Vistagen Therapeutics, Inc.

Good day, everyone. Thank you for standing by. Welcome to the Vistagen Therapeutics Fiscal Year 2026 Third 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, Lisa, and 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 third quarter, which ended December 31st, 2025, and provided an update of our progress across our clinical stage neuroscience program. We encourage you to review the PR and 10-Q which are both available in the investor section of our website. Before we begin, please note that we'll be making 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 make today. Additional information concerning risks and factors that could affect our business and our financial results are included in our fiscal year 2026 third quarter form 10-Q, and for a period ending December 31st, 25, and in future filings that we make with the SEC from time to time, again, all of which are available in the investor section of our website or, of course, on the SEC's website. With the formalities completed, 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 and Chief Executive Officer, Josh Prince, our Chief Operating Officer, and Nick Tressler, our Chief Financial Officer. Sean will provide a brief business and clinical update, and Josh and Nick will be available to provide additional feedback during the Q&A portion of our call. After our remarks, we'll take questions from the sell-side analysts participating on the call. A replay of the webcast will be available in the events section of the investor page of our website. With that taken care of, I'd now like to turn the call over to our President and CEO, Sean Singh.

Thank you, Mark, and good afternoon, everyone. It's been an important quarter for our team with the completion of the randomized portion of our Palisade III Phase III trial in social anxiety disorder as guided and focused efforts to learn from the study's results and drive high-quality and efficient execution of our ongoing Palisade IV Phase III trial. We have reviewed available data from Palisade 3 and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to Palisade 4. We've also been working with third-party collaborators on the implementation of innovative approaches to analyze the available data sets, not only from Palisade 3, but also from the facet in all studies across the Palisade program. including both the randomized and the open-label trials. Our objective is to better understand the drivers of both facet dienol and placebo response using the substantial data collected from these studies to potentially inform optimized statistical models that consistently incorporate covariates and explanatory variables across all Palisade studies, which could anchor future weight of evidence discussions with the FDA. The analyses are ongoing with our collaborators and involve the use of their proprietary artificial intelligence and machine learning technologies to identify nonspecific responses and understand and predict susceptibility to placebo response and likelihood of response to active drug in the context of the public speaking challenge study design. Overall, the full complement of ongoing work is focused on delivering practical operational understanding, predictors of response, and enhanced statistical models with the potential to impact both Palisade 4 and our regulatory strategy based on the totality of data from the Palisade program. The open label extension portion of Palisade 3 and Palisade 4 remains ongoing and is designed to evaluate the safety and tolerability of repeated as-needed intranasal administration of fasciodontal in adults with social anxiety disorder, but in real-world daily life situations. In addition to safety assessments, the study includes exploratory longitudinal measures using validated instruments such as the condition-administered Leibowitz Social Anxiety Scale, or LSAS, and the patient-reported social phobia inventory, or SPIN. While open-label data are inherently uncontrolled and exploratory, the OLE portion of the PALISADE III Phase III study could provide important context on patient experience with repeated use over time in real-world anxiety-provoking situations the patients encounter. Together with our broader analytical work across the PALISADE program, insights from open-label studies should contribute to our enhanced understanding of Facet-INL's drug effect and usage patterns. Once again, we'd like to thank the patients who participated in our Palisade studies, as well as the clinical investigators, the site staff, and our contract research organization for their ongoing dedication and professionalism as we complete Palisade 4 and advance our broader analytical efforts. As we've previously stated, if Palisade 4 is successful, Together with Palisade 2 and the broader body of evidence generated across the Palisade program, these data may support a potential new drug application submission to the U.S. Food and Drug Administration for the acute treatment of social anxiety disorder in adults. The significant unmet need in social anxiety disorder, where effective treatments are very limited, continues to guide our work and our long-term focus. Turning to our women's health program, we received an official USAN adoption statement designating PH80 as rificilone. Rificilone is our hormone-free, non-systemic intranasal product candidate with potential for the treatment of moderate to severe vasomotor symptoms, commonly referred to as hot flashes, due to menopause. We believe rificilone may also have therapeutic potential across other women's health indications. We are currently preparing to submit our U.S. Investigational New Drug Application, or IND, for rificilone to the U.S. FDA with a planned submission in the first half of 2026. This IND is intended to support further potential Phase II clinical development of rificilone in the U.S. for the treatment of moderate to severe vasomotor symptoms due to menopause. building on a previously completed placebo-controlled exploratory phase 2A clinical trial conducted in Mexico by Farron Pharmaceuticals, which is now our wholly-owned subsidiary. And that trial demonstrated clinical benefit in the vasomotor symptoms indication. We believe that indication in women's health represents a significant area of unmet need, and we remain committed to advancing rificilone as a non-systemic, hormone-free product candidate with a disciplined, data-driven approach as we prepare for the potential next phase of clinical development. Turning briefly to our financial position as of December 31st, 2025, we had $61.2 million in cash, cash equivalents, and marketable securities. During the quarter, we implemented company-wide cash preservation measures intended to enhance our operational efficiency extend our runway, and maintain strategic flexibility across our fairing pipeline. We believe we are well positioned to complete Palisade 4 and to advance preparations and planning for our fairing pipeline. In closing, our mission remains unchanged, to deliver transformative treatments and improve lives. The path forward requires discipline, rigor, and thoughtful analysis, and we believe the steps we have taken and are taking position Visagen to make informed decisions, and responsibly advance programs with the potential to deliver meaningful value to patients and to shareholders. So I want to thank you for your continued interest in the company and your support, and we look forward to updating you on our progress in the quarters ahead.