Q4 2023 VistaGen Therapeutics Inc Earnings Call
[music].
Greetings and welcome to Vista Chin Therapeutics fiscal year end 2023 corporate update conference call.
At this time all participants are in a listen only mode.
Question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
A reminder, this conference is being recorded.
It is now my pleasure to introduce your host Mark Mcpartland Senior Vice President of Investor Relations. Thank you you may begin.
Thank you Jody good afternoon, everyone and welcome to basically James fiscal year end 2023, corporate update conference call and webcast.
This afternoon, we issued a press release, providing an overview of our progress last year.
Milestones that we expect to file our fiscal year end 10-K later this afternoon.
We would encourage you to review, both which can be found under the investors section of our website.
Now before we start today's call I want to remind you that we may make forward looking statements regarding our business based on our current expectations and information.
The 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 statements made today.
Of course forward looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated.
Any forward looking statements we make today.
Additional information concerning risk factors that could affect our business and financial results is included in the fiscal year in 2023 Form 10-K, which again will be filed later today, which can also be found on our website or the Securities Exchange Commission website at SEC Gov.
And the future filings, we make with the SEC from time to time, all of which will be available on our website and then they see T website.
With that taken care of I'd like to thank and welcome all of our stockholders analysts and all of you taking an interest in this region I'm joined on the call today by Sean Zhang Our Chief Executive Officer, Sean will provide an overview of the company's progress made in 2023 upcoming milestones followed by a brief opportunity for questions for myself.
The analysts.
To remind you again that this call is being webcast and recorded and will be available for replay. The replay link can be found in the investors section of the website. Mr. Jin Dot com now at that time, I would like to turn the call over.
Sean Zhang our Chief Executive Officer, Sean.
Thank you Mark and good afternoon, everyone. Thank you for joining our call.
As we've discussed many times physicians core mission is to radically improve the mental health and the wellbeing of the millions of individuals worldwide.
Suffer from a variety of anxiety depression, and other CNS disorders that severely disrupt their daily lives.
To that end each of our innovative clinical stage CNS product candidates is designed with the potential to establish new standards of care make meaningful differences.
Patients manage their disorders and improve their lives throughout the year, we continued to advance our coke core programs for treatment of social anxiety disorder with faster Dino.
Major depressive disorder with like true long rates.
We achieved multiple clinical and regulatory milestones that are necessary to stage, what we see as key advances in those programs this year and beyond.
We also advanced strategic planning for our other four clinical stage product candidates, specifically th 80 for the treatment of menopausal Hot flashes, which is a large and unsatisfied market.
We are also advancing planning for further U S. I N D, enabling development facilitate phase two b development of ph 15, rapid onset improvement of attention and learning and subjects with cognitive impairment.
Caused by middle fatigue, and if th 284 for enhancement of subjective feelings of appetite and weight gain in subjects with cat Secchia wasting syndrome, that's associated with cancer or other disorders related to appetite loss.
With the depth and our collective body of positive safety and efficacy studies supporting our clinical stage pipeline now is the opportune time to amplify our internal efforts to secure multiple global and regional strategic development and commercialization partnerships across our entire portfolio to excel.
Great achievement of key clinical regulatory and commercial milestones within each program and deliver meaningful value to our stockholders into the millions of patients who are affected by these disorders.
Affecting both the mental health and their physical well being.
I'll begin with a brief update on Paas Dino, formerly called Th 94, B in our phase III program, and social anxiety disorder or S. A D.
Earlier this year, we reported it long term intranasal administration of <unk> 3.2 micrograms of Paas Dino self administered by patients as they needed at up to four times a day to manage their anxiety provoking situations in a real world setting was well tolerated with no new safety findings of trends identified regardless of the number of.
Doses administered by each subject overall in that study patient self administered over 30000 doses of faster die at all with the main duration of four months and a maximum study duration of over 10 months.
In exploratory efficacy results from that study demonstrated clinically meaningful reductions in fear anxiety and avoidance of anxiety provoking social and perform a situations in the daily lives of the patients involved as measured by the LIBOR, social anxiety scale or El sauce, we.
We believe the continued improvement in SaaS observed in hundreds of patients in this large study, including patients from both palisade, one and palisade to IND.
In the case of the therapeutic potential of multiple patient tailored as needed administrations of SaaS or dying all over time.
Fast at Idaho helps patients build their confidence to engage in these anxiety provoking social situations in their daily lives more frequently and with less fear and anxiety.
Further the safety and exploratory results in Phase III open label study of faster dying all along with the previous safety and efficacy results from multiple placebo controlled phase two studies, including a placebo controlled study conducted in a real world setting built support for a meeting with the FDA to this.
Because the next steps in our Peerless phase III development plan Professor buy in all honesty I D.
That is centered on the potential new drug application, enabling phase III studies, the first to buy it all in a real world setting using the SaaS as the primary efficacy outcome measure in a manner similar to the registration studies for all three of the FDA approved treatments for S. T D.
Results from our placebo controlled phase II studies demonstrate that self administration with Paas, the Dino on an as needed basis prior to anxiety provoking situations as exciting potential to achieve fast act and a persistent change in overall their city symptoms reduce fear and anxiety about social and performance situations.
And enable less frequent avoidance or those situations as measured by the El sauce.
Notably the amount of separation between faster buying all simo as measured by the SaaS at the end of the first two weeks in a placebo controlled phase II study conducted in a real world setting was comparable to SaaS results observed after 12 weeks and the registration trials through the three antidepressants.
<unk> approved by the FDA for the treatment of Mercedes.
Positive feedback from the FDA earlier this year confirmed the acceptability of our preferred use of the SaaS as the primary efficacy end point in our future phase III studies facet I know for the for the treatment of S. E D.
Again in line with all three of the previously approved products.
Our fearless phase III program that Sidney will align with the ulcer study design supporting the precedent setting NDA, enabling programs, where all three antidepressants currently approved for the treatment of U S. A D.
This peerless phase III studies will be designed to assess multiple administrations of paas or die at all on a patient tailored as needed basis in their daily lives up to six times per day in a real world outpatient setting over a multiple week period.
The clinician administered SaaS as the primary efficacy endpoint.
So with clarity from positive regulatory feedback on the path forward.
The fda's previous granted fast track designation for development of first of all in all for Us D. We're now positioned to finalize our full NDA, enabling peerless phase III development program for Paas about at all.
And for a large market program that is well suited for late stage partnering to complete phase III development and if successful commercialized faster die at all in the U S. In multiple markets worldwide for a disorder that is increasingly impacting the lives of tens of millions of patients in the U S and around the world.
Moving next to a truthful, formerly ph 10, very nasal spray candidate for potential rapid onset treatment of major depressive disorder or M. D D.
We reported favorable safety and Tolerability data from our U S phase one clinical trial with my true home whichever one was well tolerated and consistently continues to demonstrate a favorable safety profile.
Importantly results from this study builds on previous successful phase one studies and published positive placebo controlled phase Iia study of <unk> and M. B D that was conducted outside the U S. So the collective body of successful clinical studies now enable us to focus on next up phase II development of <unk> phone in the U.
<unk> is an innovative standalone rapid arc rapid onset product candidate for the treatment of MPD.
During the past year. The FDA also granted fast track designation for development of <unk>.
A M D D.
So like fast adopting all for S. E T I too long is nowadays for strategic partnering in the U S and multiple large depression markets outside the U S.
We also recently reported that ph 80 demonstrated statistically significant efficacy versus placebo in a previously unrecorded exploratory phase Iia clinical study for the acute treatment of vasomotor symptoms that aren't known as hot flashes due to menopause.
The study P. J D again statistically significant reduction in the daily number of hot flashes compared to placebo at the end of the first week of treatment and that improvement was maintained through the end of the four week treatment period.
P. J D treatment also significantly reduce the severity disruption in function and sweating related to hot classes during the treatment period as compared with placebo.
As we've seen with all variants of our pipeline P. J D was well tolerated with no serious adverse events and an adverse event profile comparable to placebo and all the clinical trials of that drug candidates to date.
Problems of menopausal Hot flashes is estimated to be about 20 million women in the U S with $9 million more women are estimated to be suffering from severe hot flashes.
Current treatments are associated with a certain side effects and significant safety concerns. So the pressing need for improved treatment options is evident when considering the millions of women, who endure the disrupted impact menopausal hot flashes in their daily lives.
Also with its novel rapid onset mechanism of action P. J D is designed to initiate in the Olympics as an old factory bulb transmitted by pathways that rapidly effect.
And a money multiple structures in the brain, including the amygdala and the hypothalamus.
<unk> mechanism of action. We also believe PHA D has therapeutic potential relief from.
Monitory, an oral symptoms of migraine.
We recently expanded the intellectual property portfolio with JD to a close.
And what of migraine the U S patent issuance and an intention to grant a European patent.
So we look forward to preparing for potential future development of <unk>.
Page 15, and page 284 as well.
These are two candidates that are also in phase II development. When we're assessing the results of previously unreported exploratory phase two studies placebo controlled phase III studies involve page 15 for improvement of cognition, especially in sleep deprived populations and page two.
Before or improvement, it's subjective feelings of hunger and late stage cancer patients in particular.
So it was with <unk>.
That's the easy one to one our oral NMDA receptor antagonist based on observations and findings from several preclinical studies and successful phase. One studies, we believe <unk> has potential to become a new oral treatment alternative for certain CNS indications that involve the NMDA receptor.
Recently, we strengthened our E. If you wanted one intellectual property portfolio after receiving a new patent granted by the European patent office, that's related to the San Francisco may be one on one certain chemical intermediaries that attract that enhances the attractiveness they'd be one to one is a valuable asset for potential strategic development and.
Commercialization partnerships.
So we are currently pursuing partnering and non dilutive grant opportunities for phase Iia clinical development that may be one on one as a treatment for one or more of those neurological disorders involving NMDA receptor likely with emphasis on dyskinesia associated with Parkinson's disease.
We believe our robust CNS pipeline puts us in a place a scientific strength in the field.
We have a broad range of positive clinical studies across multiple product candidates in multiple indications with potential for long term value creation and meaningful impact on the treatment landscape for millions of individuals affected by anxiety.
Freshen Hot flashes and several other large market CNS disorders.
Moving to our business strategy earlier this month, our board of directors authorized the stockholder approved reverse split of our common stock.
Primary corporate strategic objectives for implementing that stockholder approved reverse split included the following first and foremost we implemented the reverse split three establish compliance with nasdaq's minimum bid.
<unk> requirement to help ensure that we maintain the numerous benefits of listing our common stock on the NASDAQ capital market.
We recently announced regaining full compliance with the continued listing standards of the NASDAQ capital market, So with our stockholders, we achieve that objective.
Second.
The reverse split enables us to increase awareness of Vista, and the therapeutic and market potential of our six clinical stage drug candidates both in the capital markets among prospective strategic partners.
And among health care focused media.
Finally, the split May broaden our capital market base.
Enhanced access to institutional investors mutual funds family offices general investing public and health care focused sell side research analysts all are key components of our ongoing efforts to advance awareness understanding and the potential value of our CNS pipeline with our key stakeholders.
Given the depth of our CNS pipeline in the robust body of successful safety and efficacy studies achieved to date.
We are now pursuing multiple 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.
Amplify our internal activities and can accelerate key development milestones and timelines and enhance overall, our ongoing efforts to deliver a differentiated treatment options and significant value to our stockholders.
In closing we remain unwavering in our core mission to improve mental health and wellbeing worldwide.
As we continue advancing the next stages of our corporate development, we moved forward with a strong team.
A strong pipeline and a strong purpose that drives us to innovate better solutions for CNS disorders in large markets with significant unmet needs.
On behalf of our entire business and team. Thank you for the privilege and for the opportunity to make a difference.
One mind at a time.
Thank you Sean.
Operator, we would now like to open up the call for questions from the sell side analysts participating on the call today.
Thank you.
Our first question comes from the line of Jason Mccarthy with Maxim Group. Please proceed with your question.
Hey, guys. Thanks for taking the questions. It sounds like you've you've made a tremendous amount of progress. This year, so far and looking forward to what comes next but I'm sure I can can you explain.
A bit further why do you think the multiple dose assessment real World study design with the L test as the primary endpoint is a better approach than the single dose assessment public speaking challenge with <unk> as the primary I know you touched on it a little bit earlier, if you can just elaborate.
A bit further and why Youre confident in the new phase III study design.
Sure. Thanks, Jason Great to talk to you.
Well as you know Dr. <unk> is Dr. Michael LIBOR as the innovator of the SaaS.
And the clinical investigator who was involved in the registration trials for the three approved drugs for the treatment of <unk> and the published placebo controlled phase two studies of Paas, the Dino and S E D.
And he will be the principal investigator in our Peerless phase III program, so that matters.
His prior experience not just with Paas the die at all but obviously with Yale SaaS over the last 50 years.
Is incredibly important and we have developed with him our proprietary multi step.
SaaS training program that all the potential sites have the past his until our satisfaction before they can be included in the Peerless study. So those are key advantages unique to our phase III program.
But as it measures the overall improvement in disease severity by measuring both reduction they fear and anxiety over time about social social situations.
But also the reduction and avoidance of those anxiety provoking situation. So youre looking at patient related dynamics over time over multiple administration.
Whereas in the public speaking challenge with the subs that was a single.
Dose and a single provoke anxiety provoking situation the public speech.
We and Dr leave what's in all the Kols that we we lean into believe the SaaS by far the most appropriate endpoint to measure the efficacy of potential acesodyne, all and really any other potential treatments for STD because it reflects the true impact of the treatment on the patients' daily lives.
Over time in a real world setting.
And again using the El SaaS as the primary endpoint a fearless Chase III program is consistent with design wall the registration trials.
D M D as a precedent setting approvals for treatments diversity so.
We met with the FDA.
In the first quarter.
Because when we met with the FDA in 'twenty it wasn't possible.
Cause of Covid related restrictions in the world being sheltered in place it really wasn't possible to do the precedent base.
Real World SaaS, driven phase III studies, we could however is.
We all know.
We did do the clinic base.
Public speaking challenge using the suds, which is a different endpoint that hasnt supported any prior approvals but.
At the time that was the type of study that could be done. It was okay to do obviously, because we had a highly stat Sig phase II study I think what we didn't all understand time was noted many others the.
The impact of Covid brought to bear on executing studies like that and on the patients involved in the studies, but we met with FDA mainly in.
And this isn't the first quarter of this year to confirm that the SaaS.
Even though a drug hasn't been approved for S. A D for 20 years that the SaaS remains a valid and a reliable primary efficacy endpoint for potential NDA, enabling phase III studies are first dial in S. A D very important point when we're discussing.
<unk> partnering arrangements for potential.
Support and commercialization through phase III and beyond with prospective partners, we need to know what the FDA thinks and what the FDA regards as the go to endpoint for treatments for S. C. D. So as we reported we were very encouraged by those discussions with the FDA and again, because the SaaS captures.
Effects over time.
The ability for subject to build confidence build resilience and show through.
Australian of that clinician administered scale that they're hearing things less and they are avoiding things less often.
Great and can you I guess help everybody understand use it use a great analogy for faster die at all.
Got it.
SKU inhaler would be used for has a I think that really helps people understand how this drug can work in a real world setting can you just talk a little bit about that.
Yeah, I'm glad you brought that up it is it's really important to give patients control.
Because sometimes the dressers are predictable sometimes theyre not.
But regardless, what they need is something at hand.
They can decide when they need to use it can knock down the symptoms of anxiety that arise in the context of those situations.
And.
So it's a drug candidate that we've long held needs to be used acutely.
It's a knockdown situations when they arise but also over time similar to cognitive behavioral therapy, where.
<unk> success when exposed to those stressors builds the confidence builds the resilience to engage in those situations more frequently and then to do so with less fear and anxiety. So it's a it's very important again to be able to use our drug candidate <unk>.
Well times in any given day and some days not have to use it because when you are in S. E T patient.
If you're not exposed to your stressors, you're asymptomatic so patients don't really want to put drugs in their body, even super safe drugs. When they think when they don't think they need it in the case of a fast the Dino having that drug in your pocket in your purse in your backpack and being able to have something with onset in about 50.
10 minutes help you through that stressful situation and having that duration of that effect last about an hour to be able to go back to it if the same situation arises or different situation rises are within the same day you seem very important flexible tool again, all intended to build the confidence of the patient.
Over time, which is exactly what the SaaS captures and you cant capture that as.
As well at all with the subs because it's again, that's just the in the moment minute by minute assessment of that acute effect now and use it using it acutely overtime is the way we see this drug will be used if approved in the real world setting by.
By millions of people, who have access to it and the need because of the way their lives are impacted by a C D.
Thank you Sean Thanks for taking the questions looking forward to the continued progress over the rest of the year.
Thanks, Jason.
Our next question comes from the line of Andrew Tsai with Jefferies. Please proceed with your question.
Hey, Hi, Thanks for taking my questions. Good afternoon. Appreciate the the update so the first question is on the fear of less program actually so now you've met with the FDA you're ready to.
Kind of start up the studies one exactly could those studies start specifically and then you know for palisade, one and two are the prior studies or are there plans to share detailed data on either or both of the studies. Thanks.
Okay.
Hey, Andrew Thanks, So it depends right. So Fortunately, we are not really expensive studies each of them, it's about $15 million.
And right now the cost to get the program all the way through to an NDA relatively speaking is actually pretty modest for phase III candidate. So what that does is it puts out in front of us what we see is a lot of opportunities for them.
For phase III development in collaboration with capable partners in this space.
Either globally or multiple regional deals.
Have commercial capabilities that we think can optimize the commercial potential of the drug as well.
It will depend depends on technically piece, we can be in as early as the first quarter of 'twenty four we'll see how things go in terms of types of financing arrangements or partnering arrangements more likely that we can put together in order to.
To underwrite that program. So the important piece that moved things forward, who was very critical was to make sure. We had the kind of clarity and confidence from the agency that they all SaaS was still and is still <unk>.
<unk> go to valid and reliable endpoint for a phase III program.
And again, because now Covid is not controlling anyone's lives anywhere near the degree was the case during the palisade studies.
The large part during the acute phase of the pandemic.
That clarity is in hand so.
We are as you might expect we're on a lot of radars and no one no one.
Has any trouble figuring out what drugs are in phase III that are associated with large CNS markets. So we'll continue to advance on that in terms of palisade, one palisade too.
I think what we see downstream has been when we have a context to put both of those studies together.
And we have the ability to understand some of the impacts that really affected a lot of companies not just us.
In terms of pandemic related impacts not only on just staffing.
And surveillance, but really even on the patients the types of patients that were in studies that's right. He's heard you've heard this I know you've heard this from some other sponsors they since we're just a bit different you know there were.
Well there were cases clearly were.
People might have met the criteria for say S. A D.
Are the diagnostic criteria for S. A D for M D D for.
For other neuropsychiatric disorders during this pandemic.
May not really have had outside the context of a pandemic, but kind of a long term chronic.
Pathophysiology associated with those disorders.
We'll see but I think in terms of the two studies, yes, we'd like to put them together the appropriate context, we'll be releasing the results palisade do once we're in a position to do that sometime during the second half of this year and when the two together, we'd certainly want to put them in front of peers and into a conference presentations that are many.
It's not a publication so a lot of lessons learned from both of those studies, so a lot to be.
Well have to be looked at and want to be assessed.
Great and then shifting to your other variants on page 10 for Depression, Canada can you give us a brief update where this as it stands in the next steps what would the next design of the next study look like for instance.
Yeah, Tracy asked that so I too long.
We know there's nothing but a growing need for innovations in terms of the treatment of depression, especially anything that can act on a standalone basis, and even a relatively rapid onset manner.
Weeks, even better than months.
And so what we needed to do with <unk> was to get it back to be phase two be staged for U S development, either by us or in collaboration with a partner focused on depression and large market commercial capabilities.
And now it's in that spot and we had several successful studies are conducted outside the U S. We had to do U S. I N D, enabling studies to put it into a point, where we could skip.
Back over to a and go right into phase two b, so like faster Dino will be aggressively pursuing.
Our strategic development and commercialization partnerships for that asset not just in the U S. But in multiple markets and many of those dialogues are already ongoing so ideal situation as we'd like to see sometime around the middle of next year.
The ability to get that back into U S clinical development again alone or with a collaborator.
And then also I don't go ahead to start.
Sorry, I didn't answer the rest of your question, which is that study again will be the.
Be developing it as a potentially rapid onset standalone.
Treatment candidate for major depressive disorder, so well.
More on the protocol, but basically it's a daily it's daily as opposed to as needed and study will likely be multiple weeks four to six weeks.
Got it.
Got it and then page 80 for menopausal Hot flashes you announced some data so what exactly did you see in the data to kind of make you excited about this asset and I guess again, what are the possible next steps from here.
Yeah, but again, that's a rapid onset.
Neuro active sharing that's demonstrated positive phase iia results in reducing the frequency and severity of hot flashes that are due to menopause.
So right now we're like every other asset in the pipeline, we're exploring opportunities to advance that program.
Through phase <unk> and beyond in concert with our multiple.
Multiple collaborators in multiple markets and you can imagine I mean, there was an NK three mm.
Inhibitor that you saw recently approved by <unk>.
Astellas so that one.
It's systemic oral we know there's safety issues concerned with that one we don't see any of those attributes in the potential for ph 80, and that is a space that has incredible need and in a lot of interest among companies focused on women's health. So we know that it's a large market.
We know it's underserved we know it's the most common symptom of menopausal transition that affects about 75% menopausal women.
And about 40% of women in premenopausal so it's.
$20 million or so women in the U S and $9 million or so that suffer from severe hot flashes. So we will put this into a position where.
And like ph 10, and I Truvada to similar path, we do some IND, enabling work, we did get a U S. I N D in place and we skip back over phase two right interface to be and that phase III program can be.
Supportive then of our pathway into phase III, and then support marketing around the world if we get that.
Makes sense and then.
You do have additional parents being 15 to 80 to 84 seems pretty attractive. So can you talk a little bit more about those two drugs and when they can get into the clinic and are you also considering a partner for those assets as well.
Yes and.
We're in a spot now where especially after acquiring ferren.
We have not only the clinical stage asset six assets that are in clinical stage.
And the capability or the potential to advance additional preclinical candidates into clinical development.
And so the first platform is robust and given the depth of the pipeline and the broad nature of the of the positive safety and efficacy studies. We've got every one of those assets can be supported by either internal development or collaborative development or really a combination of both.
So those two assets in particular.
Turn to page 284, together and independently represent very large markets and cognition impairment for page 15, and subjective feelings of hunger and alike, especially in late stage cancer patients.
Yeah. So we'll be doing the same thing with those right now are assessing some of the data.
That we've got in the context of the acquisition there and.
Hopefully, we'll have some more to say in the near term in terms of the phase Iia data.
With those two programs and then they would follow a similar path to what we have done with ph tend to move it into the U S. And also will be doing with P. J D can move it into the U S than overall ultimately each of the U S. Dossier supports leverage in multiple markets outside the U S.
Very clear alright. Thank you so much <unk> congrats on the progress.
Thanks, Andrew.
Operator, I believe that's all the time, we have for questions today, if theres any additional questions. Please don't hesitate to contact us by Emailing IRR Vista June dot com or contracting the individuals listed on the bottom of our press release. The information is also available on our website.
We also we're also encourage you to sign up for website to stay connected.
News updates about this is Jim again, thank you for participating on the call today, we appreciate everyone's attention and support.
Look forward to keeping you current on our continued progress. This concludes our call have a fantastic 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.
Okay.