Vistagen Therapeutics, Inc.

Greetings. Welcome to VisaGin Therapeutics Fiscal Year 2021 Results and 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 the call, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Mark Flather, Vice President of Investor Relations. Thank you. You may begin.

Thank you, Sherry. Hello, and welcome to the Vistagen Therapeutics 2021 Fiscal Year End Financial Results and Corporate Update Conference Call. I am Mark Flather, Vice President of Investor Relations at Vistagen. Thank you for joining us today for this business update, and welcome to our shareholders, analysts, and anyone taking an interest in Vistagen. Joining me today is Sean Singh, our Chief Executive Officer, Cherry Dodson, our Chief Financial Officer, and Dr. Mark Smith, our Chief Medical Officer. The format for this call will consist of prepared remarks from the management, followed by an opportunity for questions. This call is being webcast and will be available for replay. The link 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 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 forward-looking statements that we make today. Additional information concerning risks and factors that could affect our business and financial results is included in our most recent annual report on Form 10-K 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 the SEC's website. Now, with the formalities out of the way, I'd like to turn the call over to our Chief Executive Officer, Sean Samuels.

Sean Samuels Great. Thank you, Mark, and good afternoon, everyone. On behalf of our entire team here at Visigyn, I just want to thank you for joining our call today. And as I've said to many of you before, independently, we are all changemakers. Not only our team here at Visigyn, but also all of you who support our efforts. And together, we are 100% committed to changing the lives of people all over the world by improving mental health. by developing medicines that have the potential to go well beyond the currently undesirable or inadequate standard of care for anxiety and depression disorders. Disorders that are disrupting the lives of millions of people all around the world. Not only patients who face these challenges with inadequate treatment alternatives, but their caregivers, their families, their friends, and their colleagues. people they come across all day in their daily lives. And even before the pandemic, we know that the prevalence of anxiety and depression disorders was alarming. And in today's world, it's certainly no secret that the pandemic has exacerbated what was already a challenging situation. And the lingering effects of the pandemic on mental health are likely to be very long-term. So now more than ever, perhaps those suffering from anxiety and depression disorders need new and safe and tolerable alternatives to current medicines. As we forge forward through this pandemic and as we forge forward as changemakers, more so than at any other time in our company's history, we're confident and we're excited about the potential of our CNS pipeline to do just that. to make meaningful changes in the lives of those impacted by mental illness. And despite the challenges of the COVID-19 pandemic, as we've reported, our fiscal 21 was very positive, transformative on many levels. Early in the year, our regulatory and clinical teams successfully forged a very important consensus with the FDA regarding the key design elements of our Palisade 1 um study the first of our two u.s multi-center randomized double-blind placebo-controlled clinical studies of ph94b which is our rapid onset nasal spray for the acute treatment of anxiety in adults with social anxiety disorder as well as all the other studies in our palisade phase 3 program that we believe are necessary to enable a U.S. new drug application or an NDA for PH94B should our Palisade Phase III program be successful. We also started the fiscal year by entering a strategic collaboration for clinical development and commercialization of PH94B in Greater China, South Korea, and Southeast Asia, all very large markets. Under that collaboration, we received a non-dilutive upfront payment of $5 million. and we've got the potential under that collaboration for another $172 million in additional development and commercial milestone payments on top of tiered royalties on sales of PH94B in those countries if a three development efforts there are successful. As we've noted, we retain exclusive rights to develop and commercialize PH94B and all of our other assets in our CNS pipeline in all other markets worldwide. Should our Palisade Phase III program be successful, we will commercialize PH94B on our own in the U.S. and enter into additional commercial collaborations in ex-U.S. markets. In December of last year, we significantly strengthened our balance sheet, as well as our institutional shareholder base, by successfully completing a $100 million capital raise that was led by teams at Jeffries and William Blair and involved numerous leading long-biased healthcare investors. That capital raise created a very important value inflection point for the company. It removed the need to go back to the market near term and provides us with capital to advance execution on all of our clinical development programs on multiple parallel tracks, across our entire CNS pipeline. We believe our current cash position is sufficient to advance our CNS pipeline through a very exciting stream of potential clinical development milestones in the coming months, in the coming years, with the initiation of Palisade 1 in SAD last month as the first of what we expect to be an exciting series of value-adding catalysts for the company. Before the end of calendar 21, we also expect to advance the Palisade Phase 3 program by initiating Palisade 2 as a replicate of Palisade 1, and as well as complementary clinical and certain non-clinical studies in the Palisade Phase 3 program necessary to support the NDA submission should the program be successful. And in addition, throughout the remainder of calendar 21 and during the first half of calendar 22, we expect to initiate multiple phase 2A studies involving PH94B, a phase 2B study of PH10 in major depressive disorder, and a phase 1B study of AB101 in combination with probemesis. I'll highlight some of these studies shortly during the product updates. As we all know, to advance groundbreaking treatments, you need great people. And we have continued to enhance our internal team by adding key personnel with extensive experience in CNS drug development, clinical operations, commercial operations, CMC, and regulatory affairs. Our experienced team will be driving our programs through very important late-stage clinical and regulatory milestones, as well as be responsible and appropriately time pre-commercial and commercial launch activities. Notably, the recent addition of Ann Cunningham as our chief commercial officer has been tremendously helpful in support of our pre-commercial planning for PH94B in the multiple SAD market segments that we're targeting in the U.S. and globally. We also added pharmaceutical industry veteran Dr. Joanne Curley to our board of directors. Dr. Curley brings extensive experience in product development, operations, and commercialization to the board. So overall, I have tremendous confidence in our team's ability to deliver remarkable outcomes across all the key functional areas and across our entire pipeline. So now I'll give you a brief update on each of the three drug candidates in our current CNS pipeline. I'll briefly describe each product MOA or the way we believe it works. and its potential indications, and I'll detail then the expected next steps in each of our development programs for these candidates. So first, PH94B. It gets a little technical, but hopefully I'll give you some understanding as to why we're so excited and confident about its game-changing potential. PH94B is a synthetic investigational neurosteroid that was developed from proprietary compounds called pharynx. With its novel MOA, PH94B is an odorless nasal spray that's designed to be administered at microgram level doses, not milligrams, microgram level doses, to achieve its rapid onset anti-anxiety or anxiolytic effects within about 10 to 15 minutes. PH94B's MOA is fundamentally differentiated from the MOA of all FDA-approved anti-anxiety drugs, including the three antidepressants, that are approved by the FDA for the treatment of SAD, or social anxiety disorder, and all the benzodiazepines and beta blockers that are prescribed on an off-label basis to treat SAD. H94B engages peripheral chemosensory receptors in the nasal passages. These trigger a subset of neurons in the main olfactory bulb, or OB, at the base of the brain. The OB neurons then stimulate inhibitory GABAergic neurons in the limbic amygdala. decreasing the activity of the sympathetic nervous system and facilitating fear extinction activity of the limbic hypothalamic system, which is the main fear and anxiety center of the brain, as well as in other parts of the brain. And importantly, unlike oral drugs, PH94B does not require systemic uptake and distribution to produce its rapid onset anti-anxiety effects. What you've got with PH94B very unique MOA using the nose as a portal to achieve neuropsychiatric benefits in a very rapid onset way and with an exceptional side effect and safety profile that is nothing like what we see with today's approved antidepressants or benzodiazepines or beta blockers. And as a result of our confidence in the work that we've done so far with PH94B, Our ongoing Palisades Phase III program for PH94B is designed to further demonstrate its potential as a fast-acting, non-sedating, non-addictive, acute treatment of anxiety in adults with SAD, and later in pediatric populations with SAD. SAD is a very prevalent indication. Over 23 million Americans are affected by it. Its mean duration of the illness is about 20 years, and the mean age of onset is only age 16. We believe 94B also has the potential to be developed as a novel treatment for adjustment disorder with anxiety, postpartum anxiety, especially given the fact that it's non-systemic, post-traumatic stress disorder, procedural anxiety, panic, and several other anxiety disorders. And importantly to note, PH94B has been granted fast track designation status by the FDA for treatment of SAD. As I noted earlier, after our positive meeting with the FDA last summer, we reached a consensus with the agency on the key aspects of the design of what has now become Palisade 1, initial phase 3 clinical trial in our Palisade phase 3 program for the development of PH94B as an acute treatment of anxiety in adults with SAD. And as a result of that meeting, Palisade 1 and Palisade 2 will substantially mirror the public speaking challenge of the statistically significant P.002 Phase 2 study of PH94B and SAD. And that meeting provided us, and that decision, and that consensus really provided us with substantial overall time, cost, and execution efficiencies for the Palisade Phase 3 program, which are now underway. So for a little more information on that Palisade Phase III program, Palisade I, as I noted, is a U.S. multicenter randomized double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy, safety, and tolerability of the administration of 3.2 micrograms of PH94B for the acute treatment of anxiety in adults with SAD during an induced public speaking challenge. We initiated that study in May, and we currently anticipate the top-line data to read out in the middle of 22. Palisade 2, another U.S. Phase III study of PH94B and SAD, will replicate Palisade 1 with the same overall design and objectives. We expect to initiate Palisade 2 in the second half of calendar 21 and to receive top-line data readout from this study in the second half of calendar 22. In addition to Palisade 2, during the second half of 2021, we will initiate an open-label long-term safety study of PH94B. Currently, we anticipate initiating a global study of PH94B, Palisade Global, later this year to facilitate registration of PH94B in ex-US markets. We'll provide more information on Palisade Global once we're closer to that study launch. In late 21 or early 22, we also anticipate initiating the dose response and minimal time redosing studies requested by the FDA. All of this in line with our plan to drive towards a potential US NDA for PH94B in the first half of calendar 23. Again, in addition to social anxiety disorder, we're exploring PH94B's potential and are preparing for several exploratory phase 2a clinical studies of this asset in other anxiety indications. We believe that it may also be developed as a novel treatment for adjustment disorder with anxiety, postpartum anxiety, PTSD, procedural anxiety, panic, and others, as I've noted. And we expect to begin two of these studies, adjustment disorder with anxiety and procedural anxiety, an fMRI study of PH94B's effects, in the second half of this calendar year. And two more, postpartum anxiety and PTSD, are anticipated in mid-22. Provide more information on these studies once we're closer to study launch. Now moving on to our second CNS product candidate, PH10. PH10 is a synthetic investigational neurosteroid, which also was developed from proprietary compounds called pharynx. It's got a novel and rapid-onset MOA, and it's fundamentally differentiated from the MOA of all current treatments for depression disorders. It's also an odorless nasal spray, and it's designed to be administered at microgram-level doses to produce a rapid-onset effect, and one that we have seen in Phase IIa that's been sustained over eight weeks. GATES-10 activates nasal chemosensory cells in the nasal passage. These are connected, again, to neural circuits in the brain that produce antidepressant effects. Specifically, PH10 engages peripheral chemosensory receptors in the nasal passages that trigger a subset of neurons in the main OB that then stimulate neurons in the limbic amygdala. This, in turn, increases activity of the limbic hypothalamic sympathetic nervous system and increases the release of catecholamines, importantly, And unlike any of the approved oral antidepressants, PH10 also does not require systemic uptake and distribution to produce rapid-onset antidepressant effects. In all the clinical studies to date, PH10 has not caused any psychological side effects, such as dissociation or hallucinations, or any safety concerns that may be associated with other rapid-onset ketamine-based therapies, including IV ketamine or intranasal ketamine. So our successful exploratory phase 2A clinical development of PH10 for major depressive disorder has been completed, and we are now preparing for a U.S. multicenter randomized placebo-controlled phase 2B clinical study to evaluate the efficacy, safety, and tolerability of PH10 as a standalone treatment for major depressive disorder. We expect to initiate that study in mid-22. PH10 also has potential as a novel rapid-onset treatment for TRD, postpartum depression, and suicidal ideation. I'm very excited about PH10 and its novel MOA, its rapid-onset potential, its sustained antidepressant effects, and the very positive safety profile so far exhibited and demonstrated in Phase IIa development to date. The MDD space is as many of you know, is in need of continued innovation. There's never one-size-fits-all, and we believe that PH10's differentiated profile has very exciting potential in multiple large and growing depression markets worldwide, and importantly, as a standalone therapy. Finally, our third CNS product candidate is AV101. AV101 is an oral prodrug of 7-chlorokinuronic acid, and it targets the NMDA receptor, which is an ionic ionotrophic glutamate receptor in the brain. Abnormal NMDA receptor function is associated with numerous CNS diseases and disorders. AV101 is a potent and selective full antagonist of the glycine collagenous site of the NMDA receptor that inhibits its function. Unlike ketamine and other NMDA receptor antagonists, AV101's active metabolite is not an ion channel blocker. At doses administered in all clinical studies to date, AV101 has been observed to be well-tolerated and has not exhibited any sedation or dissociative or hallucinogenic psychological side effects or any other safety concerns. In light of these findings and data from some recent preclinical studies, we believe AV101, in combination with FDA-approved probenicid, has very exciting potential to become a new oral treatment alternative for depression and several neurological indications. We expect to initiate a phase 1B study to evaluate AV101 in combination with probenicidin in the second half of this year. FDA has granted fast-track designation for AV101 as a potential adjunctive treatment for MDD and as a potential non-opioid treatment for neuropathic pain. We believe it also has potential for development as a treatment for epilepsy, levodopa-induced dyskinesia associated with Parkinson's therapy, and suicidal ideation. With our innovative CNS pipeline, very strong balance sheet, and a world-class team, I'm confident that Visagen is now in its strongest position ever to drive shareholder value going forward. I'd like to now turn it over to our CFO, Jerry Dodson, to provide you with a summary of some of the highlights from our fiscal 21 financial results. Jerry?