Vistagen Therapeutics, Inc.

Good day, everyone. Thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year 2026 Second Quarter Corporate Update Conference Call and Webcast. Please note that today's call is being recorded. At this time, I'd like to turn the call over to your host, Mark McPartland, Senior Vice President, Investor Relations at Vistagen.

Mark. Thank you, Operator. Good afternoon, everyone, and welcome to our conference call and webcast. Earlier this afternoon, we filed our quarterly report on Form 10-Q and issued a press release for our fiscal year 2026 second quarter, which ended on September 30th, 2025, providing an overview on the progress in our Palisade III program for FASA-DNL and social anxiety disorder across our other clinical neuroscience programs. We encourage you to review the PR and 10-Q, which are available in the investor section of our website. Now, before we begin, please note that we will be making forelooking statements regarding our business during today's call based on our current expectations and information. These forelooking statements speak only as of today. Except, as law requires, we do not assume any duty to update any forelooking statements made today or in the future. Of course, forelooking statements of all risks and uncertainties and other actual results could differ materially from those anticipated by any forward-looking statements we make today. Additional information concerning risks and factors that could affect our business and financial results are included in the fiscal year 2026 second quarter form 10-Q for the period ending September 30th, 2025 and in future filings that we'll make with the SEC from time to time, all of which are available in the investor section of our website or of course on the SEC's website. Now with the formalities out of the way, we warmly welcome our stockholders, sell-side analysts, and others interested in our programs and our progress. I'm joined on our call today by Shawn Singh, our President and Chief Executive Officer, and Josh Prince, our Chief Operating Officer. Shawn will provide a brief business update, clinical update, and Josh will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we will take questions from the Southside analysts participating on the call today. I remind you, a replay of the webcast will be made available in the events section of our investor page on our website. With that taken care of, I'll now turn the call over to our President and CEO, Sean Singh.

Thank you, Mark, and good afternoon, everyone. We've built a very strong momentum as we enter into what could be a potentially transformative period for Vistagen. Last week, we announced another major milestone in our Palisade program. The last patient completed the randomized double-blind portion of our Palisade 3 Phase 3 trial, evaluating our most advanced intranasal fairing product candidate, Fasodinol, for the acute treatment of social anxiety disorder. We are now preparing for the release of top-line results from the Palisade 3 study by the end of this calendar year. We extend our sincere gratitude to the patients who participated in the study as well as the dedicated and experienced clinical investigators, the clinical site staff, and our contract research organization. Their enthusiasm, their focus on detail, and the collaboration throughout the study were notable and greatly appreciated and will remain so during the ongoing open label extension of the study. Over the past several months, I've had the privilege of meeting in person with many of the dedicated teams conducting our Palisade 3 and Palisade 4 studies. The energy, the curiosity, the optimism that I've witnessed reaffirms just how great the need remains for new treatment options for individuals whose daily lives are affected by social anxiety disorder and how differentiated and innovative Fasadionol could be in meeting their needs. Together, our teams remain deeply focused on Fasadionil's potential to become the first FDA-approved acute treatment of anxiety for the millions of adults with social anxiety disorder. Looking ahead, we remain on track to report top-line results from our Palisade 4 Phase 3 trial in the first half of 2026. Both Palisade 3 and Palisade 4 share a similar public speaking challenge design and the same primary efficacy endpoint as our previously successful Palisade 2 Phase 3 trial. In parallel, we are continuing preparations designed to advance our broader farine pipeline, including itruvone for major depressive disorder and PH80 for menopausal hot flashes. Both depression and women's health represent areas where far too many patients still struggle without adequate options. We're deeply motivated to bring forward the innovative, non-systemic, neurocircuitry-focused potential of iTruvone and PH80 to help address these important and widespread needs. Turning now briefly to our financials, as of September 30, 2025, we had $77.2 million in cash, cash equivalents, and marketable securities. We believe current cash covers all known aspects of our ongoing financial U.S. registration-directed Palisade program for Fasodionol for the acute treatment of SAD, including potential NDA submission if our Palisade program is successful. Before I conclude the business update, I'd like to welcome Mr. Paul Edick to our Board of Directors. Paul joins us at a pivotal time for Vistagen, bringing decades of experience leading successful FDA approvals, commercial launches, and strategic transactions. His leadership will be invaluable as we prepare for our next phase of growth. I'd also like to extend our deep gratitude to Dr. Jerry Jin, who served on our board from 2016 until his retirement earlier in September of this year. In closing, our mission remains clear and unwavering to redefine what is possible in neuroscience to restore emotional well-being and improve quality of life for millions worldwide. With a diverse and innovative pipeline, an experienced team, several key milestones approaching, we believe we are entering one of the most exciting and potentially transformative periods in our company's history with deep confidence in our ability to deliver meaningful value for patients and for our stockholders. We want to thank you all for your continued interest, your support, and your engagement with Vistagen. It makes a lot of difference, and we look forward to sharing our progress with you in the weeks and the months ahead.