Vistagen Therapeutics, Inc.

Greetings and welcome to Visage and Therapeutics Fiscal Year 2024 Third Quarter Financial Results and Corporate Update. 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mark McPartland, Senior Vice President, Investor Relations at Vistagen. Thank you. You may begin.

Thank you, Doug. Good afternoon, everyone, and welcome to Vistagen's fiscal year 2024 third quarter corporate update conference call and webcast. This afternoon, we filed our quarterly report and issued a press release providing an overview of our recent third quarter results and our neuroscience pipeline development. We encourage you to review the release, which can be found in the investor relations section of the Vistagen website. During today's call, we'll make forelooking statements regarding our business based on our current expectations and information. The forelooking statements speak only as of today and accept as required by law. We do not assume any duty to update in the future any forelooking statement made today. Of course, forelooking 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 financial results are included in our fiscal year 2024 third quarter Form 10-Q for the period ending December 34, 2023, 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, with that taken care of, I'd like to thank and welcome all our stockholders, analysts, and everyone taking an interest in Vistagen. I'm joined on the call today by Shawn Singh, our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Josh Prince, our Chief Operating Officer. Shawn will provide an overview of our recent results and our progress across our key pipeline programs. A brief opportunity for questions from cell site analysts will follow the prepared remarks. I'd like to remind everyone this call is being webcast and will be available for replay after completion. The replay link can be found in the investor events section of the Vistagen website. I would now like to turn the call over to our chief executive officer, Sean Singh. Sean?

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. Here at Vistagen, we are pioneering neuroscience. with an intention to deliver first-in-class therapies for psychiatric and neurological disorders where there are few, if any, adequate and differentiated FDA-approved treatment options to satisfy the widespread needs of patients whose mental health and whose well-being are adversely affected by their disorders. Each of our clinical stage neuroscience product candidates is designed with the potential to establish new standards of care and make meaningful differences in how patients manage their disorders to improve their daily lives. Within the last few months, we've seen a renaissance in neuroscience, marked notably by pharma M&A in the neuropsychiatry space valued at about $23 billion. We are encouraged that novel, late-stage, neuroscience-derived product candidates with differentiated safety profiles have stimulated renewed interest in large market neuropsychiatry programs with the potential to change lives. We believe each of our clinical neuroactive ferrines, led by Fasadionol for the acute treatment of social anxiety disorder, is anchored in novel neuroscience and has the potential to produce differentiated product profiles across multiple and diverse large market therapeutic areas with high need for innovation, and high need to transform the standards of care, including anxiety, depression, women's health, and other disorders. Today, we'll briefly discuss our progress and plans for three of these, three of our five fairing assets in our clinical stage neuroscience pipeline, Fasadionol, Y-Truvalone, and PH80. As noted, our lead clinical stage program involves Fasadionol, and it's aimed at transforming the treatment paradigm for adults affected by social anxiety disorder, or SAD, which currently affects the lives of about 10% of the U.S. adult population, with very high opportunity costs in their daily life. While the prevalence of SAD continues to grow, there's still no FDA-approved, patient-tailored, acute treatment option to help individuals with SAD rapidly and safely address their anxiety when their stressors are upon them in their daily life. With the positive results from our Palisade II Phase III trial reported last year and a strong balance sheet, we're fully focused on advancing our Palisade Phase III development program in SAD with preparations to initiate this year all key remaining studies planned for that program. Since our last conference call in November, our team has been diligently focused on the preparations necessary to initiate Palisade 3, which will be our next Phase 3 clinical trial of Fasodinol for the acute treatment of anxiety in adults with social anxiety disorder. That remains on track to begin in the first half of 2024. That will be followed by Palisade 4 to be initiated in the second half of this year. Palisade 3 and Palisade 4 will be similar to our successful Palisade 2 Phase 3 trials. Both trials will involve a public speaking challenge in a clinical setting with patient-reported outcomes on the Subjective Units of Distress Scale, or SUDS, as the primary efficacy endpoint. We believe either Palisade 3 or Palisade 4, if successful, together with the positive results from Palisade 2, may establish substantial evidence of effectiveness of Fasadienol in support of a potential NDA submission for the acute treatment of anxiety in adults with SAD. Last year, we accomplished something that, to our knowledge, had never been achieved, and that is to demonstrate positive phase three results in an anxiety study with a drug candidate that does not need to be taken up systemically or act directly on neurons in the brain. We look forward to getting back into the clinic soon with Palisade 3 to continue driving on our mission to deliver a first-in-class therapy in a large neuropsychiatry market in need of differentiated, fast-acting therapies without the risk of sexual side effects, weight gain, or abuse liability concerns. Beyond fastidionol in our Phase III program in SAD, we are continuing to explore various ways to unlock the significant potential of our Atruvone asset as a differentiated new therapy for major depressive disorder, or MDD. Preparations and planning for a potential U.S. Phase IIb trial by Atruvone monotherapy in MDD are ongoing. Again, our mission in this large and unfortunately increasing neuropsychiatry market is to deliver a differentiated therapy to transform the standard of care without the risk of sexual side effects, weight gain, or abuse liability concerns. We also see great potential in our rapid-onset hormone-free PH80 nasal spray. Its potential is anchored in the previously unreported positive results from two trials in women's health indications that we announced last year. First is a treatment for vasomotor symptoms or hot flashes due to menopause. And next for the management of premenstrual dysphoric disorder or PMDD. PHAD showed statistically significant results in both studies. We are preparing to conduct non-clinical studies necessary to submit a US IND to facilitate further Phase II clinical development of PH80 for women's health indications, including the treatment of patients with moderate to severe vasomotor symptoms or hot flashes that are due to menopause. I'll now turn the call over to our CFO, Cindy Anderson, to summarize some of the highlights from our financial results for the third quarter of our fiscal 24. Cindy?