VistaGen Therapeutics, Inc. Price & Performance (VTGN)

Now with the formalities complete, we warmly welcome our stockholders, sell side analysts, and others interested in our programs and progress. I'm joined on our call today by Sean Singh, our President Chief Executive Officer, Cindy Anderson, our Chief Financial Officer Josh Prince, our Chief Operating Officer Sean will discuss recent highlights in our lead neuroscience programs and Cindy will discuss our fiscal third quarter financial results. After our prepared remarks, as the operator has already noted, there will be a brief opportunity for questions from the sell side analysts participating on the call today. As a reminder, this call is being webcast and will be available for replay after completion. The replay link can also be found on our website's Investors section under Events. I will now turn the call over to our President and Chief Executive Officer, Sean Thank you, Mark, and good afternoon, everyone. Thank you for joining our call. As many of you know, we are developing a new class of intranasal product candidates that are called pharynes. And these are designed to harness the power and the potential of nose to brain neurocircuitry to achieve a broad and diverse range of therapeutic benefits without requiring systemic absorption, or binding to neurons in the brain.

So let me start by discussing our most advanced ferrene, Facedionol, and our ongoing registration directed PALISADE Phase III program for that asset for the acute treatment of social anxiety disorder or S Currently, as I've mentioned before, there is no FDA approved medication for the treatment for the acute treatment of SAD. Which is a very serious and a potentially life threatening condition that's recognized by the FDA. And one that post COVID is estimated to affect over thirty million adults in The U. S. Who struggle with intense and debilitating anxiety and fear of Embarrassment humiliation, judgment, when they're dealing with stressful social and performance situations. And with Facedienol, our goal is to address this critical and very long neglected treat GAAP by providing a novel, convenient, safe and rapid onset as needed solution to help individuals who are affected by SAD face the challenges in their everyday lives. In 2023, we reported positive results from our PALISADE two Phase three trial, Fasodinol, for the acute treatment of SAD. In 2024, to build on the success of PALISADE-two in our registration directed Phase three program for Fasciodinol, we initiated PALISADE III and PALISADE four as Phase three trials.

Each designed as a replicate public speaking challenge with the same primary endpoint and in each case an open label extension. And today, I'm pleased to report that both PALISADE three and PALISADE four are currently continuing to advance towards expected top line results later this year. In addition, we recently announced initiation and enrollment of the first subjects in an exploratory Phase two repeat dose study of facetionol in SAD And besides the addition of a repeat dose arm it is similar in design to our Phase three PALSAID three and PALISADE four studies for the acute treatment of adults with SAD. Again including in open label [indiscernible] [indiscernible] With these studies advancing, we believe either PALISADE three or PALISADE IV is successful Together with Palisade two, may establish substantial evidence of the effectiveness of facetionol in support of a potential new drug application submission to the U. S. FDA for the acute treatment of SAD in adults In addition to advancing our facetionol Phase three program in SAD, we made progress in our development programs for iTruvone, as a standalone treatment for major depressive disorder and PH-eighty as a non hormonal non systemic treatment of vasomotor symptoms or hot flashes that are due to menopause.

Currently, we are preparing and planning for potential Phase 2b clinical development of iTruvone in The U. S. And we are conducting customary non clinical studies that we need to planned submission of an investigational new drug application or IND to the U. S. FDA to facilitate further Phase II clinical development PH-eighty for menopausal hot flashes. I'm now going to turn to some other corporate highlights. We recently reported positive results from an exploratory Phase 2a trial of PH284 in cancer CACEXIA.

PH284 is our fifth clinical stage neurocircuitary focused intranasal fairing product candidate with a positive efficacy single signal and differentiated safety. In all the studies that have been completed to date. And this recent announcement underscores [indiscernible] and diversity of our clinical stage ferritin pipeline. With five innovative non systemic investigational intranasal faring product candidates all supported by positive Phase two And in the case of acetylenol, one Phase three positive clinical study the clinical data and the placebo like tolerability that we seen across all these studies gives us tremendous confidence in the range and the diversity and the therapeutic potential of our neuroscience pipeline. The positive studies from our five fairings with clinical data across various indications drive our optimism and our confidence in the power and the promise of nose to brain neurocircuitry and the enormous potential of our intranasal farrowing pipeline.

As always, we are optimistic about the potential of our product candidates to address multiple significant treatment gaps and to transform standards of care to improve lives.

I'll now hand it over to Cindy Anderson, our CFO, to summarize our financials from the last quarter. Cindy? Thank you, Sean.

As Sean mentioned, I will highlight a few financial results from our fiscal year twenty twenty five third quarter. Research and development expenses were $11,300,000 for the quarter ended 12/31/2024, compared to $4,500,000 for the same period last year.

The increase in R and D expenses was primarily due to increase in research, development and contract manufacturing expenses related to our PALISADE Phase three program for pacinidadol and SAD as well as IND enabling programs for iTruvone and MDD and PH-eighty for the treatment of menopausal hot flashes. General and administrative expenses were 4,000,000 for the quarter ended 12/31/2024 compared to $3,800,000 for the same period last year. The increase in G and A expenses was primarily due to increased headcount. Our net loss attributable to common stockholders was $14,100,000 for the quarter ended December 31, 2024, compared to $6,400,000 for the same period last year.

As of 12/31/2024, we had $88,600,000 in cash, cash equivalents and marketable securities. I will now hand the call back over to Sean.

Thanks, Cindy.

So we are more optimistic than ever here at VistoGen with five clinical stage ovarian product candidates, each with positive patient data and differentiated safety we have now multiple opportunities to disrupt treatment paradigms enhance patient outcomes and create value for our stockholders. So I'd like to thank you all once again for your continued interest and support in what we're doing here at Vistagen. And on behalf of everyone on our team, we look forward to keeping you updated on our progress. Operator, we'd like to now open the call to questions from the sell side analysts who are participating today.

Our first question coming from the line of Andrew Tsai with Jefferies. Your line is now open.

Hey, thanks. Congrats on the quarter. I just this is Matt on for Andrew. And I just wanted to ask real quick, if you're confident that the data from PALISADE three and four will still be in the second half of this year or are you expecting any delays And also I've got to follow on to that after this. Hey, thanks, Matt. Good to talk to you. So as we've guided, we're confident that we'll see data from both PAL3 and PAL4 in 2025. So no change in that guidance. Okay, perfect. And then I guess Is there anything that keeps you up at night in terms of what more could be done on these studies in terms of execution?

Interesting question. No, it doesn't keep me up at night because the enhanced team that we've got executing on these studies, especially surveillance associated with rigors adherence to the protocol These are all very important execution related initiatives that we've gone in place, reduced reliance [indiscernible] on CRO surveillance, expansion of our internal team and just the way that we've been seeing the the conduct of the studies with the rigorous training even upfront of any enrollment at any of the sites It's just actually been significantly different than what we've seen in the past in a very positive [indiscernible] Josh Prince is on the line with me. Josh, why don't you go ahead and say a few things? You are driving a lot of the execution. Sure. Thanks, Tom. It is a very interesting question and actually to your point, we have more More visibility and into what's happening with these studies than we did before running PALISADE-one and two in the pandemic and with the enhancements that we've put in place, And so if anything, I would say it's easier to sleep at night now than it was back then without COVID in place, with masks down, with the review that we have of subject to eligibility, sure that scales are administered properly making sure that The rigorous public speaking challenge script is followed to the T and then having the ability to do quick interaction and retraining with sites if they start to deviate from that protocol.

So feel like we're these studies the best chance we could have success with those changes.

Fantastic. And then also you're starting to see a little bit we're starting to see a little bit more competition in terms of novel drugs for social anxiety disorder. Can you talk about how you think about the competition and how fast and TYML doesn't have Is immune to this competition? Thanks. Thanks for the question, Matt.

Unfortunately, we've got a robust market here in The United States in terms of the number of people affected by the disorder over thirty million a lot of adults that struggle from time to time with what most people consider everyday social and performance situation. So thing always is the case of no psychiatry. There's no one size fits all. And it's also the case certainly that there's plenty of room for a lot of treatments to come into play to try to make a difference. One very major difference with this pipeline and this is not just as the facetional for SAD, but it's for up and down the pipeline in each of the standards of care the treatment paradigms currently we're trying to disrupt whether it's depression, whether it's menopausal hot flashes or certainly SAD. Is that it's the mechanistic difference. So being able to rely on nose to brain neural circuitry and having a pipeline of drugs that don't have to go through your whole body that are activating neurons in your nose within milliseconds that project to neurons at the olfactory bulb neurons at the base of the brain and then project to different regions of the brain to achieve their different therapeutic outcomes.

A critical distinction. There's no other drug approved that has this kind of mechanism of action.

And what's important about that is it doesn't rely on the case like say an oral systemic where you've got to occupy and thread the needle just right of receptors in the brain one or two that are associated with different indications, depression, for example. So we think we've got a very unique mechanistic approach to a broad range of therapeutic areas where we've just not seen much of anything. There hasn't been a single drug approved in SCD for a long time. And the same thing in terms of menopausal hot flashes, depression, nothing with the kind of non systemic and rapid onset approaches that we're trying to to achieve in the clinical studies we've seen. So certainly, there are oral systemic approaches with different receptors in the brain that are targeted at different doses and different timeframes to onset. Think we're very confident where we stand in terms of time to onset and the ability to avoid a lot of the issues you typically see pop up in REMS or in black boxes or even things that are more common associated with say drug drug interactions. So not having to go through the liver, not having to go through the kidney, not have to really go across the brain into the brain, It's a big, big difference compared to what we see in the field in seen in the field for decades.

So we think we're in pretty good shape. If we can get to the point where we can provide this product candidate to people who have been struggling with this disorder for most of their lives. Remember, the mean durations about twenty years. With onset in adolescence. So I think there's a lot of room for improvement based on where the market sits today.

Thank you.

And our next question coming from the line of John Boyle with William Blair.

Your line is now open.

Hey, team. This is John on for Myles. Thanks so much for taking our questions. So a few from us. To start, can you give us some color on the potential paths forward for AV-one hundred and one in neuropathic pain? Now that you've received a patent for the indication, And what gives you confidence for one hundred and one in the indication given the prior failures of Athenex's NMDA modulators and DPN.

And then maybe on the PALISTAIDS program, could you remind us of the rationale for the clinician administration in PALISTA-three and four? And specifically, is there any expected difference on the placebo response for clinician versus self administering? Okay. Any other ones? Just those two? I've got some more if you want after. Always happy to talk to you, John.

So look, with respect to AV-one hundred and one, as we've announced, that's a candidate for partnering and our confidence drives not just in pain, but also in dyskinesia associated with with L dopa therapy for Parkinson's. And we've got not only Phase one data telling us that This is a compound that we think is pretty safe, but also one that we've seen in preclinical models, not yet in any patient based studies, but in preclinical models, the MPTP monkey model in terms of the Parkinson's related dyskinesia and then in some conventional pain models that have been published that we see it's a different approach and it's these are NMDA receptor at the glycine site, seven chlorokayoronic acid, which is what the prodrug produces when astrocytes take it up in the brain. That is a very selective and potent glycine site antagonist but not so much so say like a ketamine or an amantidine where it's it's blocking the ion channel. So we think it's got modulatory capabilities at that site. Both NR1 and NR2. And we're in a spot with this one where while it's not in line with the fairing assets that we've got and with clinical stage and Phase two or later positive data.

This is one that we think there is some potential for those who are focused on those neurological indications. I'd refer you to the publications that are in pain that we can send to you that will give you a little bit more comfort on the preclinical data. In terms of the clinician administration of the the test drug in the context of PAL3, PAL4, Josh, why you go ahead and address that one?

Sure. Yes, I'm about to. So with these studies compared to the prior ones, we were really focused on reducing any potential variability And so when you think about a single dose public speaking challenge, or single dose at visit two, a single dose at visit three, We really wanted to make sure that we reduce variability and rather than have to train each subject each time think about just having to train the raters or the clinicians at the site and then they administer consistently throughout the duration. So that really drove that decision, again, just reducing variability.

We really don't think there's any impact to the label or projected use because the open label that we have in place for all these studies has patients using it on their own every day, multiple times a day as needed. Issues there.

The math is coming down. Obviously, we want this drug needs to be pointed right at the mid septum, so not up into the sinuses. And in any way where we just would get in the respiratory system. So again, it just ensures that the drug's got the best opportunity to work. And those that are in the treatment side. It shouldn't affect placebo, but to be determined, I suspect. Very helpful. I guess maybe just one more from us. How are you viewing your need to hit on both sides and CGI in PALISADE-threefour Kind of just wondering if there's any sense that you might need to show some anchoring, some independent anchoring of the sites to the CGI Hi.

Well, it's not just group level, right, and CGII's individual level and it is you have seen in the past and we've seen in the past that how people do on their sides from time to time will tell you whether they are going to be a one or a two on the CGI, but they are really distinct assessments where we're focused as the primary input on the group level change between treatment and placebo. So CGII stands as does PGIC, which is now a secondary endpoint in PALFID three and four, important to provide context as to what we've seen as the clinical meaningfulness at the group level.

Appreciate it. Thanks and congrats on the quarter.

Thanks.

Thank you. Our next question coming from the line of Paul Matteis with Stifel. Your line is now open. Hi. This is Emily on for Paul. We were wondering if you could talk a little bit more about the ongoing REIT dose study and kind of what are you hoping to see in the rationale behind that And also if there would be any regulatory risk if Fasaglinol is safe but it kind of turns out two doses look a bit more efficacious than one? Thank you. Sure. Josh, go ahead and hit this one.

Sure. So for repeat dose study, as we've noted before, it's really essentially identical to what we're doing in Palisade. Three and four just with an additional arm so that we can see if the dose administered ten minutes after the first dose would have an impact on the public And the FDA asked for that essentially because they felt in the real world there's a good possibility that a subject may go ahead and still feel if they still feel nervous, take another dose. And so the thinking there is, is there any safety impact? We think there likely is not based on other higher doses that we've measured And then is there a potential efficacy benefit There could be for some patients, but you also have to keep in mind that Once those receptors are saturated with the spray, you don't really get any additional benefit. So it's to be seen as to whether or not we would see additional benefit in that arm. At the end of the day, if Palisade three or four are positive on that primary endpoint with one dose. We don't think that it would create any issues for approval to see potential benefit of a second dose.

And what it would do is likely inform the label so that physicians are able to Let patients know that they could dose again within that ten minute timeframe if they felt it might be beneficial. But beyond that, we really don't see impact. And it is a it's a smaller powered or sized like our Phase three studies are.

It's a good point, Josh. And Emily, it's key that We align with the agency on this study and I think the key takeaway for us is that a coated form of labeling, it could help docs. The question is, how are you going to tell people to take it? Well, it could inform the labeling and guide whether the second dose within ten minutes is safe. And that as we as Josh noted, as we expected, it would be Again, I think the anticipation is in the real world people may think more is better And so to know that it's okay and safe there's only so much volume the nodes can handle anyway. And as Josh noted, once you occupy and activate those nasal chemore sensory neurons, which happens in about twenty five milliseconds. On your way to what we're trying to achieve when the neurocircuitary projects to the amygdala.

Great. Thank you.

Thank you, everyone. This is all the time we have for questions today.

If you have additional questions, please do not hesitate to contact us by emailing VistaGen dot com or you can log in to the website via the contact us section and submit questions through that portal. We also encourage you to register for email updates on our website to stay connected the latest news from VistaGEN. Again, thanks for participating on the call today.

We We appreciate everyone's interest and continued support. We look forward to keeping you updated on our ongoing progress This concludes the call. Have a wonderful day.

Ladies and gentlemen, thank you for your participation.