Vistagen Therapeutics, Inc.

Good day, everyone, and welcome to today's Vistagen Fiscal Year 2024 Second Quarter Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask a question at any time by pressing the star and 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. Please note this call is being recorded. I'll be standing by if you should need any assistance. It's now my pleasure to turn the conference over to Mark McPartland. Please go ahead, sir.

Thank you, Travis. Good afternoon, everyone, and welcome to Vistagen's fiscal year 2024 second quarter corporate update conference call and webcast. This afternoon, we filed our quarterly report and issued a press release providing an overview of our progress last quarter. We encourage you to review the release, which can be found on the investor section of the Visagen website. During today's call, we will make forward-looking statements regarding our business based on our current expectations and 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 forelooking statement we make today. Additional information concerning risk factors that could affect our business and financial results is included in our fiscal year 2024 second quarter form 10-Q for the period ending September 30th, 2023, and in future filings that we will make with the SEC from time to time, all of which are or will be available on our website and the SEC's website. With that taken care of, I'd like to thank and welcome all of 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 on the recent results and our progress across our key pipeline programs. A brief opportunity for questions from our sell-side analysts will follow the prepared remarks. 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 our website. I would now like to turn the call over to our Chief Executive Officer, Sean Singh.

Thank you, Mark, and good afternoon, everyone, and thank you for joining our call. We achieved several milestones since our last call to establish a well-defined and fully funded Phase III development program for our lead farine asset, facidinol, with the potential to enable us to advance to a potential NDA submission for the acute treatment of social anxiety disorder. In the midst of the ongoing mental illness crisis, we are poised to transform the treatment paradigm for this widespread anxiety disorder that affects the lives of about 10% of our population. Social anxiety disorder, or SAD, is a disruptive disorder serious and potentially life-threatening anxiety disorder with high opportunity costs in daily life and no FDA-approved, patient-tailored, as-needed acute treatment option to help individuals rapidly and safely address their anxiety when their stresses are upon them during what, for many, is their decades-long journey with SAD. The hope of a revolutionary approach to treatment extends beyond Fasadionol and SAD to our full farine-based portfolio, and we remain fully focused on their development to create faster-acting, safer alternatives to address significant unmet needs in large CNS-related markets where current treatment options fall short for patients. Since our last conference call in August, we've continued to build on the momentum created by our successful Palisade II Phase 3 study of Fasadionol for the treatment of anxiety in adults with social anxiety disorder. During the past few months, we've strengthened our balance sheet considerably, securing $137.7 million in gross proceeds from equity financings and an exclusive negotiation agreement with Fuji Pharma regarding a potential license to develop and commercialize our PH80 in Japan. We expect this cash infusion will extend our corporate runway through several important clinical and corporate milestones as we advance our pipeline, including our primary focus on a potential US new drug application, or NDA, for fastidionol and SAD. Given that fastidionol's rapid onset mechanism of action is differentiated from all FDA-approved anxiety drugs, our primary target initial indication for fastidionol remains the acute treatment of anxiety in adults with SED. And as noted, there's no FDA-approved drug therapy for the acute treatment of SED. For that acute indication, we've previously aligned with the FDA that a simulated public speaking challenge in a clinical setting is an appropriate study design and that the subjective units of distress scale, or SUDS, is an appropriate primary efficacy endpoint to assess the efficacy of fastidionol because it provides a measure of anxiety on a minute-by-minute basis immediately related to the specific stressor. We believe utilizing a simulated anxiety-provoking public speaking challenge study design provides the most appropriate and efficient path for fastidionol to potentially become the first FDA-approved acute treatment of anxiety for adults with SAD. So to complement the positive top-line results from Palisade 2, we are currently preparing to launch two similar Phase 3 clinical trials in 2024, Palisade 3 in the first half of 2024 and Palisade 4 in the second half of 2024. Like the successful Palisade 2 study, both Palisade 3 and Palisade 4 will be multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trials designed to evaluate the efficacy, safety, and tolerability of the acute administration of fastidionol to relieve anxiety symptoms in adult patients with SAD after a single dose of fastidionol during a simulated anxiety-provoking public speaking challenge conducted in a clinical setting, and as measured using the patient-reported SUDs as the primary efficacy endpoint. Palate 3 and 4 will also have an open-label extension for up to 12 months, to provide additional long-term safety data. If successful, we believe either Palisade 3 or Palisade 4, together with Palisade 2, may establish substantial evidence of the effectiveness of fastidionol in support of a potential fastidionol NDA submission for the acute treatment of anxiety in adults with SAD in the first half of 2026. We also plan to initiate a small Facet dienol phase 2B repeat dose study in the second half of 2024. The facet dienol repeat dose study will be a multicenter, randomized, double-blind, placebo-controlled clinical trial, a small one, about 60 subjects, to evaluate the efficacy, safety, and tolerability of a repeat dose of facet dienol that's administered 10 minutes after an initial dose to further relieve symptoms of acute anxiety in adults with SAD during the anxiety-provoking public speaking challenge. That repeat dose study will consist of three different dosing arms with an open-label extension for up to 12 months. Twelve-month open-label extensions planned for the Palisade 3, 4, and repeat dose studies are all intended to expand our facet dienol safety database. Per ICH guidelines, we're targeting 300 patients treated with facet dienol for at least six months and 100 for 12 months. To date, over 750 subjects have been exposed to fastidionol, including over 30,000 doses administered in our Palisade open-label safety study. And we continue to be very encouraged with fastidionol safety profile in all clinical studies to date. The positive Palisade 2 data also bolster our growing confidence in the evidence supporting the potential of our entire fairing pipelines. We've had some recent advancements in a couple of other programs, so let's take a brief look at those. In June, we completed a successful randomized double-blind placebo-controlled Phase I study intended to investigate the safety and tolerability of vitruvone in healthy adult subjects. That trial was conducted to stage potential Phase IIb clinical development of vitruvone in the U.S., and it confirmed the favorable safety profile of vitruvone established in three previous clinical trials conducted in Mexico, including a positive, randomized, double-blind, placebo-controlled Phase IIa study of Atruvone in major depressive disorder, or MDD. As we advance and remain focused primarily on our Palisade Phase III program for Fasadinol and SAD, we also plan to explore various ways to unlock the significant potential value of Atruvone as a differentiated, non-systemic, monotherapy for MDD through potential strategic partnering arrangements in the U.S., as well as in major markets outside the U.S. We're also optimistic about our hormone-free, non-systemic PH80 nasal spray, which has now been studied in multiple significant women's health indications. Within the last two quarters, we've announced positive results from two PH80 studies in women's health indications, the first of which was the exploratory Phase IIa study of PH80 in women diagnosed with vasomotor symptoms or hot flashes that are due to menopause. In the Phase IIa study, PH80 induced a significant reduction in the daily number of hot flashes compared to placebo at the end of the first week of treatment, and the improvement was maintained through each treatment week until the end of the treatment period. PH80 treatment also significantly reduced the severity of the disruption in function and sweating related to hot flashes during the treatment period compared to placebo. It was well tolerated with no serious adverse events, and the adverse event profiles were comparable between PH80 and placebo. One of the favorable aspects of running additional trials in this particular indication is that there will be objective measures for these studies. That's to say that it's easier to measure how many hot flashes are experienced and the frequency of those symptoms versus more subjective endpoints that we often see in other studies in different indications. The other positive PHAD data we announced recently were from an exploratory phase 2A study of PHAD for the acute management of premenstrual dysphoric disorder, or PMDD. In this study, PHAD demonstrated statistically and clinically significant improvement versus placebo in symptoms of PMDD using the subject-rated PennDaily symptom report as early as day four, continuing to day six. There are limited effective treatment options that help with both physical and mood symptoms of PMDD, and we believe these results are quite promising. Given the depth of our entire CNS pipeline and the now robust body of successful safety and efficacy studies to date, we are also pursuing multiple potential non-dilutive strategic development and commercialization partnerships, both global and regional, to unlock the full value of our product candidate portfolio efficiently. We believe global and regional partnerships would amplify our internal expertise and development activities, potentially accelerate key development timelines, and enhance our overall efforts to deliver differentiated new treatment options where the current standard of care falls short. As an example of this, we recently announced the receipt of $1.5 million from our exclusive negotiation agreement with Fuji Pharma, regarding a potential license to develop and commercialize PH80 in hot flashes due to menopause and other indications in Japan. This is simply a right to discuss the potential for that license with us in a time-limited period. It's not a license. It's simply a non-refundable payment to us to talk to us. I will now turn the call over to our new CFO, Cindy Anderson, to summarize some of the highlights from our financial results for our fiscal year 2024 second quarter. Cindy has been a great recent addition to our team following the retirement of our former CFO, Jerry Dodson, after his over 10 years of distinguished service to the company. Cindy.