Q1 2024 VistaGen Therapeutics Inc Earnings Call
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Greetings and welcome to the Vista <unk> Therapeutics fiscal year, 'twenty 'twenty, four first quarter corporate update conference call.
During the presentation, all participants will be in a listen only mode. Afterwards, we will conduct a question and answer session at that time. If you have a question. Please press the one followed by the four on your telephone.
At any time during the conference you need to reach an operator, Please press star Zero and as a reminder, this conference is being recorded Thursday August 10 2023.
I would now like to turn the conference over to Mark Slaughter, Vice President of capital markets. Please go ahead.
Thank you Jennifer and good afternoon, everyone and welcome to decisions first quarter fiscal year 2020 for corporate update conference call and webcast. This afternoon, we issued a press release, providing an overview of our progress this last quarter.
We encourage you to review this which can be found on the investors section of the decision website before starting today.
We want to remind you that we may 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 the future in the future any forward looking statements made today of course forward looking statements involve risks and uncertainties.
Results could differ materially from those anticipated by any forward looking statements. We may make today additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2024.
First quarter Form 10-Q for the period ending June 32023, any future filings that will make make with the SEC from time to time, all of which will be.
Which are and will be available on our website and the SEC's website.
With that take care of them, we'd like to thank and welcome all stockholders analysts and everyone taken an interest in visteon.
I'm joined on the call today by Sean <unk>, Our Chief Executive Officer, and Josh <unk>, Our senior Vice President of business operations.
Sean will provide an overview of our progress focusing specifically on the results from our positive phase III palisade trial evaluating the efficacy safety and Tolerability and faster Dino Peach 94, b nasal spray in adults with social anxiety disorder or S. A D followed by a brief opportunity for questions from sell side analysts we want to remind you that this call is being webcast.
It will be available for replay after the call has completed.
The replay link can be found in the investors events section on our website I'd like now I'd like to turn the call over to our Chief Executive Officer, Sean thing.
To update you on our recent inspiring news regarding the palisade two phase III study results.
Thank you Mark and good afternoon, everyone and thanks for joining our call.
As I've said before many times our team has remained steadfast in our core mission, which is to radically improve the mental health and well being of millions of individuals around the world who are suffering from a wide variety of anxiety depression, and other CNS disorders that severely disrupt their daily lives and as we've recently.
It's we solidified a major cornerstone and that mission focused on improving the lives of the over 25 million individuals in America, who are affected by social anxiety disorder or S. A D. There.
It is indeed, an active and growing need for a new faster acting option for treatment of S. J D.
Without abuse potential or the side effects and safety concerns that often are associated with the currently approved medicines.
We remain focused on addressing the significant unmet health mental health need for.
For individuals across a broad range of demographics and in a diverse range of communities across the globe. We're committed to innovation of multiple differentiated treatments in alignment with our mission to shift the treatment paradigm or anxiety depression and multiple other CNS disorders.
So a lot has changed since our last conference call.
Get right to the biggest news in our company's history.
It's been a long time since a positive phase III studies brought new optimism for treatment of social anxiety disorder, and we are thrilled to be in a leadership position the compelling top line results from our phase III palisade, two trial that were announced on Monday.
These phase three results highlight the potential for fast to die at all with its innovative proposed the mechanism of action to transform what's possible for millions of individuals living with S. A D. In the U S and millions more who are affected worldwide.
In the palisade study.
That's the die and all demonstrated a rapid and clinically meaningful reduction in the subjective units of distress score or subs that score.
Indicating that a single administration of first to die at all has the potential to reduce rapidly.
<unk> symptoms during the anxiety provoking situation similar to perhaps have a rescue inhaler used on demand helps a person with asthma.
A recap this was a U S multi center randomized double blind placebo controlled phase III trial.
You know for visits by subject to a clinic that were spaced out a week apart a.
The screening visit our baseline set in public speaking challenge after administration of a placebo nasal spray.
Our second public speaking challenge, where patients were randomized to either faster die at all or placebo.
And then a follow up safety visit.
Third scores were captured at one minute intervals throughout each public speaking challenge and physician and patient assessment of improvement or captured after the second speaking challenge was completed at visit three.
In order to progress to randomization of the second public speaking challenge or visit three subjects had to exhibit high levels of anxiety. During the first public speaking challenge the baseline challenge patients in the study were confined confirmed S 80 patients with a score of 70 or above on the leave what social anxiety scale, which is <unk>.
When we referred to as the El sauce.
Without other primary psychiatric disorders, and not currently receiving active CNS medications in total 141 subjects were randomized in the trial 70 on fast the die and all and 71 and placebo.
The total enrollment reflects the pause in enrollment.
We received top line results from palisade, one to allow for independent Biostatistician to conduct an interim analysis of the 141 patients who were randomized and had completed the trial up to the date of the Pos.
Although the results of the independent interim analysis indicated that continuation of policy to would not be futile.
Business reasons, we elected to extend our pause the palisade two pending our assessment of the then impending topline results of our palisade open label safety study.
The result of two S. A D public speaking challenge studies conducted by peer companies.
Further discussions with the FDA regarding the continuing acceptability of the SaaS as the primary efficacy endpoint in phase III studies for the treatment of S. A D as well as a comprehensive assessment.
Important assessments of the expense time statistical and regulatory implications and logistical challenges associated with resuming policy too.
Following positive results from our Palisade open label study the results of the two S. N E. Public speaking challenge studies conducted by peer companies each of which did not meet.
Their primary efficacy endpoint is measured by the subs.
And our positive discussions with the FDA in early 2023 about the continuing validity and reliability of the SaaS as the primary efficacy endpoint for.
For strategic reasons, we chose to close palisade, two with 141 completed subjects rather than redo them to resume the study.
And randomized an additional 67 subjects for a total of 208 subjects as originally planned.
It's very important to note that through this process healthy two was not altered in any way.
It was simply stopped early with an intention to treat population of 141 subjects instead of the originally planned 208.
Statistical analysis plan was followed US was followed as originally planned it was similar to palisade, one and did not require a type one error correction because the study was not altered in the blind was never compromised as a result of the interim analysis.
The primary endpoint and policy to was a difference in mean <unk> score during the public speaking challenge that visit to baseline and visit three treatment prepare for patients who receive faster dine all compared to placebo.
But if the diurnal treated patients demonstrated a statistically significant greater change in least squares means that score with a reduction of 13.8 points compared to a reduction of eight points of difference between groups. The 5.8 with a P value 0.015.
We believe these results be clinically significant, especially considering there based on a single dose of faster Dino and a highly provocative public speaking challenge and are supported by high responder rates captured in the secondary and exploratory endpoints.
He had a secondary endpoint the clinical global impressions improvement scale are C. G III.
The di and all demonstrated a statistically significant difference in the proportion of clinician assessed responders versus placebo as measured by the C. G III.
Were identified as those who have rated us very much less anxious or much less anxious.
After the visit three with 37, 7% a fast the die in all treated patients read it as responders as compared to 21, 4% those treated with placebo.
With a P value of 0.033.
What these results clearly demonstrate that positions were able to recognize the improvement in patients on fast the die and I'll, even with a full week between two public speaking challenges.
<unk> two study also had an exploratory endpoint patient global impression of change scale or P. G. III very excited by the patient's ability to.
They have recognized their improvement on faster dying all because responders were identified on that scale as those whose sulphuretted very much less anxious or much less anxious after visit three.
An impressive 46% of fast and I'll pass the die in all treated patients rated themselves as responders as compared to only 18, 6% of those treated with placebo with a P value of 0.003.
This responder rate of more than double the rate of placebo clearly illustrates to us that patients could appreciate the improvement in their ability to deliver their speech and it's highly relevant clinically when you think about the potential for patients to engage with less fear.
<unk> avoidance or their anxiety provoking events situations.
Especially as they continue to use pass of dying all over time as we saw from Lsats data.
In our placebo controlled phase two crossover study and our open label Palisade Open label study.
In addition, other than the other important exploratory endpoint the percentage of fast the die and all patients who improved by 20 or more subs points that visit three was almost double the rate of placebo with 35.7% our fastest INO patients dropping by 20 or more points compared to 18.
6% on placebo of.
20 point drop is very clinically relevant.
And likely makes a difference in improving patients' ability to engage in an anxiety provoking events.
From a safety standpoint, similar to all of the prior studies. The first the diet all completed to date, including our large palisade open label study.
That included 481 subjects in over 30000 doses of faster Dino that were administered in that study.
First the die and all on policy, two was well tolerated with no serious or severe adverse events and there was no treatment emergent adverse events occurring at a rate above one 5%.
So now let's compare the primary endpoint in palisade to do the primary efficacy endpoint result in palisade one.
As many of you know, it's not uncommon in menthol studies to have both positive and negative studies in separate studies of similar design, particularly true.
Of the subject scales that given the sub to scale that has to be used in such studies and the potential for high and unexpected variability in placebo effects as we saw in palisade one.
This becomes even more likely when you add the task of consistently administering a complex public speaking challenge across numerous sites during an unprecedented pandemic.
The health crisis, and mental health epidemic. The key difference in the outcome of palisade, one compared to palisade two with a much higher placebo effect in palisade won.
The drug effect in both studies was similar.
This was generally true across the primary the secondary and exploratory endpoints. The end result was the primary endpoint in palisade one.
What was the least squares mean change in subs from visit to visit 315 six points for fast the dyno and 17.3 points for placebo the P value of <unk> 506.
We firmly believe that the systemic variability introduced by the pandemic contributed to these very unexpected and very different results between these two studies.
A large portion of palisade one was fielded in 2021 through the height of the second wave of the pandemic.
The vast majority of policy to what's fielded in 2022.
The acute phase of the pandemic has subsided.
This dynamic likely impacted palisade to disproportionately in terms of patient mindset.
Study protocol execution study oversight.
Subjects randomized in 'twenty, 'twenty, one likely where given where different given the overall level of anxiety and uncertainty in general unrest restrictions mask wearing.
And the like during the acute phase of the pandemic.
The high placebo rate in palisade. One also mean attributed to logistical issues caused by COVID-19, and 21, such as high site and C. R. O employee turnover absenteeism changes in Raiders time lapses between visit to visit three due to unpredictable and intermittent clinical site closures patients.
Postponing travel.
Monitoring visits and alike.
As these dynamics became apparent as the acute phase of the pandemic subsided in early 'twenty 'twenty. Two we also initiated retraining and renewed monitoring of sites as is customary with staggered start replicate studies and that too may have had a much larger larger impact on policy to consider it.
Was completed before the majority of patients went through that study.
We view the results of palisade, one is an outlier.
Driven by the aforementioned reasons and we are highly confident in the potential of faster die at all in future studies, given multiple positive phase III studies efficacy seen on the exploratory end point and the palisade open label study.
And now the strong results in our placebo controlled phase III palisade trial.
This is especially meaningful after the recent multiple failures in S. E. T studies by peers that may have been subject to similar systemic variability from the pandemic.
With the statistically significant and clinically meaningful results of palisade too.
We're now positioned to move our phase III development plan forward with the additional studies needed for a potential NDA submission, including our palisade three trials and field this trial, allowing us to not only confirm the acute benefit faster Dino.
Confirm what we've also long belief that the acute use the fast the Dino for SCD events continued over time will lead to a reduction in disease severity.
Coupled with the safety and Tolerability profile, we have already demonstrated we believe fast the die and all will be the ideal approach just to S. A D treatment in the future.
Preparations are now underway to initiate these next studies protocol for palisade three will be substantially similar policy too.
Again as the primary efficacy endpoint in clinic based public speaking challenges and the study design a fearless we substantially similar to the multi week real world registration trials for the only three drugs approved for the treatment of S. A D decades ago using the <unk> as the primary.
Endpoint.
As a new class of medicines are five candidates very nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas at the head of the class Dan's faster die and also potential as demonstrated in the phase III palisade trial.
That set the stage for the first fundamentally new class of medicine for individuals living with S. A D and more than 20 years.
Positive palisade to.
Bolster our growing collection of evidence supporting future clinical studies, a fast the dyno across several disorders and it gives us further confidence in the promise of our Ferring pipelines untapped potential overall.
We've had some recent in recent advancements in our other parents programs. So let's take a brief look at those.
Results from our successful U S phase one trial of like true loan previously referred to as ph 10.
Build on successful phase, one studies and a positive randomized double blind placebo controlled phase Iia study of <unk> in major depressive disorder or M. D D.
Previously conducted in Mexico and stage, a true BOE now for phase II development in the United States as a standalone rapid onset bearing product candidate for the treatment of M. D D.
Phase one trial was randomized double blind placebo controlled and investigating the safety and the Tolerability of a single dose and multiple doses of by triple nasal spray in healthy adult subjects.
No reported serious adverse events or discontinuation that were due to adverse events in the study.
All of <unk> nasal spray was well tolerated and demonstrated a favorable safety profile consistent with all prior clinical studies of our troops.
Bright people and we also reported important preclinical data radio labeled intranasal I true bone in laboratory rats, which further validates its potential to treat M. D D without systemic absorption. These new data. Additionally support the proposed mechanism of action of a true bone nasal spray as binding to receptors.
The peripheral seamless sensory neurons in the nasal cavity, but not to know rona receptors in the brain, thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure.
As was the case when.
We completed a similar study with lots of Dyno. These critical preclinical data further the substantial body of evidence supporting our troops and favorable safety profile.
We're continuing our preparations for advancing into phase <unk> development of our true bone for M. D D in 2024.
We're also very excited about our ph Eddie ferry nasal spray, which has been highly studies in multiple indications. We recently reported a positive exploratory phase Iia trial of CH 80, nasal spray, which provides new optimism for the acute treatment of moderate to severe vasomotor symptoms or hot flashes and women do.
Menopause.
In a randomized double blind placebo controlled exploratory phase Iia clinical study of PHA and eat it was designed to explore the efficacy safety and Tolerability of P. H a D for the acute treatment of menopausal hot flashes of women P. J D induced a significant reduction in the daily number of hot flashes compared to placebo.
At the end of the first week of treatment and the improvement was maintained through each treatment week until the end of the treatment period.
Baseline subjects reported a mean daily number of hot flashes up seven seven in the P. J D Group <unk>.
18 subjects and 8.0 and the placebo.
<unk>.
Of 18 subjects as well after one week of treatment number of hot flashes dropped to two eight in the Th 80 group and six four in the placebo group for a P value of less than 0.001.
And after four weeks of treatment the number of hot flashes dropped to 1.5 in the JD group and five one in the placebo group or a P value of less than 0.001.
P. J D treatment also significantly reduce the severity and the disruption in function and sweating related to hot flashes during the treatment period as compared to placebo.
T J D as well as our other fairings was well tolerated no serious adverse events and they have the adverse event profile comparable between ph alien placebo.
All 36 subjects completed four weeks of treatment and no subject discontinued participation in the study as a result of the adverse events.
One of the favorable aspects of running additional trials in this particular indication that there will be objective measures for these studies that is to say it's easier to measure how many hot flashes are experienced and their frequency of those symptoms versus more subjective endpoints that we have seen in some of the other studies in different indications.
Given the depth of our entire CNS pipeline and a robust body of successful safety and efficacy studies to date.
We're also pursuing multiple potential strategic development and commercialization partnerships, both global and regional to efficiently unlock the full value of our product candidate portfolio.
We believe global and regional partnerships, especially for commercialization to amplify our internal expertise and development activities and potentially accelerate key development timelines.
And enhance overall, our efforts to deliver differentiated treatment options.
So now for some some brief comments about our financials.
We've been able to reduce our cash burn rate.
As you will see in our to be filed 10-Q shortly.
And we've been implementing corporate initiatives to streamline operations in order to conserve our resources.
Do not anticipate any significant near term cash burn increases.
As for our cash position.
We've recently taken advantage of the unusually high trading volume in our stock strengthened cash position on our balance sheet by over an expected $30 million in gross proceeds.
Put this in high trading to put this high trading volume into perspective more than $1 billion worth of our stock has traded since the announcement of the policy to results on Monday for trading days ago.
As is industry standard we established an at the market agreement with Jefferies over two years ago.
Back in May of 2020 one.
Until just recently, we would only use this very sparingly back in calendar.
Calendar Q3 of 'twenty one we.
It will be continue we will continue to be very judicious in how we use this vehicle going forward and we have plenty of capacity remaining under our ATM to further strengthen our balance sheet should we wish to do so as well as other strategic financing options and potential non dilutive grants and partnering arrangements.
So in closing we remain steadfast in our core mission to improve mental health.
And wellbeing worldwide.
We continue advancing the next stages of our corporate development plan, we move forward with a solid team.
A strong pipeline and an unwavering drive to innovate better solutions for CNS disorders in large primary care markets with significant unmet needs.
So on behalf of the visits and team. Thank you again for the privilege or the opportunity to make a difference.
Thank you Sean Jennifer we'd now like to open up the call for questions from the sell side analysts participating on the call today.
Thank you.
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Okay.
And our first question is from the line of Andrew Tsai from Jefferies. Please go ahead.
Hey, everyone. Good afternoon, Thanks for taking my questions and I wanted to offer a big congratulations on the recent data. So you know now that you have a policy to on hand.
How confident are you of this study could be one off to you know traditionally supportive placebo controlled pivotal phase III studies for a filing and then second to that is do you think you'll meet with the FDA and if so when could we get a resolution on the next steps in the NDA package.
<unk>.
Well, Thanks, Andrew I appreciate the question and thanks for the congratulations it's certainly enable it right whether the FDA acceptance trials pivotal that's always to be determined downstream by the FDA, but there's.
There's no doubt in our mind, we didn't change anything it's the only difference as I noted was the number of subjects. So there's no type one error. There's no protocol amendment there was no deviation at all.
From the original plan other than the number of subjects, so having a highly stat Sig results with the profound safety profile that we've seen now in hundreds and hundreds of patients that.
That had been exposed to first the Dino.
You already remember, we had FDA feedback regarding abuse liability and a favorable amount of feedback from the FDA and that was even before our open label study delivered the results we reported.
I mean, I like where we stand.
Having something in this disorder with a validated endpoint with highly static data and clean safety data.
I really like our chances so.
It's certainly going to be a key pillar in our NDA submission downstream should we get to that point with additional studies.
At least one that honestly.
Hum.
And then you know.
Now that youre going to do a pop palisade three as we think about the potential outcomes do you think palisade three.
Would look similar to what you saw in palisade, two or something even better.
Because I dunno palisade too, there's maybe some COVID-19 going on but you know the kind of argument would be maybe there's some expectation bias.
Due to the positive results. So how how are you thinking about the outcome of the Palisades three and y.
Well I think there's a lot of reasons of course to be to be confident about our next couple of steps in the palisade three direction first certainly the world isn't really controlled anywhere near to the degree it was in the pandemic and that obviously impacts the entire ecosystem associated with executing successful.
Rental studies.
There's a lot of lessons learned that we have been able to gather from deconstruction of palisade, one for sure and I suspect we will from palisade to things like.
Subjects will have an old factory smell test they'll have will have.
Restrictions on use of nasal swabs upfront of the event. So there's several things that are associated with just modest amendments to the protocol, but there are positive lessons that you typically learn when you stagger starts of studies.
So that plus.
The the training that we've done the proprietary trading models and we have all up and down every aspects of conducting that type of study I don't think there's anybody better to conduct and more expertise.
Dr. Public speaking challenged in a phase II setting than we are.
I have no reservations about that so I really I like our chances going into the study I liked the expertise we have internally I like the four six standards that we've got in our network outside the company certainly Dr. Leave what's plays a key role in our ability to be successful with this clinical program with this drug so.
Yeah, we're excited got it.
Okay, and you know speaking of palisade to going back to the data.
You know when could we expect D. T share detailed results at a medical meeting or a publication, maybe it'd be great to see the curves of sites and so forth and secondly.
You know you've compared our palisade to the palisade one explain the differences.
Like can you also compare to the prior phase two study and maybe compare contrast, any efficacy differences that you saw were there different baseline <unk> scores for instance between these two studies help us reconcile any differences. Thank you.
Thanks, well first to your.
On your question about the data I'm aware this obviously falls into industry standard breaking news. So we're trying to find a nice place to present the phase two data.
Breaking news context, hopefully sometime this fall I think would probably be the earliest.
So we'll have more information on that as we are.
As we go forward certainly abstracts and the like are already in circulation. So.
And then as to your question is about as the policy or to the phase two studies I mean, obviously, it's a different environment, that's where three study or three site study.
But just prints I want you to actually just addresses just.
Just briefly.
Some of the things that we see.
Yeah, Hi, Thanks, Sean.
Everybody just.
To filling the space there.
A key kids the time difference so when we think about how long it's been since.
Those earlier phase III studies were done.
And you think about just the environment that we live in today versus then and through the pandemic and we think that has an effect, but overall to the efficacy seen for both ph 94, b and placebo in that phase II study.
Everything was kind of shifted up compared to what we've seen with palisade two in palisade won them and we really do think that that has to do with kind of the again the times and the types of patients in the conducting that study through the pandemic.
Okay. Thank you very much.
Thanks, Andrew.
And our next question is from the line of Joanne Lee from Maxim Group. Please go ahead.
Hi, good afternoon, thanks for taking the questions and congratulations on the successful outcomes of our recent phase III.
We're truly remarkable I, just given faster dine all achieved positive results and now both how to Andy Open label study could you provide some insight on the rationale behind choosing to pursue both sides in Alsace as primary measure can be Calgary in fear of less studies Ah was this decision influenced by.
You know any guidance from the FDA just curious on that.
No not well.
Thanks, Joanna first of all for the question. It's a great question, but we have long held the way that we think fast the dialogue can help people as two distinct ways that can certainly help people as we've shown in palisade too.
In an acute setting.
And as they take it out of their pocket or their purse or their backpack and they use it on demand and a patient tailored way.
Has the ability to knock down very rapidly those symptoms that said palisade. Two showed we also have placebo controlled phase two data and some exploratory data from the open label lots of subjects that also when it's used acutely but used over time it increases the confidence of a of a person and increases their resilience.
It reduces their tendency to avoid situations that could benefit their lives it reduces the opportunity cost in their lives.
And that avoidance of reduction and avoidance of engaging and social performance situations is important the leawood scale captures both of those so we're at a perfect spot right now because we've got one successful study in phase III.
And you only need two adequate and well controlled studies to get an approval of a drug.
And so it could either be from the palisade three or it could be from a fearless either way what we're trying to do is look to the most efficient path to get this drug to patients as soon as possible and it's one of those two tracks it could be both.
But you only need one other besides the one we've got at least that's our opinion at this point so doing the SaaS based study.
Again, it's consistent with the only three drugs ever approved for treatment of of social anxiety disorder that.
That was the primary efficacy endpoint, we needed to make sure and we did find this out in the fourth quarter that the FDA still believe that to be a valid and reliable endpoint and they do so that provides optionality there the other side as well we already know what they think about the the subs in point in the palisade program.
Importantly, too we have a keen interest given that social anxiety disorders normally.
The onset is typically in adolescents between say ages eight to 17.
There's a huge number as we know of.
Of miners.
Miners, who are affected with mental health disorders, especially social anxiety disorder. The leibowitz scale Theres, an els as C E, which is for children and adolescence, so much easier down the road when we want to extend our.
Our treatment opportunity to pediatrics to run a leibowitz scale based study using a modified version of that scale similar to the way that the adult study was run.
Difficult to envision a 10 year old giving a.
Public speech to a group of strangers, just a much easier to execute down the road.
Pediatric settings as well so it's really a nice combined set either one of the two ideally we see both.
And then you have.
A very robust commercial opportunity that.
It extends into the pediatric arena.
Got it that was really helpful and clearly lots of excitement around the TD program, but we're also really enthusiastic about the broader <unk> platform as well could you just add some color on the current status and progress of those programs Atkins.
Meaning 80, particularly on the lottery a piece 80 with a positive preclinical data we see the whole slashing other symptoms of menopause, receiving a lot of a lot more tension in the area of women's health. So curious if you could walk us through some of the timelines around this program. Thank you.
Sure well first with respect to I true Bona ph 10, that's now after a bit of a long run its stage to go into phase II B development in the U S. Those the efficacy study was run outside the U S and so we really had to start back to the point of a U S IND, enabling program for that one.
Because there had been no prior U S activity or no. Prior U S. I N D. We did the whole standard battery of non clinical studies, followed by a small phase one did and now be able to leap back over we believe the phase Iia that was done and move into phase two b. It's a tremendously exciting program given what we just also learned that.
Like 94 beer Fest, the Dino there's there's no.
Meaningful systemic exposure and the kinds of safety profile benefits that we see from past the die and all are also in the <unk> zone.
Meaning that we.
We didn't we don't anticipate sexual side effects, we don't anticipate weight gain we don't anticipate many of the types of.
Side effects and safety concerns that are associated with the currently approved systemic therapy. So very excited about that as the stand alone.
Treatment for major depressive disorder.
As two P. H a D again, you hit it.
Hot flashes is hot right now with the new N K three antagonist that was approved.
There's been a lot more interest of late in that space. There's an enormous population of course that's affected by.
By Hot flashes for many years with very limited options that don't cause some concern.
Whether it's hormonal therapy or the new.
New class ph 80 is is majorly distinguished from both of those are current treatment options in the antidepressants that are used for hot flashes.
Because again like faster Dino I truthfully, we don't believe it's systemically absorbed.
We think again that it also has the ability with neural circuitry, that's associated with temperature to be able to reduce the daily number of hot flashes that just as we saw in the phase Iia study, but also the severity.
Of those hot flashes in the types of things that disrupt lives, so sledding and and function and the likes so it's exciting that the challenge with that one is like ph 10, we've got to go through what probably will be about a 12 to 15 months IND, enabling program, where we do the CMC work and the pre.
Clinical work that's needed to get back into a phase II setting the difference with this one is that there's a.
There were.
Was a prior U S. I N D. So we don't think we need to do a phase one study in order to get into phase two b for this indication so there'll be a it's not a long there's not a lot of money less than $2 million for design D. Enabling programs. We have to do similar work with ph 15, NPH to 80 for the other two.
Marine assets in the pipeline so.
That's the status of boats.
Got it. Thank you for all the additional details I once again, congratulations and looking forward to more updates this year.
Thanks Joanna.
And our next question is a follow up from the line of Andrew Tsai with Jefferies. Please go ahead.
Andrew Your line is live. Please proceed with your question.
Thank you just a couple of more questions. Thank you. So much for the time I mean going back to palisade too there does seem to be you know a consistent efficacy signal across maryann point. So just wanted to make sure we're.
Are there other pre specified efficacy measures part of this study and if so how did those look I'm just wanted to make sure all stuffs pretty sunshine measure separated from placebo in the stats like manner.
Thanks.
Sorry, Andrew.
Were.
You were asking if there was a separation against placebo across all the endpoints. Yeah. There was one secondary the primary one secondary to explore toys and we reported on all of those so.
For total.
Okay, Great and you know going to the label eventual label if both palisade.
And fear of less succeeded.
What would your eventual label look like for S. A D and.
Would there be precedents around that label claim.
Yeah.
No. There is no precedent for an acute treatment for social anxiety disorder, we would be the first to blaze that trail with first the dyno drugs are used benzodiazepines for example to try to achieve that but with with considerable risk of abuse and misuse and addiction.
But they never they are not approved for the treatment of social anxiety soda. So only the three antidepressants to ssris and wellness.
And they are approved for the chronic condition the the.
They're they're likely it would be no limit in our opinion on how frequently somebody can use the drug acutely if it's palisade two plus palisade three it supports the label initially if it's later eventually.
<unk> came along and the staggered starts which is what we anticipate with palisade three first and fearless second sometime in 'twenty four.
It would be a case, where the drug would be used acutely as needed.
But over time.
And what you're trying to achieve for someone ultimately at the end of the day because they wouldn't have to take the drug.
That's often and hopefully still also combined with with talk therapy. So yeah, the the palisade too.
Hits the <unk>.
The acute side of that matched set fearless would hit the over time, although certainly people wouldn't be precluded from using.
First the dyno overtime, if what's achieved is only the acute level.
Got it.
Quickly as we can.
Think about the NDA package in the future any peripheral studies that you would need to do such as.
I guess repeat them.
Just multiple dosing per.
Per day kind of studies for.
For instance, thank you.
Sure.
So we'll do open label extensions on each of the two the palisade three and the Fearless study. So that there still has to be a safety database that gets established and then the reader study that you mentioned, so I think that's something we've reported before.
FDA wants to see what happens if someone uses the drug twice instead of just once in the acute setting.
That's something we've all before NDA, that's the small study that we'd likely be completing an.
And most likely that would be using a public speaking challenged as well so not too many subjects not too expensive, but again trying to not so much for safety and we don't really worry about multiple uses in a short period of time, but I think there is some interest at the agency and wondering whether more is better.
We've certainly established a 3.2 micrograms use P. R. N is good in palisade too so if.
If better as available great, but it won't be a central component for.
For going forward in I'll say three of the field of study.
Got it I'm actually very last one because I want you know you don't have much opportunity.
On conference calls so in the study our results did ph 94, b work equally as well between males and females and that's that's the last question. Thank you.
I think that's something we'll be able to unpack, we don't have the full data set fully unpack where the top line results. So that takes a little bit of time, but I don't think we see and we've long held since that was I think a long long time ago that that was.
Question, but.
But we think we don't think there's any reason to believe the drug doesn't work as well in women as a man or men and women whichever way you want to put it.
But they give us.
Okay.
Thanks Congrats.
Thank you.
And there are no other sell side analysts in Q you May proceed to closing comments.
Excellent. Thank you Jennifer for your help today and thank you Andrew and Joanne. We appreciate your questions. If there are any additional questions. Please do not hesitate to contact us by emailing IR at <unk> Dot com.
Contacting the individuals listed in our press release issued today or on our web site, where.
We also encourage you to sign up on our website to stay connected with the latest news from decision. Thank you for participating in our call today, we appreciate everybody's attention and support we look forward to keeping you current on our continuing progress. This concludes our call have a fantastic day you may all disconnect now.
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