VistaGen Therapeutics Q1 2026 Earnings Call Transcript

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Provided by Quartr
August 7, 2025

Key Takeaways

  • Positive Sentiment: Intranasal Facetinol is advancing in two late-stage Phase III trials for acute social anxiety disorder, with topline PALISADE III data expected in Q4 2025 and PALISADE IV results in 2026.
  • Positive Sentiment: Open-label extension conversion exceeds 80% with strong retention, reinforcing confidence in trial execution and long-term safety evaluation.
  • Positive Sentiment: Pipeline diversification continues with an IND submission for PH80 in Q4 2025 and Phase II development planning for Itruvone in major depressive disorder and PH80 in menopausal hot flashes.
  • Negative Sentiment: Research and development expenses rose to $11.7 million in Q1 FY26 from $7.6 million a year ago, contributing to a wider net loss of $15.1 million and highlighting elevated burn rates.
  • Neutral Sentiment: As of June 30, 2025, cash, cash equivalents and marketable securities totaled $63.2 million, providing runway for ongoing neuroscience program investments.
AI Generated. May Contain Errors.
Earnings Conference Call
VistaGen Therapeutics Q1 2026
00:00 / 00:00

There are 9 speakers on the call.

Operator

Good day everyone and thank you for standing by. Welcome to Vistagen Therapeutics Fiscal Year twenty twenty six First 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, please go ahead.

Speaker 1

Thank you, Justin. Good afternoon, everyone, and welcome to Vistagen's fiscal year twenty twenty six first quarter corporate update conference call and webcast. Earlier this afternoon, we issued a press release for our fiscal year twenty twenty six first quarter, which ended on 06/30/2025, provide 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 investor 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.

Speaker 1

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 twenty twenty six Form 10 Q for the period ending 06/30/2025, and in 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 Sean Singh, our President and Chief Executive Officer Cindy Anderson, our Chief Financial Officer and Josh Prince, our Chief Operating Officer.

Speaker 1

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 Investor webpage. With that, I'd now like to turn the call over to our President and CEO, Sean Singh.

Speaker 2

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 faring 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 Ferring product candidate, Intranasal Facadeinol is advancing through late Phase III development for the acute treatment of social anxiety disorder or SAD. With over thirty million adults affected in The US and no FDA approved acute pharmacologic therapy, Facadeinol has the potential to address a significant gap in the current SED treatment landscape.

Speaker 2

As we've noted, we expect to report top line data from our PALISADE III Phase III trial of Facadeinol 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 Facadeinol and SAD. Top line results for PALISADE IV, our Phase III trial in SAD similar to PALISADE III, are expected in the 2026. Both PALISADE III and PALISADE IV involve the same public speaking challenge study design and primary efficacy endpoint as our successful PALISADE II trial reported previously. We believe either PALISADE III or PALISADE IV, if successful, together with the positive results from PALISADE II, may establish substantial evidence of effectiveness of fascadinol in support of a potential US new drug application submission to the FDA for the acute treatment of social anxiety disorder in adults. 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 Facetinol to address the suffering felt by folks affected by social anxiety disorder.

Speaker 2

In parallel, we are advancing our KOL outreach and planning further Phase II development of Itruvone, our Ferrene product candidate for treatment of major depressive disorder, and PH80, our hormone free Ferrene product candidate for treatment of menopausal hot flashes. We expect to submit our US IND for PH-eighty 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 non systemic neurocircuitry focused potential of Vitruvone 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 Alissa Cote, who recently joined Visagen as our Chief Corporate Development Officer. Alissa brings extensive experience in strategic planning, commercial execution, and corporate development across the biopharma sector.

Speaker 2

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 Visagen's growth as we continue to advance our neuroscience pipeline and prepare for potential commercialization of Facetiol 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?

Speaker 3

Thank you, Sean. I'll briefly highlight our financial results for the fiscal quarter ending 06/30/2025. Research and development expenses were $11,700,000 for the quarter as compared to $7,600,000 for the same period last year, reflecting our continued investment in our PALSAID program. General and administrative expenses were $4,400,000 as compared to $4,600,000 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 $15,100,000 compared to $10,700,000 in the same period last year.

Speaker 3

As of 06/30/2025, we had $63,200,000 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 with additional details and disclosures. With that, I'll turn the call back over to Sean for closing remarks.

Speaker 2

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.

Speaker 1

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

Operator

Thank Our first question comes from the line of Paul Matisse from Stifel. The line is open.

Speaker 4

Hey, thanks very much. 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?

Speaker 4

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 very much.

Speaker 2

Hey, 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.

Speaker 5

Sure. Thanks, Sean. Thanks, Julian. We've definitely seen a really good conversion from open label or from the public speaking challenge into the open label even higher than we saw in PALISADE one and PALISADE two based on how we designed the studies. We're seeing 80% plus of subjects moving into the open label and we're seeing good retention as well.

Speaker 5

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 six and twelve month requirements.

Speaker 2

Thanks, Josh.

Speaker 1

Operator, next question.

Speaker 5

Thank you. Our next question comes from the line of Andrew Stein from Jefferies. Your line is open.

Speaker 6

Hi, good afternoon. Thanks for taking our questions. Appreciate the updates. So in the top line data in Q4, what do you envision sharing in your press release as well as the company slides? Obviously, I'm sure that you'll provide such scores and AE breakdown, but do you plan to share efficacy kinetics over time, secondary endpoints as well such as PGIC and LSATs and so forth?

Speaker 6

Thanks.

Speaker 2

Thanks Andrew, good to hear from you. What you'll see is similar to what we put out with respect to PALI SID II and the same thing for four, three and four with the similar focus on the primary and the secondaries. In PAL II, we had PGICs and exploratory, it's a secondary in three and four. So those are the three endpoints that we'd be remarking on.

Speaker 6

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 II study?

Speaker 2

Josh, well you can go ahead and address that.

Speaker 5

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

Speaker 6

And finally, do you envision PALISADE III baseline SUDS score to be any different from the baseline SUDS in PALISADE I and II? Can you remind us what they were as well? Thank you.

Speaker 2

Josh?

Speaker 5

We would expect them. We as to two. Yeah, 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 public speaking challenge is set up identically. We would expect it to be the same.

Speaker 5

I can look up that number.

Speaker 2

The difference, remember, Andrew, is in PALSADE three and four, the requirements for, two seventy five is within the five minute window in the first speech.

Speaker 5

Right. Thank you. It's different,

Speaker 2

and PAL two was at least one minute in order to move. Because remember again, as I think we've talked about enrollment is different and this does study design versus randomization. So it's those that advance to the VISIT-three second speech that are included in dataset, 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.

Speaker 6

Great, thank you.

Speaker 5

And Sean, would just add to that. We expect baseline to be in that similar range of roughly eighty, eighty five, somewhere in there for SUDs at baseline.

Speaker 2

Yeah, good point. 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 PALCE three and four are making a difference, we think to make sure we ensure that we've got a sufficiently suitable population that it ultimately gets randomized. So that's been consistent across the objectives from PALISADE two, three and four.

Operator

Thank you. Next question comes from the line of Miles Minter from William Blair. Your line is open.

Speaker 7

Hey. Thanks taking the quick question. I won't bore you with trying to interrogate PALISADE III. But on PALISADE IV, can you just comment sort of on enrollment in that? I imagine now that III is complete, you're starting enrolling IV.

Speaker 7

And do you kind of reserve some space in that trial that if you do see something in three, that means you might want to relook at the design of four 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.

Speaker 2

Thanks, Miles. Just to clarify upfront, PALISADE III is still enrolling and PALISADE IV is also enrolling. So they're both in a steady state and consistent with the guidance we gave for both, again, PALISADE three in Q4 of this year and PALISADE four in the '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.

Speaker 2

It's actually 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 for. Basically, that's where we've looked into whether we would want to do that. The answer would be at this point, no.

Speaker 7

Okay, cool. Thanks.

Speaker 5

And Sean, would just add that we had, you know, there was a staggered start with these studies. You know, it helps with training and helps with oversight of the studies as each of these sites comes up to speed, but we would expect that staggered start to, you know, it's on the front end and it'll play out on the back end as well.

Speaker 2

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

Speaker 2

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.

Speaker 1

Operator?

Speaker 8

Thank you.

Operator

Our next question comes from the line of Elena Bidros from Lucid. The line is open.

Speaker 5

Yes, good

Speaker 8

afternoon. I have two questions, please. What sort of what do you measure in the open label phase besides safety, if anything else?

Speaker 2

Next question two, both questions?

Speaker 8

Question two is, I believe, and correct me if I'm wrong, but there is only one other competing phase three trial ongoing by a company called Neuphoria, used to be called BioNomics. Just your opinion on that program, if you looked at that design, etcetera, and the rationale for that in SAD.

Speaker 2

Sure, I'll answer the second question first. So look, as we've talked about, you and I've had good conversations, there's not always or ever really one size fits all in mental health. So, fans of anybody who can make an impact to the thirty plus million people affected by the disorder. Obviously, what we like about the potential of Facetinol is that it's non systemic and it's rapid onset, 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 two and in phase two. That program you noted, again, it's admirable that they're focused on the same sort of study design that we are, which is public speaking challenge.

Speaker 2

It's different, and that there really isn't a baseline setting for speech as we have in ours. And it's also an oral alpha-seven nicotinic. So a bit different in that it's systemically delivered versus the way we're dealing with Facetiol's potential to activate neurons in the nose in about twenty five milliseconds, and the olfactory bulb hub in about two fifty milliseconds. So, just a different approach to a widespread problem. And, you know, we wish everybody success.

Speaker 2

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 course, the FDA must have acknowledged it at the same time they moved into phase three with our design. That's comforting because 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 Insert Distress Scale as a patient reported outcome.

Speaker 8

Yeah, thank you very much for that. In the open So, Josh, label,

Speaker 2

why don't you go ahead Sure, and speak to the open

Speaker 5

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

Speaker 5

And then the key thing beyond safety with efficacy is capturing a VLSAS, so the Leibowitz Social Anxiety Scale. So if you recall, that's the scale that measures, you know, over time what's the severity of social anxiety disorder that a patient experiences and it has kind of 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 LSATs 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.

Speaker 5

And that's really what LSAS measures.

Speaker 2

Because they're seeing more, it's more confidence and more resilience. Their avoidance goes down or 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 kind of 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 anything we've seen so far, really because there's no binding of our drug to abuse liability receptors of opiate, nicotine, dopamine and the like.

Speaker 2

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 eight point seven percent, nothing else more than five percent other than COVID. So, the safety profile so far established and completed studies of fascadine all in every one of the pharynx that we have in clinical stage development has just been really differentiated and remarkable versus what we know about typical standards of care.

Speaker 8

And maybe just a quick follow-up, Sean. 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 II?

Speaker 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 get the side effects regardless of whether you need it in an acute context.

Speaker 2

Other drug drugs out there like benzos, you're going to get some of the kind of 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 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.

Speaker 8

Yeah, thanks very much for the additional color.

Speaker 2

You bet, great to talk to you, thank you.

Operator

Thank you. Our next question comes back from the line of Miles Minter from William Blair. Your line is open.

Speaker 7

Hey, guys. I know I said I wasn't going to ask a question about PALISADE III, 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?

Speaker 7

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? Thanks very much.

Speaker 2

Sure. Josh, you want to address?

Speaker 5

Yeah, absolutely. It's a great question. You know, one of the things that we're definitely doing through all of these studies is, as Sean 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.

Speaker 5

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 you know at some point a site is just not a fit for the study. It can be for a whole multitude of reasons. We've had you know there's times where you know people turn over at a site in terms of a rater but really it comes down to you know is the site able to execute the study and provide the enrollment that we need that makes it worth keeping a site in.

Speaker 5

So it's a constant dialogue and something that we're you know been on top of through all these studies. So you will see that kind of shifting at times with sites in and out.

Speaker 1

Thank you. 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 irvistagen dot com or through the contact us section of our website. We also encourage you to register for email updates on our website to stay connected with the latest news from Vistagen.

Speaker 1

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.

Operator

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

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