Greetings, and welcome to Vistagen Therapeutic's Fiscal Year End 2023 Corporate Update Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mark McPartland Senior Vice President of Investor Relations. Thank you. You may begin.

Thank you, Doug. Good afternoon, everyone, and welcome to Vistagen's fiscal year-end 2023 corporate update conference call and webcast. This afternoon, we issued a press release providing an overview of our progress last year and future milestones, and we expect to file our fiscal year-end 10-K later this afternoon. We would encourage you to review both, which can be found under the Investors section of our website. Now before we start today's call, I want to remind you that we may make forward-looking statements regarding our business based on our current expectations and information. The forward-looking statements speak only as of today, and except as required by law, we do not assume any duty to update in the future any forward-looking statements made today. 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 risk factors that could affect our business and financial results is included in the fiscal year-end 2023 Form 10-K, which, again, will be filed later today, which can also be found on our website or at the Securities and Exchange Commission website, sec.gov, and the future filings we make with the SEC from time to time, all of which will be available on our website and on the SEC website. With that taken care of, I'd like to thank and welcome all of our stockholders, analysts and all of you taking an interest in Vistagen. I'm joined on the call today by Shawn Singh, our Chief Executive Officer. Shawn will provide an overview of the company's progress made in 2023, upcoming milestones, followed by a brief opportunity for questions from our sell-side analysts. We want to remind you again that this call is being webcast and recorded and will be available for replay. The replay link can be found in the Investors section of the website, vistagen.com. Now with that done, I would like to turn the call over to Shawn Singh, our Chief Executive Officer. Shawn?

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call. As we've discussed many times, Vistagen's core mission is to radically improve the mental health and the well-being of the millions of individuals worldwide who suffer from a variety of anxiety, depression and other CNS disorders that severely disrupt their daily lives. To that end, each of our innovative clinical-stage CNS product candidates is designed with the potential to establish new standards of care, make meaningful differences in how patients manage their disorders and improve their lives. Throughout the year, we continued to advance our core programs for treatment of social anxiety disorder with Fasedienol, major depressive disorder with Itruvone. We achieved multiple clinical and regulatory milestones that are necessary to stage what we see as key advances in those programs this year and beyond. We also advanced strategic planning for our other 4 clinical-stage product candidates, specifically PH80 for the treatment of menopausal hot flashes, which is a large and unsatisfied market. We are also advancing planning for further U.S. IND-enabling development to facilitate Phase IIb development of PH15 for rapid onset improvement of attention and learning in subjects with cognitive impairment that's caused by mental fatigue and of PH284 for enhancement of subjective feelings of appetite and weight gain in subjects with Cachexia or wasting syndrome that's associated with cancer or other disorders related to appetite loss. With the depth in our collective body of positive safety and efficacy studies supporting our clinical stage pipeline, now is the opportune time to amplify our internal efforts to secure multiple global and regional strategic development and commercialization partnerships across our entire portfolio to accelerate achievement of key clinical, regulatory and commercial milestones within each program, and deliver meaningful value to our stockholders and to the millions of…

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

Our first question comes from the line of Jason McCarthy with Maxim Group.

It sounds like you've made a tremendous amount of progress this year so far and looking forward to what comes next. But Shawn, can you explain a bit further why you think the multiple dose assessment real-world study design with the LSAS as the primary endpoint is a better approach than the single dose assessment public speaking challenge with SUDS as the primary. I know you touched on it a little bit earlier, if you can just elaborate a bit further and why your confident in the new Phase III study designed.

Sure. Thanks, Jason. Great to talk to you. Well, as you know, Dr. Liebowitz is -- Dr. Michael Liebowitz is the innovator of the LSAS and the clinical investigator who was involved in the registration trials for the 3 approved drugs for the treatment of SAD and the published placebo-controlled Phase II studies of Fasedienol and SAD. And he will be the principal investigator in our FEARLESS Phase III program. So that matters. His prior experience, not just with Fasedienol, but obviously with the LSAS over the last 50 years is incredibly important. And we have developed with him a proprietary multistep LSAS training program that all the potential sites have to pass to his and to our satisfaction before they can be included in the FEARLESS study. So those are key advantages unique to our Phase III program. But the LSAS, it measures the overall improvement in disease severity by measuring both reduction in fear and anxiety over time about social situations, but also the reduction in avoidance of those anxiety provoking situations. So you're looking at patient-related dynamics over time over multiple administrations, whereas in the public speaking challenge with the SUDS, that was a single dose in a single anxiety provoking situation in the public speech. So we and Dr. Liebowitz and all the KOLs that we lean into believe the LSAS is by far the most appropriate endpoint to measure the efficacy potential of Fasedienol and really any other potential treatments for SAD because it reflects the true impact of the treatment on the patient's daily lives over time in a real-world setting. And again, using LSAS is the primary endpoint in our FEARLESS Phase III program is consistent with the design of all the registration trials that supported the FDA's precedent-setting approvals for treatments of…

Great. And can you I guess, help everybody understand, you used a great analogy for Fasedienol as like a rescue inhaler would be used for asthma. I think that really helps people understand how this drug can work in the real-world setting. Can you just talk a little bit about that?

Yes, I'm glad you brought that up. It is -- it's really important to give patients control. Because sometimes the stressors are predictable, sometimes they're not. But regardless, what they need is something at hand that they can decide when they need to use it can knock down the symptoms of anxiety that arise in the context of those situations. And so it's a drug candidate that we've long held needs to be used acutely to knock down situations when they arise but also over time, similar to cognitive behavioral therapy, where consistent success when exposed to those stressors build the confidence, build the resilience to engage in those situations more frequently and then to do so with less fear and anxiety. So it's very important, again, to be able to use our drug candidate multiple times in any given day, and some days not have to use it because when you are an SAD patient, if you're not exposed to your stressors, you're asymptomatic. You don't really want to put drugs in their body, even super safe drugs, when they think -- when they don't think they need it. In the case of Fasedienol, having that drug in your pocket, in your purse, in your backpack, and being able to have something with onset in about 15 minutes, help you through that stressful situation. And having that duration of that effect last about an hour, to be able to go back to it if the same situation arises or a different situation arises within the same day. It's a very important flexible tool, again, all intended to build the confidence of the patient over time, which is exactly what the LSAS captures. And you can't capture that as well at all with the SUDS because that's -- again, that's just in the moment, minute-by-minute assessment of that acute effect. Now, again, use it -- using it acutely over time is the way we see this drug will be used if approved in the real-world setting by millions of people who have access to it and in need because of the way their lives are impacted by SAD.

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

Appreciate the update. So the first question is on the FEARLESS program actually. So now you've met with the FDA, you're ready to kind of start up the studies. When exactly could those studies start specifically? And then for PALISADE 1 and 2, the prior studies, are there plans to share detailed data on either or both of those studies?

Andrew, thanks. So it depends, right? So fortunately, these are not really expensive studies. Each of them is about $15 million. And right now, the cost to get the program all the way through to an NDA, relatively speaking, is actually pretty modest for a Phase III candidate. So what that does is it puts out in front of us what we see is a lot of opportunities for Phase III development in collaboration with capable partners in the space, either globally or multiple regional deals, that have commercial capabilities that we think can optimize the commercial potential of the drug as well. So it will depend. It depends on technically we can be in as early as the first quarter of '24. We'll see how things go in terms of the types of financing arrangements or partnering arrangements more likely that we can put together in order to underwrite that program. So the important piece that moved things forward that was very critical was to make sure we had the kind of clarity and confidence from the agency that the LSAS was still and is still the go-to valid and reliable endpoint for a Phase III program. And again, because now COVID's not controlling anyone's lives anywhere near the degree was the case during the PALISADE studies, it's, in large part, during the acute phase of the pandemic, that clarity is in hand. So we are -- as you might expect, we're on a lot of radars, and no one has any trouble figuring out what drugs are in Phase III that are associated with large CNS markets. So we'll continue to advance on that. In terms of PALISADE-1, PALISADE-2, I think what we see downstream is when we have a context to put both of those studies together,…

Great. And then shifting to your other pherines, PH10 for depression. Can you give us a brief update where this asset stands and the next steps? What would the next design of the next study look like, for instance?

Yes. Great that you asked that. So Itruvone, we know there's nothing but a growing need for innovations in terms of treatment of depression, especially anything that can act on a stand-alone basis and even a relatively rapid onset manner, weeks, even better than months. And so what we needed to do with Itruvone was to get it back to the Phase IIb stage for U.S. development, either by us or in collaboration with a partner focused on depression, and with large market commercial capabilities. And now it's in that spot. And we had several successful studies that were conducted outside the U.S. We had to do U.S. IND-enabling studies to put it into a point where we could skip back over IIa and go right into Phase IIb. So like Fasedienol, we'll be aggressively pursuing strategic development and commercialization partnerships for that asset, not just in the U.S., but in multiple markets, and many of those dialogues are already ongoing. So ideal situation is we'd like to see sometime around the middle of next year the ability to get that back into U.S. clinical development, again, alone or with collaborators.

Great. And then also can you -- go ahead.

Sorry, I didn't answer the rest of the question, which is that study, again, we'll be developing it as a potentially rapid onset stand-alone treatment candidate for major depressive disorders. So more on the protocol, but basically, it's daily as opposed to as needed, and the study will likely be multiple weeks, 4 to 6 weeks.

Got it. Got it. And then PH80 for menopausal hot flashes you announced some data. So what exactly did you see in the data to kind of make you excited about this asset? And I guess, again, what are the possible next steps from here?

Yes. Again, that's a rapid-onset neuroactive pherine that's demonstrated positive Phase IIa results in reducing the frequency and the severity of hot flashes that are due to menopause. So right now, we're -- like every other asset in the pipeline, we're exploring opportunities to advance that program through Phase IIb and beyond in concert with multiple collaborators in multiple markets. As you can imagine, I mean, there was an NK3 inhibitor that you saw recently approved by Astellas. So that one is systemic oral. We know there's safety issues concerned with that one. We don't see any of those attributes in the potential for PH80. And that is a space that has an incredible need and a lot of interest amongst companies focused on women's health. So we know that it's a large market. We know it's underserved. We know it's the most common symptom of menopausal transition. It affects about 75% of menopausal women and about 40% of women in premenopause, so it's 20 million-or-so women in the U.S. and 9 million-or-so that suffer from severe hot flashes. So we will put this into a position where, again, like PH10 and Itruvone, it's a similar path. We do some IND-enabling work. We did get a U.S. IND in place, and we skip back over Phase II right into Phase IIb. And that Phase IIb program can be supportive then of our pathway into Phase III and then support and market it around the world if we get that benefit.

Makes sense. And then you do have additional pherines, PH15 and 284 seems pretty attractive. So can you talk a little bit more about those 2 drugs and when they can get into the clinic? And are you also considering a partner for those assets as well?

Yes. And we're at a spot now where, especially after acquiring Pherin, we have not only the clinical-stage assets, 6 assets that are in clinical stage, and the capability or the potential to advance additional preclinical candidates into clinical development. So the Pherin platform is robust. And given the depth of the pipeline and the broad nature of the positive safety and efficacy studies we've got, every one of those assets can be supported by either internal development or collaborative development or really a combination of both. So those 2 assets in particular, PH15 and PH284, together and independently represent very large markets in cognition impairment for PH15 and subjective feelings of hunger and the like, especially in late-stage cancer patients with cachexia. So we'll be doing the same thing with those. Right now, we're assessing some of the data that we've got in the context of the acquisition of Pherin. Hopefully, we'll have more to say in the near term in terms of the Phase IIa data with those 2 programs, and then they would follow a similar path to what we have done with PH10, to move it into the U.S., and also, we'll be dealing with PH80 to move it into the U.S., and overall, ultimately, each of the U.S. dossier supports leverage in multiple markets outside the U.S.

Operator, I believe that's all the time we have for questions today. If there's any additional questions, please don't hesitate to contact us by e-mailing ir@vistagen.com or contacting the individuals listed on the bottom of our press release. The information is also available on our website. We also encourage you to sign up our website to stay connected about news updates about Vistagen. Again, thank you for participating on the call today. We appreciate everyone's attention and support. We look forward to keeping you current on our continued progress. This concludes our call. Have a fantastic day.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.