Q3 2024 VistaGen Therapeutics Inc Earnings Call
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Greetings and welcome to Vista, just therapeutics fiscal year, 'twenty 'twenty, four third quarter financial results and corporate update.
At this time all participants are in a listen only mode.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mark McPartland, Senior Vice President, Investor Relations, at VistaGen. Thank you. You may begin. Thank you, Doug.
Question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce Mark Mcpartland, Senior Vice President Investor Relations I visited yet.
You you may begin.
Thank you Doug Good afternoon, everyone and welcome to Vista, James fiscal year, 'twenty 'twenty, four third quarter corporate update conference call and webcast.
Mark McPartland: Good afternoon, everyone, and welcome to VistaGen's fiscal year 2024 third quarter corporate update conference call and webcast. This afternoon, we filed our quarterly report and issued a press release providing an overview of our recent third quarter results and our neuroscience pipeline development. We encourage you to review the release, which can be found in the Investor Relations section of the VistaGen website. During today's call, we'll make forward-looking statements regarding our business based on our current expectations and information. Forward-looking statements speak only as of today, and, except as required by law, we do not assume any duty to update in the future any forward-looking statement made today.
This afternoon, we filed our quarterly report and issued a press release, providing an overview of our recent third quarter results and our neuroscience pipeline development.
We encourage you to review the release, which can be found in the Investor Relations section of the Vistaprint website.
During today's call, we'll make forward looking statements regarding our business based on our current expectations and information forward.
Forward looking statements speak only as of today.
And except as required by law, we do not assume any duty.
In the future any forward looking statement made today.
Mark McPartland: Of course, forelooking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forelooking statements we make today. Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2024 3rd quarter Form 10-Q for the period ending December 31, 2023 and in future filings that we make with the SEC from time to time, all of which are or will be available on our website and the Now that that is taken care of, I'd like to thank and welcome all our stockholders, analysts, and everyone taking an interest in VistaGen. I'm joined on the call today by Sean Singh, our Chief Executive Officer, Cindy Anderson, our Chief Financial Officer, and Josh Prince, our Chief Operating Officer. Sean will provide an overview of our recent results and our progress across our key pipeline. A brief opportunity for questions from Cilcide analysts will follow the prepared remarks. I'd like to remind everyone that this call is being webcast and will be available for replay after completion. The replay link can be found in the investor events section of the VistaGen website.
Of course forward looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated by any forward looking statements we make today.
Additional information concerning risks and factors that could affect our business and financial results.
Are included in our fiscal year 2024 third quarter Form 10-Q for the period ending December 31st 2023, and then future filings that we make with the SEC from time to time, all of which are or will be available on our website and the sec's website.
Now with that taken care of I'd like to thank and welcome all of our stockholders analysts and everyone taken an interest in district yet.
I'm joined on the call today by Sean Zhang Our Chief Executive Officer Cindy.
Cindy Anderson, our Chief Financial Officer, and Josh <unk>, our Chief operating officer.
Sean will provide an overview of our recent results and our progress across our key pipeline programs.
A brief opportunity for questions from sell side analysts will follow their prepared remarks.
I'd like to remind everyone. This call is being webcast and will be available for replay after completion.
Play a link can be found in the investor events section of the Vista Gen website.
Sean Singh: I would now like to turn the call over to our Chief Executive Officer, Sean Singh. Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. Here at VistaGen, we are pioneering neuroscience with an intention to deliver first-in-class therapies for psychiatric and neurological disorders, where there are few, if any, adequate and differentiated FDA-approved treatment options to satisfy the widespread needs of patients whose mental health and whose well-being are adversely affected by their disorders. Each of our clinical-stage neuroscience product candidates is designed with the potential to establish new standards of care and make meaningful differences in how patients manage their disorders to improve their daily lives. In the last few months, we've seen a renaissance in neuroscience, marked notably by pharma, and M&A in the neuropsychiatry space, valued at about $23 billion.
I would now like to turn the call over to our Chief Executive Officer, Sean say Sean.
Thank you Mark and good afternoon, everyone. Thank you for joining our call today.
Here. This is Jim we are pioneering neuroscience with an intention to deliver first in class therapies for psychiatric and neurological disorders.
Where there are few if any adequate and differentiated F. D. A approved treatment options to satisfy the widespread needs of patients, whose mental health and wellbeing are adversely affected by their disorders.
Each of our clinical stage neuroscience product candidates is designed with the potential to establish new standards of care and make meaningful differences in how patients manage their disorders to improve their daily lives.
Within the last few months, we've seen a renaissance in neuroscience, mark, notably by pharma M&A and the neuropsychiatry space valued at about 23 billion.
Sean Singh: We are encouraged that novel, late-stage, neuroscience-derived product candidates with differentiated safety profiles have stimulated renewed interest in large-market neuropsychiatry programs with the potential to change lives. We believe each of our clinical neuroactive pharenes, led by Facadienol for the acute treatment of social anxiety disorder, is anchored in novel neuroscience and has the potential to produce differentiated product profiles across multiple and diverse large market therapeutic areas with a high need for innovation and a high need to transform the standards of care, including anxiety, depression, women's health, and other disorders.
We are encouraged that novel late stage neuroscience derived product candidates with differentiated safety profiles have stimulated renewed interest in large market neuro psychiatry programs with the potential to change lives.
We believe each of our clinical neuro active fairings.
Led by fast the die at all for the acute treatment of social anxiety disorder is anchored in novel Neuroscience and has the potential to produce differentiated product profiles across multiple and diverse large market therapeutic areas with high need for innovation and high need to transform the stay.
Nodes of care, including anxiety depression women's health and other disorders.
Sean Singh: Today we'll briefly discuss our progress and plans for three of our five faring assets in our clinical stage neuroscience pipeline, Fasadienol, Itruvone, and PH80. As noted, our lead clinical stage program involves fazadienol and is aimed at transforming the treatment paradigm for adults affected by Social Anxiety Disorder, or SAD, which currently affects the lives of about 10% of the U.S. adult population with very high opportunity costs in their daily life. While the prevalence of SAD continues to grow, there's still no FDA-approved, patient-tailored, acute treatment option to help individuals with SAD rapidly and safely address their anxiety when their stressors are upon them in their daily lives. With the positive results from our Palisade II Phase III trial reported last year, and a strong balance sheet, we were fully focused on advancing our Palisade Phase III development program in SAD with preparations Since our last conference call in November, our team has been diligently focused on the preparations necessary to initiate Palisade III, which will be our next phase 3 clinical trial of Facadienol for the acute treatment of anxiety in adults with social anxiety disorders. That remains on track to begin in the first half of 2024.
Today, we'll briefly discuss our progress and plans for three of these three of our five varying assets in our clinical stage neuroscience pipeline faster Dino I traveled to loan N P. H a D.
As noted our lead clinical stage program involves fast the dyno and it is aimed at transforming the treatment paradigm for adults affected by social anxiety disorder or S. A D.
Which currently affects the lives of about 10% of the U S. Adult population with very high opportunity cost in their daily life.
While the prevalence of S. A D continues to grow there's still no FDA approved patient tailored acute treatment option to help individuals with S. A D rapidly and safely address their anxiety, when they're stressors or upon them in their daily life.
With the positive results from our palisade two phase III trial reported last year and.
And a strong balance sheet, we're fully focused on advancing our palisade phase III development program and S. J D.
Preparations to initiate.
This year all key remaining studies planned for that program.
Since our last conference call in November our team has been diligently focused on the preparations necessary to initiate palisade, three which will be our next phase III clinical trial of fast die at all for the acute treatment of anxiety and adults with social anxiety disorder.
That remains on track to begin in the first half of 'twenty 'twenty four that'll be followed by palisade for it to be initiated in the second half of this year.
Sean Singh: That will be followed by Palisade 4, which will be initiated in the second half of this year. Palisade 3 and Palisade 4 will be similar to our successful Palisade 2 Phase 3 trial. Both trials will involve a public speaking challenge in a clinical setting with patient-reported outcomes on the Subjective Units of Distress Scale, or SUDS, as the primary efficacy endpoint. We believe either Palisade 3 or Palisade 4, if successful, together with the positive results from Palisade 2, may establish substantial evidence of effectiveness of Facadienol in support of a potential NDA submission for the acute treatment of anxiety in adults with SAD.
I'll say three in palisade four will be similar to our successful palisade two phase III trial.
Both trials are involved the public speaking challenge in a clinical setting with patient reported outcomes on the subjective units of distress scale or such as the primary efficacy endpoint.
We believe either palisade three or palisade for if successful together with the positive results from palisade to may establish substantial evidence of effectiveness. So fast the dyno in support of a potential NDA submission for the acute treatment of anxiety in adults with S. A D.
Sean Singh: Last year, we accomplished something that, to our knowledge, had never been achieved, and that was to demonstrate positive phase 3 results in an anxiety study with a drug candidate that does not need to be taken systemically or act directly on neurons in the brain. We look forward to getting back into the clinic soon with Palisade III to continue driving on our mission to deliver a first-in-class therapy in a large neuropsychiatry market in need of differentiated, fast-acting therapies without the risk of sexual side effects, weight gain, or abuse liability concerns. Beyond fazadienol in our Phase III program in SAD, we are continuing to explore various ways to unlock the significant potential of our A-Truvone asset as a differentiated new therapy for major depressive disorder, or MDD. Preparations and planning for a potential U.S. invasion
Last year, we accomplished something that to our knowledge has never been achieved and that is to demonstrate positive phase III results in an anxiety study with a drug candidate that does not need to be taken up systemically or act directly under runs in the brain.
Look forward to getting back into the clinic soon the palisade three to continue driving on our mission to deliver a first in class therapy, and a large neuro psychiatry market and need a differentiated fast acting therapies without the risk of sexual side effects weight gain or abuse liability concerns.
Beyond fast the die at all in our Phase III program and that's a D. We are continuing to explore various ways to unlock the significant potential of <unk>.
Our a true asset as a differentiated new therapy for major depressive disorder or M. D D.
Preparations and planning for a potential U S phase two b trial by two bone monotherapy in M. D D are ongoing.
Sean Singh: Phase IIb trials by Truvone Monotherapy in MDD are ongoing. Again, our mission in this large and unfortunately increasing neuropsychiatry market is to deliver a differentiated therapy to transform the standard of care without the risk of sexual side effects, weight gain, or abuse liability concerns. We also see great potential in our rapid-onset, hormone-free PHAD nasal spray. Its potential is anchored in the previously unreported positive results from two trials in women's health indications that we announced last year. The first is treatment for vasomotor symptoms, or hot flashes, due to menopause, and next for the management of premenstrual dysphoric disorder or PMDD.
Again, our mission in this large and unfortunately, increasing neuro psychiatry market is to deliver a differentiated therapy to transform the standard of care without the risk of sexual side effects weight gain or abuse liability concerns.
We also see great potential in our rapid onset hormone free P. H a D nasal spray.
Its potential is anchored in the previously unreported positive results from two trials and women's health indications that we announced last year first as a treatment for vasomotor symptoms or hot flashes due to menopause and next for the management of Premenstrual Dysport disorder or P. M. D D D.
Cindy Anderson: PHAD showed statistically significant results in both studies. We are preparing to conduct non-clinical studies necessary to submit a US IND to facilitate further phase 2 clinical development of PHAD for women's health, including the treatment of patients with moderate to severe vasomotor symptoms or hot flashes that are due to menopause. I'll now turn the call over to our CFO, Cindy Anderson, to summarize some of the highlights from our financial results for the third quarter of our fiscal 24.
P. J D showed statistically significant results in both studies, we are preparing to conduct non clinical studies necessary to submit a U S. I N D to facilitate further phase II clinical development a P. H a D for women's health indications, including the treatment of patients with moderate to severe vasomotor symptoms or hot flashes that are due to menopause.
I'll now turn the call over to our CFO Cindy Anderson to summarize some of the highlights from our financial results for the third quarter.
Of our fiscal 'twenty for Cindy.
Cindy Anderson: Thank you, Sean. As Sean mentioned, I will highlight a few plans to result from our fiscal year 2024 third quarter. I also encourage everyone to review our quarterly report on Forum 10-Q filed with the FCC earlier this afternoon for additional details and disclosures. Research and development expense was $4.5 million and $6.9 million for the three months ended December 31, 2023 and 2022, respectively. The decrease in R&D expense was primarily due to a decrease in clinical and development expenses related to the timing of such expenses incurred in our phase three trials of fethanylidol and General Administrative Expense was $3.8 million for the three-month period ending December 31, 2023, compared to $3.1 million for the prior year period. The increase is primarily due to an increase in compensation-related expenses. Our net loss attributed to common stockholders was $6.3 million and $9.8 million for the three months ending December 31, 2023, and 2022, respectively.
Thank you Sean as Sean mentioned I will highlight a few financial results of our fiscal year 2021 third quarter I also encourage everyone to review our quarterly report on Form 10-Q filed with the STC Oh. This afternoon for additional details and disclosures.
Research and development expenses were five nine and $6 9 million for three months ended December 31st 2023, and 2022, respectively.
The decrease in R&D expenses, primarily due to a decrease in clinical and development expenses related to the timing of such expenses incurred in our phase III trials, well, if that's what I had all of them.
General and administrative expense, that's a great point 8 million. The three month period ended December 31st 2023, compared to $3 1 million for the period.
Period.
Increase was primarily due to the increase in compensation related expenses.
Net loss attributable to common stockholders was $6 3 million and $9 8 million for three months ended December 31st 2023, and 2022 separately.
Sean Singh: At December 31st, 2023, we had cash and cash equivalents of approximately $126.6 million. I will also note that this afternoon, as is customary for development stage companies in our sector, we filed a new shelf registration statement on Form S-3 with the SEC to renew a previous S-3, which was set to expire next month. Child Registration Statements on Form S-3 are standard in our industry and are intended to provide us with broad flexibility to improve our balance sheet in the future as may be needed. As a reminder, please refer to our COIL report on Form 10-Q filed today with the SEC for additional details and disclosures. I will now turn the call back over to Sean. Thanks, Cindy.
At December 31st 2023.
Cash and cash equivalents of approximately $126 6 million.
I would also note that this afternoon as customary quick adoption stage companies in our sector, we filed a new shelf registration statement on form S. Three.
He said to bring your previous estimate which was set to expire next month.
Self registration statements on form S. Three are standard in our industry and are intended to provide us with flexibility to improve our balance sheet and the feature as may be needed.
As a reminder, please refer to our quarterly report on Form 10-Q filed today with the SEC for additional details and disclosures.
I will now turn the call back over to Sean.
Thanks Cindy.
Sean Singh: So as we wrap up today's call, I want to emphasize that we are very proud and very excited to be focused on reaching another key corporate milestone in the near term, and that's the initiation of our Palisade III, a Phase III trial of fazadienol for the acute treatment of anxiety in adults with SAD. We will progress through the next phases of our core corporate development strategies with confidence in our team's expertise to execute our Palisade Phase III clinical program, a facet dienol and SAD. The potential of our robust pipeline for multiple and diverse psychiatric and neurological disorders and our steadfast commitment to pioneering neuroscience to develop and commercialize truly differentiated treatment solutions. So, on behalf of our whole team here at VistaGen, I want to thank you for your continued support.
So as we wrap up today's call I want to emphasize that we are very proud and very excited to be focused on reaching another key corporate milestone in the near term. That's the initiation of our palisade three phase III trial of faster and all for the acute treatment of anxiety and adults with S. A D.
We will progress through the next phases of our core corporate development strategies with confidence in our team's expertise to execute our palisade phase III clinical program fast the Dino and S. A D. The potential of our robust pipeline for multiple and diverse psychiatric and neurological disorders.
Our steadfast commitment to pioneering neuroscience to develop and commercialize truly differentiated treatment solutions.
So on behalf of our whole team here at Vista, Jim I want to thank you for your continued support.
Operator: Thank you, Sean. Operator, we would now like to turn the call over to questions from the cell side analysts participating on the call. Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you'd like to ask a question, you may press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line between Paul Matisse and Stiefel.
Thank you Sean operator, we would now like to turn the call over for questions from the sell side analysts participating on the call today.
Thank you, ladies and gentlemen at this time well be conducting a question and answer session.
If you'd like to ask a question you May press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue you.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing that starkey.
Our first question comes from the line of Paul Matisse with Stifel. Please proceed with your question.
Paul Matisse: Please proceed with your question. Just a quick one for me. Are you still planning on doing a, You bet. Thanks Julian. Yeah, we are going to do a repeat dose study. It'll be similar in design to Palisade 3 and to Palisade 4, and thus, obviously, by extension, Palisade 2.
Hi, This is Julian on for.
Oh, thanks, so much for taking our question.
Just a quick one for me.
Are you still planning on doing.
Oh yeah.
And if so would you.
I want to provide any color on that.
Yes.
You bet. Thanks, Julien Yeah, we are going to do a repeat dose study it'll be similar in design to palisade, three and to palisade for and this obviously by extension palisade too.
Sean Singh: It'll be smaller, and it'll assess the safety and potential benefit of a second dose of fazadienol that is administered within 10 minutes after the first dose and prior to the public speaking challenge. So, similar study design, similar end point, obviously much smaller. And the results of that study, part of it is in agreement with FDA, and especially as to any potential safety issues, which we don't anticipate any with repeat dosing, but it really could inform the labeling and provide some guidance as to whether or not a second dose administered within ten minutes, which might be the case in a real-world setting, is safe and, as we anticipated..., could be again, could provide any potential benefit for some patients. Our next question comes from the line of Andrew Sy with Jeffries. Please proceed with your question. Hey, thanks. Good afternoon.
It'll be smaller and it will assess the safety and potential benefit of a second dose.
Fast the die and all that is administered within 10 minutes. After the first dose and prior to public speaking challenge. So similar study design similar endpoint, obviously much smaller and the results of that study.
Part of it too is in agreement with F D. A.
And especially as to any potential safety issue, which we don't anticipate any with repeat dosing, but it really could inform the labeling and provide some guidance as to whether or not a second dose administered within 10 minutes, which might be the case in a real world setting as safe and as we anticipated.
Could be again could provide any potential benefit for some patients. So we'll prepare to initiate that study in the second half of this year as we've got it.
Excellent. Thanks, so much.
Okay.
Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.
Hey, Thanks. Good afternoon. Appreciate you taking my questions. So maybe the first one on palisade three for you're employing obviously some studying improvements to the program. So.
Andrew Sy: Appreciate you taking my question. So, um, maybe the first one on Palisade 3, 4, um, you're employing, obviously, some study improvement to do those programs. So could it be fair to assume that, um, the SUDS separation in those studies could be even greater than what you saw in Palisade 2 because, uh, as you're mitigating for the placebo effect, could you be further maximizing the drug? Well, thanks, Andrew.
Would it be fair to assume that the suds separation and those studies could be even greater than what you saw in palisade too because as you're mitigating for placebo effect could you be further maximizing a drag on that.
Yeah.
Well, Thanks, Andrew as you mentioned I mean, we've done quite a few things to further derisk the phase III program and a lot of lessons learned on the other side of the prior studies and obviously this is not now.
Sean Singh: As you mentioned, we've done quite a few things to further de-risk the Phase III program, and a lot of lessons have been learned on the other side of the prior studies. And obviously, this is not now a study design and an endpoint that sites and investigators are seeing after a pretty long hiatus over the space of a couple decades. So the things that we've done to improve surveillance, improve and further de-risk the execution of the program, you know, certainly that's a possibility. But there are a lot of things. If you compare the world in 2022 to where we are today in 24, just at a minimum, taking masks out of the equation is a big difference; having the ability to have in-person investigator meetings, having the ability to do things that ensure rigorous adherence to the protocol, very exacting requirements of that protocol, consistently across sites, all of those things combined have the potential, of course, to improve even on what we've seen in the past in Phase II and Josh Prince, do you want to add anything to that?
A study design in an endpoint that sites and investigators are seeing after a pretty long hiatus in the space of a couple of decades. So the the things that we've done to.
To improve surveillance improve and further de risk execution of the program Yeah, certainly that's a possibility.
But there's a lot of things if you compare.
The world in 2022 to where we are today in 24, just at a minimum taken masks out of the equation is a big difference.
Having the ability to have in person investigator meetings have the ability to do things that are ensure rigorous.
Adherence to the protocol very exacting requirements of that protocol consistently across sites all of those things combined have the potential of course too.
To improve even on what we've seen in the past and in phase two it and policy to.
Josh Prince you want to add anything to that.
Josh Prince: Sure, Sean. Thank you. Yeah, I think we're very optimistic about our ability to execute a well-controlled study post-pandemic. And it's everything that you talked about, but it's also the things that we're able to do in terms of how we work with our CRO. We're putting feet on the ground in terms of our own monitors going to sites in addition to CRO monitors.
Sure Sean. Thank you Yeah, I think we're very optimistic about.
Our ability to execute a well controlled study post pandemic and it's everything that you talked about but it's also.
The things that we're able to do in terms of how we work with our with our Cerro mm, we're putting feet on the ground in terms of our own monitors go into sites. In addition to Cerro monitors.
Josh Prince: We have some additional exclusion criteria to make sure that subjects that are coming into the study have the best chance to have positive results or the opportunity to have positive results with Fascidinol and even things such as eligibility review, making sure that subjects are appropriate candidates before they're going into the Visit 2 and Visit 3 public speaking challenges. So you put all those things together, and it does give us a fair amount of optimism moving into PAL 3 and PAL 4 compared to what we had when we were executing PAL State 1 and PAL State 2. Thanks.
We have some additional exclusion criteria to make sure that the subjects that are coming into the study.
We have the best chance to have a positive.
<unk> our.
Opportunity to have positive results with a faster Dino.
And even things such as eligibility erith, you're making sure that.
Subjects are appropriate subjects before they're going into the visit to visit three public speaking challenges. So you put all those things together and it does it does give us a fair amount of optimism moving into powertrain password compared to what we had when you were executing palisade one in palisade too.
Thanks, and maybe a follow up on the repeat dose study that you're initiating in second half as we think about the three arms what are you and the F D. A.
Josh Prince: And maybe a follow-up on the repeat dose study that you're initiating in the second half. As we think about the three arms, what are you and the FDA looking for? Or said another way, what is positive data?
Josh Prince: Josh, go ahead and address that. Yeah, we expect it to be a smaller study. So, you know, at this point, we don't expect to see, you know, power for statistical significance, like you would in the Palisade 3 or Palisade 4, but it would give us indications that for some patients, an additional dose within 10 minutes could provide some benefit, and that essentially could inform the label. So, that's what I mean, at the end of the day.
You know looking for or said another way what is positive data.
Josh go and address that.
Yeah, we expect it to be a smaller study so no.
It's not at this point, we don't expect to see powered for statistical significance like you would in the.
I'll say three of palisade for them, but it would give us as you know is there any is there any indication that for some patients in additional dose within 10 minutes could provide some benefit them and that essentially can inform the label. So that I mean at the end of the day.
Sean Singh: For us, a positive study is we either see that there is some indication that there could be a benefit or we don't, but either way, you know, there's benefit from the first dose. And again, the discussions have been circled around informing labeling downstream and also real world understanding and some of that taken from Open Label Activity, where people might think more is better within a short period of time. So first and foremost, we have to check the box on safety, which again, we don't think there's much, if any, risk associated with a second dose within that 10-minute window. For those who don't know, there are three arms before a public speaking challenge: placebo-placebo, drug-placebo, drug-drug, each of the second doses within 10 minutes of the first. And that's on the front of public speaking challenges.
Perhaps a positive study as we either see that there is some indication that it could be a benefit or we don't but either way you know there's benefit from the first dose.
Yeah again, it's really the discussions have been circled around informing labeling downstream and also real world understanding and some of that taken from from open label activity, where people might think more is better within a short period of time, So first and foremost we have to check the box on safety, which.
Again, we don't think there's much of if any risk there associated with a second dose within that 10 minute window for those who don't know it's there's three arms before a public speaking challenge placebo placebo drug placebo drug drug each of the second doses within 10 minutes of the first and that's upfront of public speech.
Challenges, so again, taking into account possibilities in the real world that people will use the drug a couple of times rather than staggered as as the 15 minutes studied paradigm required showed so.
Sean Singh: So, again, taking into account possibilities in the real world that people will use the drug a couple of times rather than staggered as the 15-minute study paradigm required or showed. So we'll see how it goes. Again, it's a dialogue.
Well see how it goes again, it's a it's a dialogue it's nice to be knowing we're talking about potential labeling labeling benefit so.
Sean Singh: It's nice to be knowing we're talking about potential labeling benefits. That's how we took it. Remember, these receptors are activated in milliseconds, so it doesn't take much time to get them moving in the first place.
That's how we took these these remember these receptors are activated in milliseconds. So it's it doesn't take much time to get them moving in the first instance.
Operator: Thank you very much. As a reminder, it is star number to ask a question. Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question. For President Einauld, given a non-systemic, non-abusable profile and with a positive TAL-2 trial, could you look to gain breakthrough status with the agency? Is it something you're exploring?
Thank you very much.
As a reminder, it is star one to ask a question.
Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Thanks for the question and congratulations on a cargo on the progress.
Sure for passive and I'll give him the notwithstanding non abusable profile.
With a positive <unk> two trial could you looked again breakthrough status with the agency is that something you're exploring well there.
Tim Lugo: Will there, you know, if you were to get breakthrough status, is it something that could impact your development path at all? And in your discussions with the agency, do you have enough, maybe? I guess preclinical data around abusability. We'll have animal data around abusability to have that included in the label. Thanks, Tim. I appreciate those questions. So first, as to BTD or breakthrough, look, that's always the aspiration of any company that's got something in a space that we have. It's always an advocacy matter with the agency.
If you were to get breakthrough status is this something that could impact the development path at all.
And in your discussions with the agency do you have enough maybe.
I guess preclinical data around abuse ability one of animal data around abuse ability to to have that included in the label.
Thanks, Tim I appreciate those questions. So first as to B C. D. A breakthrough well that's always an aspiration of any company. That's got something in a space that we've got it's always an advocacy matter with the agency.
Sean Singh: I think, like I said, we just got done doing something we don't think anybody else has ever done that we've seen, and we certainly have a product profile potential that is different than anything that we see out there. We know the agency is worried about the potential for high abuse of benzodiazepines, given their drug safety communication on that during COVID. We also know that, Unfortunately, social anxiety disorder and other anxiety disorders lead to depression and then lead, unfortunately, with the increasing prevalence that we are seeing, to suicidal ideation.
I think look like I said, we just got done doing something.
We don't think anybody has ever done that we've seen and we've certainly got a product profile potential that is different than anything that we see out there. We know the agencies worried about the potential high abuse of benzodiazepines given their drug safety communication on that and during cold.
Good.
We also know that.
Unfortunately, social anxiety disorder, and other anxiety disorders lead to depression, and then lead unfortunately with increasing prevalence that we are seeing too suicidal ideation. So it's a we already know we have fast track does it mean that you necessarily fall into breakthrough, but certainly something on our mind.
Sean Singh: So, it's, we already know we have a fast track; it doesn't mean that you necessarily fall into breakthrough, but certainly something on our minds. And you're right, too, that it is important whether or not we see this drug as potentially being scheduled. As we addressed a while back, especially with a drug that is administered intranasally, one might think, well, is there some abuse potential there? As we know from the preclinical work we've done and that we submitted to the FDA, and also clinical work, a large body of work, including the open-label study, about 500 subjects with over 30,000 doses. We just were not seeing TEAEs or any, certainly no SAEs, that are usually associated with abuse liability, even in the longer-term open label. Mechanistically, it makes sense because the drug isn't taken up systemically, and most importantly, based on the GABA study that we did pre-clinically and the C14 studies that we did, there's not tissue distribution and direct activity on the abuse liability receptors in the brain, opiate, nicotine, dopamine, and not potentiating GABA, like say a benzo would, also worked in our favor.
And in your right to that it is important whether or not we see this drug is potentially being scheduled as we addressed a while back you know, especially with a drug that is administered intranasal Li one might think well is it is there some abuse potential there as we know from the preclinical.
The work we've done.
And then we submitted to the F D a.
And also clinical work a large body of work, including the open label study about 500 subjects with over 30000 doses. We just we're not seeing.
E T. A's are any certainly no S. Aes that are usually associated with abuse liability even in a no longer term open label Mechanistically. It makes sense because the drug isn't taken up systemically and most importantly based on the Gaba study that we did pre clinically and the 14 studies that.
Did theres not tissue distribution direct activity on the abuse liability receptors in the brain opiate, nicotine dopamine and alike, and and not potentiate and Gaba like say a benzo would also worked in our favor. So I think we're very confident as we continue to see clinical data.
Sean Singh: So I think we're very confident as we continue to see clinical data support the preclinical data and the whole package that says this is a differentiated safety profile because of the MOA. We're confident in a move forward where patients could have the ability to access the drug online on a recurring basis with the drug potentially not being scheduled, no REMS. So we'll see how that continues to go. But what we saw in PALS-A2, again, no TEA more prevalent than 2%. In the large open label study, nothing was more prevalent than 5% other than headache at 8.7%.
Support the preclinical data.
And the whole package that says this is a differentiated safety profile because of the MAA.
We're confident in in a go forward where patients could have the ability to access the drug online on a recurring basis with the drug potentially not being scheduled no rems. So we'll see how that continues to go but what we saw in palisade to again, no T a more prevalent than than 2%.
In the large open label study nothing more prevalent than 5% other than headache at eight 7%. So that's remarkably different than what we often here.
Sean Singh: So that's remarkably different than what we often hear when we're listening to commercials and side effects that are associated with particular therapeutic options. Great, thank you. There are no further questions in the queue. I'd like to hand the call back to Mark McPartland for closing remarks. Thank you again, everyone, for participating in the call today. Again, if you have any additional questions, please do not hesitate to contact us by email at iratvistagen.com or by contacting the individuals listed in our press release issued earlier today or the contact section of our website. Again, we also encourage you to register for email updates on our website to stay connected with the latest news from VistaGen and any future events. Thank you for participating in today's call. We appreciate everyone's interest and support, and we look forward to keeping you current on our continued progress.
When we're listening to commercials and side effects that are associated with particular therapeutic.
Therapeutic option so.
Yeah.
Great. Thank you.
Yeah.
There are no further questions in the queue I'd like to hand, the call back to Mark Mcpartland for closing remarks.
Thank you again, everyone for participating on the call today again, if you have any additional questions. Please do not hesitate to contact us by email at IR at Vista Gin dotcom or contacting the individuals listed in our press release issued earlier today.
Or the contact section of our website.
Again, we also encourage you to register for E Mail updates on our website to stay connected with the latest news from dish to gin and any future events. Thank you for participating on the call today. We appreciate everyone's interest and support we look forward to keeping you current on our continued progress. This concludes the call have a tremendous day.
Mark McPartland: This concludes the call. Have a tremendous day. Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.
Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.