Q1 2026 VistaGen Therapeutics Inc Earnings Call
Speaker #3: Good day, yone, 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.
Speaker #3: 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 head.
Speaker #4: 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 30th, 2025.
Speaker #4: It provided an overview of our progress on our lead clinical stage neuroscience programs. We encourage you to review the release and attend to, which can be found on our website's investor section.
Speaker #4: Now, before we begin, I'd like to note that we will be ing forward-looking statements regarding our business during today's call based on our current expectations and information.
Speaker #4: 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 ure.
Speaker #4: 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.
Speaker #4: 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 10Q for the period ending June 30th, 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 estor section of our website and, of course, on the SEC's website.
Speaker #4: Now, with the formalities completed, we warmly welcome the stockholders of Telside 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, Cynthia Anderson, our chief financial officer, and Josh Prince, our chief operating officer.
Speaker #4: Shawn will provide a business and clinical update and Cynthia will review our financial results. After our remarks, we will take questions from Telside Analysts.
Speaker #4: A replay of the webcast will be available in the events section of our webpage or in the events section of our investor webpage.
Speaker #4: With that, I'd now like to turn the call over to our president and CEO, Shawn Singh.
Speaker #5: 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 fairing programs that are focused on harnessing the power and the potential of nose-to-brain neural circuitry to address multiple high-prevalence disorders with currently suboptimal standards care.
Speaker #5: Our lead fairing product candidate, intranasal Fasodianal, is advancing through late phase three 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, Fasodianal has the potential to address a significant gap in the current SAD treatment landscape.
Speaker #5: As we've noted, we expect to report top-line data from our Palisade III phase three trial of Fasodianal assessing the efficacy and safety of this asset for the acute treatment of SAD, in Q4 of this year.
Speaker #5: A critical potential value inflection point in our registration-directed Palisade program for Fasodianal and SAD. Top-line results for Palisade IV are phase three trial and SAD similar to Palisade III, are expected in the first half of 2026.
Speaker #5: 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.
Speaker #5: 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 Fasodianal in support of a potential US new drug application submission to the FDA for the acute treatment of social anxiety disorder in adults.
Speaker #5: 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 Fasodianal to address the suffering felt by folks affected by social anxiety disorder.
Speaker #5: In parallel, we are advancing our KOL outreach and planning for further phase two development of iTruvone, our fairing product candidate for treatment of major depressive disorder and PH80, our hormone-free fairing product candidate for treatment of menopausal hot flashes.
Speaker #5: We expect to submit our US IND for PH80 in the fourth quarter of this year to facilitate additional phase two 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 neural circuitry-focused potential of iTruvone and PH80 to address a range of patient needs and preferences in these highly prevalent indications.
Speaker #5: Before I conclude the business update, 'd like to take a moment to welcome Alyssa Coaty, who recently joined Vistagen as our chief corporate development officer.
Speaker #5: Alyssa 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 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 Fasodianal for the acute treatment of SAD.
Speaker #5: With multiple near-term catalysts on the horizon, including a phase three 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.
Speaker #5: With that, I'll turn the call over to Cindy for a review of the financials. Cindy?
Speaker #6: Thank you, Shawn. I'll briefly highlight our financial results for the fiscal quarter ending June 30th, 2025. Research and development expenses were $11.7 million, for the quarter, as compared to $7.6 million for the same period last year.
Speaker #6: 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.
Speaker #6: Which is consistent with our growing organizational needs and strategic initiatives. Net loss attributed to common stockholders for the quarter was $15.1 million. Compared to $10.7 million in the same period last year.
Speaker #6: As of June 30th, 2025, we had $63.2 million in cash, cash equivalents, and marketable securities. As a reminder, please refer to our quarterly report on Form 10Q filed with the SEC this afternoon, with additional details and disclosures.
Speaker #6: With that, I'll turn the call back over to Shawn for closing remarks.
Speaker #4: Thanks, Cindy. At Vistagen, our mission is unwavering to redefine what's possible in neuroscience by delivering transformative therapies that harness nose-to-brain neural circuitry to restore emotional well-being and improve quality of life for patients.
Speaker #4: 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.
Speaker #4: 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 months head.
Speaker #5: Thank you, Shawn. Operator, we would now like to open up the call for questions from the Telside Analysts joining us today.
Speaker #7: Thank ou. If you'd like to ask a question, please press Start, and the one on your telephone keypad. If you'd like to withdraw your estion, you may also press Star, one again.
Speaker #7: Our first question comes from the line of Paul Matisse from Stival. The line's open.
Speaker #8: Hey, thanks y much. This is Julian on for Paul. Appreciate you all taking our estions today. I guess just first, do ou still plan to announce when you complete enrollment for the study?
Speaker #8: And if so, any estimation on when that could possibly be? And then I guess just any commentary on, you know, dropouts or retention or even conversion to the open-label extension based on what you're seeing so far?
Speaker #8: Any color would helpful. Thanks very much.
Speaker #4: Hey, thanks, Julian. Good to hear you. Yes, we will announce LPO. We, again, we're sticking with guidance that we'll see TLR in Q4. In terms of the OLE, Josh, why don't ou speak to the OLE, what we've seen is encouraging conversion rates from the randomized study into the OLE.
Speaker #9: Sure. Thanks, Shawn. Thanks, Julian. We've itely seen really good conversion from open-label or from the public speaking challenge into the open-label, even higher than we saw in Palisade I and Palisade II.
Speaker #9: Based on how we designed the studies, you know, we're seeing 80% plus of subjects moving into the open-label, and we're seeing good retention as well.
Speaker #9: 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 sixth and twelve-month requirements.
Speaker #4: Thanks, Josh. Operator, next question.
Speaker #7: Understood. Thank you. Our next question comes from the line of Andrew Tsai from Jeffries. The line's open.
Speaker #10: 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?
Speaker #10: You know, obviously, I'm sure that you'll provide SUD 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.
Speaker #10: Thanks.
Speaker #4: Yeah. Thanks, Andrew. Good to hear from you. at you'll see is similar to at we put out with respect to Palisade II. And the same thing for four, three, and four with the similar focus on the primary and the secondaries in PAL II.
Speaker #4: We had PGICs and exploratory. It's a secondary in three and four. So those are the three endpoints that would be remarking .
Speaker #7: And would you expect to see equal or equivalent efficacy by female and male? can you remind us if you did see that in the successful Palisade II study?
Speaker #4: Josh, you can go ahead and address that.
Speaker #9: Yeah. We would expect to see similar we did not see statistically significant differences between male and female in Palisade II. So we've we've not had multiple studies that we've run where male and female have been similar, in terms of response rates.
Speaker #7: And finally, do you vision Palisade III baseline SUD score to be any different from the baseline SUDs in Palisade I and II? And can you remind us what they were as well?
Speaker #7: Thank ou.
Speaker #4: Josh?
Speaker #9: Yeah. We would see a second. Yeah. As to II, 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 those numbers.
Speaker #9: Because we have similar inclusion criteria, the public speaking challenge is set up identically. We would expect it to be the same. I look up that number.
Speaker #4: The difference, remember, Andrew, is in the Palisade III and IV. The requirements for II 75s within the five-minute window in the first speech.
Speaker #7: Right. Thank you.
Speaker #4: It's different. In PAL II, it one minute. At least one minute. In order to move because remember, again, as I think we've talked , enrollment is different.
Speaker #4: And this does study design versus randomization. So 's those that advance to the visit three second speech that are included in the in the data set.
Speaker #4: Those 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.
Speaker #4: At 75, more than a little uncomfortable. At least two minutes of the five minutes during that that first speech.
Speaker #7: Great. Thank ou.
Speaker #5: And Shawn, I'll just add to that. We expect baseline to be in that similar range of, you know, roughly 80, 85, somewhere in there.
Speaker #5: For SUDs. At baseline.
Speaker #4: Yeah. 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 NICF.
Speaker #4: There's rigorous assessment clinically and then, they move through, the eligibility criteria that we've enhanced a bit in Palisade III and IV. Are making a difference, we think, to make re we ensure that we've got a sufficiently suitable population that ultimately gets randomized.
Speaker #4: So that's been consistent across the objectives from Palisade II, III, and IV.
Speaker #7: Thank you. Our next question comes from the line of Miles Minter from William Blair. The line's open.
Speaker #10: Hey, thanks. Thanks for 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?
Speaker #10: I imagine now that III is complete, you're starting to enroll in IV. And do you kind of reserve some space in that trial that if you do see something in III, that means you might want to relook at the design of IV that ou can still do that within the time?
Speaker #10: Or these are pretty much locked and loaded. There's not much room to move from an FDA regulatory perspective. And what will be will be?
Speaker #10: Thanks.
Speaker #4: 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 III and Q4 of this year and Palisade IV in the first half of '26.
Speaker #4: And they really are. They really are set. I mean, we're well down the road from the point where modifying the protocols really, we 't think there's a need to.
Speaker #4: 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.
Speaker #4: So I don't anticipate there'd be an adjustment in IV. At the basically, that's where we've looked into whether we would want to do that.
Speaker #4: The answer would be at this point, no.
Speaker #7: Okay. Cool. Thanks.
Speaker #5: And Shawn, I'll just add that we had, you know, there a staggered start with these studies. You know, it helps with the training. It helps with oversight of the studies as as each of these sites comes up to speed.
Speaker #5: 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 #4: That's a at 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 and the estigators, so that's always helpful as well.
Speaker #4: Without any protocol adjustment, it's always helpful to make sure there's rigorous adherence to the protocol. Based the recipe, that it has been laid out.
Speaker #4: So it's great. And one of the things we're ally pleased about throughout the course of this 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 before.
Speaker #4: So that subject eligibility review and the 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.
Speaker #4: At this point. So that's that's been a nice trend. And I think we expect it to continue.
Speaker #5: Operator?
Speaker #7: Thank you. Again, if you'd like to ask a estion, please press Start, and the number one on your telephone keypad. Our next question comes from the line of Elena Rios from Lucid.
Speaker #7: The line's open.
Speaker #10: Yes, good afternoon. Yes, good afternoon. Shawn, I have two questions, please. What sort of what do ou measure in the open-label phase besides safety, if anything else?
Speaker #4: Next question, too. Both questions.
Speaker #10: Question two is, I believe and correct me if I'm wrong, but there is only one other competing phase three trial ongoing by the company called Neuphoria, used to be called BioNomics.
Speaker #10: Just your opinion on that program, if you looked at that, the design, etc. And the rationale for that in SAD.
Speaker #4: Sure. I'll answer the second question first. So look, as we've ked about, you and I've had good conversations, there's not always or ever really one size fits all in mental health.
Speaker #4: So we're 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 Fasodianal is that it's non-systemic and that it's rapid onset.
Speaker #4: 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 II and in phase two.
Speaker #4: That program, you noted, and again, it's admirable that they're focused on the same sort of study design that we are, which is public speaking challenge.
Speaker #4: 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-7 nicotinic. So a bit different in that it's a systemically delivered versus the way we're dealing with Fasodianal's potential to activate neurons in the nose in about 25 milliseconds.
Speaker #4: And the olfactory bulb hub in about 250 milliseconds. So just a different approach to a widespread problem. And you know wish everybody success. I think we have a significant first mover advantage.
Speaker #4: Regardless of however we look 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.
Speaker #4: And it's a unique, specific MOA. They must think the same about their study design. So, we are happy that, of course, the FDA must have acknowledged it at the same time they moved into Phase 3.
Speaker #4: 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.
Speaker #4: With the subjective units of distress scale as a patient reported outcome. So yeah.
Speaker #10: Thank you very much for that. And in the open.
Speaker #4: Shawn. Yeah. Josh, why
Speaker #10: Yeah.
Speaker #4: 't you go ahead and speak to the open-label.
Speaker #5: Sure. Yeah. So the, 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.
Speaker #5: 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 of LSAS. So the label widths 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.
Speaker #5: 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 LSAS in that open-label study over time.
Speaker #5: So it really reinforces that point for us that you know we have a product that patients can use in the moment when they have a stressor upon them.
Speaker #5: 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.
Speaker #4: Because they're seeing more it's more confidence and more resilience. They're avoidance goes down or their stressors and that's at 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.
Speaker #4: 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.
Speaker #4: 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.
Speaker #4: 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 really because there's no binding of our drug to abuse liability receptors of opiate, nicotine, dopamine, and the like.
Speaker #4: So we're looking obviously to see that there is no hockey stick-like utilization. As people use it over a longer periods time. And I think we're very fortable with what we've seen in the open-label that Josh noted.
Speaker #4: Where the most significant TEA, he and about 500 subjects in 30-plus thousand doses was headache, 8.7%. Nothing else more than 5%. Other than COVID.
Speaker #4: So the safety profile so far established and completed studies of Fasodianal in every one of the fairings that we have in clinical stage development has just been really differentiated and remarkable versus what we know about typical standards of care.
Speaker #10: 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 II?
Speaker #4: 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.
Speaker #4: What kind 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.
Speaker #4: 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 this drug candidate is to be le to have people given the opportunity to tailor, to fit the use of the drug, to fit their life.
Speaker #4: And a 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.
Speaker #4: Other drugs out there, like benzos, you're going to get some of the kind risks and effects that people don't really want in their day-to-day life.
Speaker #4: Cognitive impairment, sedation, you know, 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 in their life's ney.
Speaker #4: And how the stressors affect them in the in the episodic nature of the disorder that they've typically built their life around.
Speaker #7: Yeah. Thanks very much for the additional call, Shawn.
Speaker #4: You bet. Great to talk to you. Thank you.
Speaker #7: Thank you. Our next question comes back from the line of Miles Minter from William Blair. The line's open.
Speaker #10: Hey, guys. I know I said I wasn't going to k a question about Palisade III, but here it is. Just in mid-June, I ink, I think you terminated a site in Pennsylvania.
Speaker #10: Can you just remind us on, like, was that related to clinical site contact at that trial site? What you did to try and remedy that?
Speaker #10: 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 clinical trial gov listing.
Speaker #10: Thanks very much.
Speaker #4: Sure. Josh, you want to ress?
Speaker #5: Yeah. Absolutely. It's a great question. You know, one the things that we're definitely doing through all of these studies is, you know, as Shawn mentioned, with our with our teams, you know, listening to everything that's happening, staying on top of subject eligibility, understanding how sites are executing the public speaking challenge.
Speaker #5: And to your point, looking at enrollment. It's a constant dialogue with the site. And there have been instances with different sites where, you know, we pause enrollment.
Speaker #5: We do retraining. Based on what we're hearing, or we have sessions with them to better understand how to get enrollment. You know, we've had sites with much lower enrollment.
Speaker #5: 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 ow at some point a site is just not a fit for the study.
Speaker #5: It could be for a multitude of reasons. We've had, you know, there are times when people turn over at a site in terms of a rater.
Speaker #5: 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've been on top of through all of our studies. You will see that kind of shifting at times, with sites in and out.
Speaker #5: 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 ir@vistagen.com or through the contact us section of our website.
Speaker #5: We also encourage you to register for email updates on our website to stay connected with the latest news, from Vistagen. Thank you for participating on our call today.
Speaker #5: 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.
Speaker #7: The meeting has now concluded. Thank you for joining. You may now disconnect.