Q3 2025 VistaGen Therapeutics Inc Earnings Call and Corporate Update
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I will now hand, the conference over to your speaker host Markman.
Mark McPartland: Mark Mcpartland. Please go ahead.
Yeah.
Mark McPartland: Thank you operator, good afternoon, everyone and welcome to Vista, Jim fiscal year, 2025, third quarter corporate update conference call and webcast.
Mark McPartland: Earlier. This afternoon, we issued a press release for the third quarter of our fiscal year 2025 ended December 31, 2024 provided an overview of our progress across our lead clinical neuroscience programs.
Mark McPartland: Encourage you to review the release, which can be found in the investors section of our website.
Mark McPartland: Based on the current expectations information, we will make forward looking statements regarding our business. During today's call 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 in <unk> in future.
Mark McPartland: Of course forward looking statements include risks and uncertainties and our actual results could differ materially from those anticipated by any forward looking statements that we make today.
Mark McPartland: Additional information concerning risks and factors that could affect our business and financial results will be included in our.
Mark McPartland: Fiscal year 2025 third quarter Form 10-Q for the period ending December 31 2020.
Mark McPartland: And in future filings, we will make with the SEC from time to time all of which.
Mark McPartland: Or will be available in investors section of our website and on the Sec's website.
Mark McPartland: Now with the formalities complete.
Mark McPartland: We warmly welcome our stockholders sell side analysts and others interested in our programs in progress Im.
Mark McPartland: Im joined on our call today by Shaun <unk>, Our President Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, Josh <unk>, our Chief operating officer.
Mark McPartland: Sean will discuss recent highlights in our lead neuroscience programs and Cindy will discuss our <unk>.
Mark McPartland: Fiscal third quarter financial results.
Mark McPartland: After our prepared remarks as the operator has already noted there will be a brief opportunity for questions from the sell side analysts participating on the call today.
Mark McPartland: As a reminder, this call is being webcast and will be available for replay. After completion a replay link can also be found on our websites investors section under events.
Mark McPartland: I will now turn the call over to our President and Chief Executive Officer, Sean Sean.
Speaker Change: Thank you Mark and good afternoon, everyone. Thank you for joining our call.
Speaker Change: Had a very productive quarter as many of you know we are developing a new class of intranasal product candidates that are called fairings.
Speaker Change: And these are designed to harness the power and the potential of nose to brain neuro circuitry too.
Speaker Change: To achieve a broad and diverse range of therapeutic benefits without requiring systemic absorption or binding to neurons in the brain. So.
Speaker Change: So let me start by discussing our most advanced <unk> first the die and all and our ongoing registration directed.
Operator: And good afternoon, everyone. Thank you for joining our call. We had a very productive quarter.
Speaker Change: Palisade Phase III program.
Thank you Mark and good afternoon, everyone. Thank you for joining our call.
Speaker Change: For that asset for the acute treatment of social anxiety disorder or <unk>.
Shawn Singh: As many of you know, we are developing a new class of intranasal product candidates that are called FAERI. And these are designed to harness the power and the potential of nose-to-brain neurocircuitry to achieve a broad and diverse range of therapeutic benefits without requiring systemic absorption or binding to neurons in the brain. So let me start by discussing our most advanced farine, facadienol, and our ongoing registration-directed. Palisade Phase III Program for the Acute Treatment of Social Anxiety Disorder or SAD. Currently, as I've mentioned before, there is no FDA approved medication for the treatment for the acute treatment of SAD, which is a very serious and a potentially life threatening condition that's recognized by the FDA.
Speaker Change: We had a very productive quarter as many of you know we are developing a new class of intranasal product candidates that are called fairings.
Speaker Change: Currently as I've mentioned before there is no FDA approved medication for the treatment for the acute treatment of SCD, which.
Speaker Change: These are designed to harness the power and the potential of nose to brain neuro circuitry.
Speaker Change: Which is a very serious and potentially life threatening condition that is recognized by the FDA and one that post COVID-19 is estimated to affect over 30 million adults in the U S who struggle.
Speaker Change: To achieve a broad and diverse range of therapeutic benefits without requiring systemic absorption or binding to neurons in the brain.
Speaker Change: So let me start by discussing our most advanced ferrying faster Dino and our ongoing registration directed.
Speaker Change: With intense and debilitating anxiety and fear of embarrassment.
Speaker Change: <unk> judgment.
Speaker Change: <unk> phase three program.
Speaker Change: When they're dealing with stressful social and performance situations.
Speaker Change: For that asset for the acute treatment of social anxiety disorder or S. A D.
Speaker Change: And with SASSA die in all our goal is to address this critical and very long neglected treatment gap by providing a novel convenient safe and rapid onset as needed solution to help individuals who are affected by SCD face the challenges in their everyday lives.
Speaker Change: Currently as I've mentioned before there is no FDA approved medication for the treatment for the acute treatment of S. E D.
Speaker Change: This is a very serious and potentially life threatening condition. That's recognized by the F. D. A and one that post COVID-19 is estimated to affect over 30 million adults in the U S, who struggle with intense and debilitating anxiety and fear of embarrassment.
Shawn Singh: And one that post COVID is estimated to affect over 30 million adults in the US who struggle with intense and debilitating anxiety and fear of embarrassment. Humiliation, judgment, when they're dealing with stressful social and performance situations.
Speaker Change: In 2023, we reported positive results from our palisade, two phase III trials faster die and all for the acute treatment of SPD.
Speaker Change: Humiliation judgment.
Speaker Change: In 2024 to build on the success of policy too and our registration directed phase III program for <unk> in all we initiated policy three.
Speaker Change: When they are dealing with stressful social and performance situations and when.
Shawn Singh: With Fasadienol, our goal is to address this critical and very long-neglected treatment gap by providing a novel, convenient, safe, and rapid-onset, as-needed solution to help individuals who are affected by SAD face the challenges in their everyday lives. In 2023, we reported positive results from our Palisade II Phase III trial facadienol for the acute treatment of SAD. in 2024 to build on the success of Palisade II in our registration-directed Phase III program for facet iodine. We initiated Palisade III and Palisade IV as Phase III trials, each designed as a replicate public speaking challenge with the same primary endpoint and, in each case, an open-label extension.
Speaker Change: Acesodyne all our goal is to address this critical and very long neglected treatment gap.
<unk> palisade for as phase III trials, each designed as a replicate public speaking challenge with the same primary endpoint and in each case in open label extension.
Speaker Change: By providing a novel convenient safe and rapid onset as needed solution to help individuals who are affected by S. A D face the challenges in their everyday lives.
Speaker Change: And today I am pleased to report that both policy III in palisade four are currently continuing to advance towards expected top line results later this year.
Speaker Change: In 2023, we reported positive results from our policy to phase III trials faster Dino for the acute treatment of S. J D.
Speaker Change: In addition, we recently announced the initiation and enrollment of the first subjects in an exploratory phase II repeat those study a facet iron all in SCD.
Speaker Change: In 2024 to build on the success of palisade too in a registration directed phase III program for faster die and all we initiated palisade three and palisade for as phase III trials, each designed as a replicate public speaking challenge with the same primary endpoint.
Speaker Change: And besides the addition of a repeat dose arm. It is similar in design to our phase III palisade three in palisade for studies for the acute treatment of adults with ICD again, including in open label.
Speaker Change: And in each case in open label extension.
Speaker Change: Extension.
Shawn Singh: And today I'm pleased to report that both Palisade 3 and Palisade 4 are currently continuing to advance towards expected top-line results later this year. In addition, we recently announced initiation and enrollment of the first subjects in an exploratory Phase II repeat-dose study of facet ionol and SAD. And besides the addition of a repeat-dose arm, it is similar in design to our Phase III and Palisade IV studies for the acute treatment of adults with SAD, again, including in open-label. extension. With these studies advancing, we believe either Palisade 3 or Palisade 4, if successful, together with Palisade 2, may establish substantial evidence of the effectiveness of facetidinol in support of a potential new drug application submission to the U.S.
Speaker Change: With these studies advancing we believe either Palisades III or palisade for a successful together with palisade to may establish substantial evidence of the effectiveness of fast the die and all in support of a potential new drug application submission to the U S. FDA for the acute treatment of SCD in adult.
Speaker Change: And today I am pleased to report that both palisade III in palisade four are currently continuing to advance towards expected top line results later this year.
Speaker Change: In addition, we recently announced the initiation and enrollment of the first subjects in an exploratory phase II repeat dose study of <unk> S. A D and.
<unk>.
Speaker Change: Besides the addition of a repeat dose arm. It is similar in design to our phase III palisade three in palisade for studies for the acute treatment of adults with ICD again, including in open label.
Speaker Change: In addition to advancing our fastest on all phase III program and we made progress in our development programs for <unk> as a standalone treatment for major depressive disorder, and <unk> is a non hormonal non systemic treatment of vasomotor symptoms or hot flashes.
Speaker Change: Extension.
Speaker Change: With these studies advancing we believe either palisade three or palisade for a successful together with palisade to may establish substantial evidence of the effectiveness of faster Dino in support of a potential new drug application submission to the U S. FDA for the acute treatment of S. A D in adults.
Speaker Change: That are due to menopause Curran.
Speaker Change: Currently we are preparing and planning for potential phase III <unk> clinical development of <unk> in the U S. And we are conducting customary non clinical studies that we need to support our planned submission of an investigational new drug application or IND.
Shawn Singh: FDA for the acute treatment of SAD in adults.
Shawn Singh: In addition to advancing our facadienol phase III program in SAD, we made progress in our development programs for itruvone as a standalone treatment for major depressive disorder, and PH80 as a non-hormonal, non-systemic treatment of vasomotor symptoms or hot flashes that are due to menopause. Currently, we are preparing and planning for potential phase 2b clinical development of itruvone in the U.S. And we are conducting customary non-clinical studies that we need to support our planned submission of an investigational new drug application, or IND, to the U.S. FDA to facilitate further phase 2 clinical development of PHAD for menopausal hot flashes.
Speaker Change: <unk>.
Speaker Change: In addition to advancing our fastest Idaho phase III program NSA D. We made progress in our development programs for <unk> as a standalone treatment for major depressive disorder, and ph 80, as a non hormonal non systemic treatment of vasomotor symptoms or hot flashes.
Speaker Change: To the U S FDA to facilitate further phase II clinical development of PHA D for menopausal Hot flashes.
Speaker Change: I'm now going to turn to some other corporate highlights. We recently reported positive results from an exploratory phase Iia trial of ph $2 84 in a cancer cachexia.
Speaker Change: That are due to menopause.
Speaker Change: Currently we are preparing and planning for potential phase III clinical development of <unk> in the U S. And we are conducting customary non clinical studies that we need to support our planned submission of an investigational new drug application or IND to.
Speaker Change: Page 284 is our fifth clinical stage neurosurgery focused intranasal ferring product candidate with a positive efficacy single signal and differentiated safety and all the studies that have been completed to date.
Speaker Change: To the U S FDA to facilitate further phase II clinical development a P. J D for menopausal Hot flashes.
Speaker Change: And this recent announcement.
Speaker Change: Underscoring the breadth.
Speaker Change: And the diversity of our clinical stage pipeline with five innovative non systemic investigational intranasal Varian product candidates all supported by positive phase II and in the case of faster design, all one phase III positive clinical study.
Shawn Singh: I'm now going to turn to some other corporate highlights. We recently reported positive results from an exploratory Phase IIa trial of PH284 in cancer cachexia. pH 284 is our fifth clinical stage neurocircuitry-focused intranasal faring product candidate with a positive efficacy signal and differentiated safety. in all the studies that have been completed to date. And this recent announcement underscores the breadth and the diversity of our clinical stage ferry and pipeline. with five innovated, non-systemic, investigational, intranasal faring product candidates, all supported by positive phase II, and in the case of fastadienol, one phase III positive clinical study.
Speaker Change: I'm now going to turn to some other corporate highlights. We recently reported positive results from an exploratory phase Iia trial of ph $2 84 in a cancer cachexia.
P. H 284 is our fifth clinical stage neurosurgery focused intranasal ferring product candidate with a positive efficacy single signal and differentiated safety and all the studies that have been completed to date.
Speaker Change: The clinical data and the placebo like Tolerability that we've seen across all of these studies.
Speaker Change: It gives us tremendous confidence in the range.
Speaker Change: And the diversity and the therapeutic potential of our neuroscience pipeline.
Speaker Change: And this recent announcement.
Speaker Change: Underscores the breadth.
Speaker Change: The positive studies from our five <unk> with clinical data across various indications drive our optimism and our confidence in the power and the promise of nose to brain or a circuitry and the enormous potential of our intranasal ferring pipeline.
Speaker Change: And the diversity of our clinical stage pipeline with five innovative non systemic investigational intranasal Varian product candidates all supported by positive phase II and in the case of faster die at all one phase III positive clinical study the clinical data.
Speaker Change: As always we are optimistic about the potential of our product candidates to address multiple significant treatment gaps and to transform standards of care to improve lives.
Shawn Singh: The clinical data and the placebo-like tolerability that we've seen across all these studies gives us tremendous confidence in the range and the diversity and the therapeutic potential of our neuroscience pipeline. Positive studies from our five fairings with clinical data across various indications drive our optimism and our confidence in the power and the promise of nose-to-brain neurocircuitry and the enormous potential of our intranasal fairing pipeline. As always, we are optimistic about the potential of our product candidates to address multiple significant treatment gaps and to transform standards of care to improve lives.
Speaker Change: Peter and the placebo like Tolerability that we've seen across all of these studies.
Speaker Change: Gives us tremendous confidence in the range.
Mark McPartland: I'll now hand, it over to Cindy Anderson, our CFO to summarize our financials from the last quarter Cindy.
Speaker Change: And the diversity and the therapeutic potential of our neuroscience pipeline.
Cindy Anderson: Thank you Sean as Sean mentioned I will highlight a few financial results from our fiscal year 2025 third quarter.
Speaker Change: The positive studies from our five fairings with clinical data across various indications drive our optimism and our confidence in the power and the promise of nose to brain or a circuitry and the enormous potential of our intranasal ferring pipeline.
Cindy Anderson: Research and development expenses were $11 3 million.
Cindy Anderson: Warner ended December 31, 2024, compared to $4 5 million for the same period last year.
Cindy Anderson: The increase in R&D expenses is primarily due to an increase in research development and contract manufacturing expenses related to our palisade phase III program for passenger at all Sandy as well as IND, enabling programs for <unk>, NTT and ph 18th to treatment in menopausal Hot flashes.
Speaker Change: As always we are optimistic about the potential of our product candidates to address multiple significant treatment gaps and to transform standards of care to improve lives.
Cindy Anderson: I'll now hand it over to Cindy Anderson, our CFO, to summarize our financials from the last quarter. Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025 third quarter. Research and development expenses were $11.3 million for the quarter ended December 31, 2024, compared to $4.5 million for the same period last year. The increase in R&D expenses is primarily due to an increase in research, development, and contract manufacturing expenses related to our Palisades Phase III program for fascinia dull and SAD, as well as IND-enabling programs for i-Truvone and MDD and PHAD for the treatment of menopausal hot flashes.
Speaker Change: I'll now hand, it over to Cindy Anderson, our CFO to summarize our financials from the last quarter Cindy.
Cindy Anderson: General and administrative expenses were $4 million.
Cindy Anderson: Thank you Sean as Sean mentioned I will highlight a few financial results from our fiscal year 2025 third quarter.
Cindy Anderson: The quarter ended December 31st 2024, compared to $33 8 million for the same period last year.
Cindy Anderson: Research and development expenses were $11 3 million.
Cindy Anderson: Increase in G&A expenses was primarily due to increased head count our net loss attributable to common stockholders was $14 1 million for the quarter ended December 31, 2024, compared to $6 4 million the same period last year.
Cindy Anderson: And at December 31, 2024, compared to $4 5 million for the same period last year to.
Cindy Anderson: The increase in R&D expenses is primarily due to an increase in research development and contract manufacturing expenses related to our palisade phase III program for <unk>, and Sandy as well as R&D, enabling programs for <unk> NTT and ph 80, the treatment in menopausal Hot flashes.
Cindy Anderson: As of December 31, 2024, we had $88 6 million in cash cash equivalents in marketable securities.
Sean Sean: I will now hand, the call back over to Sean.
Cindy Anderson: General and administrative expenses were $4.0 million for the quarter ended December 31, 2024, compared to $33.8 million for the same period last year. The increase in G&A expenses was primarily due to increased headcount. Our net loss to Trivial and Common Stockholders was $14.1 million for the quarter ended December 31, 2024, compared to $6.4 million for the same period last year.
Sean Sean: Thanks, Andy.
Cindy Anderson: General and administrative expenses were $4 million.
Sean Sean: So we are more optimistic than ever here at Vista Gin with five clinical stage Varian product candidates, each with positive patient data and differentiated safety.
Cindy Anderson: For the quarter ended December 31st 2024, compared to $33 8 million for the same period last year. The increase in G&A expenses was primarily due to increased head count.
Sean Sean: Now multiple opportunities to disrupt treatment paradigms enhanced patient outcomes and create value for our stockholders. So I'd like to thank you all once again for your continued interest and support in what we're doing here at Vista Jin.
Cindy Anderson: Net loss attributable to common stockholders was $14 1 million for the quarter ended December 31, 2024, compared to $6 4 million for the same period last year.
Cindy Anderson: As of December 31, 2024, we had $88.6 million in cash, cash equivalents, and marketable security.
Cindy Anderson: As of December 31, 2024, we had $88 6 million in cash cash equivalents and marketable securities.
Sean Sean: And on behalf of everyone on our team we look forward to keeping you updated on our progress.
Shawn Singh: I will now hand the call back over to Shawn. Thanks, Cindy. So we are more optimistic than ever here at VistaGen with five clinical stage variant product candidates, each with positive patient data and differentiated safety. We have now multiple opportunities to disrupt treatment paradigms, enhance patient outcomes, and create value for our stockholders.
Sean: I will now hand, the call back over to Sean.
Sean: Thanks, Andy.
Sean: So we are more optimistic than ever here at Vista Gin with five clinical stage Varian product candidates, each with positive patient data and differentiated safety.
Speaker Change: Operator, we'd like to now open the call to questions from the sell side analysts who are participating today.
Sean: Have now multiple opportunities to disrupt treatment paradigms enhanced patient outcomes and create value for our stockholders. So I'd like to thank you all once again for your continued interest and support and what we're doing here at Vista Jin.
Speaker Change: Ladies and gentlemen, I'd like to ask a question at this time, you will need to press star one on your telephone and lately name to be announced.
Shawn Singh: So I'd like to thank you all once again for your continued interest and support in what we're doing here at VistaGen. And on behalf of everyone on our team, we look forward to keeping you updated on our progress.
Speaker Change: A question simply press Star one again please.
Speaker Change: Please stand by while we compile the Q&A roster.
Sean: And on behalf of everyone on our team we look forward to keeping you updated on our progress.
Speaker Change: Our first question coming from the line of Andrew Tsai with Jefferies. Your line is now open.
Sean: Yeah.
Hey, Thanks, Congrats on the quarter I. Just this is Matt on for Andrew and I, just wanted to ask real quick.
Operator: Operator, we'd like to now open the call to questions from the cell site analysts who are participating today.
Speaker Change: Operator, we'd like to now open the call to questions from the sell side analysts who are participating today.
Speaker Change: You were confident that the data from palisade, three and four will still be in the second half of this year or are you expecting any delays and.
Operator: Ladies and gentlemen, black task question at this time. You will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1 1 again. Please stand by while we compile the Q&A post.
Speaker Change: Ladies and gentlemen, I'd like to ask a question at this time, you will need to press star one on your telephone and wait to be announced to withdraw your question simply press Star One again please.
Speaker Change: Also.
Speaker Change: And a follow on to that.
Speaker Change: Yeah.
Speaker Change: Hey, Thanks, Matt good to talk to you. So as we've guided we're confident that we'll see data from both <unk> and <unk> four in 2025.
Speaker Change: Please standby, while we compile the Q&A roster.
Andrew Tsai: Our first question, coming from the line up, Andrew Tsai with Jefferies, your line is now open. Hey, thanks. Congrats on the quarter.
Speaker Change: Our first question coming from the line of Andrew Tsai with Jefferies. Your line is now open.
Speaker Change: So no change in that guidance.
Speaker Change: Okay, Perfect and then I guess.
Matt: I just this is Matt on for Andrew, and I just wanted to ask real quick if you're confident that the data from Palisade 3 and 4 will still be in the second half of this year, or are you expecting any delays? And also, I've got to follow on to that.
Speaker Change: Hey, Thanks, Congrats on the quarter I. Just this is Matt on for Andrew and I just wanted to ask real quick. If you are confident that the data from palisade three and four will still be in the second half of this year or are you expecting any delays and.
Is there anything that keeps you up at night in terms of.
Speaker Change: What more can be done on these studies in terms of.
Speaker Change: Execution.
Speaker Change: Interesting question no. It doesn't keep me up at night, because the enhancements and the team that we've got executing on these studies, especially surveillance.
Speaker Change: Also.
Got a follow on to that.
Shawn Singh: Hey, thanks, Matt. Good to talk to you. So as we've guided, we're confident that we'll see data from both PAL-3 and PAL-4 in 2025. So no change in that guidance.
Speaker Change: Associated with rigorous adherence to the protocol. These are all very important execution related initiatives that we've got in place to reduce reliance on on Cerro surveillance expansion of our internal team.
Speaker Change: Hey, Thanks, Matt good to talk to you. So as we've guided we're confident that we'll see data from both <unk> and <unk> four in 2025.
Speaker Change: So no change in that guidance.
Shawn Singh: Okay, perfect. And then I guess, you know, is there anything that keeps you up at night in terms of what more could be done on these studies in terms of, you know, execution? interesting question. No, it doesn't keep me up at night because the enhancements and the team that we've got executing on these studies, especially surveillance. associated with rigorous adherence to the protocol.
Speaker Change: And just the way that we've been seeing the conduct of the studies with rigorous training even upfront of.
Speaker Change: Okay, Perfect and then I guess.
Speaker Change: Is there anything that keeps you up at night in terms of.
Speaker Change: What more can be done on these studies in terms of.
Speaker Change: Any enrollment at any of the sites.
Speaker Change: Execution.
Speaker Change: It's actually been significantly different than what we've seen in the past in a very positive way Josh Princess on the line with me Josh Once you go out and say a few things you are driving.
Speaker Change: Interesting question no. It doesn't keep me up at night, because the enhancements and the team that we've got executing on these studies, especially surveillance.
Speaker Change: A lot of the execution.
Speaker Change: Associated with rigorous adherence to the protocol.
Joshua Prince: These are all very important execution-related initiatives that we've got in place, reduced reliance on CRO surveillance, expansion of our internal team, and just the way that we've been seeing the conduct of the studies with rigorous training, even up front of any enrollment at any of the sites. It has actually been significantly different than what we've seen in the past in a very positive way.
Speaker Change: Sure. Thanks, John It is a very interesting question and actually.
Speaker Change: They are all very important execution related initiatives that we've got in place to reduce reliance on on Cerro surveillance expansion of our internal team.
Speaker Change: Your point, we have more.
Speaker Change: More visibility and.
Speaker Change: Into what's happening with these studies than we did before running palisade wanted to in the pandemic and with the enhancements that we've put in place and.
Speaker Change: And just the way that we've been seeing the conduct of the studies with rigorous training even upfront of.
Speaker Change: And so if anything I would say it's easier to sleep at night now than it was back then without COVID-19 in place with masks down with the REIT.
Speaker Change: Any enrollment at any of the sites.
Speaker Change: It's actually been significantly different than what we've seen in the past and are in a very positive way Josh.
Joshua Prince: Josh Prince is on the line with me. Josh, why don't you go ahead and say a few things? You are driving a lot of the excitement. Sure. Thanks, Shawn. It is a very interesting question. And actually, to your point, you know, we have more. more visibility and into what's happening with these studies than we did before running Palisade 1 and 2 in the pandemic and with the enhancements that we've put in place. And so if anything, I would say it's easier to sleep at night now than it was back then without COVID in place with masks down with the review that we have of subject eligibility, making sure that scales are administered properly, making sure that the rigorous public speaking challenge script is followed to the tee, and then having the ability to do quick interaction and retraining with sites if they start to deviate from that protocol.
Speaker Change: We view that we have of of subject eligibility, making sure that scales are administered properly.
Josh Princess on the line with me Josh Once you go out and say a few things you are driving.
A lot of the execution.
Speaker Change: Making sure that the <unk>.
Speaker Change: Sure. Thanks, John no it isn't.
Speaker Change: Rigorous public speaking challenge script is followed to the T. And then having the ability to do quick quick interaction and retraining with sites if they start to deviate from that protocol. So.
Speaker Change: Very interesting question and actually.
Speaker Change: Your point, we have more.
Speaker Change: More visibility and into what's happening with the studies that we did before running palisade wanted to in the pandemic and with the enhancements that we've put in place and.
Phil feel like were giving these these studies the best chance, we could add success with those changes.
Speaker Change: And so if anything I would say it's easier to sleep at night now than it was back then without COVID-19 in place with masks down with the REIT.
Speaker Change: Fantastic and then also youre starting to see a little bit we're starting to see a little bit more competition in terms of.
Speaker Change: Novel drugs for social anxiety disorder.
Speaker Change: We view that we have of of the subject eligibility, making sure that scales are administered properly.
Speaker Change: Can you talk about how you think about the competition and how fast entitle it doesn't have.
Speaker Change: Making sure that the.
Speaker Change: Rigorous public speaking challenge script is followed.
Speaker Change: Is immune to this competition.
Speaker Change: T and then having the ability to do quick quick interaction and retraining with sites if they start to deviate from that protocol. So Phil feel like were giving these these studies the best chance, we could at success with those changes.
Speaker Change: Thanks for the question, Matt. Unfortunately, we've got a robust market here in the United States in terms of the number of people affected by the disorder over $30 million.
Shawn Singh: So I feel like we're giving these studies the best chance we could at success with those changes.
Speaker Change: A lot of adults that struggle from time to time with what most people consider everyday.
Matt: Fantastic. And then also, you're starting to see a little bit, we're starting to see a little bit more competition in terms of novel drugs for social anxiety disorder. Can you talk about how you think about the competition and how FascinTitanol doesn't have, you know, is immune to this competition?
Speaker Change: Fantastic and then also youre starting to see a little bit we're starting to see a little bit more competition in terms of.
Speaker Change: Social and performance situations. So one thing always is the case Theres neuropsychiatry Theres no one size fits all and it's also the case certainly that theres plenty of room.
Speaker Change: Novel drugs for social anxiety disorder.
Speaker Change: Can you talk about how you think about the competition and how fast and tylenol doesn't have.
Speaker Change: For a lot of treatments to come into play to try to make a difference.
Speaker Change: One very major difference with this pipeline and this is not just as the fast the Dino for Sandy, but it's we're up and down the pipeline and in each of the standards of care and the treatment paradigms currently what we're trying to disrupt whether it's depression, whether its menopausal hot flashes or certainly SCD is that it's the mechanistic difference so.
Speaker Change: Is immune to this competition. Thanks.
Shawn Singh: Thanks for the question, Matt. Unfortunately, we've got a robust market here in the United States in terms of the number of people affected by the disorder, over 30 million. It's a lot of adults that struggle from time to time with what most people consider everyday social and performance situation. So one thing always is the case of neuropsychiatry, there's no one-size-fits-all. And it's also the case, certainly, that there's plenty of room for a lot of treatments to come into play to try to make a difference. One very major difference with this pipeline, and this is not just as the facadonial for SAD, but it's for up and down the pipeline in each of the standards of care and the treatment paradigms currently that we're trying to disrupt.
Speaker Change: Thanks for the question Matt.
Speaker Change: Fortunately, we've got a.
Speaker Change: Robust market here in the United States in terms of the number of people affected by the disorder over $30 million. So a lot of adults that struggle from time to time with what most people consider everyday.
Speaker Change: Being able to rely on those the brain neural circuitry and having a pipeline of drugs that don't have to go through your whole body.
Speaker Change: Social and performance situations. So one thing always is the case Theres neuropsychiatry Theres no one size fits all and it's also the case certainly that theres plenty of room.
Speaker Change: That are activating neurons in your nose within milliseconds that project to neurons that deal factory bulb neurons at the base of the brain and then project to different regions of the brain to achieve their different therapeutic outcomes. It's a critical distinction. There is no. Other drug approved that has this kind of mechanism of action.
Speaker Change: For a lot of treatments to come into play to try to make a difference.
Speaker Change: One very major difference with this pipeline and this is not just as the fastest Dino for sandy, but it's we're up and down the pipeline and in each of the standards of care and the treatment paradigms currently over trying to disrupt whether it's depression, whether its menopausal hot flashes or certainly SCD.
Shawn Singh: Whether it's depression, whether it's menopausal hot flashes or certainly SAD, is that it's the mechanistic difference. So being able to rely on nose-to-brain neurocircuitry and having a pipeline of drugs that don't have to go through your whole body, that are activating neurons in your nose within milliseconds that project to neurons at the olfactory bulb neurons at the base of the brain, and then project to different regions of the brain to achieve different therapeutic outcomes, it's a critical distinction. There's no other drug approved that has this kind of mechanism of action. And what's important about that is it doesn't rely on a case like, say, an oral systemic where you've got to occupy and thread the needle just right of receptors in the brain, one or two, that are associated with different indications, depression, for example.
Speaker Change: And what's important about that is it doesn't rely on the case like say, an oral systemic where you've got to occupy and thread. The needle just right of receptors in the brain one or two that are associated with different indications depression. For example, so we think we've got a very unique.
Speaker Change: Is that it's the mechanistic difference so being able to rely on those the brain neural circuitry and having a pipeline of drugs that don't have to go through your whole body that are activating neurons in your nose within milliseconds that project to neurons that deal factory bulb neurons at the base of the brain and then project.
Speaker Change: Mechanistic approach to a broad range of therapeutic areas, where we've just not seen much of anything there hasn't been a single drug approved in SCD for a long time.
Speaker Change: To different regions of the brain to achieve their different therapeutic outcomes.
Speaker Change: A critical distinction there is no other drug approved that has this kind of mechanism of action and what's important about that is it doesn't rely on the case like say, an oral systemic where you've got to occupy and thread the needle just right.
Speaker Change: And the same thing in terms of menopausal Hot flashes depression, nothing with the kind of non systemic.
Speaker Change: And rapid onset approaches that we're trying to achieve in the clinical studies we've seen.
Speaker Change: Certainly there are oral.
Speaker Change: Receptors in the brain, one or two that are associated with different indications depression. For example, so we think we've got a very unique mechanistic approach to a broad range of therapeutic areas, where we've just not seen much of anything there hasn't been a single drug approved in SCD for.
Speaker Change: Oral <unk>.
Speaker Change: Systemic approaches with different receptors in the brain that are targeted at.
Shawn Singh: So we think we've got a very unique mechanistic approach to a broad range of therapeutic areas where we've just not seen much of anything. There hasn't been a single drug approved in SCD for a long time. And the same thing in terms of menopausal hot flashes, depression, nothing with the kind of non-systemic and rapid onset approaches that we're trying to achieve in the clinical studies we've seen. So certainly, there are oral systemic approaches with different receptors in the brain that are targeted at different. doses and different time frames to onset. I think we're very confident where we stand in terms of time to onset and the ability to avoid a lot of the issues you typically see pop up in REMS or in black boxes or even things that are more common associated with say drug-drug interactions.
Speaker Change: At different.
Speaker Change: Doses and different.
Speaker Change: Timeframes to onset I think we're very confident where we stand in terms of time to onset and the ability to avoid a lot of the issues you typically see pop up and rems or in black boxes or even.
Speaker Change: A long time.
Speaker Change: And the same thing in terms of menopausal Hot flashes depression, nothing with the kind of non systemic.
Speaker Change: Things that are more common associated with say drug drug interactions so not having to go through the liver and not having to go through the kidney and not have to really go across the brain into the brain.
Speaker Change: And rapid onset approaches that we're trying to achieve in the clinical studies we've seen.
Speaker Change: Certainly there are.
Speaker Change: It's a big big difference compared to what we see in the field and have seen in the field for decades. So we think we're in pretty good shape. If we can get to the point, where we can provide this product candidate to people who have been struggling with this disorder for most of their lives remember the mean durations about 20 years with onset and out of less.
Speaker Change: Oral <unk>.
Speaker Change: Systemic approaches with different receptors in the brain that are targeted.
Speaker Change: At different.
Speaker Change: A dosage and different.
Speaker Change: Timeframes to onset I think we're very confident where we stand in terms of time to onset and the ability to avoid a lot of the issues you typically see pop up and rems or in black boxes or even.
Speaker Change: So I think theres a lot of room for improvement based on where the market sits today.
Speaker Change: Things that are more comment associated with say drug drug interactions so not having to go through the liver and not having to go through the kidney and not have to really go across the brain into the brain.
Speaker Change: Alright, thank you.
Shawn Singh: So not having to go through the liver, not having to go through the kidney, not have to really go across the brain into the brain. It's a big, big difference compared to what we see in the field and have seen in the field for decades. We think we're in pretty good shape, if we can get to the point where we can provide this product candidate to people who have been struggling with this disorder for most of their lives. Remember, the mean duration is about 20 years, with onset in adolescence. So I think there's a lot of room for improvement based on where the market sits today.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of John.
John Boyle: Boyle with William Blair. Your line is now open.
Speaker Change: It's a big big difference compared to what we see in the field and have seen in the field for decades. So we think we're in pretty good shape. If we can get to the point, where we can provide this this product candidate to people who have been struggling with this disorder for most of their lives remember the mean duration is about 20 years with onset and Adela.
John Boyle: Hey, Tim This is John on for Myles. Thanks, So much for taking our questions. So a few from us.
John Boyle: Can you give us some color on the potential paths forward for <unk> 101 in neuropathic pain.
John Boyle: <unk> received a patent for the indication and what gives you confidence for 101 and the indication given the prior failures of <unk>.
Speaker Change: So I think theres a lot of room for improvement based on where the market sits today.
John Boyle: All right, thank you. Our next question coming from the line of John Boyle with William Blair. Your line is now open. Hey, team. This is John on for Myles. Thanks so much for taking our questions. So, a few from us to start.
John Boyle: <unk> modulators and VPN.
Speaker Change: Alright, thank you.
John Boyle: And then maybe on the Palisades program could you remind us of the rationale for that clinician administration, and pouch and bar and specifically is there any expected difference on the placebo response for a clinician versus self administering.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of John Baugh with William Blair. Your line is now open.
John Baugh: Hey, Tim This is John on for Myles. Thanks, So much for taking our questions. So a few from us.
John Boyle: Okay and the other ones there is those two.
John Boyle: Can you give us some color on the potential paths forward for AV101 in neuropathic pain now that you've received a patent for the indication? And what gives you confidence for 101 in the indication, given the prior failures of AFTINX's NMDA modulators and DPN?
John Baugh: Can you give us some color on the potential paths forward for <unk> 101 in neuropathic pain now that <unk> received a patent for the indication and what gives you confidence for 101 and the indication given the prior failures of <unk>.
John Boyle: I've got tomorrow, if you want after that.
John Boyle: Having to talk to you John.
Speaker Change: With respect to <unk> as we've announced that's a candidate for partnering and our confidence drives.
Speaker Change: Not just in pain, but also in dyskinesia associated with with L. Dopa therapy for Parkinson's and we've got not only phase one data telling us that this is a.
John Boyle: And then maybe on the PALACEIDS program, could you remind us of the rationale for the clinician administration in PALA 3 and 4? And specifically, is there any expected difference on the placebo response for clinician versus self-administering?
John Baugh: NMDA modulators and TPN.
John Baugh: And then maybe on the Palisades program could you remind us of the rationale for that clinician administration in power three and four and specifically is there any expected difference on the placebo response for a clinician versus self administering.
Speaker Change: Compound that we think is pretty safe, but also one that we've seen in preclinical models not yet in any patient base studies, but in preclinical models of MPTP Monkey model.
Shawn Singh: Okay, any other ones?
John Baugh: Okay.
John Boyle: Just those two? I've got some more, if you want, after.
John Baugh: Okay, and the other ones those too.
John Baugh: I've got tomorrow, if you are after there.
Speaker Change: In terms of the.
Shawn Singh: Always happy to talk to you, John. So, look, with respect to AV101, as we've announced, that's a candidate for partnering, and our confidence drives not just in pain, but also in dyskinesia associated with L-DOPA therapy for Parkinson's. And we've got not only Phase I data telling us that this is a compound that we think is pretty safe, but also one that we've seen in preclinical models, not yet in any patient-based studies, but in preclinical models, the MPTP monkey model, in terms of the Parkinson's-related dyskinesia, and then in some conventional pain models that have been published, that we see it's a different approach.
Speaker Change: Parkinson's related dyskinesia, and then in some conventional pain models that had been published that we see it's a different approach and it's it's.
Speaker Change: Having to talk to you John.
Speaker Change: Look with respect to <unk> as we've announced that's a candidate for partnering and our confidence drives.
Speaker Change: Not just in pain, but also in dyskinesia associated with with L. Dopa therapy for Parkinson's.
Speaker Change: These are NMDA receptor at the glycine site seven quarter kind of on a gas which is what the prodrug produces when astrocytes take it up in the brain.
Speaker Change: We've got not only phase one data telling us that this is a.
Speaker Change: That is very selective and potent.
Speaker Change: Compound that we think is pretty safe, but also one that we've seen in preclinical models not yet in any patient base studies, but in preclinical models of MPTP Monkey model.
Speaker Change: Glycine site antagonist, but not so much so say like the Caribbean or in amantadine, where it's blocking the ion channel. So we think it's got modular Tory capabilities at that site.
Speaker Change: In terms of the.
Speaker Change: Parkinson's related dyskinesia, and then in some conventional pain models that had been published that we see it it's a different approach.
Speaker Change: Both enter one or two and we were in a spot with this one where while it is not in line with the <unk> assets that we've got and with clinical stage in phase II or later positive data. This.
Shawn Singh: These are NMDA receptor at the glycine site, seven chlorokinetic acid, which is what the prodrug produces when astrocytes take it up in the brain. That is a very selective and potent glycine site antagonist, but not so much so, say, like a ketamine or an amantadine where it's blocking the ion channel. So we think it's got modulatory capabilities at that site, both NR1 and NR2, and we're in a spot with this one where, while it's not in line with the faring assets that we've got with clinical stage and phase two or later positive data, this is one that we think there is some potential for those who are focused on those neurological indices.
Speaker Change: Sure.
Speaker Change: These are NMDA receptor at the glycine site, seven Clara <unk> acid, which is what the pro drug producers when astrocytes take it up in the brain.
Speaker Change: Is one that we think there is some potential for those who are focused on those neurological indications.
Speaker Change: And I would refer you to the publications that are in pain that we can send to you that will give you a little bit more comfort on the preclinical data.
Speaker Change: That is a very selective and potent.
Speaker Change: Glycine site antagonist, but not so much so say like the Caribbean or in amantadine words, it's blocking the ion channel. So we think it's Scott modular Tory capabilities at that site.
Speaker Change: In terms of the clinician illustration of.
The.
Speaker Change: The test drug in the context of <unk> III for Josh wants you to go ahead and address that one.
Speaker Change: Both enter one or two and we were in a spot with this one where while it is not in line with the <unk> assets that we've got and with clinical stage in phase II or later positive data.
Speaker Change: Sure Yeah.
Speaker Change: So with this study as compared to the prior ones.
Speaker Change: We were really focused on.
Speaker Change: This is one that we think there is some potential for those who are focused on those neurological indications.
Speaker Change: Reducing any potential variability and so when you think about a single dose public speaking challenge.
Shawn Singh: And I'd refer you to the publications that are in pain that we can send to you that will give you a little bit more comfort on the preclinical.
Speaker Change: I'd refer you to the publications that are in pain.
Speaker Change: <unk> dose that visit to a single dose of visit three.
Speaker Change: We can send to you that will give you a little bit more comfort on the preclinical data.
Speaker Change: We really wanted to make sure that we reduce variability and rather than have to train each subject. Each time, you think about just having to train. The the raiders are the clinicians at the site and then they administer consistently throughout the duration. So that really drove that that decision again this reduce.
Shawn Singh: In terms of the clinician administration of The the test drug in the context of PAL-3, PAL-4.
Speaker Change: In terms of the clinician administration.
Speaker Change: <unk>.
Speaker Change: The.
Speaker Change: The test drug in the context of the <unk> III <unk> for Josh wants you to go ahead and address that one.
Joshua Prince: Josh, why don't you go ahead and address that one. Sure, yeah, I would love to. So with these studies compared to the prior ones, you know, we were really focused on reducing any potential variability. And so when you think about a single dose public speaking challenge, or, you know, single dose at visit two, a single dose at visit three, We really wanted to make sure that we reduce variability. And rather than have to train each subject each time, you think about just having to train the. the raters or the clinicians at the site, and then they administer consistently throughout the duration.
Speaker Change: Sure, yes kind of above two so with these studies compared to the prior ones.
Speaker Change: <unk> variability, we really don't think theres any impact to the label or projected use because the open label that we have in place for all of these studies has patients using it on their own every day multiple times a day as needed.
Speaker Change: We were really focused on redo.
Speaker Change: Reducing any potential variability and so when you think about a single dose public speaking challenge.
Speaker Change: <unk> dose that visit to a single dose at visit III.
Speaker Change: And so we don't expect any issues that issues there.
We really wanted to make sure that we reduce variability and rather than have to train each subject. Each time, you think about just having to train the the.
Speaker Change: Right.
Speaker Change: Similar to the value.
Speaker Change: The math is coming down obviously, you want this drug needs to be pointed right at the mid September so not up into the sinuses.
Speaker Change: The Raiders are the clinicians at the site and then they administer consistently throughout the duration. So that really drove that that decision again this reducing variability, we really don't think theres any impact to the label or projected use because the open label that we have in place for all of these studies has patients using it.
Joshua Prince: So that really drove that decision, again, just reducing variability. We really don't think there's any impact to the label or projected use because the open label that we have in place for all these studies has patients using it, you know, on their own every day, multiple times a day as needed. And so we don't expect any issues there. Similar to the math that's coming down, obviously we want to, this drug needs to be pointed right at the mid-septum, so not up into the sinuses in any way where it just would get in the respiratory system.
Speaker Change: In any way, where it just would get in the respiratory system. So again it just ensures that the drug has got the best opportunity to work.
Speaker Change: And those that are in the treatment side, it shouldnt affect placebo, but.
Speaker Change: Okay.
Speaker Change: TBD to be determined I suspect.
Speaker Change: Very helpful. I guess, maybe just one more from us.
Speaker Change: Their own every day multiple times a day as needed.
Speaker Change: How are you viewing your needs to head on both sides and CGI I and palisade three four.
And so we don't expect any issues that issues there.
Speaker Change: Okay.
Speaker Change: Hi, good morning.
Speaker Change: Just wondering if there's any sense that you might need to show some anchoring and an anchoring decides to the CGI.
Speaker Change: The math is coming down obviously, you want this drug needs to be pointed right at the mid September so not up into the sinuses.
Speaker Change: Okay.
Joshua Prince: So, again, it just ensures that the drug's got the best opportunity to work in those that are in the treatment side. It shouldn't affect placebo.
Speaker Change: In any way, we're just we're getting the respiratory system. So again it just ensures that the drug has got the best opportunity to work.
Speaker Change: While the sudden just group level, right and CGI as individual level and it as you have seen in the past and we've seen in the past that.
Speaker Change: And those that are in the treatment side, it shouldnt affect placebo, but.
Speaker Change: How people do.
Shawn Singh: to be determined.
Speaker Change: Due on their sides from time to time will tell you whether they are going to be a one or two on the CGI, but they are really distinct assessments, where we're focused is the primary input on the group level change between treatment and placebo. So CGI stands as does <unk>, which is now a secondary <unk>.
Okay.
Speaker Change: TBD to be determined I suspect.
John Boyle: Very helpful. I mean, I guess maybe just one more from us.
Speaker Change: Very helpful. I guess, maybe just one more from us.
John Boyle: How are you viewing your need to hit on both SUDs and CGI-I in Palisade 3-4? I'm kind of just wondering if there's any sense that you might need to show some anchoring, some independent anchoring of the SUDs to the CGI-I. Well, the SUDS is group level, right, and CGII is individual level, and it is, you have seen in the past, and we've seen in the past, that, you know, how people to do on their sides from time to time will tell you whether they are going to be a one or a two on the CGII, but they are really distinct assessments where we're focused as the primary input on the group level change between treatment and placebo.
Speaker Change: How are you viewing your need to head on both sides and CGI I and palisade Threescore.
Speaker Change: Just wondering if there's any sense that you might need this charles some anchoring and an anchoring decides to the CGI.
Speaker Change: <unk> and <unk> three and four.
Speaker Change: Those are all important to provide context as to what we've seen is the clinical meaningfulness at the group level.
Speaker Change: Yes.
Speaker Change: While the surge as group level, right and CGI as individual level and it is you have seen in the past and what we've seen in the past that.
Speaker Change: I appreciate it thanks, and congrats on the quarter.
Speaker Change: How people do.
Speaker Change: Thanks.
Speaker Change: Due on their sides from time to time will tell you whether they are going to be a one or two on the CGI, but they are really distinct assessments, where we're focused is the primary input on the group level change between treatment and placebo. So CGI stands as does <unk>, which is now a secondary <unk>.
Speaker Change: Thank you.
Speaker Change: As a reminder to ask a question. Please press star one.
Speaker Change: Our next question coming from the line of Paul Matteis with Stifel. Your line is now open.
Shawn Singh: So CGII stands, as does PGIC, which is now a secondary input in PALFADE 3 and 4. Those are all important to provide context as to what we've seen as the clinical meaningfulness of the group. Appreciate it.
Speaker Change: Hi, This is Emily on for Paul.
Speaker Change: Wondering if you could talk a little bit more about the ongoing repeat dose study and kind of what are you, hoping to see and the rationale behind that and also is there.
Speaker Change: <unk> and <unk> three and four.
Speaker Change: Those are all important to provide context as to what we've seen is the clinical meaningfulness at the group level.
Eric would be regulatory risk.
John Boyle: Thanks and congrats on the quarter. Thanks.
Speaker Change: I appreciate it thanks, and congrats on the quarter.
Speaker Change: And all that.
Speaker Change: It kind of turns out two doses looks a bit more efficacious than one thank you.
Speaker Change: Thanks.
Speaker Change: Thank you.
Operator: And as a reminder, to ask a question, please press star 11.
Speaker Change: Sure.
Josh Princess: Josh go ahead and hit this one.
And as a reminder to ask a question. Please press star one.
Emily: Our next question coming from the line of Paul Matis with Stifel Yolanis Melpin. Hi, this is Emily on for Paul. We were wondering if you could talk a little bit more about the ongoing repeat dose study and kind of what are you hoping to see in the rationale behind that? And also, if there would be a regulatory risk if facadienol is safe, but it kind of turns out two doses look a bit more efficacious than one. Thank you.
Josh Princess: Yeah.
Speaker Change: Our next question coming from the line of Paul Matteis with Stifel. Your line is now open.
Josh Princess: Sure so for repeat dose study.
Josh Princess: As we've noted.
Josh Princess: Noted before it's really I'd essentially identical to what we're doing in palisade.
Speaker Change: Hi, This is Emily on for Paul.
Josh Princess: Three and four just with an additional arm so that we can see.
Speaker Change: Wondering if you could talk a little bit more about the ongoing repeat dose study and kind of what are you, hoping to see and the rationale behind that and also is there would be regulatory risks.
Josh Princess: We administered 10 minutes after the first dose would have an impact on the public speaking challenge.
Speaker Change: The FDA asked for that essentially because they felt in the real world. There's a good possibility that a subject may.
But it kind of turns out two doses look a bit more efficacious than one thank you.
Joshua Prince: Sure. Josh, go ahead and hit this one. Sure, so for a repeat dose study, as we've noted before, it's really essentially identical to what we're doing in Palisade. 3 and 4, just with an additional arm so that we can see if a dose administered 10 minutes after the first dose would have an impact on the public speaking challenge. and the FDA asked for that essentially because they felt in the real world there's a good possibility that a subject may go ahead and still feel if they still feel nervous take another dose and so The thinking there is, is there any safety impact?
Josh Princess: Go ahead, and still feel if they still feel nervous take another dose.
Josh: Sure Josh.
Josh: Josh go ahead and hit this one.
Speaker Change: So.
Speaker Change: The thinking there is is there any safety.
Josh: Yeah.
Josh: Sure so for repeat dose study.
Speaker Change: <unk>, we think there likely is not based on other higher doses that we've measured.
Josh: As noted before it's really essentially identical to what we're doing in palisade.
Speaker Change: And then is there a potential efficacy benefit.
Speaker Change: There could be for some patients, but you also have to keep in mind that once those receptors are saturated with the spray you don't really get any additional benefits. So it's to be seen as to whether or not we would see it there.
Josh: Three and four just within additional arm so that we can see.
Josh: Dose administered 10 minutes after the first dose would have an impact on the public speaking challenge.
Josh: And then the FDA asked for that essentially because they felt in the real world. There is a good possibility that a subject may.
Speaker Change: There is no benefit in that arm.
Speaker Change: At the end of the day if palisade.
Josh: Go ahead, and still feel if they still feel nervous take another dose.
Speaker Change: Three or four are positive on that primary endpoint with one dose.
Josh: No.
Josh: The thinking there is there any safety.
Speaker Change: I think that it would create any issues for approval to see potential benefit of a second dose.
Joshua Prince: We think there likely is not based on other higher doses that we've measured. And then is there a potential efficacy benefit? There could be for some patients, but you also have to keep in mind that once those receptors are saturated with the spray, you don't really get any additional benefit. So it's to be seen as to whether or not we would see. additional benefit in that arm.
Josh: <unk>, we think they are likely is not based on other higher doses that we've measured.
Speaker Change: What it would do is likely inform the label so that physicians are able to but.
Josh: And then is there a potential efficacy benefit.
Josh: There could be for some patients, but you also have to keep in mind that once those receptors are saturated with this Greg you don't really get any additional benefits. So it's to be seen as to whether or not we would see it there.
Speaker Change: But patients know that they could dose again within that 10 minute timeframe, if they felt it might be beneficial.
Speaker Change: But beyond that we really don't see impact I mean, it is a it's a smaller study as well it's not.
Joshua Prince: At the end of the day, if Palisade 3 or 4 are positive on that primary endpoint with one dose, we don't think that it would create any issues for approval to see potential benefit of a second dose. And what it would do is likely inform the label so that physicians are able to let patients know that they could dose again within that 10-minute timeframe if they felt it might be beneficial. But beyond that, we really don't see impact.
Speaker Change: It's not powered or size like our phase III studies are.
Josh: There is no benefit in that arm.
Josh: At the end of the day if palisade.
Speaker Change: It's a good point, Josh and Emily it's key that.
Josh: Three or four are positive on that primary endpoint with one dose.
Speaker Change: We align with the agency on this study.
Josh: I think that it would create any issues for approval to see potential benefit of a second dose.
Josh Princess: I think the key takeaway for us is that a coded form of labeling it could help docs get the question as you know how are you going to tell people to take it well it could inform the labeling and guide whether the second dose within 10 minutes is safe and that as we as Josh noted as we expected it would be.
Josh: What I would do is likely inform the label so that physicians are able to let patients know that they could dose again within that 10 minute timeframe, if they felt that might be beneficial.
Shawn Singh: And it's a smaller study as well. It's not powered or sized like our phase 3 studies. It's a good point, Josh.
Josh: But beyond that we really don't see impact and it is a it's a smaller study as well it's not it's not powered or size like our phase III studies are.
Josh Princess: And again I think the anticipation is in the real World people May think more is better and so to know that it's okay and safe.
Josh Princess: There's only so much volume the nodes can handle anyway, and as Josh noted once you occupy and activate those nasal keno sensory neurons, which happens in about 25 milliseconds.
Shawn Singh: And Emily, it's key that we align with the agency on this study, and I think the key takeaway for us is that it could inform labeling. It could help docs. The question is, you know, how are you going to tell people to take it? Well, it could inform the labeling and guide whether the second dose within 10 minutes is safe. And that, as we, as Josh noted, as we expected, it would be. And again, I think the anticipation is in the real world, people may think more much better. And so to know that it's okay and safe, there's only so much volume the nose can handle anyway.
Speaker Change: It's a good point, Josh and Emily it's key that.
Speaker Change: We align with the agency on this study and I think the key takeaway for US is that accounted form of labeling it could help docs get the question is how are you going to tell people to take it well it could inform the labeling and guide whether the second dose within 10 minutes is safe.
Josh Princess: You're on your way towards trying to achieve when we the neurosurgery projects to the amygdala.
Josh Princess: Great. Thank you.
And that as we as Josh noted as we expect it would be.
Josh Princess: Okay.
Speaker Change: Thank you everyone. This is all the time, we have for questions today.
Speaker Change: And again I think the anticipation is in the real World people May think more is better and so to know that it's okay and safe.
Speaker Change: If you have additional questions. Please do not hesitate to contact us.
Speaker Change: By E mailing <unk> dot com or you can.
Speaker Change: And there's only so much volume the nodes can handle anyway and as Josh noted once you occupy and activate those nasal keno sensory neurons, what's happens in about 25 milliseconds.
Shawn Singh: And as Josh noted, once you occupy and activate those nasal chenal sensory neurons, which happens in about 25 milliseconds, you're on your way to what we're trying to achieve when we the neural circuitry projects to the Great, thank you.
Speaker Change: Log into the website via the contact Us section.
Speaker Change: Submit questions through that portal. We also encourage you to register for E Mail updates on our website to stay connected with the latest news from Vista. Gen. Again, thanks for participating on the call today. We appreciate everyone's interest and continued support we look forward to keeping you updated on our ongoing progress. This concludes the call have a wonderful day.
Speaker Change: Youre on your way towards trying to achieve when we the neurosurgery projects to the amygdala.
Speaker Change: Great. Thank you.
Operator: Thank you, everyone.
Speaker Change: Okay.
Operator: This is all the time we have for questions today. If you have additional questions, please do not hesitate to contact us. by emailing IR at VistaGen.com or you can log into the website via the contact us section and submit questions through that portal. We also encourage you to register for email updates on our website to stay connected with the latest news from VistaGen.
Speaker Change: Thank you everyone. This is all the time, we have for questions today.
Speaker Change: Ladies and gentlemen, thank you for your participation you may now disconnect.
Speaker Change: If you have additional questions. Please do not hesitate to contact us.
Speaker Change: By Emailing IR at <unk> Dot com or you can.
Speaker Change: <unk> to the website via the contact Us section.
Speaker Change: Submit questions through that portal. We also encourage you to register for email updates on our website to stay connected with the latest news from Vista. Gen. Again, thanks for participating on the call today. We appreciate everyone's interest and continued support we look forward to keeping you updated on our ongoing progress. This concludes the call have a wonderful day.
Shawn Singh: Again, thanks for participating on the call today. We appreciate everyone's interest and continued support. We look forward to keeping you updated on our ongoing progress.
Operator: This concludes the call.
Operator: Have a wonderful day.
Operator: Ladies and gentlemen, thank you for your participation, you may now disconnect.
Speaker Change: Okay.
Speaker Change: Ladies and gentlemen, thank you for your participation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Hum.
Speaker Change: Okay.
Speaker Change: [music].