Vistagen Therapeutics, Inc.

And Chairman, greetings and welcome to Vistarjan Therapeutics Fiscal Year 2025 First Quarter Corporate Update Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mark McPartland, SVP, Investor Relations at Vistagen. Please go ahead.

Thank you, Ryan, and good afternoon, everyone, and welcome to Vistagen's fiscal year 2025 first quarter corporate update conference call and webcast. This afternoon, we filed our quarterly report with the Securities Exchange Commission on SEC Form 10Q, for our quarter-ended June 30th, 2024, and issued a press release providing an overview of our continued progress. We encourage you to review the release and our 10-Q, which can be found in the investor section of our website. We will make forward-looking statements regarding our business during today's call based on current expectations and information. These forelooking statements speak only as of today, except as required by law. We do not assume any duty to update any forelooking statements made today or in the future. Of course, forelooking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forelooking statements we make today. Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2025 first quarter 10-Q for the period ending June 30th, 2024, and will be made in the future filings that we make with the SEC from time to time, all of which will be available in the investor section of our website and, of course, on the SEC's website. With the formalities completed, we warmly welcome our stockholders, sell-side analysts, and others interested in Vistagen. I'm joined on our call today by Sean Singh, our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Joss Prince, our Chief Operating Officer. Sean will provide an update on the lead programs in our novel class of neurocircuitry-focused sparing drug candidates in our clinical stage pipeline. After that, the conclusion of our prepared remarks, there will be a brief opportunity for questions from the cell site analysts participating on the call. As a reminder, this call is being webcast and will be available for replay after completion. The replay link can also be found in the investor section of our website. I will now turn the call over to our Chief Executive Officer, Sean Singh.

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. For those of you who are joining us for the first time, we're a neuroscience company with a diverse pipeline that includes multiple clinical stage product candidates in phase two and phase three development. And each of these is a novel, non-systemic, neurocircuitry-focused product candidate. Our three lead clinical development programs target large markets with stale standards of care that leave millions of individuals with unsatisfied medical needs, specifically individuals affected by the profound fear and anxiety associated with social anxiety disorder. the serious and potentially life-threatening impacts of depression, and the disruptive effects of menopausal hot flashes. For decades, the standard of care in these markets, these very large indications, has been anchored in oral medications that require systemic uptake and are associated with a bundle of worrisome side effects and safety concerns, prolonged onset of action, and limited efficacy. And our mission is to change that. to change that with our pioneering neuroscience and our new class of clinical stage product candidates called pharynx. Distinguished from all systemic oral medications approved by the FDA, our lead neuroactive pharynx, facidinol for social anxiety, ytruvone for depression, and PH80 for menopausal hot flashes, are intentionally formulated as nasal sprays to rapidly activate unique nose-to-brain neural circuits to achieve therapeutic effects without requiring systemic uptake or direct action on neurons in the brain, and to do so with favorably differentiated safety profiles that we've observed in all clinical studies of our Farian product candidates that have been completed to date. Farians use the nose and key neurons located in the olfactory epithelium as a portal to activate neural circuitry in different regions of the brain that impact multiple medical conditions, And again, they do that without having to travel through the whole body or even into the brain. Those fundamental differences have enabled us to achieve historic clinical success in a Phase III trial for the acute treatment of social anxiety disorder, or SAD, that we reported last year, as well as also see positive results in exploratory Phase II trials involving patients with major depressive disorder, menopausal hot flashes, and premenstrual dysphoric disorder, and psychomotor impairment due to mental fatigue. Our top priority, the lead neuroscience program in which the vast majority of our team and our capital are focused on, is our U.S. registration-directed Palisade Phase III program for facidinol. That is our investigational fairy nasal spray for the acute treatment of SAD. There's no FDA-approved medication for the acute treatment of SAD, which is a very large growing and underserved market that affects 12% of adults in the U.S. As I noted many times, our principal goal is to change that. Last year with our Palisade II Phase III trial of Fasadienol, we reported the first ever positive Phase III trial of a drug candidate for the acute treatment of SAD. Earlier this year, we launched another Phase III trial, Palisade III, designed similarly to Palisade 2 with the objective of replicating the success of that study. Enrollment in the Palisade 3 study is on track, and we're also on track to initiate our Palisade 4 Phase 3 study in the second half of this year, as we've previously guided. That study will have the same design as Palisade 3 and the same objective of replicating the positive results from Palisade 2. Both of these Phase 3 studies, as well as an exploratory Phase 2A repeat dose study, will read out next year. We believe either Palisade 3 or Palisade 4, if successful, and together with Palisade 2, may establish the substantial evidence of the effectiveness of Fasadino in support of a potential U.S. new drug application submission to the FDA, which, if approved, could establish Fasadino as the first-ever FDA-approved acute treatment of SED. A new treatment option with the potential to be used on demand as needed by millions of Americans whose serious and sometimes life-threatening anxiety and fear of embarrassment, judgment, humiliation, and a wide range of social and performance situations affect their daily lives over many years, and potentially, and unfortunately, sometimes lead to depression and even suicide. So again, our U.S. Registration-Directed Palisade Phase III Program for Fasodinol for the acute treatment of SAD is our top priority. and we are on track and well-funded to do what's necessary to put us in a position with the potential to achieve that important and very valuable goal for patients and for our stockholders. We are also staging our other two lead fairing clinical stage programs in depression and hot flashes for further Phase II development in the U.S., building on positive results in exploratory Phase IIa studies in each of these large market indications, each of which has stale standards of care and no non-systemic pharmacological treatment alternative. We've seen and what we've seen in phase two from non-systemic Truvone for MDD and non-systemic hormone-free PH80 for menopausal hot flashes so far as to both efficacy and safety is driving our confidence in the potential of these product candidates to improve lives. iTruvone holds the potential to emerge as a novel and fundamentally distinct standalone treatment for major depressive disorder. We're preparing and strategizing for a Phase IIb development of iTruvone in the U.S. as a product candidate with the potential to help individuals who suffer from depression gain relief from their MDD symptoms swiftly and without many side effects of currently available systemic treatment options. Our TrueBone is distinguished by its favorable safety profile that's been observed in studies that have been completed to date, which is not associated with unwanted sexual side effects, for example, or weight gain, or potential for abuse. And finally, our non-systemic hormone-free farine product candidate for menopausal hot flashes, PH80, holds considerable medical and commercial promise in multiple women's health conditions, but most notably menopausal hot flashes that affect millions of women around the world. Similar to what we've accomplished to enable further Phase II development of vitruvone for MDD in the U.S., our ongoing non-clinical program for PH80 aims to enable our U.S. IND to further Phase II clinical development of PH80 in the U.S. as well, and to do that for menopausal hot flashes. We are confident that millions of women who are affected by menopausal hot flashes would prefer a novel, non-systemic, hormone-free treatment option over the current therapies. With that, I'll turn the call over to Cindy, our CFO, to summarize some of the financial highlights from the last quarter. Cindy?