Yahoo Finance VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Q4 2024 Earnings Call Transcript
VistaGen Therapeutics, Inc. (NASDAQ:VTGN) Q4 2024 Earnings Call Transcript June 11, 2024
Operator: Greetings, and welcome to the Vistagen Therapeutics Fiscal Year-End 2024 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. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mark McPartland, Senior Vice President of Investor Relations.
Mark McPartland: Thank you, Joe. Good afternoon, everyone, and welcome to Vistagen's fiscal year-end 2024 corporate update conference call and webcast. This afternoon, we filed our annual report with the Securities Exchange Commission or SEC on SEC Form 10-K for our fiscal year ended March 31, 2024 and issued a press release providing an overview of our progress during our fiscal year 2024. We encourage you to review the press release and our 10-K, both of which can be found in the investor section of our website. During today's call, we'll make forward-looking statements regarding our business based on our current expectations and information. These 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 statements 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 we make today. Additional information concerning risks and factors that could affect our business and the financial results is included in our fiscal year-end 2024 Form 10-K filed today with the SEC, and in the filings that we'll make with the SEC from time-to-time in the future. All of which are available in the Investors section of our website and/or on the SEC's website. With the formalities out of the way, we offer a warm welcome to all of our stockholders, sell-side analysts, and other interested in Vistagen. I'm joined on our 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 update on our lead programs in our diversified neuroscience pipeline. After the conclusion of the prepared remarks, there will be a brief opportunity for questions from the sell-side analyst. As a reminder, the call is being webcast and will be available for replay after completion. The replay link can also be found in the Investor section of our website. With that, I'd like to turn the call over to our Chief Executive Officer, Shawn Singh.
Shawn Singh: Thank you, Mark. Sorry about that, everyone. Good afternoon, and thank you for joining our call. Vistagen's fiscal 2024 was filled with a series of remarkable accomplishments. Most notably with the positive results from our PALISADE-2 U.S. Phase 3 study of fasedienol for the acute treatment of social anxiety disorder, Vistagen became the first company to achieve a positive Phase 3 study with a drug candidate for the acute treatment of SAD. In addition, with the potential to complement PALISADE-2, we recently launched our PALISADE-3 Phase 3 trial, marking that as the next major step forward in our registration-directed PALISADE-Phase 3 program for fasedienol and SAD. These significant achievements and progress across our diversified pipeline of novel neuroactive faring candidates reflect our commitment to pioneering neuroscience that's anchored in a deep understanding of nose to brain neurocircuitry, focused on developing differentiated drug candidates with potential to set new standards of care for underserved patients affected by high-prevalence neuroscience disorders.
As a brief reminder to some and as an introduction to others, our diverse clinical stage neuroscience pipeline features a new class of neuroactive intranasal product candidates known as pherines. Exclusively designed as nasal sprays, our pherine pipeline leverages an innovative approach to treating psychiatric and other neuroscience disorders by using the nose as a portal for the administration of novel rapid onset, neurocircuitry focused drug candidates that did not require systemic absorption or binding to neurons in the brain to achieve desired therapeutic effects. Administered microgram level doses within milliseconds, each member of our new class of pherines activates peripheral chemosensory neurons in the nasal cavity, influencing fundamental neurocircuitry in both the olfactory system and the brain.
With unique proposed mechanisms of action or MOAs, our non-systemic, neurocircuitry-focused pherines have demonstrated favorable and differentiated safety profiles in all clinical studies completed to date. So our aim is to develop and to commercialize diversified pipeline of neuroactive pherines for multiple high-prevalence CNS disorders, such as social anxiety disorder, major depressive disorder, and menopausal hot flashes, indications with limited differentiated FDA approved treatment options and inadequate or even non-existent current standards of care. For example, social anxiety disorder, which is a neuropsychiatric disorder that's marked by profound fear and anxiety of social and performance situations in everyday life. They're often triggered by social media and team orientation in the workplace or in academic settings.
The disorder that affects more than 30 million US adults, yet despite the high and seemingly ever growing prevalence of SAD, there is still no FDA approved acute treatment to help individuals rapidly and safely manage their anxiety symptoms when faced with social and performance stressors in their everyday life, especially when they are faced with multiple different anxiety-provoking stressors during any single day and at different times in that day. Our Phase 3 program for fasedienol intends to help close that treatment gap for the millions of underserved individuals that are affected by SAD without an adequate option for a rapid, flexible, and patient-controlled treatment. Building on our success during fiscal 2024, our registration-directed PALISADE-Phase 3 program for fasedienol for the acute treatment of SAD is progressing on track, including enrollment in our recently launched PALISADE-3 trial, which is on track for top-line data mid-year in calendar 2025, as well as preparations for our upcoming PALISADE-4 trial that we expect to initiate in the second half of this year and complete before the end of calendar 2025.
Both Phase 3 trials are designed with the potential to replicate a successful PALISADE-2 Phase 3 trial. While the public speaking challenge design of PALISADE-2 and the use of the subjective units of distress scale or SUDs is the primary efficacy endpoint and the studies are unchanged. We've built some notable enhancements into PALISADE-3 and PALISADE-4 and made some operational changes we believe will help optimize quality enrollment, enhance surveillance, and control potential variability, as well as drive rigorous protocol adherence during execution of PALISADE-3 and PALISADE-4, all against the backdrop of what is now a far more favorable and stable clinical research environment than at any time during the pandemic. During the second half of 2024, we're also planning to initiate a small placebo-controlled repeat dose study in alignment with our discussions with the FDA to evaluate the effects of a second dose of fasedienol administered 10 minutes after the first dose prior to a public speaking challenge.
Similar to PALISADE-4, we anticipate completing this study in the second half of calendar 2025 with a top-line readout near the end of calendar 2025. We believe success in either PALISADE-3 or PALISADE-4, combined with the positive results from PALISADE-2 and additional open label safety data from all fasedienol clinical trials to be completed next year, may provide substantial evidence of fasedienol's effectiveness and safety to support submission of a potential U.S. new drug application for the acute treatment of SAD during the first half of 2026, which, if approved, could be the first approval of its kind. As a reminder, the FDA has granted Fast Track designation for our development of fasedienol for the acute treatment of SAD. We are also actively exploring the therapeutic potential of our pherine itruvone, another non-systemic pherine candidate with the potential to be a new and fundamentally differentiated therapy for major depressive disorder or MDD.
Preparations and planning for US Phase 2B development of itruvone in MDD are ongoing. Our mission in this large and increasingly prevalent neuropsychiatry market is to transform the standard of care, expediting the timeframe in which individuals may find relief of their MDD symptoms with a new rapid onset product candidate with a differentiated safety profile that is not associated with unwanted side effects and safety concerns, such as sexual side effects, weight gain, or abuse liability. We also see significant medical and commercial potential in PH80, our rapid onset, non-systemic, hormone-free pherine nasal spray candidate for women's health indications. During fiscal 2024, we announced positive data from two previously unreported placebo-controlled, exploratory Phase 2A studies conducted outside the US.
PH80 demonstrated statistically significant results both as a treatment for vasomotor symptoms or hot flashes that are due to menopause and for the management of premenstrual dysphoric disorder or PMDD. We're currently conducting US IND-enabling non-clinical studies with the potential to facilitate further Phase 2 clinical development of PH80 for menopausal hot flashes in the U.S., which is another high prevalence indication affecting approximately 80% of women ages 45 to 65. Current treatment options that are not satisfactory or suitable for millions of those women worldwide. We're also pleased to enter into an exclusive negotiation agreement with Fuji Pharma, which is a leading women's health-focused company in Japan during fiscal 2024, focused on negotiating exclusively for a potential license agreement with them for the development and commercialization of PH80 in Japan.
On a corporate level, Vistagen received Mental Health America's prestigious Platinum Bell Seal Award during the first quarter of fiscal 2024, and again in the first quarter of the current fiscal year. We also received the esteemed Great Place to Work certification, with each of these awards reflecting our commitment to be a company that exceeds workplace practices and standards intended to promote and support the mental health and the well-being of our employees, by also playing a key role in promoting and advancing a broad societal shift toward destigmatizing mental illness. With that, I'll now turn the call over to our CFO, Cindy Anderson to summarize some of the highlights from our fiscal 2024. Cindy?
Cindy Anderson: Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2024. I also encourage everyone to review our report on Form 10-K, filed with the SEC earlier this afternoon for additional details and disclosures. Research and development expenses were $20 million for the year ended March 31, 2024, as compared to $44.4 million for the year ended March 31, 2023. This decrease in R&D expenses was primarily due to a decrease in clinical and development expenses related to the timing of expenses incurred in our Phase 3 trials of fasedienol and SAD. General and administrative expenses was $14.1 million for the year ended March 31, 2024, as compared to $14.7 million for the year ended March 31, 2023.
The decrease in G&A expenses was primarily due to a decrease in professional fees and stock-based compensation expense, offset by an increase in compensation expenses. Our net loss attributed to the common stockholder was $29.4 million for the year ended March 31, 2024, compared to $59.2 million for the year ended March 31, 2023. As of March 31, 2024, we had cash and cash equivalents of $119.2 million. As a reminder, please refer to our annual report on Form 10-K that was filed today with the SEC for additional details and disclosures. I will now turn the call back over to Shawn.
Shawn Singh: Thanks, Cindy. So as we conclude our prepared remarks, I just want to underscore the hard work and the commitment, as well as the pride and enthusiasm of our team around our potential to improve the patient lives we're focused on helping and to deliver value to our stockholders. With the commencement of our PALISADE-3 and the pending launch of our PALISADE-4 Phase 3 trials for fasedienol targeting the acute treatment of SAD, a market with increasing prevalence, now topping 30 million Americans, we are systematically executing our registration-directed program with the potential to achieve the first FDA approval for that indication. We have great confidence in our team's expertise in executing our PALISADE-3 -- PALISADE-Phase 3 program, and all the programs across our neuroscience pipeline. So on behalf of the entire team at Vistagen, I'd like to thank you for your ongoing interest and for your support.
Mark McPartland: Thank you, Shawn. Operator, we would now like to open up the call for questions from the cell-side analysts participating on the call today.
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