Vistagen Therapeutics, Inc.

Good afternoon, everyone, and welcome to Visigyn's fiscal year-end 2025 corporate update conference call and webcast. Earlier this afternoon, we issued a press release for our fiscal year-end 2025, which ended on March 31st, 2025, providing an overview of our progress across our lead clinical stage neuroscience programs. We encourage you to review the release and the 10-K, which can be found in our website's investor section. Before we begin, please note that we make forward-looking statements regarding our business during today's call based on current expectations and information. 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 future. 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 may make today. Additional information concerning risks and factors that could affect our business and financial results are included in our fiscal year-end 2025 Form 10-K for the period ending March 31st, 2025, and in future filings we'll make with the SEC from time to time, all of which are available in the investor section of our website and on the SEC's website. Now, with the formalities out of the way, We warmly welcome our stockholders, sell-side analysts, and interested in our program and progress. I'm joined on our call today by Shawn Singh, our President, Chief Executive Officer, and Cindy Anderson, our Chief Financial Officer. Shawn will discuss recent highlights in our lead neuroscience program, and Cindy will discuss our fiscal year-end 2025 financial results. After our prepared remarks, there will be a brief opportunity for questions from the sell-side analysts on the call. As a reminder, this call is being webcast and will be available for replay upon completion. The replay link can also be found in our website's investor events section. I will now turn the call over to our president and chief executive officer, Sean Singh. Sean, the field is yours.

Thank you, Mark, and good afternoon, everyone. Thank you for joining us. As some of you know, our team here at Visagen is at the leading edge of neuroscience that involves the therapeutic potential of nose-to-brain neurocircuitry, developing a new class of non-systemic intranasal product candidates called ferrines. We now have five clinical stage ferrine product candidates, each with a mechanism of action, or MOA, that is differentiated from all approved drugs and positive results in a controlled trial. Together, they cover a broad and diverse range of large market conditions and disorders where underserved patients have needed new and better treatment options for many years. Fiscal 2025 was another significant year of progress across our neuroscience pipeline. With multiple fairing product candidates in phase two or phase three development, we are advancing our mission to deliver transformative treatment options for patients and build value for our stockholders. Our lead Farian product candidate, Fasadionol, is in phase three development for the acute treatment of social anxiety disorder, or SED. There is no FDA-approved acute treatment for SED, a condition that now is estimated to affect over 31 million US adults who struggle with the intense stress and debilitating anxiety and fear of embarrassment, humiliation, and judgment in everyday social and performance situations. Our goal for fastidionol is for it to become the first FDA-approved acute treatment of SAD and help improve the millions of Americans whose lives are affected by this serious and potentially life-threatening disorder that often begins in adolescence and occurs for decades beyond. The ongoing phase three trials in our U.S. registration-directed Palisade program for fastidionol for the acute treatment of SAD Palisade 3 and Palisade 4 are designed to complement our success in our Palisade 2 Phase 3 trial that we reported during the second half of 2023. Our Palisade 3 trial is on track for a topline data readout in the fourth quarter of this year, and we anticipate topline results from Palisade 4 in the first half of 2026. The enthusiasm of patients and physicians participating in the Palisade program continues to be very strong, and we remain committed to very rigorous operational execution. If successful, we believe either Palisade 3 or Palisade 4, in combination with the positive results from Palisade 2, could provide the substantial evidence of effectiveness needed to support a new drug application for Fasadienol. and its potential to be the first FDA-approved acute treatment for SAD. We are also advancing ITruvone, our Farine product candidate for standalone treatment of major depressive disorder, or MDD. Following the promising results from a controlled exploratory Phase IIa study, we are encouraged by its differentiated non-systemic MOA and potential to treat MDD without the weight gain, sexual side effects, or systemic safety concerns commonly seen with traditional antidepressants. Our fairing product candidate focused on women's health indications, PH80, also continues to generate interest as we advance its development as a potential hormone-free treatment for menopausal hot flashes. PH80 also demonstrated positive signals in the controlled exploratory phase IIa study in premenstrual dysphoric disorder, or PMDD, further validating its broad utility in women's health. We are also encouraged by PH80's potential to treat the disruptive and painful effects of dysmenorrhea. We've made substantial progress preparing our US IND for PH80 to support additional Phase II clinical development in women's health, and we anticipate submitting the IND in the second half of this year. Beyond these three lead programs, our Diversified Ferrine Pipeline has potential for future development to improve cognitive and psychomotor impairment due to mental fatigue, as well as appetite-enhancing effects in patients with cancer cachexia, often overlooked conditions with limited treatment options. So across all five of our clinical stage fairing product candidates, a potential therapeutic benefit has been observed with favorable safety, a testament to the power and the promise of nose-to-brain neurocircuitry. On the U.S. regulatory front, which is on most of our minds these days, we are encouraged by the evolving regulatory landscape. Last week, I was privileged to participate in the FDA's CEO Listening Tour, which was hosted at the Stanford Medical School. This CEO-only forum was led by FDA Commissioner Dr. Marty Makary and CBER Director Dr. Vinay Prasad and their supported staff members. The forum was impressive and very productive. It was allowed for essential direct interface between the new FDA leadership and my fellow industry CEOs to drive FDA initiatives that are designed to improve the ease and frequency of communication with the agency and provide clear and early guidance to support optimal capital allocation and enhance market confidence and predictability, while also modernizing the agency's regulatory framework and leveraging AI to bring innovative, safe, and effective medications to underserved patient populations, both large and small. So I applaud Commissioner McCary for holding this unique forum in several cities across the country where industry expertise and perspectives can and will be openly shared with FDA leadership. It's a meaningful step toward fostering a far more collaborative, transparent, and innovation-friendly regulatory environment where, very importantly to us, New mechanisms of action and emerging technologies require reevaluation of legacy registrational pathways. At Vistagen, we welcome the conversations with the FDA, as always, about policies that speed up innovation, make drug development more efficient and affordable, and most importantly, improve patient outcomes. Overall, we are energized by the potential of all five of our clinical stage fairing product candidates. And with our primary focus on delivering top-line data from Palisade III in the fourth quarter of this year, doing so has the near-term potential to transform lives and produce remarkable shareholder value. So I'll now turn the call over to our Chief Financial Officer, Cindy Anderson, to highlight some of our financial results for the year. Cindy?

Thank you, Sean. As Sean mentioned, I will highlight a few financial results from our fiscal year March 31, 2025. Research and development expenses were $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million for the same period last year. The increase in R&D expenses was primarily due to increases in research, clinical and non-clinical development, contract manufacturing expenses, and headcount related to our U.S. Registrational Palisade Program for Fasini et al. and SAD, and our U.S. IND Enabling Program for PHAD and Women's Health. General and administrative expenses were 17.1 million for the fiscal year ended March 31, 2025, compared to 14.1 million for the same period last year. The increase in GMA expenses, primarily due to increased headcount, consulting, and professional fees. Our net loss attributable to common shareholders was 51.4 million for the fiscal year ended March 31, 2025, compared to 29.4 million for the same period last year. As of March 31, 2025, We had 80.5 million cash, cash equivalents, and multiple securities. I will now hand the call back over to Sean.