Vistagen Therapeutics (VTGN) Q3 2026 earnings call transcript

Thank you, Lisa, and good afternoon, everyone, and welcome to our conference call and webcast. Earlier this afternoon, we filed our quarterly report on Form 10-Q and issued a press release for our fiscal year 2026 third quarter, which ended December 31, 2025, and provided an update of our progress across our clinical stage neuroscience program. We encourage you to review the PR and 10Q, which are both available in the Investor section of our website.

Before we begin, please note that we'll be making forward-looking statements regarding our business during today's call based on current expectations and information. These forward-looking statements speak only as of today, except as law requires, we do not assume any duty to update any forward-looking statements made today or in the future. Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements we make today.

Additional information concerning risks and factors that could affect our business and our financial results are included in our fiscal year 2026 third quarter Form 10-Q and for period ending December 31st, 2025, and in future filings that we make with the SEC from time to time. 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 in progress. I'm joined on our call today by Sean Singh, our President and Chief Executive Officer, Josh Prince, our Chief Operating Officer, and Nick Tressler, our Chief Financial Officer.

Sean 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, Sean 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 III Phase III trial in social anxiety disorder as guided, and focused efforts to learn from the study's results and drive high-quality and efficient execution of our ongoing Palisade IV Phase III trial. We have reviewed available data from Palisade III and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to Palisade IV.

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 III, but also from the facet ionol studies across the Palisade program, including both the randomized and the open-label trials. Our objective is to better understand the drivers of both facetionol and placebo response using the substantial data collected from these studies to potentially inform optimized statistical models that consistently incorporate covariates and explanatory variables across all Palisade studies, which could anchor future weight of evidence discussions with the FDA. The analyses are ongoing with our collaborators and involve the use of their proprietary artificial intelligence and machine learning technologies to identify nonspecific responses and understand and predict susceptibility to placebo response and likelihood of response to active drug in the context of the Public Speaking Challenge study design.

Overall, the full complement of ongoing work is focused on delivering practical operational understanding, predictors of response, and enhanced statistical models with the potential to impact both Palisade 4 and our regulatory strategy based on the totality of data from the Palisade program. The open label extension portion of Palisade 3 and Palisade 4 remains ongoing and is designed to evaluate the safety and tolerability of repeated as-needed intranasal administration of facodianol 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 condition-administered Liebich 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 III Phase III study could provide important context on patient experience with repeated use over time in real-world anxiety-provoking situations the patients encounter. Together with our broader analytical work across the Palisade program, insights from open-label studies should contribute to our enhanced understanding of facetionyl's drug effect and usage patterns.

Once again, we'd like to thank the patients who participated in our Palisade studies, as well as the clinical investigators the site staff and our contract research organization for their ongoing dedication and professionalism as we complete Palisade IV and advance our broader analytical efforts As we've 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 pH 80 as refisalone. Refisalone 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 refisalone may also have therapeutic potential across other women's health indications. We are currently preparing to submit our U. S. Investigational New Drug Application, or IND for rafisalone to the U. S. FDA with a planned submission in the first half of 2026.

This IND is intended to support further potential Phase II clinical development of rafisalone in the U. S. for the treatment of moderate to severe vasomotor symptoms due to menopause, building on a previously completed placebo-controlled exploratory Phase IIA clinical trial conducted in Mexico by Ferrin 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 rafisilone 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. Moving briefly to our financial position as of December 31st, 2025, we had $61.2 million in cash, cash equivalents, and marketable securities.

During the quarter, we implemented company-wide cash preservation measures intended to enhance our operational efficiency, extend our runway, and maintain strategic flexibility across our ferry and pipeline. We believe we are well positioned to complete Palisade 4 and to advance preparations and planning for our fairing 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 Visagen to make informed decisions and responsibly advance programs with the potential to deliver meaningful value to patients and to shareholders. So I want to thank you for your continued interest in the company and your support, and we look forward to updating you on our progress in the quarters ahead.

Thank you, Sean. Operator, we would now like to open up the call for questions from the Southside analysts joining us today.

Hi, Andrew. 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. 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. that's where we do see definite differences.

Yeah thank you. Great question oh go ahead Sean no you go ahead sorry 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 locked the database and got to top line results Understood.

Yeah the change to the SAP would not change the enrollment or the planned enrollment for to study The key there is that it 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.

Understood. Okay, thank you guys. Thank you.

Thanks, Emily. Appreciate the question. So, it'll be consistent with the pattern for PALSAID-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 PALSAID-4 TLR, the randomized portion of PALSAID-4. Josh, you can address the second part.

I'm sorry I missed the second part can you rephrase that?

Yeah, I don't think we can't 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 that our training is reinforced and up-to-date with sites in terms of potential ways to minimize that in particular kind of how the protocol is followed the script is followed to the letter making sure that there's no you know chatting with the subjects as they come in you know anything that could potentially lend to you know a comfort for a subject or that could drive a higher placebo effect so it's those types of things that we're able to implement quickly based on what we see from Palisade 3 and also because we're listening to what's happening at each site through the audio recordings that we've talked about previously gives us the opportunity again to be hyper focused on feedback and any intervention where we see something deviating from the pre-script that we've put in place.

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 with high focus on placebo mitigation strategies and best practices across, especially from the really experienced sites.

Thanks, John. Appreciate the question. So, look, they... fundamentally, we believe that 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, 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 4, we'll be able 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 PAL-SAID-2 with a broader base of information from the totality of the program for the acute treatment of social anxiety disorder.

If PAL-SAID-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.

You don't comment on the blinded data, John.

Thank you.

Josh, you can address that.

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

Sure. Sure. I mean, part of what we're doing with AI and machine learning, it's potential. It's certainly not guaranteed. And what you're looking for is, are there any covariates that may have a potential fixed effect on 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 at each arm in prior studies, in PAL-3 in particular, that may give you some sort of signal? So the answer is we don't know yet. And as noted earlier, if we do make a modification to the SAP that's already been signed off by the agency, then we'd have to go back to them and socialize it with them. So So that's part of what we're trying to find out. If there isn't, then, again, we've got operational efficiencies and observations based on what we've seen across the studies that are being implemented into the PAL-4 execution.

Josh, anything you want to add on that from the teams? No, I think that captures it.

Yeah, it has to be whether, not only whether it's timely, the edtech 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.

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

Nick, are you on?

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.

That includes the pre-funded warrants, Elmer.

Not a silly question.

Mark, one more thing real quick. I just want to clarify. I think I missed focus. I think I said $61.2 million at the end of 12-31-25, where $61.8 is reflected in our queue.

Thanks, Sean.

Thank you.