VistaGen Therapeutics Q2 2026 Earnings Report

VistaGen Therapeutics EPS Results

• Actual EPS: -$0.54
• Consensus EPS: -$0.51
• Beat/Miss: Missed by -$0.03
• One Year Ago EPS: N/A

VistaGen Therapeutics Revenue Results

• Actual Revenue: $0.26 million
• Expected Revenue: $0.16 million
• Beat/Miss: Beat by +$101.00 thousand
• YoY Revenue Growth: N/A

VistaGen Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 11/13/2025
• Time: After Market Closes
• Conference Call Date: Thursday, November 13, 2025
• Conference Call Time: 5:00PM ET

VistaGen Therapeutics (NASDAQ:VTGN) (NASDAQ:VTGN) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of next-generation medicines for central nervous system disorders. Incorporated in Delaware in 1998 and headquartered in South San Francisco, California, VistaGen applies advanced human pluripotent stem cell technologies to accelerate drug candidate validation and optimization. The company’s core focus is on addressing unmet medical needs in major depressive disorder, neuropathic pain and dermatological conditions.

The company’s lead candidate, AV-101, is an oral prodrug designed to modulate glutamatergic neurotransmission via the N-methyl-D-aspartate (NMDA) receptor pathway, with clinical programs targeting major depressive disorder and neuropathic pain. VistaGen also develops PH-10, a topical neuroactive small molecule in clinical development for psoriasis and atopic dermatitis. To broaden its development reach, VistaGen has entered strategic partnerships, including a licensing agreement with Yuhan Corporation for AV-101 in South Korea, and continues to advance its clinical and regulatory strategy primarily in North America and Asia.

VistaGen’s proprietary Human Clinical Drug Rescue and ReRationalization platform employs patient-derived pluripotent stem cell–derived neural and cardiac cells to predict clinical efficacy and safety, reduce late-stage development risk and complement traditional preclinical models. This platform supports both in-house pipeline programs and collaborative research initiatives. Leading the company is President and Chief Executive Officer Shawn K. Singh, who has overseen VistaGen’s research and corporate development efforts since joining in 2014 and remains committed to translating innovative science into new therapeutic options for underserved patient populations.

VistaGen Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: PALISADE III completed the randomized double‑blind portion (last patient last visit) and the company expects to release top‑line results by the end of this calendar year.
• Positive Sentiment: PALISADE IV remains on track for a 2026 top‑line readout and shares the same public‑speaking challenge design and primary endpoint as the successful PALISADE II, with the company aiming to replicate those results.
• Positive Sentiment: Vistagen reported $77.2 million in cash, equivalents and marketable securities as of 9/30/2025 and says this is sufficient to cover the ongoing U.S. registration‑directed PALISADE program, including a potential NDA submission if trials are successful.
• Neutral Sentiment: The company is advancing its broader neuroscience pipeline—including itravone for major depressive disorder and PH80 for menopausal hot flashes—and is considering regulatory, commercial and partnership options as it prepares for potential approval and launch.

Presentation

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Good day, everyone. Thank you for standing by. Welcome to the VistaGen Therapeutics fiscal year 2026, second quarter, corporate update, conference call, and webcast. Please note that today's call is being recorded. At this time, I'd like to turn the call over to your host, Mark McPartland, Senior Vice President, Investor Relations at VistaGen. Mark.

[Mark McPartland, SVP of Investor Relations at VistaGen Therapeutics]

Thank you, Operator. Good afternoon, everyone, and welcome to our conference call and webcast. Earlier this afternoon, we filed our quarterly report on Form 10-Q and issued a press release for fiscal year 2026, second quarter, which ended on September 30, 2025, providing an overview on the progress in our PALISADE 3 program for fasedienol and social anxiety disorder across our other lead medical neuroscience programs. We encourage you to review the PR and 10-Q, which are available in the investor section of our website. Now, before we begin, please note that we will be making forward-looking statements regarding our business during today's call based on our current expectations and information. These forward-looking statements speak only as of today. Except as law requires, we do not assume any duty to update any forward-looking statements made today or in the future.

[Mark McPartland, SVP of Investor Relations at VistaGen Therapeutics]

Of course, forward-looking statements involve risks and uncertainties and actual results could differ materially from those anticipated by any forward-looking statements we make today. Additional information concerning risks and factors that could affect our business and financial results are included in the fiscal year 2026 second quarter Form 10-Q for the period ending September 30, 2025, and in future filings that we'll make with the SEC from time to time, all of which are available in the investor section of our website or, of course, on the SEC's website. Now, with the formalities out of the way, we warmly welcome our stockholders, sell-side analysts, and others interested in our programs and our progress. I'm joined on our call today by Shawn Singh, our President and Chief Executive Officer, and Josh Prince, our Chief Operating Officer.

[Mark McPartland, SVP of Investor Relations at VistaGen Therapeutics]

Shawn will provide a brief business update, clinical update, and Josh 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 today. I remind you a replay of the webcast will be made available in the events section of our investor page on our website. With that taken care of, I'll now turn the call over to our President and CEO, Shawn Singh.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Thank you, Mark, and good afternoon, everyone. We've built a very strong momentum as we enter into what could be a potentially transformative period for VistaGen. Last week, we announced another major milestone in our PALISADE program. The last patient completed the randomized double-blind portion of our PALISADE 3, phase III trial, evaluating our most advanced intranasal product candidate, fasedienol, for the acute treatment of social anxiety disorder. We are now preparing for the release of top-line results from the PALISADE 3 study by the end of this calendar year. We extend our sincere gratitude to the patients who participated in the study, as well as the dedicated and experienced clinical investigators, the clinical site staff, and our contract research organization. Their enthusiasm, their focus on detail, and the collaboration throughout the study were notable and greatly appreciated and will remain so during the ongoing open-label extension of the study.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Over the past several months, I've had the privilege of meeting in person with many of the dedicated teams conducting our PALISADE 3 and PALISADE 4 studies. The energy, the curiosity, the optimism that I've witnessed reaffirms just how great the need remains for new treatment options for individuals whose daily lives are affected by social anxiety disorder and how differentiated and innovative fasedienol could be in meeting their needs. Together, our teams remain deeply focused on fasedienol's potential to become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety disorder. Looking ahead, we remain on track to report top-line results from our PALISADE 4, phase III trial in the first half of 2026. Both PALISADE 3 and PALISADE 4 share a similar public speaking challenge design and the same primary efficacy endpoint as our previously successful PALISADE 2, phase III trial.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

In parallel, we are continuing preparations designed to advance our broader ferrous pipeline, including Itruvone for major depressive disorder and PH80 for menopausal hot flashes. Both depression and women's health represent areas where far too many patients still struggle without adequate options. We're deeply motivated to bring forward the innovative non-systemic neurocircuitry-focused potential of Itruvone and PH80 to help address these important and widespread needs. Turning now briefly to our financials, as of September 30, 2025, we had $77.2 million in cash, cash equivalents, and marketable securities. We believe current cash covers all known aspects of our ongoing U.S. registration-directed PALISADE program for Fasedienol for the acute treatment of SAD, including potential NDA submission if our PALISADE program is successful. Before I conclude the business update, I'd like to welcome Mr. Paul Edick to our board of directors.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Paul joins us at a pivotal time for VistaGen, bringing decades of experience leading successful FDA approvals, commercial launches, and strategic transactions. His leadership will be invaluable as we prepare for our next phase of growth. I'd also like to extend our deep gratitude to Dr. Jerry Jin, who served on our board from 2016 until his retirement earlier in September of this year. In closing, our mission remains clear and unwavering: to redefine what is possible in neuroscience, to restore emotional well-being, and improve quality of life for millions worldwide. With a diverse and innovative pipeline, an experienced team, and several key milestones approaching, we believe we are entering one of the most exciting and potentially transformative periods in our company's history, with deep confidence in our ability to deliver meaningful value for patients and for our stockholders.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

I want to thank you all for your continued interest, your support, and your engagement with VistaGen. It makes a lot of difference, and we look forward to sharing our progress with you in the weeks and the months ahead.

[Mark McPartland, SVP of Investor Relations at VistaGen Therapeutics]

Thank you, Shawn. These are definitely exciting times at VistaGen as we continue to build momentum across our programs. Operator, we'd now like to open up the call for questions from the sell-side analysts joining us today.

[Operator]

At this time, I would like to remind everyone, in order to ask a question, please press star followed by the number one on your telephone keypad. Your first question comes from the line of Andrew Say with Jefferies. Please go ahead.

[Andrew Say, SVP at Jefferies]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Our guidance—I think we're just going to stick with it, Andrew. Thanks for asking the question, and thanks for coming on. Our guidance is that we'll see top-line results released before the end of this calendar quarter, so by the end of this calendar year.

[Andrew Say, SVP at Jefferies]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

You're going to hear, as we did with PALISADE 2, right? We're going to give you, obviously, top-line results on the primary, the CGII, the secondary, and also the PGICs, the secondary, and obviously pretty customary information regarding the safety profile that we've seen throughout the course of the study through the randomized portion of the study. That's what we're printing out, and that's what we're reading out, are the top-line results from the randomized double-blind portion, which is the public speaking challenge. Any safety data that we have from that study, similar to PALISADE 2, we'll be reading that out as well.

[Andrew Say, SVP at Jefferies]

Okay. And then last question is, from what you can tell, what have been the top reasons why patients screen failed in PALISADE 3, and are the top reasons different from what we saw in PALISADE 2? Thank you.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

We can unpack that later, but what I can tell you, Andrew, is the reason that we made enhancements to the PALISADE 3 and 4 studies, again, was to make sure that there was very high-quality assessment for subject eligibility. As a result of that, we had our own teams involved here with our cert teams for subject eligibility review. We had other enhancements into the execution of the study, of course, throughout the duration of the study. I think we've seen, generally, what we've expected to see and as we've modeled forward for not only screen fail but also attrition rates throughout the course from enrollment through randomization through the end of the study. I think we're comfortable with what we've typically seen, and maybe more to come on that later.

[Andrew Say, SVP at Jefferies]

Okay.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Important piece of the puzzle is we—yeah. One more thing is, obviously, the important piece of the puzzle is that we got to the last patient's last visit with the full complement that we had modeled for purposes of the studies we've noted before. Our end target was 236. Last patient's last visit reflects our original thoughts.

[Andrew Say, SVP at Jefferies]

Perfect. Thanks again.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Mm-hmm.

[Operator]

The next question comes from the line of Paul Matisse with Stifel. Please go ahead.

[Operator]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Thank you. That's super helpful. Looking forward to the data soon.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Thanks.

[Operator]

As a reminder, if you'd like to ask a question, please press star followed by the number one on your telephone keypad. The next question comes from the line of Miles Minter with William Blair. Please go ahead.

[Miles Minter, Equity Research Associate at William Blair]

Thanks for taking the questions. This is the first one. Is it your view that Fasedienol would be eligible for a commissioner's priority review voucher? Seems to me like SAD is potentially a public health crisis, and it's certainly a massive unmet need with over 30 million patients out there. That's the first one. Then second is just, I think in late October, you updated clinicaltrials.gov. You terminated a site in Arkansas and Kansas. I'm just curious whether that was because you've completed enrollment and you didn't need those sites anymore, or just because of your site vigilance and you're going to see these sites in person. Was it something performance-related that you terminated those sites? Thanks very much.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Thanks, Miles. Thanks for the questions. Josh, why don't you go ahead and take that last question first?

[Josh Prince, COO at VistaGen Therapeutics]

Sure. Yeah. Thanks, Miles. As we've gone through the course of these studies for both PAL3, PAL4, it's a constant evaluation of fit with sites. We've had a few sites that, for whatever reason, with regard to their ability to enroll the appropriate patients, whether it was their recruitment programs or other reasons, just they were not able to enroll. At some point, it makes sense to terminate those sites. There's been one or two like that. Also beyond that, to your point, as we get towards the end of the study, we definitely take a wind-down approach for a soft landing for the study to make sure it's well controlled. We're controlling variability and making sure that we will be able to get from that end-of-study last patient out to top-line results efficiently in the timeline that Shawn mentioned.

[Josh Prince, COO at VistaGen Therapeutics]

For us, it's kind of course of business as we've gone through the process of the studies.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

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

[Miles Minter, Equity Research Associate at William Blair]

Cool. Thanks for the questions.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

You bet.

[Operator]

The next question comes from the line of Elemer Piros with Lucid Capital Markets. Please go ahead.

[Elemer Piros, Managing Director at Lucid Capital Markets]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Hey, Elemir.

[Elemer Piros, Managing Director at Lucid Capital Markets]

What I'd like to ask you is if you have any indication on the usage patterns. This is coming from perhaps more likely from PALISADE 2, then maybe to a lesser extent from PALISADE 3 at this point for those who went out to complete the OLE up to one year.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Yeah. Most of the usage pattern data is going to come from the open labels. What we can talk about, of course, is related to the reported open label, the long-term safety study that we had before. The patterns established in the context of that study give some pretty good guidance to us about what we see going forward in the real world. Remember, this is a disorder that is—it's chronic, but it manifests acutely and episodically. A lot of it, in terms of utilization, depends on where people are in their particular phase of their journey. What is their job? What academic setting are they in? How frequently do they need to interact with people on a social basis?

[Shawn Singh, President and CEO at VistaGen Therapeutics]

You definitely see in that long-term safety study we've reported on more activity during the week, especially after people are back to work, back to school, into the kind of rhythm of life that we're in now. You see more utilization during a week, especially during work kind of hours. Weekends, it tends to taper off, obviously, because people are not in similar stressful settings or maybe social situations, a barbecue with your friends, or you go to a sporting event where there's worry about how you're looking, whether you're being judged or not being judged, which is really what anchors this disorder, unfortunately. More often during the week, less often during the weekend. That's the pattern we saw early on in the open label study we reported on. It's reasonable to expect that sort of activity on a go-forward basis.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

At least that's what's anchoring a lot of our informed assumptions about how we could see the drug used in the real world. This is the truth.

[Elemer Piros, Managing Director at Lucid Capital Markets]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

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

[Elemer Piros, Managing Director at Lucid Capital Markets]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

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

[Elemer Piros, Managing Director at Lucid Capital Markets]

I understand. Lastly, how do you think about commercialization at this stage? On your own, with a partner? Have you thought about this recently?

[Shawn Singh, President and CEO at VistaGen Therapeutics]

Companies, yeah, we certainly think about it all the time. Companies in positions like we are, if you have a contemplation for a first commercial launch, you have to have a lot of good reasons for that. Here, as a company, we always position for optionality. There are many things that can happen. Key for us is to make sure we have the optimal opportunity to generate the value that could be associated with fasedienol if it gets approved. There is certainly a very solid potential commercial plan. There are also opportunities should other strategic arrangements bring greater value potential. Yes, as a company, we have the expertise. We have the planning.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

We have execution in certain cases already underway to be able to bring this extremely innovative asset into the treatment paradigm where there is just nothing sitting there that's interesting and exciting for patients to be able to recapture the agency that allows them to tailor the use of a medication to fit how these stressors are impacting their lives day to day. In the world right now, it's a very interesting market out there in terms of the dynamics of telehealth and mental health, digital psychiatry, consumer-generated influencer-based activity across the socials, what we see with anxiety very similar to what people see and hear about weight and a GLP-1 drug. There is a transformed market environment over just even the last couple of years.

[Shawn Singh, President and CEO at VistaGen Therapeutics]

You are also looking at a population of patients and maybe practitioners too who really would prefer online engagement as opposed to in person. There are some really unique opportunities, especially with what we would hope to be borne out as the target product profile and the way to access not only practitioners but also raise awareness among consumers. It is a really exciting opportunity for the company around this very unique asset that fits in so many ways for what we think are the clarion calls of not only practitioners but certainly patients.

[Elemer Piros, Managing Director at Lucid Capital Markets]

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

[Shawn Singh, President and CEO at VistaGen Therapeutics]

You bet. Thanks again.

[Operator]

There are no further questions at this time. I would now like to turn the call back over to Mark McPartland for closing remarks. Please go ahead.

[Mark McPartland, SVP of Investor Relations at VistaGen Therapeutics]

Thanks, operator. Thank you again, everyone, for joining us on the call today and for your continued interest and support. With a diverse and innovative pipeline and several key major milestones on the horizon, we believe VistaGen is entering one of the most exciting and potentially transformative chapters in our company's history. If you have any additional questions, please do not hesitate to reach out to us at ir@vistagen.com or through the Contact Us section of our website. We also encourage you, of course, to register for email updates to stay informed about our latest news and developments from VistaGen. We truly appreciate your time, engagement, and ongoing support, and we look forward to keeping you updated on our continued progress. This concludes the call. Have a great day.

[Operator]

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

Participants

Executives

• Shawn Singh, President and CEO
• Josh Prince, COO
• Mark McPartland, SVP of Investor Relations

Analysts

• Analyst at Stifel
• Elemer Piros, Managing Director at Lucid Capital Markets
• Andrew Say, SVP at Jefferies
• Miles Minter, Equity Research Associate at William Blair