Q4 2024 VistaGen Therapeutics Inc Earnings Call
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Operator: Greetings, and welcome to the VistaGen Therapeutics, fiscal year and 2024 corporate update conference call. At this time, all participants are in a listening mode.
Greetings and welcome to the Vista Gen Therapeutics fiscal year end 2024 called corporate update conference call.
Operator: And welcome to the VistaGen Therapeutics Fiscal Year and 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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. Thank you, Joe. Good afternoon, everyone, and welcome to VistaGen's fiscal year-end 2024 corporate update comment.
Speaker Change: At this time all participants are in a listen only mode.
Operator: A question and answer session will follow the formal presentation.
Speaker Change: A question and answer session will follow the formal presentation.
Operator: If anyone wants to require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker Change: If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Speaker Change: As a reminder, this conference is being recorded.
Mark McPartland: I would now like to turn the conference over to your host, Mark McPartland, Senior Vice President of Investor Relations.
Speaker Change: I'd 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 in 2024 corporate update conference call and webcast. This afternoon, we filed our end-of-report with a shared exchange commission or SEC on SEC 410K for our fiscal year ended March 31, 2024 and issued a press release providing overview of our progress during our fiscal year 2024.
Joe: Thank you Joe Good afternoon, everyone and welcome to this agenda its fiscal year end 2020 for corporate update conference call and webcast.
Mark Adrian 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 and Exchange Commission, or SEC, on SEC Form 10-K for our fiscal year ended March 31st, 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 10K, both of which can be found in the investor section of our website.
Speaker Change: This afternoon, we filed our annual report with the Securities Exchange Commission or ACC on a 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 'twenty 'twenty four we.
Mark McPartland: 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 four looking statements regarding our business based on our current expectations and information. These four 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 four looking statements made today. Of course, for looking statements involved risks and uncertainties, international results could differ materially from those anticipated by any four looking statements we make today.
Speaker Change: Encourage you to review.
Speaker Change: The press release, and our 10-K, both of which can be found in the investors section of our website.
Speaker Change: During today's call, we'll make forward looking statements regarding our business based on our current expectations and information East.
Mark Adrian McPartland: During today's call, we will 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.
These forward looking statements 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.
Speaker Change: 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.
Mark McPartland: Additional information concerning risks and factors that could affect our business and the financial results is included in our Fiscal Year in 2024, 410K, filed our alert 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 investor 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, sulfite analysts, and others interested in messaging.
Speaker Change: Additional information concerning risks and factors that could affect our business and our financial results is included in our fiscal year end 2024 Form 10-K filed their alerts today with the SEC and in the filings that will make what gets you see from time to time in the future.
Mark Adrian McPartland: Additional information concerning risks and factors that could affect our business and financial results is included in our Fiscal Year End 2024 Form 10-K filed earlier 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 investor 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 others interested in VistaGen.
All of which are available in the investors section of our website and to work on the Sec's website.
Speaker Change: With the formalities out of the way we offer a warm welcome to all of our stockholders sell side analysts and other interested in because it yet.
Mark McPartland: I'm joined on our call today by Sean Singh, our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Josh Prince, our Chief Operating Officer. Sean will provide an update on our lead programs in our diversified neuroscience pipeline. After the conclusion of the pair remarks, there'll be a brief opportunity for questions from the sulfite analysts. As a reminder, the call is being webcast and will be available for replay after completion.
Mark Adrian McPartland: 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 cell-side audience. 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 investors section of our website. With that, I'd like to turn the call over to our Chief Executive Officer, Shawn.
Speaker Change: I'm joined on our call today by Sean <unk>, Our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Josh <unk>, Our Chief operating officer.
Shawn K. Singh: Sean will provide you an update on our lead programs in our diversified neuroscience pipeline.
Shawn K. Singh: After the conclusion of the paired remarks there'll be a brief opportunity for questions from the sell side analysts.
Speaker Change: As a reminder, the call is being webcast and will be available for replay after completion.
Mark McPartland: The replay link can also be found in the investor section of our website.
Speaker Change: The replay link can also be found in the investors section of our website.
Speaker Change: With that I'd like to turn the call over to our Chief Executive Officer, Sean Zhang.
Sean Singh: With that, I'd like to turn the call over to our Chief Executive Officer, Sean Singh.
Sean Singh: Thank you, Mark. Sorry about that, everyone.
Sean Zhang: Thank you Mark sorry about that everyone.
Shawn K. Singh: Thank you, Mark. Sorry about that, everyone.
Sean Singh: Good afternoon, and thank you for joining our call. Visitors fiscal 2024 was filled with a series of remarkable accomplishments. for the Acute Treatment of Social Anxiety Disorder. VistaGen became the first company to achieve a positive Phase III study with a drug candidate for the acute treatment of SAD. In addition, with the potential to complement Palisade II, we recently launched our Palisade III Phase III trial, marking that as the next major step forward in our registration-directed Palisade Phase III program for facadiene all in SAD. The significant achievements and progress across our diversified pipeline of novel, neuroactive, fairing candidates reflect our commitment to pioneering neuroscience that's anchored in a deep understanding of nose-to-brain neural circuitry focused on developing differentiated drug candidates with potential to set new standards of care for underserved patients affected by high prevalence neuroscience disorders.
Speaker Change: Afternoon, and thank you for joining our call.
Shawn K. Singh: 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 II U.S. Phase III study of facetidinol 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 facetidinol and SAD, the significant achievements and progress across our diversified pipeline of novel neuroactive ferrying 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.
Sean Zhang: This agenda physical 2024 was filled with a series of remarkable accomplishments.
Sean Zhang: Notably with the positive results from our palisade to U S Phase III study of fast the die and all.
Sean Zhang: The acute treatment of social anxiety disorder.
Speaker Change: She didn't became the first company to achieve a positive phase III study with a drug candidate for the acute treatment of S. E D.
Speaker Change: In addition, with the potential to complement palisade to be reached.
Speaker Change: We launched our policy three phase III trial, marking that as the next major step forward.
Speaker Change: Our registration directed palisade phase III program for fast the die and all and S. E D.
Speaker Change: These significant achievements and progress across our diversified pipeline of novel Neuro active sharing candidates reflect our commitment to pioneering neuroscience. It's anchored in a deep understanding of knows the brain neural circuitry focused on developing differentiated drug candidates.
<unk> to set new standards of care for underserved patients affected by high prevalence neuroscience disorders.
Sean Singh: 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 fairings. Exclusively designed as nasal sprays, our fairing pipeline leverages an innovative approach to treating psychiatric and other neural science disorders. By using the nose as a portal for the administration of novel, rapid onset, neural circuitry focused drug candidates that did not require systemic absorption or binding to neurons in the brain to achieve desired therapeutic effects. The administered microgram level doses within milliseconds, each member of our new class of fairings activates peripheral chemosensory neurons in the nasal cavity, influencing fundamental neural circuitry in both the olfactory system and the brain.
As a brief reminder, to some and as an introduction to others are diverse clinical stage neuroscience pipeline features a new class of neuro active intranasal product candidates known as fairings.
Shawn K. Singh: 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 FAIRing. Exclusively designed as nasal sprays, our farine 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 do not require systemic absorption or binding to neurons in the brain to achieve desired therapeutic outcomes. Administered in microgram-level doses within milliseconds, each member of our new class of variants activates peripheral chemosensory neurons in the nasal cavity, influencing fundamental neurocircuitry in both the olfactory system and the brain.
Speaker Change: Exclusively designed as nasal sprays off carrying pipeline leverages, an innovative approach to treating psychiatric and other neuroscience disorders by using the nose is a portal for the administration of novel rapid onset neural circuitry focused drug candidates that did not require systemic absorption or binding to neurons.
Speaker Change: And the brain to achieve desired therapeutic effects.
Speaker Change: [noise] administered in micro Gram level doses within milliseconds, each member of our new classes of fairings activates peripheral chemo sensory neurons in the nasal cavity influencing fundamental nurse neural circuitry and both El factory system in the brain.
Sean Singh: With unique proposed mechanisms of action or MOAs, non-systemic, neural circuitry focused fairings have demonstrated favorable and differentiated safety profiles in all clinical studies completed to date. Swarring is to develop and to commercialize a diversified pipeline of neural active fairings 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 nonexistent current standards of care. For example, social anxiety disorder, which is the neuropsychiatric disorder that's marked by profound fear and anxiety of social and performance situations in everyday life.
Shawn K. Singh: With unique proposed mechanisms of action, or MOAs, our non-systemic, neurocircuitry-focused fairings have demonstrated favorable and differentiated safety profiles in all clinical studies completed to date. Thorium's goal is to develop and commercialize a diversified pipeline of neuroactive therians for multiple high-prevalence CNS disorders, such as social anxiety disorder, major depressive disorder, and menopausal hot flush, indications with limited For example, social anxiety disorder 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 an academic setting.
Speaker Change: With unique proposed mechanisms of action or M. Always are non systemic neural circuitry focus fairings have demonstrated favorable and differentiated safety profile in all clinical studies completed to date.
Speaker Change: So our aim is to develop and commercialize diversified pipeline of neuro active fairings for multiple high prevalence CNS disorders, such as social anxiety disorder major depressive disorder, and menopausal Hot flashes indications with limited differentiated F D. A approved treatment options.
Speaker Change: And inadequate or even nonexistent current standards of care.
Speaker Change: For example, social anxiety disorder, which is the 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.
Sean Singh: 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 U.S. 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 them. Day. Our Phase III program for FESSA DINAL intends to help close that treatment gap for the millions of underserved individuals that are affected by FAD without an adequate option for a rapid, flexible, and patient-controlled treatment.
Speaker Change: And team orientation in the workplace or in academic settings.
Shawn K. Singh: The disorder affects more than 30 million U.S. 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 three program for Fasadenal 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.
Speaker Change: The disorder that affects more than 30 million U S. Adults yeah. Despite the high end seemingly ever growing prevalence of S. A D. There is still no FDA approved acute treatment help individuals' rapidly and safely manage their anxiety symptoms when faced with social and performance stressors in their everyday life.
Speaker Change: Especially when they are faced with multiple different anxiety provoking stressors during any single day and at different times in that day.
Speaker Change: Our phase III program for classifying all intends to help close that treatment gap for the millions of underserved individuals that are affected by S. A D without an adequate option for a rapid flexible and places patient controlled treatment.
Sean Singh: Building on our success during fiscal 24, our registration-directed policy to Phase III program for FESSA DINAL for the acute treatment of FESSA D is progressing on track, including enrollment in our recently launched policy III trial, which is on track for top-line data mid-year in calendar 2025, as well as preparations for our upcoming policy for trial that we expect to initiate in the second half of this year and complete before the end of calendar 2025. Both Phase III trials are designed with the potential to replicate our successful Policy II Phase III trial. While the public speaking challenge design of policy II and use of the subjective units of distress scale or SUDS is the primary efficacy and point in the studies that are unchanged, we've built some notable enhancements in the policy III and policy IV and made some operational changes.
Speaker Change: Building on our success during fiscal 'twenty for our registration directed palisade phase three program for faster die at all for the acute treatment of S. J D is progressing on track including.
Shawn K. Singh: Building on our success during fiscal 24, our registration-directed Palisade Phase 3 program for fazadienol for the acute treatment of SADs is progressing on track, including enrollment in our recently launched Palisade III 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 Both Phase III trials are designed with the potential to replicate our successful Palisade II Phase III trial.
Speaker Change: Including enrollment and our recently launched policy three trial.
Speaker Change: Which is on track for top line data mid year in calendar 2025, as well as preparations for upcoming palisade for trial that we expect to initiate in the second half of this year complete before the end of calendar 2025.
Speaker Change: Both phase III trials are designed with the potential to replicate our successful palisade two phase III trial.
Speaker Change: While the public speaking Charles design, a policy to and use the subjective units of distress scale there such as the primary efficacy endpoint in the studies are.
Shawn K. Singh: 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 Pal 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 fastadienol administered 10 minutes after the first dose prior to a public speaking challenge.
Speaker Change: Were unchanged, we built some notable enhancements in the palisade three in palisade for and made some operational changes, we believe will help optimize quality enrollment enhanced surveillance and.
Sean Singh: We believe will help optimize quality enrollment, enhance surveillance, and control potential variability, as well as drive rigorous protocol adherence during execution of Policy III and Policy IV. All it gets 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 facidino administered 10 minutes after the first dose, prior to a public speaking challenge.
And control potential variability as well as drive rigorous protocol adherence through execution of palisade three in palisade for all against the backdrop of what is now a far more favorable and stable clinical research environment than at any time during the pandemic.
Speaker Change: During the second half of 'twenty 'twenty four we also plan. We're also planning to initiate a small placebo controlled repeat dose study and alignment with our discussions with the F. D. A.
Speaker Change: Evaluate the effects of a second dose the fast the dyno administered 10 minutes. After the first dose prior to a public speaking challenge.
Sean Singh: Similar to policy IV, we anticipate completing this study in the second half of calendar 2025, with the top-line readout near the end of calendar 2025. We believe success in either policy III or policy IV, combined with the positive results from policy II in additional open-label safety data from all facidino clinical trials to be completed next year, may provide substantial evidence of facidino 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.
Speaker Change: Similar to palisade four we anticipate completing this study in the second half of calendar 2025.
Shawn K. Singh: 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 faceti and all clinical trials to be completed next year, may provide substantial evidence of fascidienol'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.
Speaker Change: <unk> line readout near the end of calendar 2025.
Speaker Change: We believe success in either palisade three four palisade for combined with the positive results from policy to an additional open label safety data from all fast the die in all clinical trials to compete to be completed next year.
Speaker Change: It may provide substantial evidence of fast the die and all effectiveness and safety to support submission of a potential U S. New drug application for the acute treatment of S. A D. During the first half 'twenty 'twenty, six which if approved could be the first approval of its time.
Sean Singh: As a reminder, the FDA has granted fast-track designation for our development of facidino for the acute treatment of SAD. We're also actively exploring the therapeutic potential of our faring itrival. Another non-fistemic faring candidate with the potential to be a new and fundamentally differentiated therapy for major depressive disorder or MDD. Preparations in planning for U.S.-based 2B development by Truvone and MDD are ongoing. Our mission in this large and increasingly prevalent neuropsychiatry market is to transform the standard of care, expediting the time of frame in which individuals may find relief of their MDD symptoms with a new rapid onset product candidate with the differentiated safety profile that is not associated with unwanted side effects and safety concerns, such as sexual side effects, weight gain, or abuse liability.
Shawn K. Singh: As a reminder, the FDA has granted FastTrack designation for our development of Facadienol for the acute treatment of SED. We are also actively exploring the therapeutic potential of our farine I-Truvone, another non-systemic variant candidate with the potential to be a new and fundamentally differentiated therapy for major depressive disorder, or MDD. Preparations and planning for U.S.
Speaker Change: As a reminder, the FDA has granted fast track designation for our development of past the die at all for the acute treatment of S. E D.
Speaker Change: We are also actively exploring the therapeutic potential of our Ferring I true long.
Another non systemic pairing candidate with the potential to be a new and fundamentally differentiated therapy for major depressive disorder or M. D D.
Cynthia Lynn Anderson: Phase 2B development by Truvone and MDD is 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 PH-80, a rapid-onset, non-systemic, hormone-free, sparing nasal spray candidate for women's health indications.
Speaker Change: Preparations and planning for U S phase two b development by a true up on an empty theater ongoing.
Speaker Change: Our mission in this large and increasingly prevalent neuro psychiatry market is to transform the standard of care.
Speaker Change: Expediting the time frame in which individuals may find relief, where they're M. D. D symptoms with a new rapid onset product candidate with a differentiated safety profile profile that is not associated with unwanted side effects and safety concerns such as sexual side effects weight gain or abuse liability.
Sean Singh: We also see significant medical and commercial potential in pH-80, our rapid onset, non-systemic, hormone-free, varying 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 U.S. pH-80 demonstrated statistically significant results both as a treatment for vessel motor symptoms or hot flashes that are due to menopause and for the management of pre-menstrual dysphoric disorder or PMDD. We are currently conducting U.S. IND enabling non-clinical studies with the potential to facilitate further Phase 2 clinical development for pH-80 for menopausal hot flashes in the U.S.
Speaker Change: <unk>.
Speaker Change: We also see significant medical and commercial potential and ph 80, our rapid onset non systemic hormone free Berry nasal spray candidate for women's health indications during.
Cynthia Lynn Anderson: During fiscal 2024, we announced positive data from two previously unreported placebo-controlled exploratory Phase IIa studies conducted outside the U.S. PHA has 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 are currently conducting U.S. IND-enabling non-clinical studies with the potential to facilitate further Phase II clinical development of PHAD for menopausal hot flashes, 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.
Speaker Change: During fiscal 'twenty 'twenty, four we announced positive data from two previously unreported Siebel controlled exploratory phase Iia studies conducted outside the U S.
Speaker Change: P. J D demonstrated statistically significant results both as a treatment for vasomotor symptoms Hot flashes.
Speaker Change: Due to menopause and for the management of Premenstrual, just fork disorder or P. M D D.
Speaker Change: We're currently conducting U S. I N D, enabling non clinical studies with the potential to facilitate further phase II clinical development P. H a D for menopausal hot flashes in the U S.
Sean Singh: There's another high prevalence in the case in affecting approximately 80% of women ages 45 to 65. Current treatment options; they're not satisfactory or suitable for millions of those women worldwide.
Speaker Change: Just another high prevalence indication affecting approximately 80% of women aged 45 to 65.
Speaker Change: Current treatment options that are not satisfactory a suitable for millions of those women worldwide.
Sean Singh: We're also pleased to enter into an exclusive negotiation agreement with Fujifilm, which is a leading women's health focused company in Japan during fiscal 24, focused on negotiating exclusively for a potential life agreement with them for the development and commercialization of pH-80 in Japan.
Speaker Change: We're also pleased to enter into an exclusive negotiation agreement with <unk> pharma, which is a leading women's health focused company in Japan during fiscal 'twenty four focused on negotiating exclusively for a potential license agreement with them for the development and commercialization of P. H a D.
Cynthia Lynn Anderson: 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 24, focused on negotiating exclusively for a potential license agreement with them for the development and commercialization of PHAD 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.
Speaker Change: In Japan.
Sean Singh: On a corporate level, this is generally the received Mental Health America's prestigious Platinum Belceal Award during the first quarter of fiscal 2024 and again in the first quarter for 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 mental health and the well-being of our employees. We're also playing a key role in promoting and advancing a broad societal shift toward destigmatizing mental illness.
Speaker Change: On a corporate level.
It's a generous ive received mental health Americas prestigious Platinum Belsito award during the first quarter of fiscal 2024 and again in the first quarter for the current fiscal year. We also received the esteemed great place to work certification.
Cynthia Lynn Anderson: We also received the esteemed Great Place to Work certification, each of these awards reflecting our commitment to be a company that exceeds workplace practices and standards intended to promote and support 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 24.
Each of these awards, reflecting our commitment to be a company that exceeds workplace practices.
Speaker Change: Standards intended to promote and support mental health and the well being of our employees.
Speaker Change: So playing a key role in promoting and advancing a broad societal shifts.
Speaker Change: D stigmatizing mental illness.
Cindy Anderson: With that, I'll now turn the call over to our CFO, Cindy Anderson, to summarize some of the highlights from our fiscal 24.
Speaker Change: With that I'll now turn the call over to our CFO Cindy Anderson to summarize some of the highlights from our fiscal 'twenty four.
Shawn K. Singh: 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 disclosure. 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 three trials of fafanidol and SAD.
Cindy Anderson: Cindy? Thank you, Sean. As Sean mentioned, I will highlight a few financial results from our fiscal year 2024.
Cindy.
Cynthia Lynn Anderson: Thank you Sean as Sean mentioned I will highlight a few financial results from our fiscal year 'twenty 'twenty four.
Shawn K. Singh: General and administrative expenses were $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 GNA expenses was primarily due to a decrease in professional fees and stock-based compensation expenses, offset by an increase in compensation expenses. Our net loss attributed to common stockholders was $29.4 million for the year ended March 31, 2024, compared to $39.2 million for the year ended March 31, 2023.
Cindy Anderson: 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 $29,000 per 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 child of $1,000 on SAD. General and administrative expenses were $14.1 million for the year ended March 31, 2024, as compared to $14.7 million for the year ended March 31, 2023.
Cynthia Lynn Anderson: Encourage everyone to review our report on Form 10-K filed with the SEC earlier this afternoon for additional details and disclosures.
Speaker Change: Search and development expenses were 29.
Speaker Change: Year ended March 31, 20000 crore as compared to $44 4 million a year ended March 31, okay.
Speaker Change: Increase in R&D expenses was primarily due to a decrease in clinical and development expenses.
Speaker Change: The timing of expenses incurred in our phase three trial that that's an add on.
Speaker Change: General and administrative expenses were $14 1 million for the year ended March 31, 2024, as compared to $14 7 million.
Speaker Change: Ended March 31, 2023, the decrease in G&A expenses.
Cindy Anderson: The decrease in GNA 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 of tribular comments stockholders was $29.4 million for the year ended March 31, 2024, compared to $39.2 million for the year ended March 31, 2023. As of March 31, 2024, we had cash and cash equivalents of $119.2 million.
Speaker Change: Primarily due to a decrease in professional fees and stock based compensation expense.
Speaker Change: Offset by an increase in compensation.
Speaker Change: Our net loss to be able to common stockholder was 29 4 million for the year ended March 31, 2020 core compared with $9 2 million at.
Speaker Change: At March 31, right.
Shawn K. Singh: 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.
Speaker Change: As of March 31, 24, we had cash and cash equivalents of $119 2 million.
Cindy Anderson: As a reminder, please refer to our annual report on Form 10-K that was filed today with the SEC traditional details and disclosures.
Speaker Change: As a reminder, please refer to our annual report on Form 10-K that was filed today.
Speaker Change: Great that's nothing that's close yes.
Sean Singh: I will now turn the call back over to Shawn.
I will now turn the call back over to Sean.
Sean Singh: Thank you, Cindy. As we conclude our prepared remarks, I just want to underscore the hard work in 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 policy three and the pending launch of our policy four phase three trials, we're fasted in all targeting the acute treatment of SAD, a market with increasing prevalence now topping 30 million Americans.
Sean Zhang: Thanks, Cindy so as we conclude our prepared remarks, I just want to underscore the hard work and commitment as well as the pride and the enthusiasm of our team around our potential to improve patient lives.
Mark Adrian McPartland: 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 patient lives. We are focused on helping and delivering value to our stockholders. With the commencement of our Palisade 3 and the pending launch of our Palisade 4 Phase 3 trials for fastadienyl targeting the acute treatment of SAD, a market with increasing prevalence now topping 30 million Americans.
Speaker Change: We're focused on helping them to deliver value to our stockholders with.
Speaker Change: With the commencement of our palisade three and the pending launch of our palisade for phase III trials for faster die and all targeting the acute treatment of S. A D. A.
Speaker Change: With increasing prevalence now topping 30 million Americans.
Sean Singh: We are somatically 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 policy three, policy phase three program and all the programs across our neuroscience pipeline.
Mark Adrian McPartland: We are. Systematically executing our registration directive 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 PAL-SAIT 3. Palisade Phase III 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.
Speaker Change: We are.
Speaker Change: Thematic Lee executing our registration directed program with the potential to achieve the first FDA approval for that indication.
Speaker Change: We have great confidence in our team's expertise in executing our palisade three.
Speaker Change: Palisade phase III program and all the programs across our neuroscience pipeline.
Sean Singh: So, on behalf of the entire team of this, Jen, I'd like to thank you for your ongoing interest and for your support.
Vista Gen: On behalf of the entire team at Vista Gen like to thank you for your ongoing interest and for your support.
Vista Gen: Okay.
Operator: 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.
Speaker Change: Thank you Sean operator, we would now like to open up the call for questions from the sell side analysts participating on the call today.
Operator: Operator, we would now like to open up the call for questions from the cell side analysts participating on the call today. Thank you. Ladies and gentlemen, if you'd like to ask a question, please press star one on your telephone keypad. And the confirmation tone will indicate your lines in the question queue. You may press star two if you would like to remove your question from the queue.
Vista Gen: Yes.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, if you'd like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question key. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. And our first question comes from the line of Andrew Tsai with Jeffries. Please proceed.
Speaker Change: Ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
You May press star two if he would like.
Speaker Change: To remove your question from the queue.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the startings.
Speaker Change: For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys.
Andrew Sy: And the first question comes from the line of Andrew Sy with Jefferies. Please proceed.
Speaker Change: And our first question comes from the line of Andrew Tsai with Jefferies. Please proceed.
Matt: Hey, good afternoon, and congratulations on the progress. This is Matt on behalf of Andrew, and I just had a couple of questions, if you don't mind. In Palisade 3, how many patients have you enrolled so far, and is the enrollment cadence looking stronger or slower than the first couple of studies? And then also, if you don't mind commenting on the screen failure rate and how that compares to the prior studies as well. Thank you.
Speaker Change: Hey, good afternoon, and congrats on the progress. This is Matt on for Andrew and I just had a couple of questions. If you don't mind in palisade three how many patients have you enrolled so far and is enrollment cadence looking stronger or slower than the first couple of studies.
Matt: Hey, good afternoon, and congrats on the progress. This is Matt on for Andrew, and I just had a couple of questions if you don't mind. In policy three, how many patients have you enrolled so far and is enrollment cadence looking stronger or slower than the first couple of studies? And then also, if you don't mind commenting on the screen failure rate and how that compares to the prior studies as well, thank you.
Speaker Change: And then also.
Speaker Change: If you don't mind, commenting on the screen failure rate and how that compares to the prior studies as well. Thank you.
Sean Singh: I'm sorry, I didn't catch your name. Matt, thank you. Oh, hey, Matt.
Speaker Change: I'm, sorry, I didn't catch your name.
Shawn K. Singh: I'm sorry, I didn't catch your name. Matt, thank you. Oh, wait a minute.
Speaker Change: Matt Thank you.
Speaker Change: Hey, Matt.
Shawn K. Singh: So, we haven't given any guidance on enrollment, on specifics of enrollment and screen fail rates and the like, but what I can tell you is what I emphasized during my prepared remarks, which is that we're very happy with the way that Palisade 3 has kicked off. We've been able to build in some really important efficiencies, not only throughout the execution of the study but up front even, between lead generation and actual enrollment through VISIT-1 and screening, and we've been able to achieve a lot of things that reflect and leverage the lessons learned through the course of the prior execution of studies of this particular design, leading all the way back to phase 2.
Sean Singh: So we haven't given any guidance on enrollment, all on specifics of enrollments and screen fail rates. They're like, but what I can tell you is what I emphasize during the prepare remarks, which is we're very happy with the way that policy three has kicked off. We've been able to build in some really important efficiencies, not only throughout the execution of the study, but upfront even between lead generation and actual enrollment through visit one in the screening. And we've been able to achieve a lot of the things that reflect and leverage the lessons learned through the course of the prior execution of studies of this particular design.
Speaker Change: So we haven't given any guidance on enrollment all on specifics of enrollments and screen fail rates, they like but what I can tell you is what I emphasized during the.
Speaker Change: The prepared remarks, which is well.
Speaker Change: We're very happy with the way the palisade threes kicked off we've been able to build in some really important efficiencies not only throughout the execution of the study, but upfront even between our lead generation and.
Speaker Change: Actual enrollment through visit one in the screening.
Speaker Change: And we've been able to to achieve a lot of the things that reflect and leverage the lessons learned through the course of the prior execution of studies of this particular design then all the way back to phase two times. So I think our team is extremely well positioned to continue this study on track on the same day.
Sean Singh: They know way back to face two times.
Joshua Prince: So I think our team is extremely well-positioned to continue this study on track, and the same be the case for policy four, with the ability to achieve the readouts right around the time that we've guided, which would be mid 25. Good job, David G. Adler to that.
Shawn K. Singh: So, I think our team is extremely well-positioned to continue this study on track, and the same will be the case for Palisade 4, with the ability to achieve the readouts right around the time that we've guided, which would be mid-25 and then near the end of 25 for Palisade 4.
Speaker Change: The case for palisade for them with the ability to achieve the readouts right around the time that we've we've guided which would be mid 'twenty five and then near the end of 'twenty five for palisade for.
Speaker Change: Okay got it thank you.
Matt: Okay, I got it. Thank you.
Speaker Change: Yeah.
Speaker Change: Josh anything to add.
Joshua Prince: Josh, do you have anything to add to that?
Speaker Change: Did that.
Joshua Prince: I would just say that we are pleased with the startup of Palisade 3, that it's meeting our expectations in terms of recruitment rates, in terms of screen failure rates, those types of things. So at this point, we're very pleased with our progress.
Speaker Change: Gosh, Yes, I would just yeah, Hello, Sam yes. Thanks, I would just say that we are pleased with the start up with the palisade three but.
Joshua Prince: Josh? Yes, I would just, yeah, hello, Shawn. Yes, thanks. I would just say that we are, you know, pleased with the start-up of both of Palisade 3, that it's meeting our expectations in terms of recruitment rates and in terms of screen failure rates, those types of things. So, at this point, we're very pleased with our progress. Thanks, Josh.
Josh: But it's it's meeting our expectations in terms of.
Josh: Recruitment rates in terms of screen failure rates those types of things. So at this point, we're very pleased with our progress.
Josh: Yeah.
Thanks, Josh.
Paul Matisse: And the next question comes from the line of Paul Matisse with Steeple. Please proceed.
Speaker Change: And our next question comes from the line of Paul Matisse with Stifel. Please proceed.
Operator: And the next question comes from the line of Paul Matisse with Stiefel. Please proceed.
Julian: Hi, there. This is Julian on for Paul. Thanks so much for taking our question. You described a couple of notable enhancements that you made, things like operational changes, enhance surveillance, et cetera.
Speaker Change: Hi, there this is Julian on for Paul. Thanks, So much for taking our question. You described a couple of notable enhancements that you've made things like operational changes enhanced surveillance et cetera, do you mind, just providing a little bit more color on what exactly you're doing and why that gives you greater confidence.
Julian: Hi there, this is Julian for Paul. Thanks so much for taking our question. You described a couple of notable enhancements that you made, things like operational changes, enhanced surveillance, etc. Do you mind just providing a little bit more color on what exactly you're doing and why that gives you greater confidence as you continue enrolling Palisade 3 and soon Palisade 4? And then just really quickly, one quick question. On the repeat dose study, would you mind telling us just what you're looking to achieve here? And is this more about building a safety database, or is this more about replicating efficacy with a multi-dose paradigm? Thank you.
Julian: Do you mind just providing a little bit more color on what exactly you're doing and why that gives you greater confidence as you continue in rolling Palisade 3 and soon Palisade 4?
Speaker Change: As you continue enrolling palisades three and soon palisade for and then just really quickly. One quick question on the repeat dose study do you mind do you mind us are telling us just what youre looking to achieve here and is this more about building the safety database or is this more about.
Sean Singh: And then just really quickly, one quick question on the repeat dose study: do you mind us telling us just what you're looking to achieve here, and is this more about building the safety database, or is this more about replicating, you know, efficacy with a multi-dose paradigm? Thank you. Great. Hey, thanks, Julian. Appreciate the questions.
Speaker Change: Replicating efficacy with that multi dose paradigm. Thank you.
Julia: Great Hey, Thanks, Julia I. Appreciate the question so just to be clear right up front that public speaking challenge design.
Shawn K. Singh: Great. Hey, thanks, Jillian. I appreciate the questions.
Sean Singh: So, just to be clear right up front, the public speaking challenge design will remain the same across Palisade 2, 3, and 4. So will the suds as the primary efficacy end point, so no changes there. Those will continue again to remain consistent throughout the development of facadile for the acute treatment of SD. And that's been the case all the way back to the Phase 2. So the refinements that we made, Palisade 3 and 4, really are based again on experience that we have very unique and extensive experience, scaling up to a large phase 3 study that come from our observations of the conduct of the Palisade phase 3 program from, again, the early through the late stages of the pandemic in particular.
Shawn K. Singh: So, just to be clear right up front, the public speaking challenge design will remain the same across PALSADE 2, 3, and 4. Similarly, the SUDs as the primary efficacy endpoint will remain unchanged. Those will continue, again, to remain consistent throughout the development of FASTA dial for the acute treatment of SAD, And that's been the case all the way back to Phase 2.
Speaker Change: Ill remain the same across palisade, two three and four so as well as the primary efficacy end point. So no changes there those will continue again to remain consistent throughout the development of fast at all for the acute treatment of S. A D.
Speaker Change: And that's been the case, all the way back to phase two.
Speaker Change: So the refinement that we made the palisade three and four are really our base again, an experience that we have very unique and extensive experience scaling up to a large phase III study.
Shawn K. Singh: So, the refinements that we made to PALSADE 3 and 4 really are based, again, on experience that we have, very unique and extensive experience scaling up to a large Phase 3 study that comes from our observations of the conduct of the PALSADE Phase 3 program from, again, the early through the late stages of the pandemic in particular. So, the enhancements to PALSADE 3 and 4 apply primarily to ensuring that we've got optimal subjects in the study, really extensive, precise, and universally applied screening, inclusion, and exclusion criteria, and that the public speaking challenge protocols are administered properly and consistently with limited variability.
Speaker Change: That come from our observations of the conduct of the palisade phase III programs from again the early through the late stages of the pandemic in particular, so the enhancements to the past say three and four applied primarily to ensuring that we've got optimal subjects. In this study really extensive precise and universally applied screening.
Sean Singh: So the enhancements to Palisade 3 and 4 apply primarily to ensuring that we've got optimal subjects in the study, real extensive precise and universally applied screening, inclusion and exclusion criteria, and that the public speaking challenge protocols are administered properly and consistently with limited variability. So, for example, one of the exclusion criteria that's been added is limiting high-frequency smoking or vaping, HCU's signs of COVID, or any recent nasal swabs, all of which could have some sort of an impact possibly on the receptors and impact a single dose public speaking challenge.
Speaker Change: Inclusion exclusion criteria and that the public speaking challenge protocols administered properly inconsistently with limited variability so.
Speaker Change: For example, one of the exclusion criteria.
Shawn K. Singh: So, for example, one of the exclusion criteria that's been added is limiting high-frequency smoking or vaping, THC use, signs of COVID, or any recent nasal swabs, all of which could have some sort of an impact on receptors and impact a single-dose public speaking challenge. Josh, maybe talk about some of the other things that you and the team have been seeing some really significant benefits on as we've even pre-launched and now as we've gotten into the execution of Palisade 3.
Josh: Well that's been added is limiting high frequency smoking or vaping THC use signs of COVID-19 or any recent nasal swabs all of which could have some sort of an impact possibly on receptors and impact a single dose public speaking challenge Josh.
Joshua Prince: Josh, maybe talk about some of the other things that you and the team have been seeing some really significant benefits on as we've even pre-started up and now as we've gotten into the execution of Palisade 3. Yeah, absolutely. I think two of the key things you touched on shown are our experience of going through Palisade 1 and Palisade 2, but then also being able to operate in a pandemic-free environment as we got Palisade 3 up and running. As we look forward to getting Palisade 4 up and running, this has allowed us to really drive consistent execution across sites to reduce the potential variability.
Speaker Change: Josh maybe talk about some of the other things that you and the team had been seeing some really significant benefits on as we've even pre startup and now as we've gotten into the execution of palisade III.
Josh: Yeah, absolutely I think two of the key things you touched on some R.
Joshua Prince: Yeah, absolutely. I think two of the key things you touched on, Shawn, are our experience of going through Palisade 1 and Palisade 2, but then also being able to operate in a pandemic-free environment as we got Palisade 3 up and running and as we look forward to getting Palisade 4 up and running. It's just allowed us to really drive consistent execution across sites to reduce potential variability. And it's really about changing our approach to both study monitoring and our staffing model, right?
Josh: Our experience of going through palisade, one in palisade too, but then also being able to operate in a pandemic free environment as we got Palisades, III up and running and as we look forward to getting palisade for up and running it's just allowed us to really drive consistent execution across sites to reduce the potential variability I mean, its really around.
Joshua Prince: I mean, it's really around changing our approach to both study monitoring and our staffing model, right? So, it gives us rigorous training of sites and then oversight of study conduct. So, if you think about where we are with Palisade 3 compared to Palisade 1 or 2, we had an in-person investigator meeting for Palisade 3. So we had that face-to-face in-person training of PIs, Raiders, study coordinators, which we couldn't do in one and two. And then, as we've gotten sites up and running, kind of that startup process, we've already had more in-person site visits in Palisade 3 than we did in either a Palisade 1 or Palisade 2 because of the restrictions of the pandemic.
Josh: Changing our approach to both study monitoring and in our staffing model right. So it's it gives us rigorous training of sites and then oversight of study conduct. So if you think about where we are with palisade three compelling compared to palisade, one or two you know we had an in person investigator meeting for.
Joshua Prince: So it gives us rigorous training of sites and then oversight of study conduct. So, if you think about where we are with Palisade 3 compared to Palisade 1 or 2, you know, we had an in-person investigator meeting for Palisade 3. So, we had that face-to-face, in-person training of PIs, raters, study coordinators, which we couldn't do in 1 and 2. And then, as we've gotten sites up and running, kind of that startup process, you know, we've already had more in-person site visits in Palisade 3 than we did in either Palisade 1 or Palisade 2 because of the restrictions of the And so that new site-facing staffing model gives us a lot more oversight and an increased level of site communication to make sure that the studies are going the way that we want them to.
Joshua Prince: I also add that we've eliminated mask-wearing in Palisades 3 and 4 by either the subject or the public speaking audience, and also the... The drug dose will be administered by the healthcare provider, just to ensure, again, proper dosing for the study. So a lot of little, small things, as well as some significant changes, all intended to really enhance and optimize surveillance, control variability, the things that actually, you know, make a difference to outcomes.
Josh: Palisade III so.
Josh: So we have that face to face in person training of P is Raiders study coordinators, which we couldn't do in one or two and then as we've gotten sites up and running kind of that startup process. We've already had more in person site visits in palisade three than we did in either of palisade Warner palisade to be.
Josh: Cause of the restrictions of the pandemic.
Sean Singh: Mike. And so that new site-facing staffing model, just giving us a lot more oversight and increased level of site communication to make sure that the studies are going the way that we want them to. I also add that we've eliminated mask wearing in these Palsay 3 and 4 by either the subject or the public speaking audience. And also, the drug dose will be administered by the healthcare provider, just to ensure, again, proper dosing for the study. So a lot of little small things, as well as some significant changements, all intended to really enhance and optimize surveillance, control variability, the things that actually make a difference on outcome. But those are some significant mitigators, we think, to some of the risks that are typically associated in your scaling up to a multiple center study.
Josh: And so that that new site facing staffing model, just giving us a lot more.
Josh: Oversight and increased level of site communications to make sure that the studies are going the way that we want them to.
I'd also add that we've eliminated mask wearing ah in these I'll say three and four by either the subjects or the public speaking audience.
Josh: And also the.
Speaker Change: The drug dose would be will be administered by the health care provider just to ensure again proper dosing for this study so a lot of little small things as well as some significant change.
Speaker Change: All intended to really enhance and optimize surveillance control variability.
Speaker Change: Things that actually make a difference in outcome, but those are some significant mitigate or as we think so.
Joshua Prince: But those are some significant mitigators, we think, to some of the risks that are typically associated when you're scaling up to a multiple center study. And then as to the repeat dose study, I'll let Josh speak to that in a minute as well, but again, we're in line with what the FDA has been discussing with us for a while on that one. While there could be some safety benefits from the study, we also think it could get us some benefits in labeling. So, Jess, why don't you just amplify a little more on what we've been thinking about the repeat dose study? Yeah, absolutely.
Speaker Change: The risks that are typically associated with scaling up to a multiple center study.
Joshua Prince: And then, as to the repeat dose study, I'll let Josh speak to that in a minute as well, but again, we're in line with what the FDA has been discussing with us for a while on that one. And while there could be some safety benefits from the study, we also think it can also get us some benefits on labeling. So, Josh, once you disamplify a little more on what we've been thinking on the repeat dose study. Yeah, absolutely. It's essentially the same design as Policy 3 and Policy 4, just with the addition of an additional dose 10 minutes after the first, and then the subject moves into the public speaking challenge.
And then as to the repeat dose study.
Speaker Change: I'll, let John speak to that in a minute as well, but again, where we were in line with what the FCA has been discussing with us for a while on that one and Oh.
Speaker Change: There could be some safety.
John: Benefits from this study. We also think can also get us some benefits on labeling. So just once you just amplify a little more on what we've been thinking on the repeat dose study.
Joshua Prince: Yeah, absolutely. It's essentially the same design as Palisade 3 and Palisade 4, just with the addition of an additional dose 10 minutes after the first, and then the subject moves into the public speaking challenge. The reason we're doing the study is because the FDA, you know, specifically asked and said, you know what? In the real world, patients might still feel nervous after a first dose and want to take another dose. So, we'd like you to, you know, kind of see what happens in that instance.
Speaker Change: Yeah, absolutely and it's essentially the same design as palisade Grand Palisade for just with the addition of an additional 10 minutes. After the first and then the subject moves into the public speaking challenge. The reason we're doing the study is because the FDA specifically asked and said you know what in the real world patient might still feel nervous after first.
Joshua Prince: The reason we're doing the studies is because the FDA specifically asked. It said, you know what, in the real world, a patient might still feel nervous after a first dose and want to take another dose. So we'd like you to, you know, kind of see what happens in that instance. And so that's why we're doing that. Really for the purpose of, you know, informing the label for informing physicians on how they should advise patients. And the other piece of that is we will have an open-label extension, or we plan on for that study. And so that'll let us kind of see, again, in the real world, you know, what happens if patients are able to use the product again within 10 minutes and whether or not they, you know, they even do.
Speaker Change: So you wanted to take another dose so we'd like you to kind of see what happens in that instance, and so that's why we're doing that.
Joshua Prince: And so, that's why, you know, we're doing that really for the purpose of, you know, informing the label, for informing physicians on how they should advise patients. And the other piece to that is we will have an open-label extension, or we plan on, for that study. And so that will let us kind of see, again, in the real world, what happens if patients are able to use the product again within 10 minutes and whether or not they actually do.
Speaker Change: For the purpose of informing the label for informing physicians on how they should advise patients.
Speaker Change: And the other piece to that is we will have an open label extension or we plan on for that study and so that'll let us kind of see you again in the real world what happens if if patients are able to use the product again within 10 minutes and whether or not they you know they even do so again it informs the label on informs physicians on how to win.
Joshua Prince: So, again, it informs the label and informs physicians on how to advise patients. And then, finally, just to clarify, it's three arms. So it's, you know, placebo followed by a placebo, facdienol dose followed by placebo, and then facdienol dose followed by placebo for the three arms.
Joshua Prince: So again, it informs the label and informs physicians on how to advise, advise patients.
Speaker Change: <unk> advised patients and then finally just to clarify it's there's three arms. So it's you know placebo followed by placebo facet dine all dose followed by placebo and then fast the dyno test followed by faster Dino for the three arms.
Joshua Prince: And then finally, just to clarify, it's, it's three arms. So it's, you know, placebo followed by a placebo, facidine, all those followed by placebo, and then facidine, all those followed by facidine, all for the three arms. Peter, remember this, these, uh, fairings, they activate the chemotherapy neurons within milliseconds. There's also a limited capacity for the nose to accept the volume of spray.
Peter: Peter remember this these fairings they activate the chemo sensory neurons within milliseconds.
Shawn K. Singh: Here to remember this, these pharynx, they activate the chemosensory neurons within milliseconds. There's also a limited capacity for the nose to accept the volume of spray. So we're actually not expecting much, any really safety-related concern associated with the multiple doses. But it does, as Josh noted, it has the potential to help inform labeling and give some guidance to what we do think is certainly safe, which is if someone were to dose it more frequently than, say, every hour, which is the typical duration of effect of a fascidile that we've seen in prior studies.
Peter: Also a limited capacity for the nose to accept the volume of spray so we're actually not expecting.
Kim Lugo: So we're actually not expecting much, uh, any really safety-related concern associated with the multiple dosing, but it does, it's just noted it has the potential to help inform labeling and give some guidance to, uh, which, what you think is certainly safe, which is if someone works who does it, um, more frequently than, uh, say every hour, which is the typical, um, er, er, er, er, er, er, er, er, er, er, er, er, er, er, er, er, er, er. And then the next question will come from the line of Kim Lugo with Boolean Blair.
Speaker Change: Much of any really safety related.
Speaker Change: Certain associated with multiple dosing, but it does it just noted it has the potential to help inform labeling and give some guidance too.
Speaker Change: Which we do think is certainly safe, which is if someone were to dose it.
Speaker Change: More frequently than say every hour, which is the typical duration of effect of a fast the dial that we've seen in prior studies.
Speaker Change: Excellent. Thank you for the details.
Julian: Excellent. Thank you for the details.
Speaker Change: And then the next question will come from the line of Tim Lugo with William Blair. Please proceed.
Operator: And then the next question will come from the line of Kim Lugo with William Blair. Please proceed.
Kim Lugo: Thank you for the question, and congratulations on all the progress for PAL-3. And I guess my question relates to PAL-3, how many sites are up and are rolling patients and other sites, and maybe the planned sites for PAL-3? How many of those sites also overlap with PAL-1 and PAL-2?
Tim Lugo: Thank you for the question and congratulations on all the progress for PAL-III. And I guess my question relates to PAL-III. How many sites are already enrolling patients? And of those sites and maybe the planned sites for PAL-3, how many of those sites also overlap with PAL-1 and PAL-2?
Tim Lugo: Thank you for the question and congratulations on all the progress for Palace three.
Tim Lugo: And I guess my question relates to <unk>, how many sites are up and enrolling patients.
Speaker Change: And of those sites and maybe the plan size for power three how many of those sites also overlap with power one and power two.
Sean Singh: Thanks, Tim.
Tim Lugo: Thanks, Tim I appreciate the question so one of the good things about having.
Shawn K. Singh: Thanks, Tim. I appreciate the question. So one of the good things about having the experience that we've got within the clinical research community is the ability to really assess those that we think play at a varsity level and others that might not be quite there. And the emphasis certainly for what we're putting together for both of these phase three studies that try to replicate PALSE II is what we hope is and believe is a varsity squad. So some of them do overlap with the prior studies. I think right now, what we publicize.
Joshua Prince: Appreciate the question. So one of the good things about having the experience that we've got within the clinical research community is the ability to really assess sites that we think play at a varsity level and others that might not be quite there. And the emphasis certainly for what we're putting together for both of these race-based studies to try to replicate PAL-3-2 is what we hope and believe is the varsity squad. So some of them do overlap from the prior studies. I think right now, what we've publicized, Josh, I'm not sure if we got them up today, but it should be right around 10 sites up, so a good pace and for PAL-3.
Speaker Change: The experience that we've got within the clinical research community is the ability to really assess.
Speaker Change: Sites that we think play to varsity level and others that might not be quite there and the emphasis certainly for what we're putting together for both of these phase III studies to try to replicate palisade to is what we hope is and believe is the varsity squad. So.
Josh: Some of them do overlap from the prior studies I think right now what we publicized Josh.
Joshua Prince: Josh, I'm not sure if we got them up today, but should be right around 10 sites up, so, at a good pace, and for Palisade 3, and some of them will have been in 1 or 2, but all of them uniquely, as we've talked about, even if they have been before. We know there's always a benefit, we've seen it, with the fact that this is the third time that this protocol, There's a lot of good experience and understanding and really positive read-through that we've seen at a lot of the scientific conferences where we've presented PALSADE-2 data.
Josh: Josh I'm not sure if we got them up today, but it should be right around 10 sites up so.
Speaker Change: Correct good pace.
Speaker Change: And for palisade, three and some of them will have been in one or two.
Sean Singh: And some of them will have been in one or two. But all of them uniquely, as we talked about, even if they have been before, we know there's always a benefit. We've seen it with the fact that this is the third time that this protocol, after a very long drought, really nothing in social anxiety disorder, let alone for the acute treatment, like we said, we've never seen. There's a lot of good experience and understanding and really positive re-through that we've seen at a lot of the scientific conferences where we presented PAL-3-2 data. There's a great level of awareness, even sites, and then PIs not involved in the program about what we're doing, the MOA associated with this class of drugs and this one in particular.
Speaker Change: <unk>.
But all of them uniquely as we've talked about even if they have been before we know theres always a benefit we've seen it with the fact that this is the third time. This protocol after a very long drought really nothing.
Speaker Change: And and social anxiety disorder, let alone and for the acute treatment like we said, we've never seen a theres a lot of good experience and understanding and really positive read through that we seen at a lot of the scientific conferences, where we presented palisade to data there's.
Joshua Prince: There's a great level of awareness, even sites and NPIs not involved in the program about what we're doing, the MOA associated with this class of drugs and this one in particular, and how what we're seeing is really a fundamentally differentiated approach and a drug candidate for what's been a challenge for practitioners for a very long time, which is to have something that a patient can use flexibly, control the use of it, use it multiple times a day and even at different times of day for different stressors on a certain day, and then have the ability to not use it on days when they're not stressed and don't want any medication of any kind, even a super safe one, in their body. So I think the benefit is the pool of potential sites and the sites that we actually expect to see in these two studies is not only expanded but of a much higher quality than we've ever seen before at this point.
Speaker Change: There's a great level of awareness even sites in N. P is not involved in the program about what we're doing the MLA associated with this class of drugs in this one in particular and how what we're seeing is really a fundamentally differentiated approach.
Sean Singh: And how what we're seeing is really a fundamentally differentiated approach and a drug candidate for what's been a challenge for practitioners for a very long time, which is to have something that a patient can use flexibly, control the use of it, use it multiple times a day, and even different times of day for different stressors when it's a certain day, and then have the ability to not use it on days when they're not stressed and don't want any medication of any kind, even a super safe one, in their body. So I think the benefit is the pool of potential sites, and the sites that we actually expected to see in these two studies is not only expanded, but of a much higher quality than we've ever seen before at this point. A lot of that's due to our own work, but it's also due to the awareness of the need, and especially because there is no, not only is there not an approved treatment, acute treatment for STD, but even the available therapies for use on an off-label basis just fall away short of what this population seems to need to be able to be unimpaired cognitively, not worry about abuse liability, and to be able to really control and fit a medication to their life and the circumstances in their life that debilitate them and create and generate significant opportunity costs.
Speaker Change: And any drug candidate for what's been a challenge for practitioners for a very long time, which is to have some things out of patient in use flexibly control the use of it.
Speaker Change: Use it multiple times, a day and even a different times of day for different stressors when a certain day.
Speaker Change: And then have the ability to not use it on days when they're not stress and don't want any medication of any kind, even a super safe one.
Speaker Change: And their body so.
Speaker Change: The benefit is that the pool of potential sites and some in the site. So we actually expect to see in these two studies is not only expanded but have a much higher quality than we've ever seen before at this point and a lot of that's due to our own work, but it's also due to the awareness of the need and especially.
Joshua Prince: And a lot of that's due to our own work, but it's also due to the awareness of the need and especially because not only is there not an approved treatment, an acute treatment for SAD, but even the available therapies for use on an off-label basis just fall way short of what this population seems to need to be able to be unimpaired cognitively, not worry about abuse liability, and to be able to really control and fit a So, Tim, the bottom line is we really expect to have universal varsity programs on both Palisade III and IV, and a lot of that has to do with the way that we manage these studies.
Speaker Change: Because there is no not only if they're not an approved treatment for acute treatment for STD, but even the available therapies for use on an off label basis, just fall away short what this population seems to need to be able to be.
Speaker Change: Unimpaired cognitively not worry about abuse liability.
And to be able to really control and and fit a medication to their life and the circumstances in their life that debilitate them in and create and generate significant opportunity cost so yeah.
Sean Singh: So, yes, Tim, though, the bottom line is we really expect to have universal varsity programs on both PALCID 3 and 4, and a lot of that has to do with the way that we manage these studies. It's not just a quick in-person investigator's meeting, but it's kind of like painting the Golden Gate Bridge up by you, and that is you start and you go through the sites, then you go back through the sites and back through the sites. We're also not seeing the type of attrition and staff turnover at sites and at CRO, the CRO support that was the case often through the pandemic.
Speaker Change: Yes, Tim the bottom line is we really expect to have universal varsity programs on both palisade, three and four and a lot of that has to do with.
Speaker Change: With the way that we manage these studies, it's not just a a quick in person investigators meeting, but it's it's kind of like painting, the Golden Gate bridge up by you.
Joshua Prince: It's not just a quick in-person investigator's meeting, but it's kind of like painting the Golden Gate Bridge by you, and that is when you start and you go through the sites, and you go back through the sites, and back through the sites. And we're also not seeing the type of attrition and staff turnover at sites and at CRO, with CRO support, that was often the case during the pandemic. So there's a normative sense now within the clinical research community, at least for our neuropsychiatric focus for this program, that we're just really excited that the enhancements to the protocol on top of a more stable environment are a really good combination. Thank you.
Speaker Change: And that is where you start and you go through the sites and you go back to the sites and back to the sites and we're also not seeing the type of attrition.
And staff turnover at sites and that's C. R. O C. R. A support that was the case often through the pandemic. So there's a normative sense now within the clinical research community at least for our neuropsychiatric focus for this program that just really excited.
Sean Singh: So, there's a normative sense now within the clinical research community, at least for our neuropsychiatric focus for this program that is just really excited.
Sean Singh: Instead, the enhancements to the protocol on top of a more stable environment is a really good. Thank you for that.
Speaker Change: The enhanced hansman to the protocol on top of a more stable environment is a it's a really good combination.
Tim Lugo: And I guess one more question for the small placebo-controlled repeat dose study. As you mentioned for labeling purposes, will there be a sub-score recorded prior to the repeat dose and then after the repeat dose, or is it more of a safety and tolerability type of study?
Speaker Change: Thank you for that and I guess, one more question for the small placebo control a repeat dose study you mentioned for labeling person purposes, well there'd be a sub SCOR recorded prior to the repeat dose and then after the repeat dose or is it more of a safety and tolerability the type of stuff.
Kim Lugo: I guess one more question for the small placebo control repeat dose study. You mentioned for labeling purposes.
Joshua Prince: Will there be a sub-score recorded prior to the repeat dose and then after the repeat dose, or that more of a safety and tolerability type of study?
Speaker Change: Eddie.
Speaker Change: Josh.
Joshua Prince: Josh? Yes, it's their sub-scores collected. Identical to the sub-scores that are collected in Policy Three and Policy Four. So there's the kind of the pre-speech subs, and then once the speech starts, obviously those subs are captured for the primary endpoint. So the actual endpoint will be identical to those in Policy three and four.
Speaker Change: Yes, there absolutely are sub scores collected them identical to the sub scores that are collected and palisade three in palisade for.
Joshua Prince: Yes, absolutely SUD scores are collected, identical to the SUD scores that are collected in PALS 8-3 and PALS 8-4. So, there's the kind of the pre-speech thuds, and then once... The speech stars, obviously, those are captured for the primary endpoint. So the actual endpoints will be identical to those in PALS 8-3 and 4.
Speaker Change: So there is that the kind of the pre pre speech subs and then once the.
Joshua Prince: Speech starts I Havent see those subs are captured for the primary endpoint. So that the actual endpoints will be identical to those and I'll say three and four.
Tim Lugo: Will certain non-response after the first dose score kind of trigger that second dose, or do you just collect all the data? Let people feel like they need to redose, let them redose.
Joshua Prince: Will a certain non-response after the first dose score trigger that second dose, or do you just collect all the data? Let people feel they need to read those; let them read those. So there's, so in the public speaking challenge portion of the study, there is, there's a, if you recall, in the study design, there's a 15-minute waiting period after the subject takes the dose. So that second dose is administered in that same period, and you know we think, you know, that the activation with facidine all is almost instantaneous. We think, but in terms of the clinical study, we wait 15 minutes before the subject engages in the public speaking challenge, and so that's really during that waiting period where that second dose is administered.
Speaker Change: Well well certain non response after the first dose score kind of trigger that second dose or do you just collect all the data that people if they feel like I need to read those let them you dose.
Speaker Change: So theres so many in the public speaking challenge portion of the study.
Joshua Prince: And so there's-in the public speaking challenge portion of the study, there is-if you recall in the study design, there's a 15-minute waiting period after the subject takes the dose. So that second dose is administered in that same period, and, you know, we think that the activation with Vasodinol is almost instantaneous. We think, but in terms of the clinical study, we wait 15 minutes before the subject engages in the public speaking challenge. And so that's-it's really during that waiting period where that second dose is administered. So, beyond that, the study is identical to Palisade 3 and 4. Oh my!
Speaker Change: There is there's a if you recall in the study design, there's a 15 minute waiting period. After the subject takes the dose. So that second dose is administered in that same period, and we think that the activation with faster Dino is almost instantaneous we think but in terms of the clinical study, we wait 15 minutes before the subject.
Tim Lugo: Oh, okay, so it's two doses, potentially two doses before the public speaking challenge, not one dose, public speaking, then another dose. Okay. Thank you so much.
Speaker Change #100: <unk> engages in the public speaking challenge and.
Speaker Change #100: So that's it's really a during that waiting period, where that second doses administered. So then beyond that the study is identical to the palisade three and four.
Joshua Prince: So then, beyond that, the study is identical to the policy three and four. Oh, okay, so it's potentially two doses before the public speaking challenge, not one dose public speaking, then another dose.
Speaker Change #101: Oh, Okay. So it's two to potentially two days before the public speaking challenge not Caroline Joe's Publix racking then another dose okay. Thank you so much correct yep.
Joshua Prince: Okay, thank you so much. Yep.
Speaker Change #101: Yeah.
Operator: Operator, I believe that's all the time we have for questions today. If there's any additional questions, please do not hesitate to contact us by email at IR at Vistagin. Olivia, the contact section of our website. We also encourage you to register for email updates on our website to stay connected to the latest news from Vistagin. Again, thank you all for participating on our call today. We appreciate everyone's interest and support. We look forward to keeping you current on our continued progress.
Operator: Operator, I believe that's all the time we have for questions today. If there are any additional questions, please do not hesitate to contact us by email at IR at VistaGen or via the contact section of our website. We also encourage you to register for email updates on our website to stay connected to the latest news from VistaGen. Again, thank you all for participating in our call today. We appreciate everyone's interest and support, and we look forward to keeping you current on our continued progress. This concludes our call. Have a marvelous day.
Operator, I believe that's all the time, we have for questions today.
Speaker Change #102: If theres any additional questions. Please do not hesitate to contact us by email at IR at Vista Gen. Four.
Speaker Change #102: Or via the contact section of our website. We also encourage you to register for email updates on our website to stay connected to the latest news from Vista journey.
Speaker Change #102: Again, thank you all for participating on our call today, we appreciate everyone's interest and support.
Speaker Change #102: Look forward to keeping you current on our continued progress. This concludes our call have been magnificent day.
Operator: This concludes our call.
Operator: Have a magnificent day.
Operator: Okay.
Operator: This concludes today's conference. You may now disconnect your line to this time. Enjoy the rest of your day.
Speaker Change #103: This concludes today's conference you may now disconnect your lines at this time and enjoy the rest of your day.
Operator: This concludes today's conference. You may now disconnect your lines at this time. Enjoy the rest of your day.
Speaker Change #103: Yeah.
Speaker Change #103: Yeah.
Hum.
Speaker Change #103: Uh-huh.
Speaker Change #103: Hum.
Speaker Change #103: Hum.
Speaker Change #103: Hmm.
Speaker Change #103: Mhm.
Speaker Change #103: [music].
Speaker Change #103: Yeah.
Speaker Change #103: Hum.
Speaker Change #103: Yes.
Speaker Change #103: Uh huh.
Speaker Change #103: Yeah.