Q1 2023 VistaGen Therapeutics Inc Earnings Call
Welcome to the Vista Therapeutics first quarter fiscal year 2023 results conference call.
At this time all participants are in a listen only mode.
We will conduct a question and answer session.
I'll now turn the call over to your host Mark whether vice President of Investor Relations. Mr. Father, you may begin.
Thank you Erica Hello, and welcome to decisions conference call covering our first quarter of fiscal year 2023 financial results and business update I'm, Mark flatter Vice President of Investor Relations and Mr. Jim. Thank you for joining us today and welcome to our stockholders analysts and anyone taken an interest in Vista joined.
Joining me today are Sean <unk>, our Chief Executive Officer, and Jerry Dodson, our Chief Financial Officer.
Format for this call will consist of prepared remarks from management, followed by a brief opportunity for questions. This call is being webcast and will be available for replay the link to access the replay can be found in the investors IR calendar section of our website website Vista Gen Dotcom.
Today's call, we will make forward looking statements regarding our business based on our current expectations and current 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 of course forward looking statements involve risks and uncertainties and our actual results could differ materially.
Those anticipated by any forward looking statements that we may make today.
Information concerning risks and factors that could affect our business and financial results is included in our most recent quarterly report on Form 10-Q filed earlier today with the Securities and Exchange Commission or SEC and in future filings that we 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 now I'd like to turn the call over to our CEO Sean thing.
Thank you Mark and good afternoon, everyone and be hot on behalf of our entire team here at Vista and thank you all for joining the call today.
This agenda is working to address unmet men mental health needs in communities all across the globe.
We are focused on improving patient care and mental health and our talented team is driving innovation to help patients live healthier and more enjoyable and productive lives.
Drug pipeline. Currently includes includes three central nervous system therapies that have the potential to fundamentally shift the treatment paradigm for anxiety and depression and other CNS disorders. The prevalence of these disorders has grown considerably since the beginning of the pandemic and it is crystal clear that currently approved treatments.
Are undeserving under serving people struggling with with these conditions individuals' across a broad range of demographics need new faster acting treatment options without having to worry about the negative side effects and safety concerns often associated with currently approved medicines.
We know that we've had a recent setback, but we remain focused on getting pizza 94 be back on track and maintaining our course of developing and commercializing new differentiated treatments with the potential to improve lives and.
In previous studies ph 94, B has demonstrated potential efficacy as compared to placebo.
And a favorable safety profile when used acutely as needed.
Before stressors at home work or elsewhere.
For this reason we have decided to continue late stage clinical development of ph 94, b as a potential treatment for social anxiety disorder of jaw adjustment disorder with things I D and potentially other anxiety disorders.
As a result of the outcome of palisade one.
In addition to our interim analysis of policy too.
We are currently assessing different study designs for submission to the FDA later this year.
This includes studies designs that may consist of multiple administrations multiple use assessments over an extended period of time.
As well as the potential utilization of both the LIBOR, social anxiety scale and a subjective units of distress scale as efficacy end points.
Leave with social anxiety scale, our LSA as is a well established 24 item questionnaire.
The 1987 by Dr. Michael Liebowitz, while he was professor of Psychiatry at Columbia University.
Historically, the Alsace has been the diagnostic gold standard preclinical assessment of social anxiety disorder.
There was the primary efficacy endpoint supporting the approval of the three antidepressants currently approved by the FDA for the treatment of S. E D.
Since our meeting with the FDA back in the Middle of 2020, we have developed extensive new data reinforcing our confidence in ph 94, BS potential to transform the lives of millions of people suffering from the debilitating effects of sandy and other anxiety disorders.
For example, preliminary data from nearly 200 subjects in our palisade open label safety study suggests that as needed use of ph 94, b over overtime has potential to help patients achieve cumulative functional improvement in the severity of social anxiety disorder as measure.
By the LSA S Bay.
Based on a cohort of nearly 200 subjects, who have completed three months of exposure.
We saw increasingly reduced severity of S. A D as measured by the I'll say, yes at the end of each of months, one two and three with a greater than 20 point reduction on the SaaS compared to baseline at each of those time points importantly at three months over half of the subjects in that cohort had a greater than 20.
Point reduction on the El sauce.
20 point reduction on the Alsace is very important and it's usually associated with functional improvement.
This is similar to SaaS scores that we saw from multiple use assessments in the published randomized double blind placebo controlled phase II study.
Conducted by Dr. <unk> in a real world outpatient setting.
Also preliminary data from the open label safety study reflect that the level of severity of social anxiety disorder has dropped over time and many subjects with severe and very severe F. C. D E.
These preliminary data further fortify our steadfast confidence that ph 94, B can help people struggling with S. A D.
Help them reduce joy stealing opportunities from the avoidance of situations and experiences that most of us lean into regularly to enrich the quality of our lives.
It also help reduce fear anxiety and avoidance of situations necessary for building relationships academic achievements and vocational successes.
Notably we continued to see data showing page 94, B's favorable safety profile, which has been consistent through all ph 94, B clinical studies conducted to date.
Ph 94, B's designed to reduce anxiety acutely as needed.
Fortunately the findings from the multiple phase II studies.
Multiple use phase II study, which was conducted again in the real world environment, rather than in a clinical setting suggests that once a person with <unk> experience as a benefit from page 94, B. They may gained confidence in their ability to function in stressful situations and that confidence can persist.
That's our Paramount goal for ph 90 for me and we're seeing similar results in a substantial percentage of subjects in the palisade open label study.
Accordingly, we plan to meet with the FDA later this year.
To pursue consensus around a clearly defined development plan for further phase III development of ph 94, B S D.
This development plan will ideally maintain an emphasis on a multiple use assessment study design with the <unk> as a primary efficacy endpoint as it was for the three antidepressants previously approved by the FDA for the treatment of <unk> and with <unk> as a secondary endpoint.
Our randomized double blind placebo controlled exploratory phase Iia study and adjustment disorder with anxiety is ongoing the study involves daily use of <unk> 94, B in an outpatient setting for 28 days and Dr. Liebowitz as the principal investigator of that study.
As the need for safe and fast acting treatments expands we will continue to thoughtfully pursue ph 94, BS potential as a therapy for various anxiety disorders. In addition to social anxiety disorder and adjustment disorder.
Our team continues to advance other CNS candidates in our pipeline we are developing another ferry nasal spray ph 10, as a potential rapid onset standalone treatment for major depressive disorder and potentially other distinct depression disorders.
We will provide further guidance on our development plan for ph 10 later this year.
101 in combination with probenecid.
We'll complete our phase one b trial as planned later this year. This study follows two positive preclinical studies showing that the combination of <unk> and <unk>.
And probenecid.
Substantially increased the brain concentration of the active metabolite of maybe one to one which is targeted at reducing rather than blocking disordered NMDA receptor signal.
We will provide for the guidance on a development plan for if you Wanna. One later next later this year.
As you can see there's a lot of work underway here at vis agenda to bring new therapies to patients who urgently need them.
I'd now like our CFO , Jerry Datsun to summarize some of the highlights from financial results for the first quarter of our fiscal 'twenty three Gary.
Yeah.
Thank you Sean.
As Sean mentioned I'll highlight a few of the financial results from our first from the first quarter of our fiscal year 2023, I would also encourage everyone to review our quarterly report on Form 10-Q that we filed with the SEC earlier. This afternoon for additional details and disclosures.
Our research and development expenses increased by $9 8 million from $5 5 million to $15 3 million for the quarter ended June 30.
2021, and 2022, respectively.
This increase is primarily due to expenses related to conducting our palisade phase III program for ph 94, b, including palisade, one palisade too.
Palisade open label safety study.
The ph 94, B phase III study and adjustment disorder with anxiety.
As well as non clinical development and outsourced manufacturing activities for both ph 94, B and ph Tim.
Our general and administrative expenses increased to approximately $4 $8 million for the quarter ended June 32022, compared to approximately $2 6 million for the first quarter of the fiscal year ended June 32021.
That increase was primarily due to the addition of senior management and other personnel during calendar 2021 in the first half of calendar 2022.
As well as ph 94, B create prelaunch commercialization market research studies and analyses.
Our net loss attributable to common stockholders for the quarter ended June 30th 2022 was approximately $19 $8 million versus a net loss attributable to common stockholders of approximately $8 $1 million for the quarter ended June 32021.
At June 32022, the company had cash and cash equivalents of approximately $52 million.
As a result of the deferral of several research and development and pre commercial activities involving ph 94, B the company anticipates.
Considerable reduction in our external spending to conserve cash and extend our cash runway for at least the next 12 months.
Again, please refer to our annual and quarterly report on Form 10-Q filed today with the SEC for additional details and disclosures.
I will now turn the call back to Sean.
Thanks Jerry.
So while we would have hoped that palisade one would've been positive we've long believed that the paramount potential benefit of page 19 for being patient.
Would come through.
Cute as needed use but overtime.
The mean duration of SCD for most subjects is somewhere around 20 years in the onset as I've mentioned before it's typically in adolescents between the ages of $8 15.
But the use over time would allow patients to face anxiety provoking situations and engage in the activities that Dave long avoided in the past and.
And given what we've recently learned from palisade, one and the palisade Open label study. We believe LSA asked measurements over time may be better suited to demonstrate efficacy in the true impact of ph knife or be on patients' lives.
We've seen page 94, b improve SaaS scores in both our phase II study.
Placebo published study after two weeks of use and then our recent open label study of a cohort of nearly 200 subjects by capturing the monthly change from baseline on the Alsace.
In both instances, we've seen rapid and robust improvement.
And then the open palisade open label study, we have seen continued improvement over several months.
All of these studies reinforce our confidence in the potential of Peach 94, B to help people to help people in a world, where Saudi and other anxiety disorders are more and more prevalent everyday.
So again, our mission is clear and I'm confident in the potential of our pipeline and our team to accomplish it.
And thats the radically change the trajectory of mental health care and improve the lives of millions of people around the world, who battle mental health challenges, including anxiety and depression disorders everyday.
We're thankful for that privilege and were also thankful for that powerful opportunity to make a difference.
Thank you Sean This concludes our prepared remarks, Erica we'd like to now open up the call for questions.
If you would like to ask a question. Please press star one on your telephone keypad now you'll be placed into the queue in the artery themes. Please prepare to ask a question when prompted once again if you have a question. Please press star one on your phone now.
First question comes from Tim Lugo from William Blair. Please state your question.
Hi, This is Jonathan.
For taking a question.
Wanted to get a little bit more clarity on these preliminary results that youre seeing from the Ali.
So patients are using the drug over time as needed.
<unk> improvement in their acute response to the drug or just in general overall anxiety, regardless, if they've just administered.
And are you also evaluating sites in the open label, where just the lethal at scale.
Yes.
Hi, Paula.
Zaidi disorder study.
And when you have the Hamilton anxiety scale can.
Can you just give us some color on how that compares to science and legal at scale and how youre thinking about that endpoint you might have given us up to date knowledge from condensate tanks.
Yes, I'll work backwards adjustment disorder study has him a as the primary endpoint so totally different disorder totally different study design.
That study the drug is given four times a day daily for 28 days. So it's different it's a different type of disorder in a different type of scale, that's necessary to assess potential benefit in that study.
Looking for a signal.
And that study on him a in terms of what we're seeing in the cohort that I mentioned, that's nearly 200 200 subjects that have completed.
Three months of.
Use of 94, b and comparing their <unk> scores against baseline.
We're just looking at Alsace and so we wouldn't be looking at this case. These are just Alsace data not such related data, but what we are seeing is and importantly, a significant number even after one month are showing.
$20 plus reduction in SCD severity as measured by the <unk>. So that's an important point.
Somewhere around one out of three of them.
Is likely to see that kind of reduction based on this cohort data after only one month.
Okay.
Okay. Thanks for the additional color.
You bet.
Okay.
Our next question comes from Andrew Tsai from Jefferies. Please state your question.
Hi, This is the chi on for Andrew Thanks for taking our question I guess two questions on my part number one the interim palisade to analysis to ensure you just give a little more detail on that like where it's that have you seen any data from the analysis and what you're allergic to die out of the analysis and the second question about.
Palisade one trial what is their leading hypothesis in terms of what happened that drove the difference in the result between the phase II and the phase III and was there any separation with ph 94, b at all in the side stores across the time points.
Well I'll answer the second one first sounds like this is like the San Francisco Giants lineup, we got a lot of pinch hitters. So happy to talk to you I didn't catch your name sorry about that.
As the power one it's still too early there is so much that we need to assess associated with that study. We also with the fact that we have the palisade study.
Study in an interim analysis mode.
We're just going to need more time to try to figure. It out there. There are obviously a lot of things that you can speculate about but it would just be speculation CMC related methodology related COVID-19 related.
There's a lot of potential variables that could've brought noise into.
Two of the study, especially a study that we had to scale up to 20 sites during.
During the pandemic, so there'll be more on that we will certainly expect to give more details at a future date. Once we've been able to go through everything that is available as the data continues to come through.
As to the interim analysis again, that's it's an independent bio.
Biostatistician interim analysis, so we don't get anything on that until the data are gathered by that statistician and then the interim analysis is generating so sometime within the next hopefully in about a month or so.
We will see some.
Maybe a little bit more than a month.
We will see some of the data from that interim analysis and that will give us some guidance and some additional guidance to provide to the FDA when we get in front of them hopefully before the end of the year that's the goal to.
To discuss the path forward, which in large part will depend on what.
What we learn about our palisade one between now and that meeting what we learned from the interim analysis between now and that meeting what we learned further from the open label safety between now and that meeting so.
There's been a lot of.
Doses administered in that open label safety study over 25000 doses. So we'll have a robust body of work and Theres been a lot thats generated since that last time that we met with FDA in the middle of 2020 to settle on this designed for palisade wanted policy too which was.
Which was using the sides as the primary endpoint. So we're going back into that discussion obviously with the mindset of seeing what we've seen or will see related to the palisade studies, but at the same time, we are we're not going for an endpoint that is without precedent.
So the three approved drugs they are all antidepressants for.
Social anxiety disorder.
Were all approved on the basis of that gold standard Elsa, So which is why we've been focusing a lot on it then you remember most of you that we had the two different studies.
In phase II, both one that was real world based with the SaaS as one of the endpoints and then the other was the.
The single use assessment like palisade, one in palisade too.
A clinical environment. So there's a lot to talk about with the FDA and what we do know is we're confident in the ability of the drug to make a difference in the lives of people and that's what we Gotta do now we've got to find the study design that fits.
The pharmacology and what we're seeing in the studies that now involve multiple assessments over long periods of time.
That's how we see the drug being used in the real world. So.
Got it got it. Thank you yeah. Thank you for the details and understand that there is still a lot going on with palisade, one and so figuring that out but just wondering if you can share how that drug and placebo arms performed relative to phase II. The primary endpoint and like what's there led to higher placebo response. The first is the phase III for example.
We will get to that later, we're not ready to put it out right now in the context of the interim analysis.
We need to see more data, but we'll put more details out of that in a future date.
Didn't hit the primary endpoint. So simple is that at this point.
Got it got it thank you.
Yeah.
Our next question comes from Brian <unk> from Baird. Please state your question.
Hey, good afternoon, guys. Thanks for taking my question.
On the open label extension.
What you said about 20 point reduction.
Just a couple of questions. There I guess at what point is the two point reduction from I think Theres, a couple of different time points as it going into the challenge.
Itself is it some average baseline leading up to the challenge just trying to get a feel for when you say, a 20 point reduction, but it's not sort of.
At our peak anxiety portion of the study.
And then I assume.
Label, everyone sort of knows that they're going on treatment. So there's some placebo factor I guess have you looked back historically.
Initiation of something that Ah patients being told as an active treatment what sort of placebo effect you're going to have.
In sort of a three months period.
Yes, Brian those are good points.
All solid no question about it.
Remember this study design is is different than the palisade study. So this is again more like what we saw in the phase II study, where people took the drug and have the at home and they were had the ability to take it up to four times a day over a two week period here what happens it's the same thing people over.
Multiple months.
And it continues.
They are set a baseline ourselves right at the visit where they are dispensed drug for the first time and so the subsequent 20 point increases at one month, it's about 40% to two months a little bit over 40% three months over 50% of that cohort on the SaaS saw reduced anxiety.
On the SaaS right so each month.
Compared against the baseline.
For that particular subject.
So.
And yes, 20 point drop anywhere on that LIBOR, social anxiety scale, which for many of you. If you don't know that scale.
Dr Liebowitz established.
It provides a score across 24 different questions, both as to fear or anxiety and also as to avoidance. So that combined score, but at 20 point reduction really on any point of the scale, where the subject is at baseline is a very significant change in that.
<unk> ability to manage their CD, so lets say someone was a severe.
Subject and they dropped 20 points on that scale, they would drop down to somewhere in the moderate social anxiety scale. So so we think 20 points is it's a big deal in some cases, it's been a little bit more than that but.
What what we saw is that basically for every two patients in that cohort who were treated with 94 b for three months one of them would show a 20 point or greater reduction in SCD severity as measured on the Lcs.
And even at the one month point it was basically for every three years or so patients with treated with 94 B and again they are doing this at home on their own as provoked as needed because its an acute as needed.
Dynamic that we want to assess what this drug how do people when they are about to embrace what typically is anxiety provoking for them situation social performance whatever it is.
They use the drug acutely.
And but that acute use over time builds confidence.
Success building on success, we see that that's what we see underlying the continued improvement and you use the SaaS to look back.
Over the prior week, which.
Which is why it's more of a chronic clinical assessment tool.
And these are the signals and of course, there is something to be said about placebo.
Typically.
People aren't going to hang around in a long term safety study.
Placebo at some point doesn't work but.
We're taking that into consideration. So it's again, it's just a signal and it's going to be guiding us as to how we would design I'll go forward phase III study that can build on.
Really the composite framing of all this work that's been done so far.
Alright, Thanks, Sean.
Okay.
Once again, ladies and gentlemen, if you would like to ask a question. Please press star one on your phone now.
Yeah.
Okay.
At this time, we have no more questions.
Thank you Erica if you have any additional questions. Please do not hesitate to get in touch with us by E mailing IR at <unk> dot com or contacting the individuals listed in our press release issued today.
Also encourage you to sign up on our website to stay connected with the latest news from Vista, Jim. Thank you for tuning in and we appreciate everyone's attention and support and look forward to keeping you current on our continuing progress. This concludes our call have a great day you may all disconnect now.
That concludes today's conference call. Thank you for attending.
The host has ended this call goodbye.