Vistagen Therapeutics, Inc.

Good day and welcome to the Vistagen second quarter fiscal year 2023 results conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mark Flather, Vice President of Investor Relations. Please go ahead, sir.

Thank you, Jenny. Hello and welcome to Vistagen's conference call covering our second quarter of fiscal year 2023 financial results and business update. 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, and Jerry Dodson, our Chief Financial Officer. The format for this call consists of prepared remarks from management, followed by a brief opportunity from questions from sell-side analysts. 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 current expectations and current information. The forward-looking statements speak only as of today 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, Shawn Singh.

Thank you, Mark, and good afternoon, everyone. Thank you for joining the call. As I've said many times, Visigyn remains laser-focused on addressing the significant and growing unmet mental health needs in communities across the globe. And as I discussed last quarter with the U.S. Surgeon General and other leaders throughout the ecosystem focused on mental health and the epidemic, the world needs a marked change in the stigma surrounding mental illness, available treatment options, and the overall trajectory of mental health care. Individuals across a diverse range of communities need faster-acting treatment options that are not associated with unwanted side effects or risks of misuse, overuse, or addiction. It's crystal clear to our team at Vistagen that patients are counting on us, families are counting on us, and communities are counting on us. So we're steadfast in our mission and we're confident in our strategy and the potential of our pipeline to shift the treatment paradigm for anxiety and depression disorders and improve the trajectory of mental health care, one mind at a time. So let's get into some of the detail about progress across our pipeline, starting with our Palisade Phase III program for PH94B in social anxiety disorder, or SAD. That's our Palisade 1 and Palisade 2 double-blind placebo-controlled phase 3 studies and our Palisade open-label study. While the outcome of Palisade 1 was a setback that will extend our timeline for bringing PH94B to market, it was by no means the end of the line for PH94B and SAD, quite to the contrary. Setbacks, especially in neuropsychiatry, can certainly set up comebacks, and that's where we believe we are at today with PH94B. We've been gathering and analyzing the data from this study and have identified a few areas, especially related to the impacts of the pandemic, that may have contributed to the results that were so different from what we've observed in previous clinical studies of PH94B in SAD, including the recently assessed Palisade open-label safety study, which we'll talk about later in the call. We're making every effort possible to minimize these potential issues as we advance further in the development of 94B in SAD and other anxiety disorders, including recruitment and screening efficiencies and rigorous protocol adherence. The second component of our Palisade Phase III program in SAD is our Palisade II study. As previously noted, this study was paused during the last quarter to allow for an interim analysis to be performed by independent biostatisticians and to determine whether it'd be prudent to continue with this study as originally planned or to close it. And as we announced in September after they conducted an unblinded interim analysis of the 140 subjects who had completed the study at the time, the independent biostatisticians recommended that we continue Palisade 2 as planned to our target enrollment of 208 subjects. So that's what we'll do. And we'll do that armed with the recommendation and the insights that have formed that inform our preparations for the restart of Palisade 2, and we're on track to restart that study in the near term and deliver top-line results in 2023. The third important component of our Palisade Phase 3 program is the Palisade Open Label Study, which we initiated in October of 2021 to evaluate the safety and tolerability of PH94B in adult subjects with SAD, taken as needed prior to acute anxiety-provoking social and performance situations in their daily life, up to four times per day and over a period of up to 12 months. In addition to assessing safety and tolerability, we also included several exploratory efficacy objectives, including assessment of PH94B's potential to achieve overall symptom reduction and improvement in the severity of SAD as measured by the Leibowitz Social Anxiety Scale. That's the efficacy endpoint required by the FDA for all of the prior SAD approvals. In August, and to conserve cash and also to assess these key safety tolerability and LSAS data, we closed recruitment and enrollment in that Palisade Open Label Study. And as we reported today, our preliminary analysis now of nearly 400 subjects in that final data set for the Palisade Open Label Study, we see that there was robust functional improvement in anxiety-provoking social and performance situations in the daily life of the subjects as measured by the LSAS, or the Leibowitz Social Anxiety Scale. So, as to efficacy, we now have two important data sets supporting PH94B's ability to improve LSAS scores, the Palisade Open Label Study over a period of one month and beyond, and a published double-blind, placebo-controlled Phase II real-world crossover study after two weeks of use. These two studies combined demonstrate the potential for PH94B to achieve robust overall reduction in the symptoms of SAD and improvement in the severity of SAD over time, as measured by the LSAS. So we believe the LSAS measurements over time may be very well suited for a Phase III trial to demonstrate the efficacy and the true impact of PH94B on patients' lives, given that it measures overall improvement in disease severity by capturing the reduction in fear and anxiety, as well as the avoidance of social and performance situations. These studies further reinforce our belief in the potential of PH94B when it's used acutely, as needed, in daily life to provide onset, rapid onset, clinically meaningful, and sustained response in SAD patients, all with a very favorable safety and tolerability profile. So we're planning to meet with the FDA during the first quarter of 23, and our objective for that meeting will be to reach a consensus with the FDA around a clearly defined next step plan for further development of PH94B and SAD. Moving to our second target indication for PH94B, adjustment disorder with anxiety, we're progressing in our phase 2A clinical trial in that indication. As noted earlier today, we've completed enrollment in this study which is ongoing. It's an exploratory, double-blind, placebo-controlled phase 2A clinical trial that's designed to evaluate, again, the efficacy, safety, and tolerability of 94B as a potential treatment of adults with adjustment disorder with anxiety. The study protocol in this phase 2A study involves multiple administration assessments of PH94B, which in the study, it's administered four times a day for 28 days. So we anticipate announcing top-line results from this study during the first quarter of calendar 23. We've also made very notable progress with our second faring asset, PH10. And you might recall that in a small, published, exploratory, randomized, double-blind, placebo-controlled Phase IIa study of PH10 in major depressive disorder, a study that was conducted in Mexico, At the 6.4 microgram dose that was administered intranasally twice a day for eight weeks, PH10 significantly reduced depressive symptoms as early as one week based on the 17-item Hamilton Depression Scale scores compared to placebo, P.022. So PH10 was also, as 94B is, very well tolerated, did not cause any psychological side effects, any dissociation or hallucinations or other safety concerns that you might find associated with other rapid onset therapies such as ketamine. So we recently submitted last quarter our U.S. investigational new drug application to the FDA to enable us to initiate a small and very brief phase one clinical study of PH10 in the U.S. in healthy volunteers. So should the FDA permit us to proceed, we plan to initiate that study before the end of this calendar year. And this study is intended to facilitate moving back into Phase 2 development, Phase 2B development this time, of PH10 in the U.S., and either on our own or with a collaborator. And our target is for PH10 to become a potential fast-acting standalone treatment for MDD. So similar to the robust anxiety market, we know there is a significant unmet need in the major depressive disorder universe where current treatments are just either undesirable or inadequate or both. And with the differentiated mechanism of action that we have designed into PH10, designed to be fast-acting, non-systemic, non-sedating, PH10 has potential to radically shift the treatment paradigm for MDD. Having this asset in the clinic in the U.S. is a very important milestone on our path to bringing PH10 to the many individuals who are suffering and battling with depression disorders. Finally, as to AV101, in combination with FDA-approved oral probenicid, our exploratory Phase 1b drug-drug interaction study of that combination is ongoing. We anticipate completing the study during the second calendar quarter of 2023. After that, we'll assess all the AV101 data that we have generated to date, preclinical and clinical, and consider exploratory phase 2a development of AV101 combination with probenicid either on our own or again with a collaborator as potential oral treatment for CNS disorders that involve the NMDA receptor. So as we stand at the threshold of having now all three of our CNS drug candidates in active clinical trials, we believe we're in a position of notable strength. A strong team, a strong and novel pipeline that's aimed at large and growing markets, with tremendous need and a strong mission that drives us to deliver better solutions, all intended to improve mental health care and improve lives. It's a very exciting time for our company, market conditions notwithstanding, and we believe that we are very well positioned for 2023 and beyond. Now, our CFO, Jerry Dotson, will summarize some of the highlights of our financial results for the second quarter. Jerry?