Q2 2025 VistaGen Therapeutics Inc Earnings Call and Business Update
Operator: Good afternoon, ladies and gentlemen, and welcome to the VistaGen Therapeutics Fiscal Year 2025 Second Quarter Corporate Update Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator.
Good afternoon, ladies and gentlemen, and welcome to the Vista Jounce Therapeutics fiscal year 'twenty, five second quarter corporate update conference call.
At this time all lines are in listen only mode. Following the presentation. We will conduct a question and answer session. If at any time during the call you require assistance. Please press star zero for the operator.
Operator: This call is being recorded on Thursday, November 7, 2024.
This call is being recorded on Thursday November seven plenty plenty for.
Mark McPartland: I would now like to turn the call over to Mr. Mark McPartland, Senior Vice President Investor Relations at VistaGen.
Speaker Change: I would now like to turn the call over to Mr. Mark Mcpartland, Senior Vice President Investor Relations Mr. Jim.
Speaker Change: Please go ahead.
Speaker Change: Yeah.
Mark McPartland: Thank you, operator. Good afternoon, everyone, and welcome to VistaGen's fiscal year 2025 second quarter corporate update conference call and webcast. Earlier this afternoon, we filed our quarterly report with the Securities Exchange Commission on the SEC Form 10-Q for our second quarter that ended September 30, 2024.
Speaker Change: Thank you operator, good afternoon, everyone and welcome to Mr. James fiscal year, 2025, second quarter corporate update conference call and webcast.
Speaker Change: Earlier. This afternoon, we filed our quarterly report with the Securities Exchange Commission on the SEC Form 10-Q for our second quarter that ended September 32024, and we also issued a press release, providing an overview of our progress across our lead neuroscience program.
Mark McPartland: And we also issued a press release providing an overview of our progress across our lead neuroscience We encourage you to review the release and our 10-Q, 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 our 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, forward-looking statements involve risk uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements we make today.
Speaker Change: We encourage you to review the release in our 10-Q.
Speaker Change: Can be found in the investors section of our website.
Speaker Change: We will make forward looking statements regarding our business. During today's call are based on our 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 forward looking statements involve risk.
Speaker Change: Uncertainties and our actual results could differ materially from those anticipated by any forward looking statements we make today.
Mark McPartland: Additional information concerning risk factors that could affect our business and financial results is included in our fiscal year 2025 second quarter form 10-Q for the period ending September 30, 2024, and in future filings that we make with the SEC from time to time, all of which, again, are on our website in the investor section on the SEC website.
Speaker Change: Information concerning risk factors that could affect our business and financial results is included in our fiscal year 2025 second quarter Form 10-Q for the period ending September 32024, and in future filings that we make with the SEC from time to time, all of which again are on our website or on our website.
Speaker Change: In the investors section on the FTC website.
Mark McPartland: With the formalities completed, I would like to warmly welcome our stockholders, sell-side analysts, and others interested in our programs and progress.
With the formalities completed I would like to warmly welcome our stockholders sell side analysts and others interested in our programs in progress 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.
Mark 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 discuss our recent highlights in our LEAD neuroscience programs, and Cindy will discuss our second quarter financial results. At the conclusion of our prepared remarks, as the operators already noted, there will be a brief opportunity for questions from the cell site analysts. As a reminder, this call is being webcast and will be available for replay after completion. The replay link, again, can be found on our website, Shawn.
Speaker Change: Shawn will discuss our recent highlights and our lead neuroscience programs and Cindy will discuss our second quarter financial results at the conclusion of our prepared remarks as the operators already noted there will be a brief opportunity for questions from the sell side analysts as a reminder, this call is being webcast and will be available for replay after completion.
Speaker Change: The replay link again can be found on our website the guidance section.
Speaker Change: Sean.
Shawn Singh: Thank you, Mark.
Sean: Thank you Mark good afternoon, everyone and thank you for joining our call today.
Shawn Singh: Good afternoon, everyone, and thank you for joining our call today. As the neuroscience renaissance continues, we are advancing at VistaGen a neuroscience pipeline that's unlike any other in the industry, with multiple clinical stage product candidates in phase two and phase three development, each from a new class of potential intranasal therapies that we call FAIRines. Each has a differentiated mechanism of action and differentiated safety. And so we are, with this pipeline, advancing multiple opportunities to set new standards of care. in several high-prevalence pharmaceutical markets. Distinguished from all systemic medications that are currently approved by the FDA, each intranasal faring product candidate in our lead programs, and that includes facadienol for social anxiety disorder, itruvone for major depressive disorder, and PHAD for menopausal hot flashes, each is designed and formulated to activate key nose-to-brain neural circuitry within milliseconds.
Sean: As the neuroscience Renaissance continues we are advancing at vis agenda neuroscience pipeline that is unlike any other in the industry.
Sean: With multiple clinical stage product candidates in phase II and phase III development, each from a new class of potential intranasal therapies that we call fairings.
Sean: Each has a differentiated mechanism of action and differentiated safety.
So we're up we are with this pipeline advancing multiple opportunities to set new standards of care.
Sean: In several high prevalence pharmaceutical markets.
Sean: Distinguished from all systemic medications that are currently approved by the FDA.
Sean: Each intranasal Ferring product candidate in our lead programs and that includes first the die and all for social anxiety disorder.
Sean: <unk> for major depressive disorder, and ph 84, menopausal Hot flashes hot flashes each is designed and formulated to activate key nose to brain neural circuitry within milliseconds to achieve the desired therapeutic effects in all without <unk>.
Shawn Singh: to achieve the desired therapeutic effects and all without requiring systemic absorption or binding to neurons in the brain. We have observed statistically significant efficacy and favorable safety data in each of our lead intranasal faring development programs. for Facetidinol in a Phase III trial for the acute treatment of social anxiety disorder, for iTruvone in a Phase IIa trial for the treatment of major depressive disorder, and for PHAD in a Phase IIa trial for menopausal hot flashes. It is these successes that have led to the success of our research. seen with multiple fairing product candidates across multiple indications that drive our confidence in the power and the elegance of nose-to-brain neurocircuitry and the enormous potential of our intranasal faring platform.
Sean: Wiring systemic absorption or binding to neurons in the brain.
Sean: We have observed statistically significant efficacy and favorable safety data in each of our lead intranasal ferry in development programs for.
Speaker Change: Professor Dino and a phase III trial for the acute treatment social anxiety disorder for a true loan in a phase Iia trial for the treatment of major depressive disorder.
Speaker Change: For ph, a D and a phase Iia trial for menopausal Hot flashes is these successes seen with multiple varian product candidates across multiple indications that drive our confidence in the power and the elegance of noticed the brain neuropsychiatry and the enormous potential.
Of our intranasal Ferring platform.
Shawn Singh: Currently, there is no FDA-approved medication for the acute treatment of social anxiety disorder, which is a mental health disorder affecting over 30 million adults in the U.S. And our goal is to fill a major acute treatment gap in SAD with facadienol and deliver new hope and new optimism to the millions of individuals who are anxious and fear embarrassment, humiliation, and judgment when facing anxiety-provoking social and performance situations in their daily lives. Last year, we reported positive results from our Palisade II Phase III trial of fasadienol for the acute treatment of SAD. And this year, with the goal of complimenting the success of Palisade II, we've initiated our replicate Palisade III and Palisade IV Phase III trials on time and as planned.
Speaker Change: Currently there is no FDA approved medication for the acute treatment of social anxiety disorder, which is a mental health disorder affecting over 30 million adults in the U S and our goal is to fill a major acute treatment gap in S. A D with faster Dino and deliver new hope and new optimism to the millions of individuals who are anxious.
Speaker Change: And fear embarrassment humiliation and judgment when facing anchor.
Speaker Change: Xiety provoking social and performance situations in their daily life.
Speaker Change: Last year, we reported positive results from our palisade two phase III trial of <unk> for the acute treatment of S. D.
Speaker Change: And this year with the goal of complementing the success of palisade too we've initiated a replicate palisade three and palisade for phase III trials on time and as planned with.
Shawn Singh: With those milestones now completed, we are now laser focused on efficient execution. to our top-line results from both studies next year. And if successful, we believe either Palisade 3 or Palisade 4, together with Palisade 2, could provide sufficient evidence of safety and efficacy to support the submission of an NDA to the FDA for facadienol for the acute treatment of anxiety in adults with SAD. Our iTrueBone program has shown exciting potential as a new, non-systemic, standalone treatment for major depressive disorder. And we're preparing for planned phase 2B development in the US. Based on the Phase IIa clinical data, iTruvone has the potential to relieve MDD symptoms rapidly and without many of the unwanted side effects associated with current systemic antidepressants, especially weight gain and sexual dysfunction.
Speaker Change: With those milestones now completed we are now laser focused on efficient execution.
Speaker Change: Two our topline results from both studies next year.
And if successful we believe either palisade three or palisade for together with palisade two could provide sufficient evidence of safety and efficacy to support the submission of an NDA to the FDA for fast the die and all for the acute treatment of anxiety in adults with S. A D.
Alright, <unk> program is shown exciting potential as a new non systemic standalone treatment for major depressive disorder, and we are preparing for planned phase <unk> development in the U S.
Based on the phase Iia clinical data <unk> has the potential to relieve MTT symptoms rapidly and without many of the unwanted side effects associated with current systemic antidepressants, especially weight gain and sexual dysfunction.
Shawn Singh: Our PHAD program for menopausal hot flashes is also programmed. Based on positive Phase IIa clinical data, our non-systemic, hormone-free farine product candidate has game-changing potential in this major women's health market. in which women are faced with a very limited. opportunity for treatment options. We're advancing PHAD through the remaining nonclinical programs and CMC requirements to support our submission of a US IND next year. The intent for that is to facilitate our plans for further phase 2 development of PHAD for treatment of menopausal hot flashes in the US.
Speaker Change: R. J D program tremendous puzzle Hot flashes is also progressing well.
Speaker Change: Just on positive phase Iia clinical data are non systemic hormone free federal product candidate has game changing potential in this major women's health market.
Speaker Change: In which women are faced with a very limited.
Speaker Change: Opportunity for treatment options.
Speaker Change: We're advancing PHA D through the remaining non clinical programs and CMC requirements to support our submission of a U S. D. Next year. The intent for that is to facilitate our plans for further phase II development of ph Eddie for treatment of menopausal Hot flashes in the U S.
Cindy Anderson: I'll now hand the call over to Cindy Anderson, our CFO, to summarize our financials from the last quarter.
Speaker Change: I'll now hand, the call over to Cindy Anderson, our CFO to summarize our financials from the last quarter Cindy.
Cindy Anderson: Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025 second quarter. Research and development expenses were $10.2 million for the quarter ended September 30, 2024, compared to $3.9 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 our Palisade Phase III program for fascinoidal for the acute treatment of SAD, an increase in head count, and an increase in consulting professional services. General administrative expenses were $4.2 million for the quarter ended September 30, 2024, compared to $3.2 million for the same period last year.
Cindy Anderson: Thank you Sean that Sean mentioned I will highlight a few financial results from our fiscal year 2025 second quarter.
Cindy Anderson: Search and development expenses were $10 2 million for the quarter ended September 32024, compared to three 9 million for the same period last year.
Cindy Anderson: The increase in R&D expenses was primarily due to an increase in clinical and development expenses.
Cindy Anderson: Now to our palisade phase III program for passenger idle cutting acute treatment F&B and increase in head count and an increase in consulting and professional services.
Cindy Anderson: General and administrative expenses were $4 2 million kind of quarter ended September 30 of 2024 compared to $3 2 million in the same period last year the.
Cindy Anderson: The increase in GNA expenses was primarily due to an increase in headcount and professional service. Our net loss attributable to common stockholders was $13 million for the quarter ended September 30, 2024, compared to $6.6 million for the same period last year. As of September 30, 2024, we had $97.6 million in cash, cash equivalents, and marketable security.
Cindy Anderson: The increase in G&A expenses was primarily due to an increase in head count and professional services fees.
Cindy Anderson: Our net loss of checking out the common stockholder was $13 million for the quarter ended September 32024, compared to $6 6 million kind of same period last year.
Cindy Anderson: As of September 32024, we had $97 6 million in cash cash equivalents and marketable securities as.
Cindy Anderson: As a reminder, please refer to our quarterly report on Form 10-Q, filed with the SEC this afternoon, for additional details and disclosures.
Cindy Anderson: A reminder, please refer to our quarterly report on Form 10-Q filed with the SEC. This afternoon for additional detail from disclosures.
Shawn Singh: I will now hand the call back over to Shawn.
Speaker Change: I'll hand, the call back over to Sean.
Shawn Singh: Thanks, Cindy. Leveraging our pioneering neuroscience, our deep understanding of nose-to-brain neurocircuitry and multiple positive clinical trials to date, our fairing pipeline has the power and the potential to improve millions of lives who are affected by debilitating effects of neuroscience disorders. To do that by replacing inadequate therapies and setting entirely new standards of care.
Speaker Change: Thanks, Andy.
Sean: Bridging our pioneering neuroscience, our deep understanding of knows the brain neural circuitry and multiple positive clinical trials to date.
Sean: Our Ferring pipeline has the power and the potential to improve millions of lives who are affected by debilitating effects of neuroscience disorders to do that by replacing inadequate therapies and setting entirely new standards of care.
Shawn Singh: Our broad and our diverse neuroscience pipeline offers multiple shots at that core goal. And our team is motivated and it's driven by the opportunities to disrupt treatment paradigms, improve lives, and in turn create potential value for our stockholders.
Sean: Our broad and our diverse neuroscience pipeline offers multiple shots at that court that that core goal.
Sean: And our team is motivated and it's driven by the opportunities to disrupt treatment paradigms improve lives and in turn create potential value for our stockholders.
Shawn Singh: So on behalf of everyone at VistaGen, once again, I want to thank you for your continued interest in our efforts and for your support, and we look forward to keeping you informed of our continuing progress.
Sean: So on behalf of everyone, who visits and once again I want to thank you for your continued interest in our efforts and for your support and we look forward to keeping you informed of our continuing progress.
Shawn Singh: Thank you, Shawn.
Speaker Change: Thank you Sean operator, we would now like to open up the call for questions from the sell side analysts participate here on the call today.
Operator: Operator, we would now like to open up the call for questions from the cell site analysts participating on the call today. Thank you.
Speaker Change: Okay.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number. If you are using a speakerphone, please lift the handset before pressing any key. One moment, please, for your first question.
Speaker Change: Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your Touchtone you will hear a promise that your hand, there's been rate.
Speaker Change: Should you wish to decline from the polling process, Chris just a little bit in <unk>.
Speaker Change: If you are using a speaker phone please lift the handset before pressing any teams.
Speaker Change: One moment. Please for your first question.
Julian: First question will be coming from Paul Mattis from Stuyvesant. Hi there. This is Julian on for Paul. Thanks so much for taking my question and congrats on the progress. Just wondering if you could provide a little bit of color on the pace of enrollment so far. What are you hearing from investigators about the demand to the demand and enrolling in the study? And I was wondering if these parallel studies share trial sites or anything else that you could share about, you know, the sites that you've chosen for each study. And then lastly, a quick one.
Speaker Change: First question will be coming from Paul Matisse from stifle.
Speaker Change: Hi, Barry this is Julian on for Paul. Thanks, So much for taking my question and congrats on the progress.
Speaker Change: Just wondering if you could provide a little bit of color on it.
Speaker Change: The pace of enrollment so far what are you hearing from investigators about the demand or the demand and enrolling in the study and.
Speaker Change: I was wondering if these parallel studies sure trial sites are or anything else that you could share about.
Speaker Change: The sites that you've chosen for each study and then lastly, a quick one.
Julian: Can you just remind us on the timing of when you expect to have data here? Previously, you've said you're targeting mid-25 for PAL-3 and, you know, towards the end of 2025 for PAL-4. Just curious if you're still tracking towards that goal. Thank you.
Speaker Change: Can you just remind us on the timing of when you expect to have data here.
Speaker Change: So you've said you're targeting mid 25 for <unk>.
Speaker Change: Towards the end of 2025 or <unk> four just curious if.
Speaker Change: You are still tracking towards that goal. Thank you.
Shawn Singh: Thanks, Julian. I appreciate the question. A couple things there.
Speaker Change: Okay. Thanks, Julia I appreciate the question.
Shawn Singh: I'll try to do them sort of in reverse order. In terms of timelines, still sticking with the guidance that we had previously laid out, as you just articulated, for PAL-3 and PAL-4 respectively. So, we're happy that we were able to... initiate both of the studies on time, as I noted, middle of the first half of this year for PAL-III and the middle of the second half of this year for PAL-IV. You know, there's tremendous excitement across the PIs and the site staffs that we've been able now to bring together for Palisade 3 and Palisade 4, as you can imagine, on the other side of the Palisade 2 success.
Speaker Change: Couple of things there I'll try to.
Speaker Change: I'm sort of in reverse order in terms of timelines still sticking with the guidance that we had.
Speaker Change: Previously laid out as you just articulated for propel III and how far respectively. So we're happy that we were able to.
Speaker Change: Initiate both of the studies on time as I noted middle of the first half of this year for <unk> three in the middle of the second half of this year for about four or so.
Speaker Change: You know there is tremendous excitement across the Pi and the site staffs that we've been able now to bring together for palisade three and palisade for you can imagine on the other side of the palisade to success.
Shawn Singh: We've got 16 sites now that are activated for Palisade 3 and a dozen for Palisade 4. You know, the color I can give you is, again, we, this is a very important indication.
Speaker Change: We've got 16 sites now activated for palisade, three and another and a dozen for palisade for so.
Speaker Change: Yes.
Speaker Change: You know the the color I can give you is again, we this is a very important indication it's very clear throughout the research community and a lot of these sites of course have of psychiatrists.
Shawn Singh: It's very clear throughout the research community, and a lot of these sites, of course, have psychiatrists that have been treating patients for a very long time, and they just haven't seen anything new in a very long time, let alone something for the acute treatment of social anxiety disorder, which is so important with this disorder, is enabling people to engage and not have fear of engaging in the things that stress them in their life, that create anxiety and opportunity costs in their life, because they're self-isolating or withholding from engaging. So, it's a really exciting time across all both studies.
Speaker Change: That have been treating patients for a very long time and they just haven't seen anything new.
Speaker Change: Long time, let alone something for the acute treatment of social anxiety disorder, which is so important with this disorder is enabling people to.
Speaker Change: To engage.
Speaker Change: And not have fear of engaging in the things that stress them in their life that creating xiety an opportunity cost in their lives.
Speaker Change: Because they are self isolating or withholding from engaging so.
Speaker Change: It's it's a really exciting time across all both studies, there's no overlap in the sites from in either of the two studies of course we've.
Shawn Singh: There's no overlap in the sites from, in either of the two studies. Of course, we've got sites from Palisade I and Palisade II that we've been very happy with from the past. So, I'd say overall, you know, we are really excited to work with our CRO, with the sites, with our internal team. We've really enhanced surveillance with our own owned assets, as well as augmenting that with what we've got as resources from the CRO. So, there's a lot of intense training. There's very close surveillance and adherence to the protocols, which is very important, obviously, to control variability.
Speaker Change: <unk> got sites from palisade, one in palisade too that we have.
Speaker Change: Very happy with from the past so.
Speaker Change: I'd say overall, we are really excited to work with our CRO with the sites with our internal team, we've really enhanced surveillance.
Speaker Change: With our own owned assets as well as augmenting that with what we've got is resources from the CRO. So theres a lot of intense training theres very close surveillance and adherence to the protocols.
Speaker Change: Which is a very important obviously to control variability. So I think overall, where we're happy with how things are going.
Shawn Singh: So, I think overall, we're happy with how things are going.
Joshua Prince: Josh Prince on the edge of the color Josh, you want to add anything to that? Yeah, I would just, I'd love to add a little bit of color to the PI excitement that you mentioned. You know, we've now had in-person investigator meetings for both Palisade 3 and Palisade 4. And what really comes out there is we have the opportunity to speak with PIs that are there and really express their excitement and enthusiasm to participate in a study like this that's really unlike any other study that they've done before or kind of have come across their plates now.
Speaker Change: Josh you want to add the color John.
Josh you want to add anything to that.
Josh: Yes, I would just I'd love to add a little bit of color to the excitement that you mentioned.
Speaker Change: We've now had in person investigator meetings for both Palisades III and palisade for.
Speaker Change: And what really comes out there is we have the opportunity to speak with Pis that are there and really expressed their excitement and enthusiasm to participate in a study like this.
Speaker Change: Unlike any other study that they have done before or kind of have come across there.
Joshua Prince: So, just want to add that color that we really do see that excitement, enthusiasm, engagement from the PIs and the desire to do these studies. It's a good point. And that just came out.
Speaker Change: Their play it's now so just wanted to add that color that we really do see that excitement enthusiasm.
Speaker Change: <unk> from the Pis and <unk>.
Speaker Change: The desire to do the studies.
Speaker Change: It's a good point that just came out we had a recent town hall with the sites is something that we do from time to time, where it's sort of like a fireside chat with me and with the rest of the team. So keeping the momentum is always key when you're trying to execute efficiently a program, especially with parallel studies in motion and it always.
Shawn Singh: We had a recent town hall with the sites is something that we do from time to time, or sort of like a fireside chat with me and with the rest of the team. So keeping the momentum is always key when you're trying to execute efficiently a program, especially with parallel studies in motion. And, and it always helps when what you're working on is at the leading edge of trying to treat people who've been dealing with this disorder for decades. But thanks for the question, Julian, appreciate it.
Speaker Change: Helps when what you're working on is at the leading edge of trying to treat people who have been dealing with this disorder for decades.
Speaker Change: But thanks for the question Julian appreciate it.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Okay.
Andrew Tai: Next in line will be coming from Andrew Tai from Jeffery. Hey, good afternoon. Thanks for the updates. Appreciate you taking my questions. Maybe a tangential question from before that I was just asked, but for these phase three studies, both of them that are underway, what are you seeing on the front lines that gives you the confidence? It's definitely different this time for fazedinyl. Maybe talk about how sites are operating, the rigor of these study protocols, whether public speaking challenges being done correctly and so forth. Thanks.
Speaker Change: Next in line will be coming from Andrew.
Speaker Change: Im Jeffrey.
Speaker Change: Hey, good afternoon. Thanks for the updates I appreciate you taking my questions maybe.
Speaker Change: Maybe a tangential question from before that was just asked that.
Speaker Change: For the Phase III studies are both of them that are underway. What are you seeing on the front lines that gives you the confidence it's definitely.
Speaker Change: Different at this time for Fabs Dino maybe talk about how the sites are operating the rigor of these study protocols whether public speaking.
Speaker Change: Challenge is being done correctly and so forth.
Shawn Singh: Thanks, Andrew. Appreciate the question. You know, one thing, of course, is significantly different now than where we were even during during Palisade two, let alone earlier in that during the pandemic. It's just the.
Speaker Change: Thanks, Andrew I. Appreciate the question one thing of course is significantly different now than where we were even there in palisade to let alone earlier than that during the pandemic.
It's just the.
Shawn Singh: The ability to have person-to-person contact, to have in-person training, like Josh mentioned, in-person investigators' meetings mean a tremendous amount. To be able to regularly and predictably have site visits and also have subjects schedule each phase and each visit during their... with their challenge sequence, it is all different. It is just fundamentally different. The attrition rates that we typically saw before at sites with site staff, we're just not seeing. Same thing with CROs. You're not seeing the kinds of things that would have been. frustrating variability coming into, you know, to a protocol that the recipe is pretty clear and when it's followed, it helps tremendously.
Speaker Change: The ability to have person to person contact to have in person training like Josh mentioned.
Speaker Change: In person investigators meetings mean, a tremendous amount to be able to regularly and predictably have site visits and also have subjects schedule each phase and each visit during their.
Speaker Change: Their challenge sequence.
Speaker Change: It is all different it is just fundamentally different the attrition rates that we typically saw before.
Speaker Change: Sites with site staff, we're just not seeing same thing with Crows youre not seeing the kinds of things that would have been.
Speaker Change: Frustrating variability coming into.
Speaker Change: Two a protocol that the recipe is pretty clear and when it's followed it helps tremendously so that plus things that huge.
Shawn Singh: So that plus things that we've talked about before, right? No masks involved, no COVID related. potential with the subjects in the study. So there's just fundamental things that are different on a macro basis and then site-by-site on a micro basis.
Speaker Change: We've talked about before I know masks involved no COVID-19 related.
Speaker Change: Potential with with the subjects in the study so there is.
Speaker Change: Just fundamental things that are different on a macro basis, and then site by site on a micro basis and just having the ability for the protocol to not be novel. This is something of course now thats on the third and the fourth labs within the research community. So.
Shawn Singh: And just having the ability for the protocol to not be novel. This is something, of course, now that's on the third and the fourth laps within the research community. So the study design isn't new. The endpoint isn't new. So all the things that really help. I think with the pace of play and with the ability really to surveil and to hopefully make sure that we've got rigorous adherence to the protocol across all the sites.
Speaker Change: <unk> design isn't new the endpoint isn't new.
Speaker Change: So all those things that really helped.
Speaker Change: I think with the pace of play and with the ability.
Speaker Change: Really to surveil into hopefully they will make sure that we've got rigorous adherence to the protocol across all the sites.
Joshua Prince: I just want to give Josh a chance to add to it. Josh oversees the program primarily so I want to give you a chance, Josh, anything I missed? Sure, we could add to what you said, and it kind of builds on the in-person piece. In addition to the in-person investigator meetings, we've had an in-person site initiation visit for every site.
Speaker Change: And John that said.
Okay go ahead, sorry, no I just wanted to give Josh a sense to add to a judge oversees the program primarily so want to give you a chance Josh anything I missed.
Speaker Change: Sure we could add to what you said and it kind of builds on the in person piece.
Speaker Change: In addition.
Speaker Change: So the in person investigator meetings, we've had and in person.
Speaker Change: Site initiation visit for every site right. So that's kind of the double double reinforcement of training an investigator meeting and then.
Joshua Prince: So it's kind of the double reinforcement of training an investigator meeting and then a good three to four hours with the study staff in their site location, again, hitting all the key details and pieces and components of what it takes to properly execute a public speaking challenge. And then through the monitoring that Shawn mentioned, there have been specific examples where we've identified something that wasn't being done quite right, and the next day there's an intervention or a discussion or a retraining or a reminder. So those are the kinds of things that could not happen in our prior Palisade studies and are happening now, which gives us, again, that confidence that we're getting the right patients and that we're reducing variability as much as possible across sites for the public speaking challenge.
Speaker Change: Good three to four hours with the study staff in their site location again, hitting all the key key details in pieces and components of what it takes to properly executed public speaking challenge and then through the monitoring that Shawn mentioned there.
Speaker Change: There have been specific examples where we've identified.
Speaker Change: <unk> something that wasn't being done quite right and the next day, there's an intervention or a discussion or a retraining or a reminder, so those are the kinds of things that could not happen in our prior palisade studies and are happening now, which gives us again that confidence that.
Speaker Change: We're getting the right patients and that we're reducing variability as much as possible across sites for the public speaking challenge.
Speaker Change: Yeah.
Andrew Tai: Makes sense. And, um...
Speaker Change: Makes sense.
Shawn Singh: You know, in the unfortunate circumstance, should Palisade 3 not hit Stat City, would you still plan to move forward and complete Palisade 4, just given the turn of events that happened last time with Palisade 1 and 2? Yeah, 100%. No question about it, Andrew. The whole program continues. That's what's the benefit having a fully funded program.
Speaker Change: And the unfortunate circumstance should palisade III not pit stature do you still would you still plan to move forward and complete palisade for just given the turn of events that happened last time with palisade wanted too.
Speaker Change: Yes, 100% no question about it Andrew.
Speaker Change: Whole program.
Speaker Change: Continues that's what's the benefit of having a fully funded program. So.
Shawn Singh: So we're in a spot now where, in the very short order here, we will have initiated everything in 24 that we think we need to read out in 25, and that, if positive, would support our NDA in the early part of 26 for facadienols. So, yes, absolutely, 100%, regardless, both studies will be. will be run to completion.
Speaker Change: Now we're in a spot now where in the very short order here, we will have initiated everything in 24 that we think we need to read out in 'twenty five and that if positive would support our NDA in the early part of 'twenty six for fast at Idaho, So, yes, absolutely, 100% regardless both.
Speaker Change: <unk> will be well.
Speaker Change: We'll be a run to completion.
Andrew Tai: Thank you again.
Speaker Change: Thank you again.
Speaker Change: You bet.
Myles Minter: Our next question will be coming from Myles Minter from William Blair. Hi everyone, thanks for taking the questions. I've got three if I may, so bear with me. The first one is just on, I think... thought about whether relying on the fact.
Speaker Change: Our next question will be coming from Myles Minter from William Blair.
Speaker Change: Yes.
Speaker Change: Hi, everyone and thanks for taking the questions I've got three if I may so bear with me.
Speaker Change: First one is just on <unk>.
Speaker Change: I think previously you guided.
Speaker Change: Got it towards submitting the phase Iia protocol an M. D day by year end. It was still on track for that or is that slightly.
Speaker Change: It might be looking into next year.
Speaker Change: One is in that particular MSA days study have you thought about whether like a maybe a caregiver or a physician would be administering the drug that's a self administration as I know that that is a consideration, but find health until four or are you just relying on the fact that multiple doses in that trough probably.
Speaker Change: Net that expires it out.
Myles Minter: And finally, I'm wondering in the healthy subject data that you just presented at NEI on the depolarization of the electrograms there, did you actually... I appreciate the questions, Myles.
Speaker Change: And then finally I'm wondering in the healthy subject data that you just presented it at AI.
On the day polarization of the electric grants that did you actually do dosing.
Speaker Change: Self administering or a combination of self administering versus physician administered to show that there was actually differences in those electric grams in the exposure of the drug.
Speaker Change: I know, there's a lot there, but would appreciate any thoughts thanks sure.
Speaker Change: The question Smiles, so as the first one and we're working very closely with our Kols and our internal team for that the phase <unk> protocol.
Shawn Singh: So, as to the first one, we're working very closely with our KOLs and our internal team for the Phase IIb protocol. It still is the intention, and we're well down the road with it. We've got some pretty key thoughts already under our belts as to how we want to see that study proceed. A lot of it's simply based on what we saw in the Phase IIa study and what we think are the unique attributes of iTruvone in MDD. especially as it relates to folks with anxious depression. So I think that is a target we likely will hit.
Speaker Change: It still is the intention.
Speaker Change: Well down the road with it we've got some pretty key thoughts already under our belt as to how we want to see that study proceed a lot of it simply based on what we saw in <unk>.
Speaker Change: The phase Iia study and what we think are the unique attribute of our true own an empty D. M D D.
Speaker Change: Especially as it relates to the folks with anxious depression. So I think that is a target we likely will hit if not it'll just creep maybe a little bit into January but I think right now we've had a very substantial.
Shawn Singh: If not, it'll just creep maybe a little bit into January, but I think right now we've had a very substantial bit of discussions across all the folks that we want to provide some input. And that protocol is well down the road.
Speaker Change: Bit of discussions across all of the folks who we want to provide some input and.
And that protocol is well down the road. So in terms of self administration. During the study we don't see that this.
Shawn Singh: So in terms of self-administration, during the study, we don't see that. This is different. This is likely to be a six-week study with twice-daily administration, so on an outpatient basis by the folks, so they'll be self-administering it on an outpatient basis.
Speaker Change: This is different the this is likely to be a six week study with.
Speaker Change: With twice Daily administration, so on an outpatient basis by the the.
Speaker Change: Folks so there'll be self administering it on an outpatient basis.
Joshua Prince: And then as to the last question, Josh, I'll let you jump on that one.
Speaker Change: And then.
Speaker Change: As to the last question Joshua lets you jump on that one.
Joshua Prince: Sure, yeah, the studies that we do in the lab with Dr. Monti, kind of the inventor of pharynx, they're... They're based on physician administration, and they really have to be because of the equipment that people are hooked up to. And so, you know, sensors on the frontal lobe or receptors kind of in the nasal cavity, those things require a lot of precision to do the measurements and to reduce noise in those capture of data. And so it's for that reason, it has to be physician-induced. Those studies are conducted here in our headquarters in South San Francisco, and so the subjects are laying down, and the electrodes are placed inside and up by the bridge of their nose, right where the olfactory bulbs are.
Joshua: Sure, Yes, the studies that we do in the lab.
Joshua: With Doctor Monte Canada, the inventor of variance there.
Joshua: They're based on physician administration and they are they really have to be because of the equipment that people are hooked up to them.
Joshua: And so sensors on the frontal lobe or.
Joshua: Receptors kind of in the nasal cavity.
Joshua: Those are those things require a lot of precision to do the measurements and to reduce noise.
Joshua: And those and the capture of data.
Joshua: And so for that reason has to be a physician administered.
Joshua: Those studies are conducted here in our headquarters in South San Francisco and our.
Joshua: And so the subjects are laying down and electrodes are placed inside and on up by the bridge there knows right, where the olfactory bulbs are so they as Josh noted the very sensitive and you have to.
Joshua Prince: So, as Josh noted, they're very sensitive, and you have to... It's the best way to do it is just to have the IP administered by Dr. Monti and the team.
Joshua: That's the best way to do it is just too.
Joshua: Have the IP administered by Dr. Marty and the team.
Myles Minter: Thanks a ton of sense.
Speaker Change: Thanks, a ton of sense. Thanks for the questions Congrats on the progress.
Myles Minter: Thanks for the questions.
Myles Minter: Congrats on the progress.
Operator: Thanks. Again, if you have any questions, please press star 1. and your hand will be raised.
Joshua: Thanks.
Joshua: Okay.
Joshua: Okay.
Joshua: Okay.
Speaker Change: And then if you have any questions. Please press star one.
Speaker Change: And your hand, we'll be rates.
Madison El-Sadi: Our last question for today will be coming from Madison El-Sadi from Be Riley. Hey guys, congrats on all the progress and I appreciate you taking my call. I guess, could you remind us... what's gating to the hot flash study as well as a bit of a follow-up to the prior question. What's really gating to that phase 2b? And then secondly, I know it's in the PR, you mentioned an increase in head count. So I was just wondering if this was just kind of related to general activities, you know, across the enterprise or that was more related to one specific program.
Speaker Change: Our last question for today will be coming from Madison, I know Sandy from B Riley Securities.
Speaker Change: Hey, guys. Congrats on all the progress and I appreciate you taking my question.
Speaker Change: I guess could you remind us.
Speaker Change: What's gating to the.
Speaker Change: Hot Flash study as well as a bit of a follow up to the prior question.
Speaker Change: Whats really gating to that place to be.
Speaker Change: And then.
Speaker Change: Secondly.
Speaker Change: There isn't a PR you mentioned an increase in head count. So I was just wondering if this was just kind of related to general activities.
Across the enterprise or if that was more related to one specific program.
Madison El-Sadi: Thanks.
Speaker Change: Thanks.
Shawn Singh: Great, thanks for the questions. We appreciate it.
Great. Thanks for the questions really appreciate it so a couple of things.
Shawn Singh: So, a couple things. So, as to the gating for the PH80 study in vasomotor symptoms or hot flashes due to menopause, what we're doing now is a USIND-enabling program. So, to bring that study, the initial study was done in Mexico, and to bring the program into the United States, we're doing just the typical requisite non-clinical studies, CMC-related studies, tox studies that bridge some of the older work. And then, of course, the CMC, because we had to make an entirely new supply of PH80 for the clinical program. So, that's what's in motion in order to put us into position to then submit an IND that would leap us right back into Phase II development in the US.
Speaker Change: So as to the gating for the ph 80 study investment motor symptoms or hot flashes due to menopause. What we're doing now is a U S. IND, enabling program. So to bring that study. The initial study was done in Mexico and to bring the program into the United States. We're doing just the typical requisite.
Speaker Change: Non clinical studies.
Speaker Change: CMC related studies Tox studies that bridge some of the older work and then.
Speaker Change: And of course, the CMC, because we had to make a an entirely new supply.
Speaker Change: Of PHA D for the clinical program. So that's whats in motion in order to put us in a position to then submit and indeed that would lead us right back into phase II development in the U S. So phase likely face.
Shawn Singh: So, likely Phase II. for the Phase II development, but just in hot flashes. We have positive data in PMDD, but hot flashes is the main direction, given what we see as the tremendous opportunity there for really nothing that we see that is non-systemic and what's hormone-free. The NK3 antagonists do have some limitations.
Speaker Change: Further phase II development in but just in hot flashes, we have positive data in PMD, but hot flashes as the main direction, given what we see as a tremendous opportunity there for really.
Speaker Change: Nothing that we see that as non systemic and whats hormone free the NK three antagonist to have some limitations so.
Shawn Singh: So that CMC work, non-clinical work, puts the regulatory package in place, and that should be sometime in the second quarter, I think is our target for that at this point.
Speaker Change: CMC work non clinical work puts the regulatory package in place and that should be sometime in the second quarter. I think is our target for that at this point.
Shawn Singh: And then as to the MDD study, again, finalizing the protocol is really what's left there. We have an IED that's already open. We've got phase one support for the supply that we built, that we produced. And again, with these, when we acquired these, we had to really go back to the beginning and do the CMC work necessary to enable the clinical work and the regulatory packages. So all those boxes have been checked.
Speaker Change: And then as to the the MTV study again finalizing the protocol is really what's left there and then.
Speaker Change: We have an idea that's already open we've got phase one support for the supply that we built.
Speaker Change: That we produced and again with these when we acquired these we had to really go back to the beginning and do the CMC work necessary to enable the clinical work and the regulatory packages. So all of those boxes have been checked and.
Shawn Singh: And... So I think we're on the final lap of the preparations up front of the MDDC.
Speaker Change: So I think we're on the final lap of the preparations upfront of the MPD study.
Shawn Singh: And then headcount-wise, you know, we're about 50 right now. And as you can imagine... as we have expanded clinical work, and we've got a little bit of additional GNA support that's needed, but most of it's R&D-related. A lot of it relates to owning, especially the surveillance and the training that's associated with the PEPFAR-3 program, trying to decouple some of that reliance that was a little bit more variable than we wanted to see during the pandemic. So that allows us to really have our own competence and own consistent surveillance, especially for the Palisade Phase III program, and of course, other things related to some of the pre-commercial activities on the CMC side especially.
Speaker Change: And then head count Wise, we're about 50, right now and as you can imagine.
Speaker Change: As we have expanded clinical work and we've got a little bit of additional G&A support that's needed, but most of its R&D related a lot of it relates to owning especially the surveillance and the training that's associated with three program trying to decouple some of that reliance that was.
Speaker Change: <unk>.
Speaker Change: A little bit more variable than we wanted to see during the pandemic. So that allows us to really have confidence in one consistent surveillance, especially for the palisade phase III program and of course other things related to some of the pre commercial activities on the CMC side, especially so.
Madison El-Sadi: So a little bit in headcount on the GNA side on finance, but for the most part, it's an R&D increase that's enabling us to do quite a bit more across each of the lead development programs that we've got. Got it. Very helpful. Thanks, guys.
Speaker Change: A little bit in head count on the G&A side on finance, but for the most part it's an R&D increase that's enabling us to do quite a bit more across each of the lead.
Speaker Change: Development programs that we've got.
Speaker Change: Yeah.
Speaker Change: Got it very helpful. Thanks, guys.
Speaker Change: Okay.
Operator: Operator, I believe that's all the time we have for questions today.
Speaker Change: Operator, I believe that's all the time we have.
Speaker Change: Our question today, Thank you everyone.
Operator: Thank you, everyone. at this time. If you have any additional questions, please do not hesitate to contact us via 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.
Speaker Change: At this time.
Speaker Change: If you have any additional questions. Please do not hesitate to contact us via E mail at IR, Mr Jan or via the contact section of our website.
Speaker Change: We also encourage you to register for E Mail updates on the website to stay connected to the latest news.
Operator: Again, thank you for participating on the call today. We appreciate everyone's interest and support. We look forward to keeping everyone updated on our ongoing progress.
Speaker Change: Again, thank you for participating on the call today, we appreciate everyone's interest and support we look forward to keeping everyone updated on our ongoing progress. This concludes our call have a great day.
Operator: This concludes our call. Have a great day. This concludes our conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a great one, everyone.
Speaker Change: This concludes our conference call for today, we thank you for participating and ask that you. Please disconnect your lines have a great win nevermind.