Vistagen Therapeutics, Inc.

Good day. Thank you for standing by. Welcome to this agenda predicts third quarter fiscal year 2025 corporate update conference call. At this time, all participants on the list are normally mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to speaker host, Mark McPartland, please go ahead.

Thank you, operator. Good afternoon, everyone, and welcome to Vistagen's fiscal year 2025 third quarter corporate update conference call and webcast. Earlier this afternoon, we issued a press release for the third quarter of our fiscal year 2025 into December 31st, 2024, providing an overview of our progress across our lead clinical neuroscience programs. We encourage you to review the release, which can be found in the investor section of our website. Based on the current expectations information, we will make forelooking statements regarding our business during today's call. 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 and or in future. Of course, forelooking statements include risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements that we make today. Additional information concerning risks and factors that could affect our business and financial results will be included in our fiscal year 2025 third quarter Form 10-Q for the period ending December 31, 2020. For and in future filings, we will make with the SEC from time to time, all of which are or will be available in the investor section of our website and on the SEC's website. 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 Shawn 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 operators 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 investor 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. We had a very productive quarter. As many of you know, we are developing a new class of intranasal product candidates that are called pharynx. 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 farine, Fasadinol, and our ongoing registration-directed Palisade Phase III program for that asset for the acute treatment of social anxiety disorder, or SAD. 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 30 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 Fasadinol, our goal is to address this critical and very long-neglected treatment gap 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 II Phase III trial of Fasadionol for the acute treatment of SAD. In 2024, to build on the success of Palisade II in our registration-directed Phase III program for Fasadionol, we initiated Palisade III and Palisade IV as Phase III 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 III and Palisade IV 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 II repeat-dose study of Fasadionol and SAD. And besides the addition of a repeat-dose arm, it is similar in design to our Phase III, Palisade III, and Palisade IV studies for the acute treatment of adults with SAD, again, including in open-label extension. With these studies advancing, we believe either Palisade III or Palisade IV, if successful, together with Palisade II, may establish substantial evidence of the effectiveness of Fasadino in support of a potential new drug application submission to the US FDA for the acute treatment of SAD in adults. In addition to advancing our Fasadinol Phase III program in SAD, we made progress in our development programs for ITruvone as a standalone treatment for major depressive disorder and PH80 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 support our planned submission of an investigational new drug application, or IND, to the U.S. FDA to facilitate further Phase 2 clinical development of PH80 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 cachexia. PH284 is our fifth clinical stage neurocircuitry-focused intranasal faring product candidate with a positive efficacy signal and differentiated safety in all the studies that have been completed to date. And this recent announcement underscores the breadth and diversity of our clinical stage fairing pipeline, with five innovative non-systemic investigational intranasal fairing product candidates, all supported by positive phase two, and in the case of fastidionol, one phase three positive clinical study. The clinical data and the placebo-like tolerability that we've 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 fairing 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?