Good day, everyone, and thank you for standing by. Welcome to Vistagen Therapeutics Fiscal Year 2026 First Quarter Corporate Update Conference Call and Webcast. Please note that today's call is being recorded. At this time, I would like to turn the call over to your host, Mark McPartland, Senior Vice President, Investor Relations at Vistagen. Mark, please go ahead.

Thank you, Justin. Good afternoon, everyone, and welcome to Vistagen's Fiscal Year 2026 First Quarter Corporate Update Conference Call and Webcast. Earlier today, we released a press announcement regarding our fiscal year 2026 first quarter, which concluded on June 30, 2025, detailing our advancements in our primary clinical stage neuroscience programs. We encourage you to review the announcement and the 10-Q, available in the Investors section of our website. Before we begin, I want to point out that we will be making forward-looking statements about our business during this call based on our current expectations and information. These forward-looking statements are valid only as of today. Unless required by law, we do not undertake any obligation to update any forward-looking statements made today or in the future. It's important to note that forward-looking statements carry risks and uncertainties, and our actual outcomes may significantly differ from those anticipated in any forward-looking statements we present today. Additional details regarding our risks and uncertainties, along with factors that could impact our business and financial outcomes, are outlined in our first quarter fiscal year 2026 Form 10-Q for the period ending June 30, 2025, and in future SEC filings, all of which can be accessed in the Investors section of our website and on the SEC's website. Now that we're through the formalities, we warmly welcome stockholders, sell-side analysts, and others interested in our programs and progress. I'm joined today by Shawn Singh, our President and CEO; Cindy Anderson, our CFO; and Josh Prince, our COO. Shawn will provide an update on our business and clinical progress, while Cindy will discuss our financial results. After our remarks, we will open the floor for questions from sell-side analysts. A replay of the webcast will be accessible in the Events section of our Investor webpage. With that, I would like to hand the call over to our President and CEO, Shawn Singh.

Thank you, Mark, and good afternoon, everyone. We had another very productive quarter advancing the lead late-stage clinical programs in our neuroscience pipeline, our intranasal pherine programs that are focused on harnessing the power and the potential of nose-to-brain neurocircuitry to address multiple high-prevalence disorders with currently suboptimal standards of care. Our lead pherine product candidate, intranasal fasedienol, is advancing through late Phase III development for the acute treatment of social anxiety disorder, or SAD. With over 30 million adults affected in the U.S. and no FDA-approved acute pharmacologic therapy, fasedienol has the potential to address a significant gap in the current SAD treatment landscape. As we’ve noted, we expect to report top line data from our PALISADE-3 Phase III trial of fasedienol assessing the efficacy and safety of this asset for the acute treatment of SAD in Q4 of this year, a critical potential value inflection point in our registration-directed PALISADE program for fasedienol and SAD. Top line results for PALISADE-4, our Phase III trial in SAD similar to PALISADE-3 are expected in the first half of 2026. Both PALISADE-3 and PALISADE-4 involve the same public speaking challenge study design and primary efficacy endpoint as our successful PALISADE-2 trial reported previously. We believe either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of effectiveness of fasedienol in support of a potential U.S. new drug application submission to the FDA for the acute treatment of social anxiety disorder in adults. The enthusiasm and the interest in our PALISADE program continue to reinforce the significant unmet clinical need for innovation and support our conviction for the exciting potential of fasedienol to address the suffering felt by those affected by social anxiety disorder. In parallel, we are advancing our KOL outreach and planning for further Phase II development of Itruvone, our pherine product candidate for treatment of major depressive disorder and PH80, our hormone-free pherine product candidate for the treatment of menopausal hot flashes. We expect to submit our U.S. IND for PH80 in the fourth quarter of this year to facilitate additional Phase II development. Depression and women's health remain among the most underserved areas in medicine, and we are eager to further advance the innovative nonsystemic neurocircuitry-focused potential of Itruvone and PH80 to address a range of patient needs and preferences in these highly prevalent indications. Before I conclude the business update, I'd like to take a moment to welcome Elissa Cote, who recently joined Vistagen as our Chief Corporate Development Officer. Elissa brings extensive experience in strategic planning, commercial execution, and corporate development across the biopharma sector. We're excited to have her on board and look forward to the important contributions she'll make as we move into the next phase of Vistagen's growth as we continue to advance our neuroscience pipeline and prepare for the potential commercialization of fasedienol for the acute treatment of SAD. With multiple near-term catalysts on the horizon, including a Phase III data readout in Q4 and a pipeline of differentiated product candidates in high prevalence markets, we remain optimistic about our ability to deliver long-term value to patients and stockholders. With that, I'll turn the call over to Cindy for a review of the financials. Cindy?

Thank you, Shawn. I'll briefly highlight our financial results for the fiscal quarter ended June 30, 2025. Research and development expenses were $11.7 million for the quarter compared to $7.6 million for the same period last year, reflecting our continued investment in our PALISADE program. General and administrative expenses were $4.4 million compared to $4.6 million for the same period last year, which is consistent with our growing organizational needs and strategic initiatives. Net loss attributable to common stockholders for the quarter was $15.1 million compared to $10.7 million in the same period last year. As of June 30, 2025, we had $63.2 million in cash, cash equivalents, and marketable securities. As a reminder, please refer to our quarterly report on Form 10-Q filed with the SEC this afternoon for additional details and disclosures. With that, I'll turn the call back over to Shawn for closing remarks.

Thanks, Cindy. At Vistagen, our mission is unwavering to redefine what's possible in neuroscience by delivering transformative therapies that harness nose-to-brain neurocircuitry to restore emotional well-being and improve quality of life for patients. With a diverse and innovative pipeline now covering multiple large market indications with suboptimal standards of care, we're entering one of the most exciting and potentially transformative phases in our company's evolution. We extend our sincere thanks to our stockholders, partners, investigators, and especially the patients participating in our trials. Your continued enthusiasm and support drives our progress, and we look forward to sharing meaningful clinical milestones in the months ahead.

Thank you, Shawn. Operator, we would now like to open up the call for questions from the sell-side analysts joining us today.

Our first question comes from Paul Matteis from Stifel.

This is Julian on for Paul. Appreciate you all taking our questions today. I guess just first, do you still plan to announce when you complete enrollment for the study? And if so, any estimation on when that could possibly be? And then I guess just any commentary on dropouts or retention or even conversion to the open-label extension based on what you're seeing so far? Any color would be helpful.

Thanks, Julian. Good to hear from you. Yes, we will announce LPO. Again, we're sticking with guidance that we'll see TLR in Q4. In terms of the OLE, Josh, why don't you speak to the OLE? What we've seen is encouraging conversion rates from the randomized study into the OLE.

Sure. Thanks, Shawn. Thanks, Julian. We've definitely seen really good conversion from the public speaking challenge into the open label, even higher than we saw in PALISADE-1 and PALISADE-2 based on how we design the studies. We're seeing 80% plus of subjects moving into the open label, and we're seeing good retention as well. So the assumptions that we had in place around people continuing in the open label have held up, and so that's good. And it's moving us towards the ICH requirements that we need for total exposures, but especially the 6 and 12-month requirements.

Our next question comes from the line of Andrew Tsai from Jefferies.

Appreciate the updates. So in the top line data in Q4, what do you envision sharing in your press release as well as the accompanying slides? Obviously, I'm sure that you'll provide SAT scores and AE breakdown, but do you plan to share efficacy kinetics over time, secondary endpoints as well, such as PGIC and LSAS and so forth?

Thanks, Andrew. It's great to hear from you. What you'll see will be similar to what we released regarding PALISADE-2, and the same applies to studies 3 and 4, focusing on the primary and secondary endpoints. In PAL-2, we had PGICs and exploratory endpoints, while in studies 3 and 4, it will be secondary endpoints. So those are the three endpoints we will be discussing.

And would you expect to see equal or equivalent efficacy by female and male? And can you remind us if you did see that in the successful PALISADE 2 study?

Josh, you can go ahead and address that.

Yes. We would expect to see similar. We did not see statistically significant differences between male and female in PALISADE-2. So we've now had multiple studies that we've run where male and female have been similar in terms of response rates.

And finally, do you envision PALISADE-3 baseline SUDS score to be any different from the baseline SUDS in PALISADE 1 and 2? And can you remind us what they were as well?

Josh?

Yes, as to 2, I have to look at that. I don't have that off the top of my head, but we would expect them to be similar in terms of those numbers because we have similar inclusion criteria, the post-speaking challenge is set up identically. We would expect it to be the same. I can look up that number.

The difference, remember, Andrew, is in PALISADE-3 and 4, the requirements for 275 is within the 5-minute window in the first speech.

Right...

So it was different. In PAL-2 was at least 1 minute in order to move. Because remember, again, as I think we've talked about, enrollment is different in this study design versus randomization. So it's those that advanced to the visit 3 second speech that are included in the data set. Those are the ones who are randomized. So they have to be sufficiently stressed in the first speech in order to qualify for randomization, and that's set at the 2 minutes at least 75, more than a little uncomfortable, at least 2 minutes of the 5 minutes during that first speech.

And Shawn, I would just add to that, we expect baseline to be in that similar range of roughly 80, 85, somewhere in there per SUDS at baseline.

Yes, that's a good point. What we have observed is that the more severely and chronically someone is affected by the disorder, we conduct extensive assessments upfront to evaluate eligibility, with very strict criteria even before someone signs an informed consent form. There is a rigorous clinical assessment. As they progress through the enhanced eligibility criteria in studies PALISADE-3 and 4, we believe these improvements are ensuring that we have a suitably qualified population for randomization. This approach has remained consistent across the objectives in PALISADE-2, 3, and 4.

Our next question comes from the line of Myles Minter from William Blair.

I won't bore you without trying to interrogate PALISADE-3. But on PALISADE-4, can you just comment sort of on enrollment in that? I imagine now that 3 is complete, you're starting to enroll 4. And do you kind of reserve some space in that trial that if you do see something in 3 that means you might want to relook at the design of 4 that you can still do that within the time? Or these are pretty much locked and loaded. There's not much room to move from an FDA regulatory perspective and what will be?

Thanks, Myles. To clarify, both PALISADE-3 and PALISADE-4 are actively enrolling. This is consistent with our previous guidance, with PALISADE-3 expected to complete in Q4 of this year and PALISADE-4 in the first half of 2026. We are confident in the current design and don't anticipate any need for protocol modifications. We have successfully integrated enhancements into the trials and are satisfied with their progress. Therefore, at this time, we do not see a reason to adjust the study for PALISADE-4.

And Shawn, I would just add that we had a staggered start with these studies. It helps with training and oversight as each of these sites comes up to speed. But we would expect that staggered start to be on the front end and play out on the back end as well.

It's a great point. There are also best practices that can be utilized throughout both studies, thanks to the interactivity we have with the sites and investigators. This is beneficial without changing the protocol. It's important to ensure strict adherence to the established protocol. One of the aspects we're particularly pleased with during these trials is our team's capability to directly oversee and communicate with the sites. We've reduced our dependence on the CROs, as we've mentioned before. This includes subject eligibility reviews and in-person training, which assures us that we are executing these protocols efficiently, something we have more experience with than anyone else at this point. This has been a positive trend, and we anticipate it will continue.

Our next question comes from the line of someone from Lucid.

Shawn, I have two questions. Besides safety, what else do you measure in the open-label phase?

Next question, 2, both questions?

Question 2 is, I believe, and correct me if I'm wrong, but there is only one other competing Phase III trial ongoing by the company called Neuphoria, used to be called Bionomics. Just your opinion on that program, if you looked at the design, et cetera, and the rationale for that in SAD?

Sure. I'll address the second question first. As we've discussed, mental health solutions are not one-size-fits-all. We appreciate any effort that helps the over 30 million people affected by these disorders. What attracts us to fasedienol is its nonsystemic nature, rapid onset, and ability to produce therapeutic effects without needing to process through the body and into the brain, as evidenced in PALISADE-2 and Phase II trials. The program you mentioned is commendable for utilizing a similar study design focused on public speaking challenges, but it lacks the baseline measurement we have. Additionally, their approach involves an oral alpha-7 nicotinic, which is systemically delivered, unlike fasedienol that targets neurons in just 25 milliseconds and the olfactory bulb in about 250 milliseconds. This represents a different strategy for addressing a widespread issue, and we wish them success. We believe we hold a significant first-mover advantage over existing therapies and anything in development, but I am confident in our study design that suits our drug's unique mechanism of action. They likely have confidence in theirs as well. It's reassuring that the FDA has acknowledged our efforts, especially as they have moved into Phase III with our design. We believe the public speaking challenge and the subjective distress scale are the most effective ways to consistently provoke anxiety across various sites and measure efficacy in acute settings through patient-reported outcomes.

And in the open label? Yes.

Josh, why don't you go ahead and speak to the open label?

Certainly. Safety is our primary focus, as you mentioned. We assess not only traditional safety and adverse events but also include a patient withdrawal checklist, which is essential for demonstrating the absence of addictive or abusive qualities in accordance with FDA requirements. We are pleased to demonstrate this based on our product’s profile. Additionally, beyond safety, we are focused on efficacy, particularly by capturing the Liebowitz Social Anxiety Scale (LSAS). This scale measures the severity of social anxiety disorder over time, including both acute anxiety and avoidance behaviors. We assess this monthly. From our previous long-term safety study, we were encouraged to observe a decline in LSAS scores over time during the open-label study. This reinforces our belief that our product is beneficial for patients during moments of stress, as the more they use it and experience positive outcomes, the more likely they are to see ongoing benefits, which is what the LSAS indicates.

They are experiencing increased confidence and resilience, which leads to a reduction in avoidance behaviors and stressors. This is what we're aiming to observe in their engagement with previously stressful aspects of their lives. We seek transformative changes that open up new opportunities for individuals as they come to understand that they can navigate these stressors without fear of judgment or embarrassment. Additionally, in the open label study, we assess utilization not just to project future commercial success but also as an indicator of potential abuse liability. Importantly, we have established that there are no concerns regarding abuse liability because our drug does not bind to the receptors associated with substances like opioids or nicotine. We expect to see consistent utilization over extended periods. From the open label findings, particularly noted by Josh, the most significant adverse event in around 500 subjects who received over 30,000 doses was headache, reported at 8.7%, with no other events exceeding 5% besides COVID. The safety profile we have observed so far in completed studies of fasedienol across all clinical stages has been notably distinguished and impressive compared to typical standards of care.

And maybe just a quick follow-up, Shawn. Since it's an open-label study, are you seeing anything that is similar in terms of utilization pattern of what you've seen in PALISADE-2?

Yes, it's quite consistent. This disorder is episodic, so it's not present every day all the time. It really varies based on where individuals are in their lives, their jobs, and how often they interact with others. For instance, we generally notice lower usage on weekends when people are away from their stressors and slightly increased usage during the week based on school, relationships, or work. However, it remains relatively constant. Our goal with this drug candidate is to enable individuals to customize their usage to suit their lifestyles. Many current medications are ineffective because you take an antidepressant and experience side effects whether or not it's needed in a specific situation. Other medications, like benzodiazepines, come with risks and effects that people don’t want in their everyday lives, such as cognitive impairment, sedation, or potential addiction. Therefore, we appreciate seeing patients adapt their usage according to their personal circumstances and how their stressors influence the episodic nature of the disorder that often shapes their lives.

Our next question comes back from the line of Myles Minter from William Blair.

I know I said I wasn't going to ask a question about PALISADE-3, but here it is. Just in mid-June, I think, you terminated a site in Pennsylvania. Can you just remind us on like was that related to clinical site conduct at that trial site? What you did to try and remedy that? Was that due to enrollment or something? I'm just trying to understand what the kind of rules of thumb here are for keeping a trial site in versus terminating, as I see there on the ClinicalTrials.gov listing?

Sure. Josh, do you want to address?

Yes, that's a great question. We are actively engaged in monitoring all aspects of our studies. As Shawn mentioned, our teams are closely listening to what is happening, staying informed about subject eligibility, and evaluating how sites are handling the public speaking challenge and enrollment. We maintain a continuous conversation with the sites, and there have been times when we paused enrollment or conducted retraining based on feedback or held sessions to better understand how to improve enrollment. Some sites have had significantly lower enrollment, and we collaborate with them accordingly. We have three recruitment programs that can be tailored to specific sites. However, there are occasions when a site may not be suitable for the study due to various reasons, including staff turnover. Ultimately, the key factor is whether the site can effectively execute the study and provide the necessary enrollment to justify their participation. We consistently monitor this throughout our studies, leading to adjustments in site participation as needed.

Thank you, everyone. Operator, this concludes our time for questions today. If you have any additional questions, please don't hesitate to contact us by emailing [email protected] or through the Contact Us section of our website. We also encourage you to register for e-mail updates on our website to stay connected with the latest news from Vistagen. Thank you for participating in our call today. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing process. This concludes the call. Have a tremendous day.

The meeting has now concluded. Thank you all for joining. You may now disconnect.