Vistagen Therapeutics, Inc.

Greetings, and welcome to Vistage and Therapeutics Fiscal Year-End 2023 Corporate Update 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 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 McPartland, Senior Vice President of Investor Relations. Thank you. You may begin.

Thank you, Doug. Good afternoon, everyone, and welcome to VisiGen's fiscal year-end 2023 corporate update conference call and webcast. This afternoon, we issued a press release providing an overview of our progress last year and future milestones, and we expect to file our fiscal year-end 10-K later this afternoon. We would encourage you to review both, which can be found under the investor section of our website. Now, before we start today's call, I want to remind you that we may 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 statements made today. Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ maturely from those anticipated by any forward-looking statements we make today. Additional information concerning risk factors that could affect our business and financial results is included in the fiscal year 2023 Form 10-K, which again will be filed later today, which can also be found on our website or the Securities Exchange Commission website, sec.gov. In future filings we make with the SEC from time to time, all of which will be available on our website and MSCC website. With that taken care of, I'd like to thank and welcome all of our stockholders, analysts, and all of you taking an interest in Vistagen. I'm joined on the call today by Shawn Singh, our Chief Executive Officer. Shawn will provide an overview of the company's progress made in 2023, upcoming milestones, followed by a brief opportunity for questions from our sell-side analysts. We want to remind you again that this call is being webcast and recorded and will be available for replay. The replay link can be found in the investor section of the website, visigen.com. Now, with that done, I would like to turn the call over to Sean Singh, our Chief Executive Officer. Sean?

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call. As we've discussed many times, Visigen's core mission is to radically improve the mental health and the well-being of the millions of individuals worldwide who who suffer from a variety of anxiety, depression, and other CNS disorders that severely disrupt their daily lives. To that end, each of our innovative clinical stage CNS product candidates is designed with the potential to establish new standards of care, make meaningful differences in how patients manage their disorders, and improve their lives. Throughout the year, we continue to advance our core programs for treatment of social anxiety disorder with Fasadinol, major depressive disorder with Ytruvone. We achieved multiple clinical and regulatory milestones that are necessary to stage what we see as key advances in those programs this year and beyond. We also advanced strategic planning for our other four clinical stage product candidates, specifically PH80, for the treatment of menopausal hot flashes, which is a large and unsatisfied market. We are also advancing planning for further US IND enabling development to facilitate Phase 2B development of PH15 for rapid onset improvement of attention and learning in subjects with cognitive impairment that's caused by mental fatigue, and of PH284 for enhancement of subjective feelings of appetite and weight gain in subjects with Caxachia, a wasting syndrome that's associated with cancer, or other disorders related to appetite loss. With the depth in our collective body of positive safety and efficacy studies supporting our clinical stage pipeline, now is the opportune time to amplify our internal efforts to secure multiple global and regional strategic development and commercialization partnerships across our entire portfolio to accelerate achievement of key clinical, regulatory, and commercial milestones within each program, and deliver meaningful value to our stockholders and to the millions of patients who are affected by these disorders, affecting both their mental health and their physical well-being. I'll begin with a brief update on Fasadienol, formerly called PH94B in our Phase III program in social anxiety disorder, or SAD. Earlier this year, we reported a long-term intranasal administration of 3.2 micrograms of Fasadienol. Self-administered by patients as they needed it up to four times a day to manage their anxiety-provoking situations in a real-world setting was well-tolerated, with no new safety findings or trends identified regardless of the number of doses administered by each subject. Overall in that study, patients self-administered over 30,000 doses of Fasadinol with a mean duration of four months and a maximum study duration of over 10 months. Key exploratory efficacy results from that study demonstrated clinically meaningful reductions in fear, anxiety, and avoidance of anxiety-provoking social and performance situations in the daily lives of the patients involved, as measured by the Leibowitz Social Anxiety Scale, or LSAS. We believe the continued improvement in LSAS observed in hundreds of the SAD patients in this large study, including patients from both Palisade 1 and Palisade 2, indicates the therapeutic potential of multiple patient-tailored, as needed, administrations of Fasadionol over time. Fasadionol helps patients build their confidence to engage in these anxiety-provoking social situations in their daily lives more frequently and with less fear and anxiety. Further, the safety and exploratory results of the Phase III open-label study of Fasadionol, along with the previous safety and LSAS efficacy results, from multiple placebo-controlled Phase II studies, including a placebo-controlled study conducted in the real-world setting, built support for a meeting with the FDA to discuss the next steps in our fearless Phase III development plan for Fasadionil and SAD. The plan that is centered on the potential new drug application enabling Phase III studies of Fasadionil in a real-world setting using the LSAS as the primary efficacy outcome measure in a manner similar to the registration studies for all three of the FDA-approved treatments for SAD. Results from the placebo-controlled phase two studies demonstrate that self-administration of vasodilinol on an as-needed basis prior to anxiety-provoking situations has exciting potential to achieve fast-acting and persistent change in overall SAD symptoms, reduce fear and anxiety about social and performance situations, and enable less frequent avoidance of those situations as measured by the LSAS. Notably, the amount of separation between facet-ionol and placebo as measured by the LSAS at the end of the first two weeks in the placebo-controlled phase two study conducted in a real-world setting was comparable to LSAS results observed after 12 weeks in the registration trials for the three antidepressants approved by the FDA for the treatment of SAD. Positive feedback from the FDA earlier this year confirmed the acceptability of our preferred use of the LSAS as the primary efficacy endpoint in our future Phase III studies for the treatment of SAD, again, in line with all three of the previously approved SAD products. Our Freelance Phase III program and SAD will align with the LSAS-based study design, supporting the precedent-setting, NDA-enabling programs for all three antidepressants currently approved for the treatment of SAD. The fearless phase three studies will be designed to assess multiple administrations of facet dienol on a patient-tailored, as-needed basis in their daily lives up to six times per day in a real-world outpatient setting over a multiple-week period with the clinician-administered LSAS as the primary efficacy endpoint. So, with clarity from positive regulatory feedback on the path forward, and the FDA's previous grant of Fast-Track designation for development of fastidionol for SAD, we're now positioned to finalize our full NDA-enabling, fearless Phase III development program for fastidionol, a plan for a large market program that is well-suited for late-stage partnering to complete Phase III development and, if successful, commercialize fastidionol in the U.S. and multiple markets worldwide for a disorder that is increasingly impacting the lives of tens of millions of patients in the U.S. and around the world. Moving next to ITruvone, formerly PH10, our varying nasal spray candidate for potential rapid onset treatment of major depressive disorder, or MDD. We recently reported favorable safety and tolerability data from our U.S. Phase I clinical trial of ITruvone. ITruvone was well tolerated and consistently continued to demonstrate a favorable safety profile. Importantly, results from this study build on previous successful Phase I studies and a published positive placebo-controlled Phase IIa study by Truvone and MBD that was conducted outside the U.S. So the collective body of successful clinical studies now enable us to focus on next step Phase IIb development by Truvone in the U.S. as an innovative standalone rapid onset product candidate for the treatment of MBD. During the past year, the FDA also granted Fast-Track designation for development of itruvone for the treatment of MDD. So, like Fasadienol for SAD, itruvone is now states for strategic partnering in the U.S. and multiple large depression markets outside the U.S. We also recently reported that PH80 demonstrated statistically significant efficacy versus placebo in a previously unreported exploratory phase 2A clinical study for the acute treatment of vasomotor symptoms that are known as hot flashes that are due to menopause. In the study, PHAD induced a statistically significant reduction in the daily number of hot flashes compared to placebo at the end of the first week of treatment, and that improvement was maintained to the end of the four-week treatment period. PHAD treatment also significantly reduced the severity, disruption, and function and sweating related to hot flashes during the treatment period as compared with placebo. As we've seen with all fairings in our pipeline, PH80 was well-tolerated with no serious adverse events and an adverse event profile comparable to placebo in all the clinical trials of that drug candidate to date. The prevalence of menopausal hot flashes is estimated to be about 20 million women in the U.S., with 9 million more women estimated to be suffering from severe hot flashes. Current treatments are associated with certain side effects and significant safety concerns. So the pressing need for improved treatment options is evident when considering the millions of women who endure the disrupted impact of menopausal hot flashes in their daily lives. Also, with its novel rapid onset mechanism of action, PHAD is designed to initiate neural impulses in the olfactory bulb transmitted by pathways that rapidly affect the function of multiple structures in the brain, including the amygdala and the hypothalamus. Due to its mechanism of action, we also believe PH80 has therapeutic potential to relieve premonitory and oral symptoms of migraine. We recently expanded the intellectual property portfolio of PH80 to include treatment of migraine, the U.S. patent issuance, and an intention to grant a European patent. So, we look forward to preparing for potential future development of PH15 and PH284 as well. These are two varying candidates that are also in Phase 2 development, and we're assessing the results of previously unreported exploratory Phase 2A studies, placebo-controlled Phase 2A studies that involve PH15 for improvement of cognition, especially in sleep-deprived populations, and PH284 for improvement in subjective feelings of hunger in late-stage cancer patients in particular, those with Caxachia. As to AV101, our oral NMDA receptor antagonist, based on observations and findings from several preclinical studies and successful Phase I studies, we believe AV101 has potential to become a new oral treatment alternative for certain CNS indications that involve the NMDA receptor. Recently, we strengthened our AV101 intellectual property portfolio after receiving a new patent granted by the European Patent Office that's related to the synthesis of AV101 and certain chemical intermediaries. That enhances the attractiveness of AB101 as a valuable asset for potential strategic development and commercialization partnerships. So we are currently pursuing partnering and non-dilutive grant opportunities for Phase IIa clinical development of AB101 as a treatment for one or more of those neurological disorders involving the NMDA receptor, likely with emphasis on dyskinesia associated with Parkinson's therapy. We believe our robust CNS pipeline puts us in a place of scientific strength in the field. We have a broad range of positive clinical studies across multiple product candidates and multiple indications with potential for long-term value creation and meaningful impact on the treatment landscape for millions of individuals affected by anxiety, depression, hot flashes, and several other large market CNS disorders. Moving to our business strategy. Earlier this month, our board of directors authorized the stockholder approved reverse split of our common stock. Our primary corporate and strategic objectives for implementing that stockholder approved reverse split included the following. First and foremost, we implemented the reverse split to reestablish compliance with NASDAQ's minimum bid price requirement to help ensure that we maintain the numerous benefits of listing our common stock on the NASDAQ capital market. We recently announced regaining full compliance with the continued listing standards of the NASDAQ capital market. So, together with our stockholders, we achieved that objective. Second, the reverse split enabled us to increase awareness of Visagen and the therapeutic and market potential of our six clinical stage drug candidates, both in the capital markets, among prospective strategic partners, and among healthcare-focused media. And finally, the split may broaden our capital market base through enhanced access to institutional investors, mutual funds, family offices, general investing, public, and healthcare-focused self-side research analysts. All are key components of our ongoing efforts to advance awareness, understanding, and the potential value of our CNS pipeline with our key stakeholders. Given the depth of our CNS pipeline and the robust body of successful safety and efficacy studies achieved to date, we are now pursuing multiple strategic development and commercialization partnerships, both global and regional, to efficiently unlock the full value of our product candidate portfolio. We believe global and regional partnerships amplify our internal activities and can accelerate key development milestones and timelines and enhance overall our ongoing efforts to deliver differentiated treatment options and significant value to our stockholders. In closing, we remain unwavering in our core mission to improve mental health and well-being worldwide. As we continue advancing the next stages of our corporate development, we move forward with a strong team, a strong pipeline, and a strong purpose that drives us to innovate better solutions for CNS disorders in large markets with significant unmet needs. On behalf of our entire Vistagen team, thank you for the privilege and for the opportunity to make a difference, one mind at a time.