Vistagen Therapeutics Inc (VTGN) 2026 Q1 法說會逐字稿

Good day everyone and thank you for standing by. Welcome to Vistagen Therapeutics fiscal year 2026 first quarter corporate update conference call and webcast. (Operator Instructions) At this time, I'd 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 this afternoon, we issued a press release for our fiscal year 2026 first quarter, which ended on June 30, 2025, providing an overview of our progress on our lead clinical stage neuroscience programs. We encourage you to review the release and the 10-Q, which can be found on our website's Investors section.

Now, before we begin, I'd like to 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.

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 our risks and uncertainties and factors that could affect our business and financial results are included in our first-quarter fiscal year 2026 Form 10-Q for the period ending June 30, 2025, and then future filings that we'll make with the SEC from time to time, all of which are or will be available in the Investor section of our website and, of course, on the SEC's website.

Now, with the formalities completed, we warmly welcome the 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; Cindy Anderson, our Chief Financial Officer; and Josh Prince, our Chief Operating Officer.

Sean will provide a business and clinical update, and Cindy will review our financial results. After our remarks, we will take questions from sell-side analysts.

A replay of the webcast will be available in the Events section of our webpage or in the Events section of our Investor webpage. With that, I'd now like to turn 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 3 development for the acute treatment of social anxiety disorder or SAD. With over 30 million adults affected in the US 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 3 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 3 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 US 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 for support -- and support our conviction for the exciting potential of fasedienol to address the suffering felt by folks affected by social anxiety disorder.

In parallel, we are advancing our KOL outreach and planning for further Phase 2 development of Itruvone, our pherine product candidate for treatment of major depressive disorder and PH80, our hormone-free pherine product candidate for treatment of menopausal hot flashes. We expect to submit our US IND for PH80 in the fourth quarter of this year to facilitate additional Phase 2 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 potential commercialization of fasedienol for the acute treatment of SAD.

With multiple near-term catalysts on the horizon, including a Phase 3 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, Sean. I'll briefly highlight our financial results for the fiscal quarter ending June 30, 2025. Research and development expenses were $11.7 million for the quarter as 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 as 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 cash, cash equivalents, and marketable securities. As a reminder, please refer to our quarter report on Form 10-Q filed with the SEC this afternoon with additional details and disclosures.

With that, I'll turn the call back over to Shawn for closing remarks.

Thanks Cindy. The advantage in 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 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.

(Operator Instructions) Paul Matteis, Stifel.

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.

Hey, thanks Julian. Good to hear from you. Yes, we will announce LPO. We again, we're sticking with guidance that we'll see TLR in in Q4, in terms of the OLE, Josh, once 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 open label -- or 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.

Andrew Tsai, 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 SUDS 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. Good to hear from you. What you'll see is similar to what we put out with respect to PALISADE-2 and the same thing for 4 -- 3 and 4 with a similar focus on the primary and the secondaries. In PAL-2, we had PGICs and exploratory. It's a secondary in 3 and 4. So those are the three endpoints that we'd be remarking on.

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 five-minute window in the first speech.

Right (multiple speakers) --

So it was different. In PAL-2 was one minute -- at least one 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 three 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 two minutes at least at 75, more than a little uncomfortable, at least two minutes of the five 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. Good point. But what we have seen, of course, is the more severely affected and chronically affected someone is with the disorder, and we do a lot upfront to assess that eligibility -- very strict eligibility criteria. Even before someone signs an ICF, there's rigorous assessment clinically.

And then as they move through the eligibility criteria that we've enhanced a bit in PALISADE-3 and 4 are making a difference, we think, to make sure we ensure that we've got a sufficiently suitable population that ultimately gets randomized. So that's been consistent across the objectives from PALISADE-2, 3, and 4.

Myles Minter, William Blair.

I won't bore you without trying to interrogate PALISADE-3. But on PALISADE-4, can you just comment on enrollment in that? I imagine now that 3 is complete, you're starting enrolling 4.

And do you 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 (inaudible)

Thanks, Myles. Just to clarify upfront, PALISADE-3 is still enrolling and PALISADE-4 is also enrolling. So they're both in a steady state and consistent with the guidance we gave for both. Again, PALISADE-3 in Q4 of this year and PALISADE-4 in the first half of '26.

And they really are set. I mean we're well down the road from the point where modifying the protocols, really, we don't think there's a need to, given the way that we've built in additional enhancements and additional rigor and additional surveillance. It's actually -- we're pretty pleased with the way that we've been able to integrate the enhancements.

So I don't anticipate there'd be an adjustment in 4. Basically, that's where we've looked into. Whether we would want to do that? The answer would be, at this point, no.

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

It's a great point. And there's -- there are also best practices that occur and can be leveraged into both of the studies as they go on, given the interactivity that we have with the sites and investigators. So that's always helpful as well.

Without any protocol adjustment, it's always helpful to make sure there's rigorous adherence to the protocol based on the recipe that has been laid out. So it's great.

And one of the things we're really pleased about throughout the course of these trials is our team's ability to directly oversee and interface with the sites. And we've unbundled a lot of reliance on the CROs, as we've talked about before.

So that subject eligibility review and the training in person, the ability to really have confidence that we're doing what we think we can do and anybody can do to execute efficiently these protocols, which we have the most experience of anybody at this point. So that's been a nice trend and I think we expect it to continue.

(Operator Instructions) Elena Bidros, Lucid.

Mr. Shawn, I have two questions, please. What -- what do you measure in the open-label phase besides safety, if anything else?

Next question too, both questions?

Question two is, I believe, and correct me if I'm wrong, but there is only one other competing Phase 3 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 answer the second question first. So look, as we've talked about, you and I have had good conversations, there's not always ever really one size fits all in mental health. So we're fans of anybody who can make an impact to the 30-plus million people affected by the disorder.

Obviously, what we like about the potential of fasedienol is that it's nonsystemic and that it's rapid onset and that we don't have to drive a drug through the body and into the brain to achieve the therapeutic effect that we've seen in PALISADE-2 and in Phase 2.

That program you noted, and again, it's admirable that they're focused on the same study design that we are, which is a public speaking challenge. It's different and that there really isn't a baseline setting first speech as we have in ours.

And it's also an oral alpha-7 nicotinic. So a bit different in that it's systemically delivered versus the way we're dealing with fasedienol's potential to activate neurons in the nodes in about 25 milliseconds and the olfactory bulb hub in about 250 milliseconds.

So just a different approach to a widespread problem, and we wish everybody success. I think we have a significant first-mover advantage regardless of however we look at this disorder with existing therapies and anything that might be in the pipeline. But I'm confident that we've got the right study design for our drug and its unique specific MOA, and they must think the same about their study design.

So -- but we are happy that, of course, the FDA must have acknowledged it. At the same time, they moved into Phase 3 with our design. That's comforting because it is -- there's no doubt in our mind that the public speaking challenge and the SUDS are not only the most appropriate study design to provoke anxiety consistently across sites, but also the best way to measure efficacy in an acute setting with the subjective in distress scale as a patient-reported outcome. So --

And in the open label? Yes.

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

Sure. Yes. So the -- as you mentioned, safety is the key that we're measuring there. That's the primary purpose, obviously. In addition to traditional safety and capture of adverse events, we also capture the patient withdrawal checklist.

So that's the FDA requirement to demonstrate that you don't have addictive or abusive qualities. So we're happy to be doing that based on the profile of the product that we have.

And then the key thing beyond safety with efficacy is capturing the LSAS, so the Liebowitz Social Anxiety Scale. So if you recall, that's the scale that measures, over time, what's the severity of social anxiety disorder that a patient experiences, and it has the acute anxiety as well as the avoidance piece of it.

And so we measure that monthly over time. You may recall from the prior long-term safety study that we did, one of the things that really encouraged us was we saw a drop in that LSAS in that open-label study over time.

So it really reinforces that point for us that we have a product that patients can use in the moment when they have a stressor upon them. But the more that they do that and the more success that they see, the more likely they are to see benefit over time and that's really what LSAS measures.

Because they're seeing more -- it's more confidence and more resilience, their avoidance goes down and their stressors and that's what we're looking to see and their engagement in the things that previously stressed them that they may have built their whole life around. We're looking for the potentially transformative changes that are associated with a whole new range of opportunities that we hope will develop for people over time, as they realize that they can make it through these previously stressful events without worry of judgment or humiliation or embarrassment.

And the other thing we look at in the open label also is we're looking at utilization, not only as it relates to how we can forecast forward on the commercial side, but also, it's obviously a signal as to abuse liability potential. And one of the main things we've talked about before and have established is there are no worries at the -- anything we've seen so far because there's no binding of our drug to abuse liability receptors of opiate, nicotine, dopamine, and the like.

So we're looking, obviously, to see that there is no hockey stick like utilization as people use it over longer periods of time. And I think we're very comfortable with what we've seen in the open label that Josh noted, where the most significant TEA in about 500 subjects and 30-plus thousand doses was headache, 8.7%, nothing else more than 5% other than COVID.

So the safety profile so far established in completed studies of fasedienol in every one of the pherines that we have in clinical stage development has just been really differentiated and remarkable versus what we know about typical standards of care.

And maybe just a quick follow-up, Shawn, and 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?

Yeah, it's pretty consistent. I mean, again, this is a disorder that's episodic, so it's not GAD all day every day, and really it depends on where people are in their life journey, what kind of job they have, how frequently they engage in people. Are they going back to the office? Are they at school?

We typically tend to see less utilization on the weekends when people aren't exposed to their stressors and a little more during the week depending on whether it's school or relationships or jobs, but It's pretty constant. And that's what's -- again, what we want with this drug candidate is to be able to have people given the opportunity to tailor to fit the use of the drug to fit their life.

And a lot of the reasons why existing medications fall short is you'll take an antidepressant, for example, and you're going to get the side effects regardless of whether you need it in an acute context. Other drugs out there like benzos, you're going to get some of the risks and effects that people don't really want in their day-to-day life: cognitive impairment, sedation, potential risk of addiction.

So having the ability for a patient and we'd love to see this in utilization in the open label to fit it to wherever they are on their life's journey and how the stressors affect them in the episodic nature of the disorder that they've typically built their life around.

Myles Minter, 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 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, absolutely. It's a great question. One of the things that we're definitely doing through all of these studies is, as Shawn mentioned, with our teams listening to everything that's happening, staying on top of subject eligibility, understanding how sites are executing the public speaking challenge and to your point, looking at enrollment. It's a constant dialogue with the site, and there have been instances with different sites where we pause enrollment, we do retraining based on what we're hearing or we have sessions with them to better understand how to get enrollment.

We've had sites with much lower enrollment. And so we work with them. We have three recruitment programs in place that can be customized towards sites. We do all of that work, but there are times where, at some point, a site is just not a fit for the study. It can be for a multitude of reasons.

We've had -- there's times where people turn over at a site in terms of a rater. But really, it comes down to is the site able to execute the study and provide the enrollment that we need that makes it worth keeping a site in. So it's a constant dialogue and something that we've been on top of through all these studies. So you will see that shifting at times with sites in and out.

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 e-mailing ir@vistagen.com 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 on 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.