Vistagen Therapeutics, Inc.

Greetings and welcome to VistaGen Therapeutics' second quarter of fiscal year 2022 results conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mark Flather, Vice President of Investor Relations. Thank you. You may begin.

Thank you, Doug. Hello, and welcome to Vistagen's conference call covering its fiscal year 2022 second quarter financial results and recent accomplishments. I'm Mark Flather, Vice President of Investor Relations at Vistagen. Thank you for joining us today, and welcome to our shareholders, analysts, and anyone taking an interest in Vistagen. Joining me today are Shawn Singh, our Chief Executive Officer, Jerry Dodson, our Chief Financial Officer, Dr. Mark Smith, our Chief Medical Officer. The format for this call will consist of prepared remarks from management, followed by an opportunity for questions. To ask a question during the Q&A portion of this call, be sure to hit star followed by the one key at any time to be placed into the queue. 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 and 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, or SEC, and future filings that we make with the SEC from time to time, all of which are or will be available on our website and 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 at Vistagen, thank you for joining this call today. We sincerely hope you are all safe, healthy, and doing well. The current mental health treatment paradigm requires new, faster-acting medicines, medicines without the negative side effects and safety concerns that are often associated with currently approved options. As the prevalence of anxiety and depression disorders has grown considerably over the last 20 months, both in the US and across the globe, the unmet need has become more acute than ever. During the second quarter of our fiscal 22, we continued our strong performance and continued to build momentum across all aspects of our business. As we head toward the end of 21 and into 2022, we are increasingly confident and excited about the potential of our CNS pipeline to mitigate many mental health challenges and make meaningful improvements in the lives of millions of individuals around the world who are suffering from the debilitating effects of anxiety and depression. Among the milestones we achieved during the second quarter of fiscal 22 was the initiation of Palisade 2, the second major phase 3 trial in our Palisade phase 3 program for PH94B in social anxiety disorder, or SAD. Like Palisade 1, Palisade 2 is a U.S. multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy, safety, and tolerability of our PH94B nasal spray for the acute treatment of anxiety in adults with SAD. As a reminder, according to the U.S. National Institute of Health, SAD is the third most common psychiatric condition in the U.S. after depression and substance abuse. and it now affects over 23 million Americans. The initiation of Palisade II is another important step forward in our efforts to confirm the positive efficacy and safety data we observed in Phase II development of PH94B in SAD. It successfully developed in our Palisade Phase III program. PH94B has the potential to be the first FDA-approved, fast-acting, non-sedating, acute treatment of anxiety for millions in the U.S. who suffer from the debilitating effects of SAD. PH-94B is designed to be used as needed, on demand, as an acute treatment of anxiety for adults with SAD, treating their anxiety and fear of embarrassment, judgment, or humiliation in the context of an anxiety-provoking interaction, situation, or event in a manner similar to how a rescue inhaler is used to prevent the onset of an asthma attack. or as an acute migraine treatment is used to prevent the onset of a migraine episode. A market approval of PH94B in the U.S. would also pave the way for potential regulatory approvals in numerous additional high-value markets around the world. All ongoing studies in our Palisade Phase III program for PH94B and SAD are progressing well, and we remain on track for top-line data from Palisade 1 in mid-22, and from Palisade 2 in the second half of 2022. With its unique mechanism of action and safety profile we've observed in all clinical studies to date, we believe PH94B also has therapeutic potential across a broad range of anxiety disorders beyond SAD. During the quarter, we launched our exploratory phase 2A clinical development program for PH94B, with the initiation of a phase 2A clinical trial in adjustment disorder with anxiety. With emotional stress and impaired functioning brought on by sudden changes in health, safety, economic and social circumstances that many have experienced at heightened levels since the beginning of the pandemic, the increasing prevalence of adjustment disorder with anxiety has become very apparent to our team and the clinicians within our ecosystem. We believe PH94B has potential to offer hope to the growing number of individuals whose ability to function in their daily lives has been impaired by the onset of adjustment disorder. We expect top line results for this Phase IIa study in the second half of 2022. In the coming quarters, we plan to initiate additional small exploratory Phase IIa studies to assess PH94B's potential in populations suffering from anxiety disorders beyond SAD and adjustment disorder where we believe the current treatment alternatives are inadequate. During the quarter, we also reported important new preclinical data on PH94B's potential mechanism of action. Data from a tissue distribution study in laboratory rats demonstrate that a single intranasal administration of radiolabeled PH94B was largely confined to the nasal passages, with minimal or undetectable levels in most other tissues, including the CNS. And importantly, no appreciable activity was observed in the brain. We believe these results further highlight how the mechanism of action of PH94B is fundamentally differentiated from that of all current anxiety therapies. Because PH94B administered intranasally involves binding to peripheral neurons in the nasal passages, we believe there is limited transport of PH94B molecules to the circulatory system, thereby minimizing systemic exposure. When this radiolabeled PH94B data is combined with previously announced preclinical electrophysiology data demonstrating that the mechanism of action of PH94B does not involve direct activation of GABA-A receptors, which is in distinct contrast to the mechanism of action of benzodiazepines, we see a growing body of evidence suggesting that PH94B has potential to achieve anti-anxiety effects without requiring systemic uptake and distribution. and without causing benzodiazepine-like side effects and safety concerns. Regarding our other clinical stage drug candidates, PH10 nasal spray and our oral prodrug AV101, we are on plan to initiate our Phase IIb study for PH10 as a potential standalone rapid-onset treatment of major depressive disorder in mid-22, and to initiate our drug-drug interaction study of the combination of AV101 with probenicid near the end of this calendar year. We believe our current cash position is sufficient to advance our CNS pipeline well beyond a steady stream of potential data and regulatory catalysts from our Palisade Phase III program for PH94B and SAD, not only in calendar 22, but into calendar 2023, as well as other important clinical opportunities across our pipeline. We believe we have the flexibility and options to further strengthen our balance sheets beyond the multiple key data readouts with potential to be significant value-creating catalysts for the company. As we advance development of mental health treatments with groundbreaking potential, we've added to our strong team of great people with extensive experience in CNS drug development, clinical operations, CMC, commercial operations, and medical and regulatory affairs. During our last quarter, we also expanded leadership expertise on our board of directors with the additions of Mary Rotundo and Maggie Fitzpatrick to our board. which now has a female-led majority, significant distinction in board representation within the biopharmaceutical space. Our experienced team is well-positioned to advance our programs through important late-stage clinical and regulatory milestones and navigate a responsible path forward to potential commercialization of PH94B and social anxiety disorder. Our team is comprised of amazing individuals who not only possess vast knowledge and experience within our industry, but who also share our passion for social change and align with our corporate values. As we forge forward as changemakers in the mental health arena, we are confident and very excited about the potential of our CNS pipeline to make meaningful transformations in the daily lives of those impacted by mental illness. I'd now like to turn it over to Jerry Dodson, our CFO, to summarize some highlights from our fiscal year 22 second quarter financial results. Jerry?