Vistagen Therapeutics, Inc.

Greetings and welcome to the VistaGen Therapeutic first quarter 2022 results conference call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question and answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star 0. As a reminder, this conference is being recorded today, Thursday, August 12th, 2021. I would now like to turn the conference over to Mr. Mark Flather, Vice President of Investor Relations. Please go ahead, sir.

Thank you, Nadir. Hello and welcome to the Vistagen's conference call covering its fiscal year 2022 first quarter financial results and corporate update. I am Mark Flather, Vice President of Investor Relations at Vistagen. Thank you for joining us today for this business update, and welcome to our shareholders, analysts, and anyone taking an interest in Vistagen. Joining me today are Sean Singh, our Chief Executive Officer, Jerry Dodson, our Chief Financial Officer, and Dr. Mark Smith, our Chief Medical Officer. The format for this call consists of prepared remarks from management, followed by an opportunity for questions. This call is being webcast and will be available for replay. The link can be found in the Investors IR Calendar section of our website, vistagen.com. On today's call, we will make forward-looking statements regarding our business based on our current expectations and current information. The forward-looking statements speak only as of today and accept as required by law. We do not assume any duty to update in the future any forward-looking statement made today. Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statement that we may make today. Additional information concerning risks and factors that could affect our business and financial results is included in our most recent quarterly report on Form 10Q filed earlier today with the Securities and Exchange Commission. And in the future, filings that we make with the SEC from time to time, all of which are or will be available on the SEC's website. Now with the formalities out of the way, I'd like to turn the call over to our Chief Executive Officer, Sean Singh.

Thank you, Mark. Good afternoon, everyone. On behalf of our entire team here at Vistagen, I thank you for joining our call today. And with the recent surge in the pandemic from the Delta variant, we certainly hope you and yours are healthy and doing very well. As I've mentioned many times before, at our core, we're changemakers, a team at Vistagen that's committed to improving the mental health of individuals around the world. with new medicines that go beyond the inadequate current standard of care for anxiety and depression disorders. During the first quarter of fiscal 22, we maintained that steadfast commitment to our core mission and continued the strong momentum that we generated throughout fiscal 21 across all aspects of our business. Even before the pandemic, anxiety and depression disorders represented a large and growing unmet medical need both in the U.S. and across the globe. Unfortunately, while the prevalence of these conditions has grown substantially during the pandemic, meaningful expansion of differentiated FDA-approved treatment alternatives has not yet occurred. Now, arguably more than ever before, those suffering from anxiety and depression disorders need new and differentiated treatment alternatives. Against the backdrop of the substantial progress we made throughout fiscal 2021, and now through the first quarter of this fiscal year, we are confident and excited about the potential of our CNS pipeline to make meaningful changes in the lives of those impacted by mental illness related to anxiety and depression. Our most significant milestone during the quarter was the initiation of our Palisade Phase III program, led by Palisade I, our U.S. Phase III multicenter randomized double-blind placebo-controlled clinical study to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with social anxiety disorder, or SAD. According to the U.S. National Institute of Health, SAD is the third most common psychiatric condition after depression and substance abuse. The Phase III trial is a key step in our efforts to confirm the positive efficacy and safety results that we've seen in Phase II development of PH94B as a differentiated rapid onset acute treatment in SAD. PH94B is designed to be an acute as needed treatment of anxiety for adults with SAD, treating their anxiety in the context of a triggering or anxiety provoking situation or events similar to how a rescue inhaler is used to prevent the onset of an asthma attack. At a time when we are seeing a continuing increase in the number of Americans suffering from SAD, now over 23 million Americans, and a current drug treatment paradigm that falls short of delivering necessary relief without worrisome consequences, an innovative, differentiated, fast-acting acute treatment alternative is imperative. If successfully developed, H94B has the potential to be the first fast-acting, non-systemic, non-sedating acute treatment of anxiety for the millions of Americans and others around the world who suffer from the debilitating effects of SAD and several other anxiety disorders. During the quarter, we advanced significantly on our plan to initiate, by calendar year-end, several additional clinical studies in our Palisade Phase III program, to enable the eventual submission of a PH94B new drug application to the FDA should the program be successful. Notably, Palisade 2, which will be a replicate of Palisade 1, is expected to be initiated before the end of this year. We also made significant progress with the FDA to enable the initiation of our exploratory Phase 2A clinical program for PH94B. program that will include activity in at least four additional anxiety indications, the first of which will be adjustment disorder with anxiety. With the study may proceed notice from the FDA now in hand, we are on track to start the phase 2A study in adjustment disorder with anxiety as planned before the end of calendar 2021. We also completed certain additional non-political studies of PH10, our depression candidate. that we believe are necessary to advance our Phase 2B development plan for PH10 as a potential standalone rapid-onset, non-systemic treatment of major depressive disorder. Finally, we also advanced on our plan for clinical development of AV101 in combination with probenicin, and we are on track with our plan to initiate the Phase 1B drug-drug interaction study for that combination by calendar year-end. We believe our current cash position is sufficient to advance our CNS pipeline through a very exciting stream of potential clinical and regulatory milestones with potential to be value-adding catalysts for the company. Another important milestone for Vistagen during the quarter was our recent inclusion in the Russell 2000 Index, which, as many of you know, is one of the most cited performance benchmarks for small cap companies. This milestone is notable as a notable example of how far we've advanced our company, especially during the past 15 months since our consensus-building meeting with the FDA in mid-2020. We believe we are only in the beginning stages of what has exciting potential to be a remarkable growth curve for all of our stakeholders. Inclusion in the Russell 2000 Index has already increased awareness of our company within the investment community, and we expect this trend to continue in the years ahead. We certainly welcome the larger audience. We continue to execute on additional noteworthy milestones during the second half of this year and well beyond. Vistagen is dedicated to creating change in the mental health landscape. And to help accomplish this, we continue to strengthen our team with individuals who not only possess vast knowledge and experience, but who also share our passion for social change and align with our company values. We believe that in the search to create medicines for a diverse global population with unmet needs, we must seek out and listen to the opinions of diverse individuals. Recently, Vistagen announced the appointment of two new female members to our board of directors, Mary Rotono and Margaret Fitzpatrick, who combined with prior appointments of Anne Cunningham and Dr. Joanne Curley, bring Vistagen's board to a female-led majority. significant advancement and worthy distinction in board representation within the public biopharma space and beyond. Ms. Rotuno brings extensive healthcare expertise to Visigyn's board as both a leader and a strategist. She began her career serving patients as a registered nurse and transitioned to serving clients in healthcare law, allowing her to pursue both her commitment to helping others and advancing the future of mental health and wellness. Ms. Fitzpatrick has a strong background in developing and executing multiple high-impact, customer-focused marketing communications initiatives for some of the world's largest and most successful companies, including Johnson & Johnson and Cigna. Both of these announcements highlight the importance of bringing broader perspectives and experiences to our boardroom, and we hope to enact meaningful change, helping to set the stage for more public and private companies across all sectors to continue to diversify board memberships. I would now like our CFO, Jerry Dodson, to provide a summary of some of the highlights from our fiscal year 2022 first quarter financial results. Gary?