Vistagen Therapeutics, Inc.

Greetings. Welcome to the Vistagen Therapeutics 2022 Fiscal Year End Results Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the conference over to your host, Mark Flather, Vice President of Investor Relations for Vistagen. You may begin.

Thank you, Kyle. Hello, and welcome to Vistagen's conference call covering our fiscal year 2022 financial results, recent accomplishments, and anticipated milestones. I'm Mark Flatter, Vice President of Investor Relations at Vistagen. Thank you for joining us today, and welcome to our stockholders, analysts, and anyone taking an interest in Vistagen. Joining me today are Sean Singh, our Chief Executive Officer, Jerry Dotson, our Chief Financial Officer, and Dr. Mark Smith, our Chief Medical Officer. The format of this call, as Kyle mentioned, will consist of prepared remarks for management, followed by a brief opportunity for questions. This call is being webcasted and will be available for replay. The link to access the replay 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 as accepted 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 statements 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 annual report. On Form 10-K, filed earlier today with the Security and Exchange Commission, or SEC, and future filings that we make with the SEC from time to time, all of which will be available on our website and the SEC's website. Now I'd like to turn the call over to our Chief Executive Officer, Sean Singh.

Thank you, Mark, and good afternoon, everyone. On behalf of our entire team here at Visigyn, thanks for joining the call today. We sincerely hope that you and those who are very important to you are doing well, both mentally and physically. As the prevalence of anxiety and depression disorders has grown considerably since the beginning of the pandemic, it's crystal clear to us that currently approved treatments are underserving millions of individuals who are living with anxiety, depression, and many other CNS disorders. Individuals across a broad range of demographics need new, faster-acting treatment options without having to worry about the negative side effects and safety concerns that are often associated with currently approved meds. We are committed to developing and commercializing new differentiated treatments with potential to improve lives. Our fiscal year 2022 was defined by progress in all areas of our business, further enhancing our confidence about the potential of our CNS pipeline. We have advanced through our past fiscal year and into the current year with momentum and anticipation for several key milestones. During the second half of calendar 22, we anticipate reporting key top-line data readouts in our Palisade Phase 3 program for PH94B in social anxiety disorder, or SAD, as well as the expansion of other important clinical programs, moving us closer to our goal of transforming the way that anxiety and depression are understood and treated, one mind at a time. Several recent advancements provide opportunities to unlock shareholder value. In our Palisade Phase 3 program for PH94B and SAD, we reported a major clinical milestone yesterday with the last patient's completion of the study protocol in our Palisade 1 trial. This Phase 3 clinical trial, as we've reported, is a U.S. multi-center, randomized, double-blind, placebo-controlled, parallel-designed clinical study in adults who are diagnosed with SAD. The study is designed to evaluate the efficacy, the safety, and the tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adults living with SAD during a simulated public speaking challenge, measured using the Subjective Units of Distress Scale, or SUDS. We are grateful, as I noted in the press release yesterday, to the many individuals diagnosed with SAD who participated in the study. Also, Dr. Michael Leibowitz, the principal investigator of the study and among the world's leading experts in SAD, and our CRO, the clinical investigators, and their staff. Together with our team, everyone played a key role in completing the study, and we're very grateful for that. We're looking forward to evaluating the PALSAD1 data when it's available, and we're expecting to announce the top-line results, as we noted, in mid-22. consistent with our prior guidance. Vistagen is also evaluating PH94B for SAD in a second phase three clinical trial, Palisade 2, which is a replicate of Palisade 1. Top line results for Palisade 2 are anticipated in late 22. These data readouts represent potential catalytic moments for this product candidate, for our company and for the millions living with social anxiety disorder. Should Palisade 1 and Palisade 2 be successful? they have the potential to anchor our U.S. new drug application for PH94B and SAD. In May, we announced a key regulatory update on PH94B regarding abuse liability. We previously contacted the FDA to gather feedback on whether a human abuse potential study would be necessary for PH94B for the acute treatment of SAD. In their written response, as we announced, the FDA indicated that non-clinical and clinical data and studies completed to date provide no signal of abuse potential. Additionally, receptor binding data do not show that PH94B has affinity for abuse-related sites such as dopamine, opiate, and GABA. Also, no additional non-clinical studies are needed to evaluate the abuse potential of PH94B. And finally, while the need for a human abuse potential study with PH94B is may be revisited by the FDA upon the completion of our current and our planned PH94B clinical trials. The studies completed to date provide no signal of abuse potential, and at this time, conducting a human abuse potential study of PH94B is not necessary. We are very encouraged by our consensus view with the FDA on this important dimension of abuse liability potential, which of course will be an important matter for healthcare providers and patients to consider hopefully in the future with respect to use of PH94B. To further illustrate some of the unique benefits that we've seen with PH94B in studies to date, we shared additional details from previously reported carbon-14 radiolabeled PH94B study at the annual meeting of the Society of Biological Psychiatry, the American Society of Clinical Psychopharmacology, and the Medscape Live Psych Update spring meeting. The preclinical data from the tissue distribution study in laboratory rats demonstrated 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. More importantly, no appreciable activity was observed in the brain. We believe these results further demonstrate the fundamental difference in PH94B's mechanism of action, or MOA, compared to that of all current anxiety therapies. When the data from this radiolabeled PH94B tissue distribution study are combined with that from previous in vitro studies, demonstrating that the MOA of PH94B does not involve direct activation of GABA-A receptors, we see a growing body of evidence that PH94B has the potential to achieve rapid onset anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects and safety concerns. In another important step forward, we and our partner, AFIMED, have completed regulatory preparations to initiate Palisade Global, a Phase III clinical trial to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with SAD. Modeled as a replicate of our Palisade I and our Palisade II Phase III studies, Palisade Global is meant to support a commercialization of PH94B in markets outside the U.S. We anticipate initiating Palisade Global in the U.S., China, and likely Canada in the second half of 2022. Should the trial be successful, Palisade Global is an important component when combined with our activities in the U.S. Palisade Phase III program to expand access globally for individuals with SAD who could potentially benefit from PH94B. Beyond progress and expansion of the Palisade Phase III program, we initiated an exploratory phase 2A clinical study of PH94B in adjustment disorder with anxiety. This is the first study in our evaluation of PH94B's potential in an anxiety indication beyond SAD. We anticipate top line data from this adjustment disorder trial somewhere near the end of the year. Regarding our other clinical stage drug candidates, we are preparing for phase 2B clinical development of PH10 as a potential rapid onset standalone treatment in major depressive disorder. We will provide further guidance on our development plan for PH10 later in the year. For AV101 in combination with probenicid, our phase 1B trial is underway. The study follows two positive preclinical studies showing that the combination of AV101 and probenicid substantially increased the brain concentration of the important active metabolite of AV101. We believe these results can give us some evidence, some indication of what we might want to do in the future with that combination. So I now like our CFO, Jerry Dodson, to summarize some of the highlights from our fiscal year 22. Jerry?