10: Understood.

Speaker #9: Thanks, Sean.

Elemér Piros: Thank you.

Shawn Singh: Thank you.

Speaker #10: Thank you.

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

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