Q1 2025 VistaGen Therapeutics Inc Earnings Call and Business Update
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Operator: Ladies and gentlemen, greetings and welcome to VistaGen Therapeutics' Fiscal Year 2025 First Quarter Corporate Update Conference Call. At this time, all participants are in a listen-only mode.
Speaker Change: Ladies and gentlemen, greetings and welcome to VistaGen Therapeutics Fiscal Year 2025 First Quarter Corporate Update Conference Call.
Operator: A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mark McPartland, SVP, Investor Relations at VistaGen. Please go ahead.
Speaker Change: At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker Change: It is now my pleasure to introduce your host, Mark McPartland, SVP, Investor Relations at Vistagen. Please go ahead.
Mark McPartland: Thank you, Ryan, and good afternoon, everyone, and welcome to VistaGen's Fiscal Year 2025 First Quarter Corporate Update Conference Call and Webcast. This afternoon, we filed our quarterly report with the Securities and Exchange Commission on SEC Form 10-Q for the quarter ended June 30, 2024, and issued a press release providing an overview of our continued progress. We encourage you to review the release and our 10Q, which can be found in the investor section of our website.
Mark McPartland: Thank you, Ryan, and good afternoon, everyone, and welcome to VISTAGEN's Fiscal Year 2025 First Quarter Corporate Update Conference Call and Webcast.
Speaker Change: This afternoon, we filed our quarterly report with the Securities Exchange Commission on SEC Form 10-Q for our quarter ended June 30th, 2024 and issued a press release providing an overview of our continued progress.
Speaker Change: We encourage you to review the release and our 10-Q, which can be found in the investor section of our website.
Mark McPartland: We will make forward-looking statements regarding our business during today's call based on current expectations and information. These forward-looking statements speak only as of today, except as required by law. We do not assume any duty to update any forward-looking statements made today or in the future.
Speaker Change: We will make forward-looking statements regarding our business during today's call based on current expectations and information.
Speaker Change: These for looking statements speak only as of today, except as required by law, we do not assume any duty to update any for looking statements made today or in the future.
Mark McPartland: Of course, forelooking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forelooking statements we make. Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2025 first quarter 10-Q for the period ending June 30, 2024, and will be made in the future filings that we make with the SEC from time to time, all of which will be available in the investor section of our website and, of course, on the SEC.
Speaker Change: Of course, forelooking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forelooking statements we make today.
Operator: Ladies and gentlemen, greetings, and welcome to VistaGen Terraputex, fiscal year 2025, first quarter corporate update conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
Speaker Change: Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2025 first quarter 10-Q for the period ending June 30th 2024 and will be made in the future filings that we make with the FCC from time to time.
Operator: If anyone should require operator assistance during the conference, please press stars and zero on your telephone keypad. As a reminder, this conference is being recorded.
Speaker Change: all of which will be available in the investors section of our website and of course on the FCC's website.
Mark McPartland: With the formalities completed, we warmly welcome our stockholders, sell-side analysts, and others 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. Singh will provide an update on the lead programs in our novel class of neurocircuitry-focused varying drug candidates in our clinical stage pipeline. After that, the conclusion of our prepared remarks. There will be a brief opportunity for questions from the cell site analysts participating in the call. As a reminder, this 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.
Speaker Change: With the formalities completed, we warmly welcome our stockholders, sell-side analysts, and others interested in Vistagen.
Mark McPartland: It is now my pleasure to introduce your host, Mark McPartland, SVP Investor Relations at VistaGen. Please go ahead. Thank you, Ryan, and good afternoon everyone and welcome to VistaGen, fiscal year 2025, first quarter corporate update conference call and webcast. This afternoon, we filed our quarterly report with the Securities Exchange Commission on SEC form 10Q for a quarter ended June 30th, 2024, and issued a press release providing overview of our continued progress.
Speaker Change: I'm joined on our call today by Shawn Singh, our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Joss Prince, our Chief Operating Officer.
Speaker Change: Shawn will provide an update on the LEAD programs in our novel class of neurocircuitry-focused sparing drug candidates in our clinical stage pipeline. After that, the conclusion of our prepared remarks.
Speaker Change: There will be a brief opportunity for the questions from the sell-side analysts participating on the call. As a reminder, this call is being webcast and will be available for replay after completion.
Mark McPartland: We encourage you to review the release and our 10Q which can be found in the investor section of our website. We will make forward-looking statements regarding our business during today's call based on current expectations and information. These forward-looking statements speak only as of today except as required by law. We do not assume any duty to update any forward-looking statements made today or in the future. Of course, for-looking statements involving risks and uncertainties and our actual results could differ materially from those anticipated by any for-looking statements we make today.
Speaker Change: The replay link can also be found in the investor section of our website.
Mark McPartland: I will now turn the call over to our Chief Executive Officer, Shawn... Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. For those of you who are joining us for the first time, we're a neuroscience company with a diverse pipeline that includes multiple clinical stage product candidates in phase 2 and phase 3 development. Each of these is a novel, non-systemic, neurocircuitry-focused product candidate.
Speaker Change: I will now turn the call over to our Chief Executive Officer, Shawn Singh.
Shawn Singh: Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. For those of you who are joining us for the first time,
Speaker Change: We're a neuroscience company with a diverse pipeline that includes multiple clinical stage product candidates in phase 2 and phase 3 development. Each of these is a novel, non-systemic, neurocircuitry-focused product candidate.
Shawn Singh: Our three lead clinical development programs target large markets with stale standards of care that leave millions of individuals with unsatisfied medical needs, specifically individuals affected by the profound fear and anxiety associated with social anxiety disorder, the serious and potentially life-threatening impacts of depression, and the disruptive effects of menopausal hot flashes. For decades, the standard of care in these markets, these very large indications, has been anchored in oral medications that require systemic uptake and are associated with a bundle of worrisome side effects and safety concerns, prolonged onset of action, and limited efficacy.
Mark McPartland: Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2025, first quarter, 10Q for the period in the June 30th, 2024, and will be made in the future filings that we make with the SEC from time to time. All of which will be available in the investor section of our website and of course on the FCC's website.
Speaker Change: Our three lead clinical development programs target large markets with stale standards of care that leave millions of individuals with unsatisfied medical needs, specifically individuals affected by the profound fear and anxiety associated with social anxiety disorder.
Speaker Change: the serious and potentially life-threatening impacts of depression.
Speaker Change: and the disruptive effects of menopausal heart flashes.
Mark McPartland: With the formalities completed, we warmly welcome our stockholders, cell site analysts, and others interested in messaging.
Speaker Change: For decades, the standard of care in these markets, these very large indications, has been anchored in oral medications that require systemic uptake and are associated with a bundle of worrisome side effects and safety concerns.
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 the lead programs in our novel class of neurosurgery, focused, varying drug candidates in our clinical stage pipeline. After that, the conclusion of our prepared remarks, there will be a brief opportunity for questions from the cell site analyst participate in our call.
Shawn Singh: And our mission is to change that, to change that with our pioneering neuroscience and our new class of clinical stage product candidates called FAIRing, distinguished from all systemic oral medications approved by the FDA, are lead neuroactive farines, facadienol for social anxiety, itruvone for depression, and PH80 for menopausal hot flash, are intentionally formulated as nasal sprays to rapidly activate unique nose-to-brain neural circuits to achieve therapeutic effects, without requiring systemic uptake or direct action on neurons in the brain, and to do so with favorably differentiated safety profiles that we've observed in all clinical studies of our faring product candidates that have been completed to date. Fairings used the nose and key neurons located in the olfactory epithelium as a portal to activate neurocircuitry in different regions of the brain that impact multiple medical conditions. And again, they do that without having to travel through the whole body or even into the brain.
Speaker Change: prolonged onset of action, and limited efficacy. And our mission is to change that.
Shawn Singh: Those fundamental differences have enabled us to achieve historic clinical success in a Phase III trial for the Acute Treatment of Social Anxiety Disorder, or SAD, that we reported last year, as well as to see positive results in exploratory phase 2 trials involving patients with major depressive disorder, menopausal hot flashes, premenstrual dysphoric disorder, and psychomotor impairment due to mental fatigue. Our top priority, the lead neuroscience program for which the vast majority of our team and our capital are focused, is our U.S. registration-directed Palisade Phase III program for fascidinol. That is our investigational fairy nasal spray for the acute treatment of SED.
Speaker Change: To change that with our pioneering neuroscience and our new class of clinical stage product candidates called Fairings
Speaker Change: Distinguished from all systemic oral medications approved by the FDA,
Speaker Change: are lead neuroactive variants, facadienol for social anxiety, itruvone for depression, and PH80 for menopausal hot flashes.
Mark McPartland: As a reminder, this 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.
Speaker Change: are intentionally formulated as nasal sprays to rapidly activate unique nose-to-brain neural circuits.
Sean Singh: I will now turn the call over to our chief executive officer, Sean Singh. Thank you, Mark, and good afternoon everyone. Thank you for joining our call today.
Speaker Change: to achieve therapeutic effects.
Speaker Change: without requiring systemic uptake or direct action on neurons in the brain and to do so with favorably differentiated safety profiles that we've observed in all clinical studies of our fairy and product candidates have been completed to date.
Sean Singh: For those of you who are joining us for the first time, we're a neuroscience company with a diverse pipeline that includes multiple clinical stage product candidates in Phase 2 and Phase 3 development. Each of these is a novel, non-systemic, neural circuitry focused product candidate. Our three lead clinical development programs target large markets with stale standards of care that leave millions of individuals with unsatisfied medical needs, specifically individuals affected by their profound fear and anxiety associated with social anxiety disorder.
Speaker Change: Faring used the nose and key neurons located in the olfactory epithelium as a portal to activate neurocircuitry in different regions of the brain that impact multiple medical conditions.
Speaker Change: And again, they do that without having to travel through the whole body or even into the brain.
Speaker Change: Those fundamental differences have enabled us to achieve historic clinical success in a phase 3 trial for the acute treatment of social anxiety disorder or SAD.
Sean Singh: The serious and potentially life-threatening impacts of depression, and the disruptive effects of menopausal hot flashes. For decades, the standard of care in these markets, these very large indications has been anchored in oral medications that require systemic uptake and are associated with a bundle of worrisome side effects and safety concerns, prolonged onset of action, and limited efficacy.
Speaker Change: that we reported last year, as well as also see positive results in exploratory phase two trials involving patients with major depressive disorder, menopausal hot flashes, premenstrual dysphoric disorder, and psychomotor impairment due to mental fatigue.
Speaker Change: Our top priority, the lead neuroscience program in which the vast majority of our team and our capital are focused on, is our U.S. Registration-Directed Palisade Phase III program for fascidinol.
Sean Singh: An art mission is to change that. To change that with our pioneering neuroscience and our new class of clinical stage product candidates called fairings. Distinguished from all systemic oral medications approved by the FDA, our lead neuroactive fairings, facidineol for social anxiety, atruvo and for depression, and Ph. A.J.D, for menopausal hot flashes, are intentionally formulated as nasal sprays to rapidly activate unique nose-to-brain neural circuits to achieve therapeutic effects without requiring systemic uptake or direct action on neurons and the brain, and to do so with favorably differentiated safety profiles that we've observed in all clinical studies of our fairing product candidates that have been completed to date.
Shawn Singh: There is no FDA-approved medication for the acute treatment of SED, which is a very large, growing, and underserved market that affects 12% of adults in the U.S. As I noted many times, our principal goal is to change that. Last year, with our Palisade II Phase III trial of facetidinol, we reported the first ever positive Phase III trial of a drug candidate for the acute treatment of SAD. Earlier this year, we launched another phase 3 trial, Palisade 3, designed similarly to Palisade 2 with the objective of replicating the success of that study.
Speaker Change: That is our investigational fairy nasal spray for the acute treatment of SED.
Speaker Change: There's no FDA-approved medication for the acute treatment of SED, which is a very large, growing, and underserved market that affects 12% of adults in the U.S.
Speaker Change: As I noted many times, our principal goal is to change that.
Speaker Change: Last year with our Palisade 2 Phase 3 trial of facadienol, we reported the first ever positive Phase 3 trial of a drug candidate for the acute treatment of SAD.
Speaker Change: Earlier this year we launched another phase 3 trial, Palisade 3, designed similarly to Palisade 2 with the objective of replicating the success of that study.
Shawn Singh: Enrollment in the Palisade 3 study is on track, and we're also on track to initiate our Palisade 4 Phase 3 study in the second half of this year, as we've previously guided. That study will have the same design as Palisade 3 and the same objective of replicating the positive results from Palisade 2. Both of these Phase III studies, as well as an exploratory Phase IIa repeat dose study, we'll read out next year.
Sean Singh: Fairings used the nose and keen neurons located in the olfactory epithelium as a portal to activate neural circuitry in different regions of the brain that impact multiple medical conditions, and again they do that without having to travel through the whole body or even into the brain. Those fundamental differences have enabled us to achieve historic clinical success in a phase 3 trial for the acute treatment of social anxiety disorder or SAD that we reported last year. As well as also see positive results in exploratory phase 2 trials involving patients with major repressive disorder, menopausal hot flashes, premenstrual dysphoric disorder, and psychomotor impairment due to mental fatigue.
Speaker Change: Enrollment in the Palisade 3 study is on track and we're also on track to initiate our Palisade 4 Phase 3 study in the second half of this year as we've previously guided. That study will have the same design as Palisade 3 and the same objective of replicating the positive results from Palisade 2.
Speaker Change: Both of these phase 3 studies, as well as an exploratory phase 2a repeat dose study, we'll read out next year.
Shawn Singh: We believe either Palisade 3 or Palisade 4, if successful, and together with Palisade 2, may establish substantial evidence of the effectiveness of fastadienol in support of a potential US new drug application, submission to the FDA, which, if approved, could establish fastadienyl as the first-ever FDA-approved acute treatment of SED. A new treatment option with the potential to be used on demand, as needed, by millions of Americans whose serious and sometimes life-threatening anxiety and fear of embarrassment, judgment, humiliation, and a wide range of social and performance situations affect their daily lives over many years, potentially and unfortunately sometimes leading to depression and even suicide. So again, our U.S.
Speaker Change: We believe either Palisade 3 or Palisade 4, if successful, and together with Palisade 2, may establish the substantial evidence of the effectiveness of fastadienol in support of a potential U.S. new drug application.
Speaker Change: submission to the FDA, which if approved, could establish fastadienyl as the first ever FDA approved acute treatment of SED.
Sean Singh: Our top priority, the lead neuroscience program in which the vast majority of our team and our capital are focused on, is our U.S, registration directed policy phase 3 program for facidino. That is our investigational fairy nasal spray for the acute treatment of SAD. There's no FDA approved medication for the acute treatment of SAD, which is a very large growing and underserved market that affects 12% of adults in the U.S. As I noted many times our principal goal is to change that.
Speaker Change: A new treatment option with the potential to be used on demand as needed.
Sean Singh: Last year with our policy 2 phase 3 trial of facidino, we reported the first ever positive phase 3 trial with a drug candidate for the acute treatment of SAD. Earlier this year we launched another phase 3 trial, policy 3, designed similarly to policy 2 with the objective of replicating the success of that study. Enrollment in the policy 3 study is on track, and we're also on track to initiate our policy 4 phase 3 study in the second half of this year as we previously guided.
Speaker Change: by millions of Americans who's serious and sometimes life-threatening anxiety and fear of embarrassment, judgment, humiliation in a wide range of social and performance situations affect their daily lives over many years.
Speaker Change: and potentially and unfortunately sometimes lead to depression and even suicide.
Shawn Singh: The Registration Directed Palisade Phase III program for fazadienol for the acute treatment of SAD is our top priority, and we are on track and well-funded to do what's necessary to put us in a position with the potential to achieve that important and very valuable goal for patients and for our stockholders. We're also staging our other two lead Farian clinical stage programs in depression and hot flashes for further phase 2 development in the US, building on positive results in exploratory phase 2a studies in each of these large market indications, each of which has stale standards of care and no non-systemic pharmacological treatment alternative.
Speaker Change: So again, our U.S. Registration Directed Palisade Phase 3 program for facadienol for the acute treatment of SAD is our top priority And we are on track and well funded to do what's necessary to put us in a position With the potential to achieve that important and very valuable goal for patients and for our stockholders
Speaker Change: We are also staging our other two lead faring clinical stage programs in depression and hot flashes for further Phase II development in the U.S., building on positive results in exploratory Phase IIa studies in each of these large market indications.
Speaker Change: Each of which has stale standards of care and no non-systemic pharmacological treatment alternative
Shawn Singh: We've seen, and what we've seen in phase two from non-systemic true bone for MDD and non-systemic hormone-free PH80 for menopausal hot flashes so far as to both efficacy and safety is driving our confidence in the potential of these product candidates to improve lives. Itruvon holds the potential to emerge as a novel and fundamentally distinct stand-alone treatment for major depressive disorder.
Sean Singh: That study will have the same design as policy 3 and the same objective of replicating the positive results from policy 2. Both of these phase 3 studies as well as an exploratory phase 2 a repeat those study will read out next year. We believe either policy 3 or policy 4 if successful and together with policy 2 may establish the substantial evidence of the effectiveness of facidino in support of a potential U.S, drug application.
Speaker Change: We've seen and what we've seen in Phase 2 from non-systemic TrueVone for MDD and non-systemic hormone-free PH80 for menopausal hot flashes so far as to both efficacy and safety is driving our confidence in the potential of these product candidates to improve lives.
Speaker Change: so
Speaker Change: Itruvon holds the potential to emerge as a novel and fundamentally distinct standalone treatment for major depressive disorder.
Shawn Singh: We're preparing and strategizing for a Phase IIb development by Truvone in the US as a product candidate with the potential to help individuals who suffer from depression gain relief from their MDD symptoms swiftly and without many side effects of currently available systemic treatment options. Our true vote is distinguished by its favorable safety profile that has been observed in studies that have been completed to date, which is not associated with unwanted sexual side effects, for example, or weight gain, or potential for abuse.
Sean Singh: Submission to the FDA, which you've approved, could establish FACIDIAL as the first ever FDA approved acute treatment of SED. A new treatment option with the potential to be used on demand as needed by millions of Americans who are serious and sometimes life-threatening anxiety in fear of embarrassment, judgment, humiliation in a wide range of social and perform situations affect their daily lives over many years. And potentially, and unfortunately, sometimes lead to depression and even suicide.
Speaker Change: We're preparing and strategizing for Phase 2b development by Truvone in the U.S.
Speaker Change: as a product candidate with the potential to help individuals who suffer from depression gain relief from their MDD symptoms swiftly and without many side effects of currently available systemic treatment options.
Speaker Change: Our True Vote is distinguished by its favorable safety profile that's been observed and studies that have been completed to date, which is not associated with unwanted sexual side effects, for example, or weight gain or potential for abuse.
Shawn Singh: And finally, our non-systemic, hormone-free, faring product candidate for menopausal hot flashes, PH80, holds considerable medical and commercial promise for multiple women's health conditions, but most notably for menopausal hot flashes that affect millions of women around the world.
Speaker Change: And finally, our non-systemic, hormone-free, faring product candidate for menopausal hot flashes, PH80, holds considerable medical and commercial promise in multiple women's health conditions, but most notably menopausal hot flashes that affect millions of women around the world.
Sean Singh: So, again, our U.S, registration-directed PALSAID Phase III program for FACIDIAL for the acute treatment of SED is our top priority and we are on track and well-funded to do what's necessary to put us in a position with the potential to achieve that important and very valuable goal for patients and for our stockholders.
Shawn Singh: Similar to what we've accomplished to enable further phase 2 development of iTruvone for MDD in the US, our ongoing non-clinical program for PHAD aims to enable our US IND to further phase 2 clinical development of PHAD in the US as well, and to do that for menopausal hot flashes. We are confident that millions of women who are affected by menopausal hot flashes would prefer a novel, non-systemic, hormone-free treatment option over the current therapy. With that, I'll turn the call over to Cindy, our CFO, to summarize some of the financial highlights from the last quarter. Cindy?
Speaker Change: Similar to what we have accomplished to enable further Phase II development of i-Truvone for MDD in the U.S.,
Sean Singh: We are also staging our other two lead ferrying clinical stage programs in depression and hot flashes for further Phase II development in the U.S. Building on positive results in exploratory Phase IIA studies in each of these large market indications, each of which has stale standards of care and no non-systemic pharmacological treatment alternative. We've seen, and what we've seen in Phase II from non-systemic atruvone for MDD and non-systemic hormone-free PHAD for menopausal hot flashes so far is to both efficacy and safety is driving our confidence in the potential of these product candidates to improve lives.
Speaker Change: Our ongoing non-clinical program for PHAD aims to enable our U.S. IND to further phase 2 clinical development of PHAD in the U.S. as well, and to do that for menopausal hot flashes.
Speaker Change: We are confident that millions of women who are affected by menopausal hot flashes would prefer a novel, non-systemic, hormone-free treatment option over the current therapies.
Cindy Anderson: Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025. I also encourage everyone to review our report on Form 10-Q filed with the SEC earlier this afternoon for additional details and disclosures. Research and development expenses were $7.6 million for the quarter ending June 30, 2024, compared to $4.2 million for the same period last year. The increase in R&D expenses was primarily due to an increase in clinical and development expenses related to the commencement of Palisade 3 and costs related to preparation for the initiation of Palisade 4 Phase 3 trials of Fasanado and SAD, an increase in headcount costs, and an increase in consulting professionals. General and Administrative expenses were $4.6 million for the quarter ending June 30, 2024, compared to $3 million for the same period last year.
Speaker Change: With that, I'll turn the call over to Cindy, our CFO, to summarize some of the financial highlights from the last quarter. Cindy?
Cindy Anderson: The increase in GINA expenses is primarily due to an increase in headcount costs and professional service expenses. Thank you all for joining us today, and we look forward to continuing to support the continued expansion of our administrative activities. Our net loss of Tributal to Common Shareholders was 10.7 million for the quarter ended June 30th, 2024, compared to 6.9 million for the same period. As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $108.4 million. As a reminder, please refer to our quarterly report on Form 10-Q filed today with the SEC for additional details. I will now turn the call back over to you. Thanks, Cindy.
Cindy Anderson: Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025 first quarter. I also encourage everyone to review a report on Form 10-Q filed with the SEC earlier this afternoon for additional details and disclosures.
Sean Singh: Atruvone holds the potential to emerge as a novel and fundamentally distinct standalone treatment for major depressive disorder. We're preparing and strategizing for Phase IIB development by Truvone in the U.S. As a product candidate with the potential to help individuals who suffer from depression gain relief from their MDD symptoms swiftly and without many side effects of currently available systemic treatment options. Our Truvone is distinguished by its favorable safety profile that's been observed and studies have been completed to date which is not associated with unwanted sexual side effects for example or weight gain or potential for abuse.
Speaker Change: Research and development expenses were $7.6 million for the quarter ending June 30, 2024, compared to $4.2 million for the same period last year.
Speaker Change: The increase in R&D expenses was primarily due to an increase in clinical and development expenses.
Speaker Change: related to the commencement of Palisade 3 and costs related to preparation for the initiation of Palisade 4 phase 3 trials of Fasanado and SAD, an increase in headcount costs, an increase in consulting professional fees.
Speaker Change: General and administrative expenses were $4.6 million for the quarter ending June 30, 2024, compared to $3 million for the same period last year.
Sean Singh: And finally our non-systemic hormone-free fairing product for product candidate for menopausal hot flashes PHAD holds considerable medical and commercial promise in multiple women's health conditions but most notably menopausal hot flashes that affect millions of women around the world. Similar to what we've accomplished to enable further Phase II development by Truvone for MDD in the U.S. Our ongoing non-clinical program for PHAD aims to enable our U.S. IND to further face two clinical development of PHAD in the U.S, as well and to do that for menopausal hot flashes. We are confident that millions of women who are affected by menopausal hot flashes would prefer a novel non-systemic hormone-free treatment option over the current therapies.
Speaker Change: The increase in G&A expenses is primarily due to an increase in headcount costs and professional service expenses to support the continued expansion of our administrative activities.
Speaker Change: Our net loss of Trivial to Common Shareholders was $10.7 million for the quarter ended June 30, 2024, compared to $6.9 million for the same period last year.
Speaker Change: As of June 30, 2024, we had cash, cash equivalents, and marketable securities of $108.4 million.
Speaker Change: As a reminder, please refer to our quarterly report on Form 10-Q filed today with the SEC for additional details and disclosures. I will now turn the call back over to Shawn.
Shawn Singh: What drives our team day in and day out is the opportunity to improve patient lives with our pioneering neuroscientists, along with the potential value for stockholders that often accompanies that type of competition. For example, with our on-track progress in our U.S. registration-directed Palisade Phase III program for facetidinol that's aimed at the acute treatment of SAD, which is a mental health disorder that's growing It's now affecting over 30 million Americans on the other side of the pandemic, and none of them yet have an FDA-approved, flexible, patient-tailored acute treatment option.
Shawn Singh: Thanks, Cindy.
Cindy Anderson: With that I'll turn the call over to Cindy, our CFO to summarize some of the financial highlights from the last quarter. Cindy? Thank you Sean. As Sean mentioned I will highlight a few financial results from our fiscal year 2025 first quarter. I also encourage everyone to review a report on Form 10Q, filed with the SEC earlier this afternoon for additional details in this close. Research and Development Expenses were $7.6 million for the quarter ending June 30, 2024, compared to $4.2 million for the same period last year.
Shawn Singh: What drives our team day in and day out is the opportunity to improve patient lives with our pioneering neuroscience.
Shawn Singh: along with the potential value for stockholders that often accompanies that type of accomplishment.
Shawn Singh: With our on-track progress in our U.S. registration-directed Palisade Phase III program for facetidinol that's aimed at the acute treatment of SAD,
Shawn Singh: which is a mental health disorder that's growing in prevalence. It's now affecting over 30 million Americans on the other side of the pandemic, and none of them have yet an FDA-approved, flexible, patient-tailored acute treatment option.
Cindy Anderson: The increase in R&D expenses was primarily due to an increase in clinical and development expenses related to the commencement of Palisade 3 and cost related to preparation for the initiation of Palisade 4 phase 3 trial of Fasinado and SAD, an increase in headcount costs and increase in consulting and professional fees. General administrative expenses were $4.6 million for the quarter ending June 30, 2024, compared to $3 million for the same period last year.
Shawn Singh: So we're confident in advancing on our goal, to secure that first FDA approval. And it's a very serious and very life-threatening and highly prevalent indication that requires the kind of serious attention and effort that our team is putting into driving this Palisade Phase III program forward, building on the success we achieved last year from the Palisade II study. So on behalf of everybody at VistaGen, I just want to thank you all for your continued interest and your continued support of our mission. Thank you, Shawn.
Shawn Singh: So we're confident in advancing on our goal.
Shawn Singh: to secure that first FDA approval.
Shawn Singh: And it's a very serious and a very life-threatening and highly prevalent indication that requires the kind of serious attention and effort that our team's putting on driving this Palisade Phase III program forward, building on the success we've achieved last year from the Palisade II study.
Cindy Anderson: The increase in R&D expenses was primarily due to an increase in headcount costs and professional service expenses to support the continued expansion of our administrative activities. Our net law for Tribal to common shareholders was $10.7 million for the quarter ended June 30, 2024, compared to $6.9 million for the same period last year. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $108.4 million. As a reminder, please refer to our quarterly report on Form 10Q filed today with the SEC for additional details and disclosures.
Shawn Singh: So on behalf of everybody at VistaGen, I just want to thank you all for your continued interest and your continued support on our mission.
Operator: Operator, we would now like to open the call for questions from the cell side analysts participating. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and 2 if you'd like to remove your question from the queue.
Speaker Change: Thank you, Shawn. Operator, we would now like to open the call for questions from the cell site analysts participating today.
Speaker Change: Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and 1 on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue. You may press star and 2 if you'd like to remove your question from the queue.
Sean Singh: I will now turn the call back over to Sean. Thanks, Indy. What drives our team day in and day out is the opportunity to improve patient lives with our pioneering neuroscience, along with the potential value for stockholders that often accompanies that type of accomplishment. With our on track progress in our U.S, registration-directed Palisade Phase 3 program, Professor Dinal, that's aimed at the acute treatment of SED, which is a mental health disorder that's growing in prevalence. It's now affecting over 30 million Americans on the other side of the pandemic, and none of them have yet an FDA-approved flexible patient tailored acute treatment option.
Operator: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Ladies and gentlemen, we will wait for a moment while we poll for questions. Our first question is from the line of Paul Mattis with T-Phil. Please go ahead. Hey, thanks for taking our question. This is Mark on behalf of Paul.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: Ladies and gentlemen, we will wait for a moment while we poll for questions.
Speaker Change: Our first question is from the line of Paul Mattis with Stifel. Please go ahead.
Mark: You know, we were curious if you could provide any color on, you know, the types of patients that are currently enrolling in the phase three trials for aphasidinol. That would be great. Thank you. Sure. Mark, thanks a lot. Josh, you want to address that? Josh is on top, primary on top of our execution of the Palisade program.
Mark McPartland: Hey, thanks for taking our question. This is Mark on to Paul. You know, we were curious in just hearing if you can provide any color on, you know, the types of patients that are currently enrolling for the phase three trials for afazidinil. That would be great. Thank you.
Josh: Sure, Mark, thanks a lot. Josh, you want to address that? Josh is on top, primary on top of our execution of the Palisade program.
Mark McPartland: So we're confident in advancing on our goal to secure that first FDA approval, and it's a very serious and a very life-threatening and highly prevalent indication that requires the kind of serious attention and effort that our team's putting on driving this Palisade Phase 3 program forward, building on success we've achieved last year from the Palisade 2 study. So on behalf of everybody at Vistagin, I just want to thank you all for your continued interest and your continued support on our mission.
Josh Prince: Any just brief insights, Josh? Yes, so it's, I mean, it's very similar patients to those that were enrolled in our Palisade II study. So from an, you know, inclusion and exclusion criteria: LSAS scores greater than 70, for example. No other kind of primary health disorders, no other primary mental health disorders, it has to be SAD, it would have to be primary, those types of things.
Speaker Change: Any just brief insights, Josh?
Josh: Yes, so it's I mean it's very similar patients to those that were enrolled in our Palisade 2 study. So from an you know inclusion exclusion criteria, LSAS scores greater than 70 for example. No other kind of primary
Josh: health disorders no other primary mental health disorders that has to be SAD would have to be primary that's those those types of things I'm in addition you know some of the
Mark McPartland: Thank you, Sean. Operator, we've now liked to open the call for questions from the self-identals participating today. Ladies and gentlemen, we will now be conducting a question and answer session. If you'd like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd 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 keys. Ladies and gentlemen, we will wait for a moment while we pull for questions.
Josh Prince: In addition, you know, some of the... The exclusion criteria that we had incorporated were elimination of excessive smoking or vaping, for instance. But it's typically a primary SAD diagnosis with a high enough severity among the typical patients that are coming in. Thank you. Thanks, Josh. It's important.
Josh: exclusion criteria that we had incorporated were elimination of excessive smoking or vaping for instance but it's but it's typically primary primary SAD diagnosis with high enough severity that's the typical patients that are coming in.
Shawn Singh: Obviously, we do quite a bit to ensure that we've got folks that properly meet the IE criteria. And we also, obviously, are focusing on people with a disorder that's chronic. The typical onset for this disorder, as many people know, is in adolescence, and the duration is typically about 20 years.
Josh: Thank you.
Josh: Thanks, Josh. It's important, obviously, we do quite a bit to ensure that we've got folks that properly meet the IE criteria, and we also, obviously, are focusing on people with a disorder.
Speaker Change: that's chronic. The typical onset with this disorder, as many people know, is in adolescence and the duration is typically about 20 years. So you have people that obviously you want to get people involved who can be impacted by the medication. So we have specific
Joshua Prince: Our first question is from the line of Paul Mattis, which Tiefel, please go ahead. Hey, thanks for taking our questions. This is Mark on the fall. You know, we were curious in just hearing if you can provide any color on, you know, the types of patients that are currently enrolling for the Phase III trials for a thousand dino. That would be great. Thank you. Sure, Mark, thanks a lot. Joshua, I want to address that.
Shawn Singh: So you have people that, obviously, you want to get people involved who can be impacted by the medication. So we have specific levels set up to make sure that there's appropriate chronicity and severity. We also make sure that they haven't had any more recent medical issues that would have caused them to be ineligible for the study. But very high scrutiny and up front in recruitment and lead generation and pre-screening as well as making sure people are perfectly aligned with our IE Criteria.
Speaker Change: levels set up to make sure that there's appropriate
Speaker Change: medical issues that would have caused them to be ineligible for the study but very high scrutiny and upfront in recruitment and lead generation and pre-screening as well as making sure people are perfectly aligned with our IE criteria.
Joshua Prince: Joshua is on top, primary on top of our execution of the policy program. Any just brief insights, Josh? Yeah, so it's, I mean, it's very similar patients to those that were enrolled in our policy to study. So from an, you know, inclusion, exclusion criteria, LSAS scores greater than 70, for example, no other kind of primary health disorders, no other primary mental health disorders, that has to be FAD would have to be primary.
Joshua Prince: That's those types of things. In addition, you know, some of the exclusion criteria that we had incorporated were elimination of excessive smoking or vaping, for instance. But it's, but it's typically primary, primary FAD diagnosis with high enough severity. That's the typical patients that are coming in. Thank you. Thanks, Josh.
Andrew Tsai: Our next question comes from the line of Andrew Tsai with Jefferies. Please go ahead. Hey, good afternoon.
Speaker Change: Thanks.
Speaker Change: Thank you
Speaker Change: Our next question comes from the line of Andrew Tsai with Jefferies. Please go ahead.
Josh Prince: Thanks for the updates, and thanks for taking my questions. So, first one, for Palisade 3, are you, by chance, seeing higher screen failure rates compared to Palisade 1 and 2? And is there anything else that you might be seeing in real time that gives you that extra boost of confidence you are doing the right thing, you know, enrolling the right patients and executing the study even more rigorously than before? Josh, would you like to give a little further insight into that?
Andrew Tsai: Hey, good afternoon. Thanks for the updates and thanks for taking my questions. So first one for Palisade 3, are you by chance seeing higher screen failure rates compared to Palisade 1 and 2 and is there anything else that
Speaker Change: you might be seeing in real time that gives you that extra boost of confidence you are doing the right thing, you know, enrolling the right patients and executing the study even more rigorously than last time.
Josh Prince: Yes, absolutely. Thank you for the question. I think at this point, what we've seen in terms of green failure rates, in terms of those that have a high enough score in the first public speaking challenge in terms of an anxiety score to move on to the second public speaking challenge, we've been pleasantly surprised that those rates have come in consistent with our projections. So we're seeing, you know, again, progress in the study that's in line with expectations towards the targets that we've established And so I think in general, you know, really things are going as expected.
Speaker Change: Josh, you want to give a little further insight on that?
Josh: Yes, absolutely. Thank you for the question. I think at this point what we've seen in terms of
Joshua Prince: It's important, obviously, we do quite a bit to ensure that we've got folks that properly meet the IE criteria. And we also, obviously, are focusing on people with a disorder that's chronic. The typical onset with this disorder, as many people know, is in adolescence and the duration that's typically about 20 years. So you have people that, obviously, want to get people involved who can be impacted by the medication. So we have a specific level set up to make sure that there's appropriate curiosity and severity.
Josh: Green failure rates in terms of
Josh: Those that have a high enough score in the first public speaking challenge in terms of an anxiety score to move on to the second public speaking challenge
Josh: We've been pleasantly surprised that those rates have come in.
Josh: consistent with our projections, so we're seeing...
Josh: progress of the study that's in line with expectations towards the targets that we've.
Josh: established.
Josh: And so I think
Joshua Prince: We also make sure that they haven't had any more recent medical issues that would have caused them to be ineligible for the study. But very high scrutiny and upfront in recruitment and lead generation and pre-screening, as well as making sure people are perfectly aligned with our IE criteria. Thanks. Thank you.
Shawn Singh: And then, can you remind us how long it took for you to start and end Palisade I and II, I guess maybe Palisade I, and whether the enrollment cadence for Palisade III is looking stronger or faster than the first one? Andrew, thanks for the question. The enrollment cadence is on track with what we've guided. I mean, obviously, the black swan of the pandemic impacted a lot of activity in one and two.
Speaker Change: And then can you remind us how long it took for you to start?
Speaker Change: and end Palisade 1 and 2, I guess maybe Palisade 1, and whether the enrollment cadence for Palisade 3 is looking stronger or faster than the first study.
Speaker Change: Andrew, thanks for the question there.
Speaker Change: The question is the enrollment cadence is on track with what we've guided I mean looking, you know, obviously the the black swan of the pandemic impacted a lot of activity in one and two
Joshua Prince: Our next question comes from the line of Andrew's side. With Jeffries, please go ahead. Hey, good afternoon. Thanks for the updates and thanks for taking my question. So first one, for Policy 3, are you, by chance, seeing higher screen failure rates compared to Policy 1 and 2, and is there anything else that you might be seeing in real time that gives you that extra boost of confidence? You are doing the right thing, you know, enrolling the right patients and executing the study even more rigorously than last time.
Shawn Singh: What we've been so pleasantly surprised by, not really surprised but expected and happy to see is how normative the clinical development environment is and how we are able to have a lot more predictability on the things that caused fits and starts in prior studies during the pandemic, especially PAL-CID-1. I can tell you that we're comfortable with the cadence, and we're on track. Josh, anything else you want to add to that? I think that captures it.
Speaker Change: What we've been so pleasantly surprised by, not really surprised, but expected and happy to see, is how normative the clinical development environment is now.
Josh: and how we are able to have a lot more predictability on the things that caused fits and starts in prior studies during the pandemic, especially PAL-SID-1. So I can tell you that we're comfortable with the cadence and we're on track. Josh, anything else you wanna add to that?
Josh Prince: The one thing I should have mentioned before was just a reminder that we have two public speaking challenges, right? So a key part of this study is the screen out at visit two in the first public speaking challenge of those subjects who don't have a high enough anxiety level to really show improvement. It's one of the things that differentiates our study.
Joshua Prince: Josh, you want to give a little further insight on that? Yes, absolutely. Thank you for the question. I think at this point, what we've seen in terms of green failure rates in terms of those that have a high enough score in the first public speaking challenge, in terms of an anxiety score to move on to the second public speaking challenge, we've been pleasantly surprised that those rates have come in consistent with our projections.
Josh: I think that captured it. The one thing I should have mentioned before was the.
Josh: There's just the reminder that we have two public speaking challenges, right? So...
Josh: A key part of this study is the screen out in Ad Visit 2 in the first public speaking challenge.
Josh: of those subjects who don't have a high enough anxiety level to really show improvement. It's one of the things that differentiates our study and it's not includes an exclusion but it's a key piece of making sure that we have the right subjects.
Josh Prince: And it's not inclusion-exclusion, but it's a key piece of making sure that we have the right subjects moving forward to the randomization portion of the study. And those rates, those are critical for study execution. Those rates have been similar to what we observed in Palisade 1 and Palisade 2.
Joshua Prince: So we're seeing, you know, again, progress of the study that's in line with expectations towards the targets that we've established. And so I think in general, you know, really things things going as expected, and then can you remind us how long it took for you to start and palisade one and two, I guess maybe palisade one and whether the enrollment cadence for palisade three is looking stronger or faster in the first way.
Josh: moving forward to the randomization portion of the study, and those rates, those are critical for study execution. Those rates have been similar to what we've observed in Palisade 1 and Palisade 2.
Shawn Singh: Great. Last question is, um... What's the latest on the Palisade II publication as well as a potential breakthrough designation filing? Andrew. Look, obviously, what we achieved in Palisade II is historic. No one's ever done it before.
Speaker Change: Great. Last question is what's the latest on the Palisade 2 publication as well as a potential breakthrough designation filing? Thank you.
Speaker Change: Andrew.
Speaker Change: look we we know obviously what we achieved in Palisade 2 is historic no one's ever done it and so that's given rise to interest in terms of manuscript that we will be submitting to
Shawn Singh: And so that's given rise to interest in terms of a manuscript that we will be submitting to a journal that we believe is the best fit for that. That's in a very nice mature stage of development. The other part of it is, look, as you know, we've achieved fast track designation already. That's a serious and life-threatening indication. There's no question about that.
Joshua Prince: Andrew, thanks for the question. The question, the enrollment cadence is on track with what we've guided. I mean, looking obviously the black swan on the pandemic impacted a lot of activity in one and two, what we've been so pleasantly surprised by, not really surprised but expected and happy to see is how normative the clinical development environment is now and how we are able to have a lot more predictability on the things that caused fits and starts in prior studies during the pandemic, especially palisade one.
Speaker Change: to a journal that we believe is the best fit for that. That's in a very nice, mature stage of development.
Speaker Change: The other part of it is, look, as you know, we've achieved Fast Track designation already. It's a serious and life-threatening indication.
Shawn Singh: What we achieved in Palisade II is a very significant differentiator. So, you know, we'll see how it goes. There's never any guarantee you can make about any activity with the agency, but I like the chances that... We have in fitting the profile that's typically associated with it, moving beyond. Perfect, perfect.
Speaker Change: There's no question about that. What we achieved in Palisade 2 is a very significant differentiator So, you know, we'll see how it goes. There's never any any guarantee you can make about any activity with the agency, but I like the chances that We have in fitting the profile that's typically associated with
Joshua Prince: So I can tell you that we're comfortable with the cadence and we're on track. Josh, anything else you want to add to that? I think that captures it. The one thing I should have mentioned before was the, there's just a reminder that we have two public speaking challenges, right? So a key part of this study is the screen out and at visit to in the first public speaking challenge of those subjects who don't have a high enough anxiety level to really show improvement.
Shawn Singh: Thanks so much for the call, Eric. Thanks. Thank you. Our next question is from the line of Tim Lugo with William Blair. Please go ahead.
Speaker Change: with Moving Beyond Fast Track.
Speaker Change: Perfect. Perfect. Thanks so much for the call there. Thanks.
Speaker Change: Thank you.
Speaker Change: Our next question is from the line of Tim Lugo with William Blair. Please go ahead.
Tim Lugo: Thanks for the question, and congratulations on the progress in the quarter. Can you remind us if you had discussions with the FDA about self-administration in PILE 1 and 2 versus HCP administration in PILE 3 and 4, and how you expect that to impact any dosing language in the label? Sure. Thanks, Tim.
Tim Lugo: Thanks for the question and congratulations on the progress in the quarter.
Joshua Prince: It's one of the things that differentiates our study. And it's not inclusion exclusion, but it's a key piece of making sure that we have the right subjects moving forward to the randomization portion of the study. And those rates, those are critical for study execution. Those rates have been similar to what we observed in the palisade one and palisade two.
Tim Lugo: I am, can you, can you remind us.
Tim Lugo: If you had discussions with the FDA about self-administration in PAL 1 and 2 versus the HCP administration in PAL 3 and 4 and how you expect that to impact any dosing language in the label?
Shawn Singh: Sure, we've obviously submitted the protocols to the agency, and they understand both of them. It's more consistent with what occurred in Phase 2, the ACP administration of the single dose. So, again, you're trying to ensure that you've got no variability site to site.
Sean Singh: Great. And last question is, what's the latest on the Palisade two publication as well as a potential breakthrough designation finally? Thank you. Andrew, look, we know obviously what we achieved in palisade two is historic. No one's ever done it. And so that's given rise to interest in terms of the manuscript that we will be submitting to a journal that we believe is the best fit for that. That's in a very nice mature stage of development.
Speaker Change: Sure, thanks Tim. Sure, we've obviously submitted the protocols and to the agency and they understand both of them. It's more consistent with what occurred in phase two.
Speaker Change: the the ACP administration of the single dose. So again, you're trying to ensure
Shawn Singh: So, we don't think it'll impact anything associated with what we see at the end of the day if we're successful in three and four combined with two, three or four combined with two. And that is, you know, for the acute treatment of SAD, full stop, and up to multiple times a day, four to possibly even six times a day. Given, as you know, people have some days with no stressor events, and some days they have multiple different stressor events.
Speaker Change: that you've got no variability site-to-site, so we don't think it'll impact anything associated with what we see at the end of the day if we're successful in three and four combined with two.
Speaker Change: three or four combined with two, and that is for the acute treatment of SAD.
Sean Singh: The other part of it is, look, as you know, we've achieved fast track designation already. It's a series in life threatening indication. There's no question about that while we achieved in palisade two is a very significant differentiator. So, you know, we'll see how it goes. There's never any guarantee you can make about any activity with the agency, but I like the chances that we haven't fitting the profile that's typically associated with moving beyond fast track. Let's look to see.
Speaker Change: Full stop and up to multiple times a day four to possibly even six times a day
Speaker Change: Given as you know people have some days no stressor events and some days they have multiple different stressor events so we see the ability for patients to be able to use the drug on demand and
Shawn Singh: So we see the ability for patients to be able to use the drug on demand, and that's consistent with the kind of discussions we've had with the agency in the past. So we want it to be an opportunity for people to have this drug in their backpack and in their pocket to be able to, especially when they anticipate and predict stressors coming upon them, to be able to use it to knock down those symptoms that flare and cause them to not be able to either engage or deal with all kinds of fear and disruptive anxiety.
Speaker Change: And that's consistent with the kind of discussions we've had with the agency in the past So we want it to be an opportunity for people to have this drug in their
Andrew: Perfect. Thanks so much for the color. Thanks. Thank you.
Speaker Change: in their backpack, in their pocket, to be able to, especially when they anticipate and predict stressors coming upon them, to be able to use it to knock down those symptoms that flare and cause them to not be able to either engage or to engage with all kinds of fear and disruptive anxiety.
Tim Lugo: Our next question is from the line of Tim Louisville with William Blair. Please go ahead. Thanks for the questions and congratulations on the progress in the quarter.
Shawn Singh: I'm fearing embarrassment or humiliation, so we really do like, and I think that's part of why we're so comfortable with the patient-reported outcomes that are associated with the study design, both PGIC as well as the SUDS on the front end. We want patients to be in control, and what we've shown in PALS-A2 is that they can be in control. And the same thing now to replicate the efficacy of the drug, just to ensure that you've got no potential variability.
Sean Singh: I can you can remind us if you had discussions with the SBA about self administration and pal one and two versus that HCP administration and pal screen four and how you expect that to impact any dosing language in the label. Chair, thanks, Tim. Sure, we've obviously submitted the protocols to the agency and they understand both of them. It's more consistent with what occurred in Phase 2. The ACP administration of the single dose, so, again, you're trying to ensure that you've got no variability side to side.
Speaker Change: I'm fearing embarrassment or humiliation. So we we really do like and I think that's part of why we're so
Speaker Change: comfortable with the patient-reported outcomes that are associated with the study design, both PGIC as well as the SUDS on the front end. We want patients to be in control and will be shown in PALS-A2 that they can be in control.
Speaker Change: And the same thing now to replicate the efficacy of the drug just to ensure that you've got no potential variability with
Shawn Singh: We'll still do a pretty normal human factor test downstream, but we don't see any. Okay. And can you – I think maybe I missed this in the prepared commentary, but was there any granularity on phase 2B and MDD when that's going to be kicked off? Is that by end? No, it won't be by year end. Right now, we are working with some really good KOLs around the country on that program.
Speaker Change: with the use. We'll still do also a pretty normal human factor test downstream, but we don't see any issues.
Speaker Change: Okay, and can you, I think maybe I missed this in the prepared commentary, but was there any granularity on the Phase 2B and MDD when that's going to be kicked off?
Sean Singh: So we don't think it'll impact anything associated with what we see at the end of the day if we're successful in three and four combined with two, three or four combined with two. And that is, you know, for the acute treatment of SAD, full stop. And up to multiple times a day, four to possibly even six times a day, given that, you know, people have some days no stressor events and some days they have multiple different stressor events.
Speaker Change: No, it won't be by year-end. Right now we are working with some really good KOLs around the hoop on that program and so we're finalizing, got a solid protocol synopsis that's developed. We're now moving that into the full protocol which will submit to the agency before the end of the year.
Shawn Singh: And so we're finalizing. We have a solid protocol synopsis that's been developed. We're now moving that into the full protocol, which will be submitted to the agency before the end of the year. And so we'll see how things progress on the other side. Okay, thank you. Thank you. Ladies and gentlemen, a reminder, if you wish to ask a question, please press star and 1. Our next question is from the line of Madison L. Sari with Be Riley Securities. Please go ahead.
Sean Singh: So we see the ability for patients to be able to use the drug on demand and that's consistent with the kind of discussions we've had with the agency in the past. So we wanted to be an opportunity for people to have this drug in their backpack and their pocket to be able to, especially when they anticipate and predict stressors coming upon them to be able to use it to knock down those symptoms that flare and cause them to not be able to either engage or to engage with all kinds of fear and disruptive anxiety and fear and embarrassment or humiliations.
Speaker Change: and so we'll see how things progress on the other side of that.
Speaker Change: Okay, thank you.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, a reminder, if you wish to ask a question, please press star and 1.
Speaker Change: Our next question is from the line of Madison L. Sari with Be Riley Securities. Please go ahead.
Madison L. Sari: Hey guys, congrats on the progress you made. So a couple of questions from me: can you remind us if Palisade 4 will be performed at the same clinical sites as Palisade 3? And will we see top-line data from Palisade 3 before dosing starts in Palisade 4? So the first question was, will there be distinct sites in the studies? The answer to that is yes.
Speaker Change: Hey guys, congrats on the progress you made and thanks for taking my question.
Speaker Change: Also a couple from me, can you remind us if Palisade 4 will be performed at the same clinical sites as Palisade 3?
Sean Singh: So we really do like, and I think that's part of why we're so comfortable with the patient reported outcomes that are associated with the study design, both PGIC as well as the SADS on the front end. We want patients to be in control and we'll be showing in policy too that they can be in control. And the same thing now to replicate the efficacy of the drug, just to ensure that you've got no potential variability with the use. We'll still do also a pretty normal human factor test downstream, but we don't see any issues.
Speaker Change: and we'll see top-line data from Palisade 3 before dosing starts in Palisade 4.
Shawn Singh: We'll have about 15-16 sites per study, and we're not anticipating any overlap in the sites from the two studies. And then, I'm not quite sure I heard the last part of the question, but if it was associated with when we'll initiate Palisade 4, is that what it was? If we'll see top-line data from Palisade 3 before dosing starts in Palisade 4. No. No.
Speaker Change: So the first question was, will there be distinct sites in the studies? And the answer to that is yes. We'll have about 15, 16 sites per study, and we're not anticipating any overlap in the sites from the two studies.
Speaker Change: and then I'm not quite sure I heard the last part of the question but if it was associated with when we'll initiate Palisade 4, is that what it was?
Sean Singh: Okay, and can you, I think maybe I missed this in the prepared commentary, but were there any granularity on the state to be an MDD when that's going to be kicked off? Who's that by? No, I won't be by year end. Right now we are working with some really good KLs around the hoop on that program. And so we're finalizing, got a solid protocol synopsis to develop. We're now moving that into the full protocol, which will submit to the agency before the end of the year. And so we'll see how, see how things progress on the other side of that. Okay, thank you. Thank you. Ladies and gentlemen, a reminder, if you wish to ask a question, please press star and one.
Speaker Change: If we'll see top line data from Palisade 3 before dosing starts in Palisade 4.
Shawn Singh: PALS-AID-3 top-line data, both those studies we'll read out in 2025. So currently, our target for PAL-III is mid-2025, and for PAL-IV, it will be near the end of 2025. Both of them, every aspect of the PAL-SAFE Phase III program, every single component of it that remains associated with this U.S.-directed, Registration Directed Program will be started this year and completed next year. Got it, that's helpful. And then, if I could ask, what are, I guess, the gating steps for the MDD phase 2B trial?
Speaker Change: No, no. PAL-SAID 3 top-line data, both those studies will read out in 2025. So currently a target for PAL-3 is mid-2025 and for PAL-4 will be near the end of 2025.
Speaker Change: Both of them, every aspect of the PAL-SAFE Phase III program, every single component of it, that remains associated with this U.S.-directed program.
Speaker Change: Registration Directed Program will be started this year and completed next year.
Speaker Change: Got it. That's helpful. And then if I could ask.
Speaker Change: What are, I guess, the gating steps to the MDD Phase 2B trial? And it looks like you guys have kind of reached the top of the dose efficacy curve with the current 6.4 microgram dose.
Shawn Singh: And it looks like you guys have kind of reached the top of the dose efficacy curve with the current 6.4 microgram dose. Is that how you're looking at it, or could that dose change? Now, we think that's where we'll land.
Madison L. Sorry: Our next question is from the line of Madison L. Sorry, with B. Riley Securities, please go ahead. So you guys can grab on the progress we made, thanks for taking our questions. Also a couple from me, you remind us, you know, Palisade 4 will be performed at the same clinical size as Palisade 3. And we'll see top line data from Palisade 3 before our dosing starts in Palisade 4. Oliver. So the first question was, will there be distinct sites in the studies?
Speaker Change: Is that how you're looking at it or could that dose change?
Shawn Singh: We saw some very nice success in the Phase 2a study at two different dose levels. And where I think we're landing on that one, again, we're trying to finalize the protocol, working with some of the KOLs you all have seen on our SAB, Maurizio Fava, Jerry Santacora, Sanjay Mathew, and Michael Leibowitz, all with long-term experience in depression. And what we see, again, with this drug, similar to, obviously, the way that we've achieved clinical success with the other farines is being able to get there through neurocircuitry-focused MOAs that do not drive on to the same side effect and safety profile lane as we've typically seen with every single drug that's out there.
Speaker Change: Now we think that's where we'll land we saw some very nice success in in the phase 2a study at two different dose levels
Speaker Change: And where I think we're landing on that one, again, we're trying to finalize the protocol working with some of the KOLs you all have seen on our SAB, Maurizio Fava, Jerry Santacora, Sanjay Matthew, Michael Leibowitz, all with long-term...
Madison L. Sorry: The answer to that is yes. Well, about 15-16 sites per study, and we're not anticipating any overlap in the sites from the two studies. And then, not quite sure I heard the last part of the question, but if it was associated with when we'll initiate Palsaid 4, is that what it was? It will see top line data from Palsaid 3 before dosing starts in Palsaid 4. No. Palsaid 3, top line data, both of those studies will read out in 25.
Speaker Change: experience in depression and what we see again with this drug
Speaker Change: similar to obviously the way that we've achieved clinical success with the other fairings is to be able to get there
Speaker Change: through neurocircuitry-focused...
Speaker Change: MOAs that do not drive on to the same side effect and safety profile lane as we've typically seen every single drug that's out there. And so what we think we can do here
Shawn Singh: And so, what we think we can do here in a standalone monotherapy study, and we'll probably shoot it over six weeks. With the 6.4 dose, double-blind, placebo-controlled, 1-to-1 randomization, we'll lean into Hamilton. HAM-D17 is the primary endpoint, just like we did in Phase 2. A lot of that has to do with what we've seen with anxious depression and the benefits that we've seen there with this asset. If you get it, it'll be a fairly conventional approach from an endpoint standpoint, and I think a six-week program is what we're looking at, twice-a-day dosing over six weeks at 6.4 microgram
Speaker Change: in a stand-alone monotherapy study and we'll probably shoot it over six weeks.
Madison L. Sorry: So currently, a target for Pals 3 is mid 25, and for Pals 4 will be near the end of 25. Both of them, the data remains associated with this US-directed registration-directed program will be started this year and completed next year. Got it. That's helpful.
Speaker Change: with the 6.4 dose, double blind, placebo controlled, one-to-one randomization. We'll lean into Hamilton. HAM-D17 is the primary endpoint, just like we did in Phase 2. A lot of that has to do with what we've seen with anxious depression and the benefits that we've seen there with this asset.
Speaker Change: It will be a fairly conventional approach from an endpoint standpoint and I think a six-week program is what we're looking at.
Sean Singh: And then, if I could ask, what are, I guess, the gating steps to the MDD phase 2B trial? And it looks like you guys have kind of reached the top of the dose efficacy curve with the current 6.4 microgram dose. Is that how you're looking at it, or could that dose change? No, we think that's where we'll land. We saw some very nice success in the phase 2A study at two different dose levels, and where I think we're landing on that one.
Speaker Change: twice a day dosing over six weeks.
Speaker Change: at the 6.4 microgram level.
Speaker Change: Got it. Thank you.
Madison L. Sari: Got it. Thank you. Ladies and gentlemen, there are no further questions. I would now hand the conference over to Mark McPartland for his closing comments.
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, there are no further questions. I would now hand the conference over to Mark McPartland for his closing comments. Mark?
Mark McPartland: Thank you, operator, and thank you everyone for participating in the call today. If you have any other questions, please do not hesitate to contact us by email at ir at vistagen.com or the contact us section of the website. We also encourage you to register for email updates on the website to stay connected to the latest news and events for VistaGen.
Mark McPartland: Thank you, operator, and thank you, everyone, for participating on the call today. If you have any other questions, please do not hesitate.
Sean Singh: Again, we're trying to finalize a protocol working with some of the KOLs you all have seen on our SAB, Marie Tiofawa, Jerry Santa Cora, Sanji Matthew, Michael Lieblitz, all with long-term experience in depression. And what we see, again, with this drug, similar to obviously the way that we've achieved clinical success with the other fairings, is to be able to get there through neurocircuitry-focused MLAs that do not drive on to the same side effect and safety profile lane as we've typically seen every single drug that's out there.
Speaker Change: to contact us by email at ir at vistagen.com or the contact us section of a website. We also encourage you to register for email updates on the website to stay connected to the latest news and events for Vistagen.
Mark McPartland: Thank you all again for participating in the call. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing progress. This concludes the call. Have a marvelous day. Thank you. Ladies and gentlemen, the conference of VistaGen Therapeutics has now concluded. Thank you for your participation. You may now disconnect your lines. [music]
Speaker Change: Thank you all again for participating on the call. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing progress. This concludes the call. Have a magnificent day.
Speaker Change: Thank you. Ladies and gentlemen, the conference of vestigian therapeutics has now concluded. Thank you for your participation. You may now disconnect your lines.
Sean Singh: And so what we think we can do here in a standalone model therapy study, and we'll probably shoot it over six weeks with the 6.4 dose, double blind placebo control, one-to-one randomization, we'll lean into Hamilton. HamD17 is the primary endpoint, just like we did in phase 2. A lot of that has to do with what we've seen, with thanks to depression and the benefits that we've seen there with this asset.
Operator: So get it, it'll be a fairly conventional approach from an endpoint standpoint, and I think a six-week program is what we're looking at by twice-a-day Ladies and gentlemen, there are no further questions.
Mark McPartland: I would now hand the conference over to Mark McParkland for his closing comments. Mark? Thank you, operator, and thank you everyone for participating on the call today. If you have any other questions, please do not hesitate to contact us by email at iratvistigen.com or contact us section of a website. We also encourage you to register for email updates on the website to stay connected to the latest news and events for this agenda. Thank you all again for participating in the call. We appreciate everyone's interest and support. We look forward to keeping you updated on our ongoing progress.
Speaker Change: [inaudible]
Operator: This concludes the call. Have a magnificent day. Thank you.
Operator: Ladies and gentlemen, the conference of VistaGen teleputics has now concluded. Thank you for your participation. You may now disconnect your lines. Thank you very much.