Vistagen Therapeutics, Inc.

Greetings. Welcome to the Vistagen Therapeutics third quarter of fiscal year 2022 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. And 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. Thank you. You may begin.

Thank you, John. Hello, and welcome to Vistagen's conference call covering our fiscal year 2022 third quarter financial results, recent accomplishments, and anticipated milestones. I'm Mark Flather, 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, Terry 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 a brief opportunity for questions. This call is being webcast and will be available for replay. The link to access the replay can be found in the investor's 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. Forward-looking statements speak only as of today and and except 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 quarterly report on Form 10-Q, filed earlier today with the Securities and Exchange Commission, or SEC, and in 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, 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 at Vistagen, thank you for joining this call. We sincerely hope you and those who are important to you are doing well, both physically and mentally. Taking care of your mental health is essential at every stage of life, and as we enter into the third year of the COVID-19 pandemic, it's safe to say that at one point or another, everyone's mental well-being may have been impacted in some manner. And even before the pandemic, anxiety and depression disorders represented large and accretive global markets with unsatisfied medical needs. Now, perhaps more so than ever before, innovative treatments for anxiety and depression disorders are needed to improve the lives of millions of individuals around the world who are suffering from these mental health conditions. Our team is on task and is working tirelessly to develop much needed novel treatments with the potential to deliver rapid onset relief without the negative side effects and safety concerns of current medications. Our third quarter results reflect notable progress across our pipeline and all other aspects of our business. During calendar 22, we anticipate key top line phase three data readouts with exciting potential to transform major aspects of mental health care. Our Palisade phase three program is designed to further demonstrate the potential of PH94B as a rapid onset as needed acute treatment of anxiety in adults with social anxiety disorder, or SAD. Our two ongoing phase three studies in the program, Palisade 1 and Palisade 2, and our Palisade long-term safety study are on track for top-line data readout as previously anticipated. Specifically, Palisade 1 is expected to deliver top-line results mid-year this year, and Palisade 2 is expected to deliver top-line results in the second half of this year. Should they be successful, we anticipate that these studies and a couple of smaller studies will anchor our U.S. new drug application for PH94B in SAD. In addition to the milestones we achieved in our Palisade Phase III program during the recent quarter, we launched our Phase IIa clinical study of PH94B in adjustment disorder with anxiety as the first study in our exploratory clinical evaluation program for PH94B and anxiety indications beyond SAD. With emotional stress and impaired functioning brought on by sudden change in health, safety, and economic and social circumstances that many have experienced at heightened levels since the beginning of the pandemic, the need for an innovative therapy for adjustment disorder with anxiety has become increasingly apparent to our team and the clinicians in our ecosystem. We believe PH94B has the potential to offer relief to the growing number of individuals whose routine daily functioning has been impaired by the onset or exacerbation of adjustment disorder with anxiety. We anticipate top line results for this Phase IIa study in the second half of 22. Later this year, we also plan to initiate additional small exploratory clinical studies to assess PH94B's potential in populations suffering from anxiety disorders beyond both SAD and adjustment disorder, indications where we believe the current treatment alternatives are inadequate. Also during the quarter, we reported important new preclinical data on PH94B's potential mechanism of action, or MOA. Data from a 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 highlight the fundamental difference in PH94B's MOA compared to that of all current anxiety therapies. When the data from this radiolabeled PH94B tissue distribution study is combined with that from previous in vitro studies demonstrating that the MOA of PH94B does not involve direct activation of GABA receptors, We see a growing body of evidence suggesting that PH94B has the potential to achieve rapid anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects or other safety concerns. Regarding our other clinical stage drug candidates, we are preparing to initiate a phase 2B clinical study of PH10 as a potential rapid onset standalone treatment in major depressive disorder in the second half of 22. We believe PH10 has potential across multiple depression disorders. Also during the quarter, we initiated a Phase 1B trial for oral prodrug candidate AV101 in combination with an FDA-approved probenicin. The study follows two positive preclinical studies showing that the combination of AV101 and probenicin substantially increased the brain concentration of the active metabolite of AV101 targeted at reducing rather than blocking NMD receptor signaling. We believe AB101 in combination with probenecid has the potential to be developed as an innovative treatment for several CNS conditions involving the NMDA receptor. I would now like our CFO, Jerry Dodson, to summarize some of the highlights from our fiscal 22 third quarter financial results. Jerry?