Q2 2024 VistaGen Therapeutics Inc Earnings Call
Good day, everyone and welcome to todays Vista in fiscal year 2024 second quarter corporate update conference call. At this time all participants are in a listen only mode. Later, you will have the opportunity to ask questions. During the question and answer session. You May Register and ask a question at any time personally star and one.
On your telephone keypad, you may withdraw yourself from the queue by pressing star two. Please note. This call is being recorded I'll be standing by if you should need any use. It is now my pleasure to turn the conference over to Mark Mcpartland. Please go ahead Sir.
Thank you Travis and good afternoon, everyone and welcome to <unk> fiscal year, 'twenty 'twenty, four second quarter corporate update conference call and webcast.
This afternoon, we filed our quarterly report and issued a press release, providing an overview of our progress last quarter. We encourage you to review the release, which can be found on the investors section of the distributed website.
During today's call we will make forward looking statements regarding our business based on our current expectations and information.
Forward looking statements speak only as of today and except as required by law, we do not assume any duty to update in the future any forward looking statements made today.
Of course forward looking statements involve risks and uncertainties and our actual results could differ materially from those anticipated by any forward looking statement, we make today.
Additional information concerning risk factors that could affect our business and financial results is included in our fiscal year 'twenty four 'twenty 'twenty four second quarter Form 10-Q for the period ending September 32023, and in future filings that we will make with the FCC from time to time all of which.
Are or will be available on our website and the Sec's website.
That taken care of I would like to thank and welcome all of our stockholders analysts and everyone taken an interest in district, yet I'm joined on the call today by Sean <unk>, Our Chief Executive Officer.
N D Anderson, our Chief Financial Officer, and Josh <unk>, our Chief operating officer.
Sean will provide an overview on our recent results and our progress across our key pipeline programs.
A brief opportunity for questions from our sell side analysts will follow their prepared remarks.
This call is being webcast and will be available for replay after completion.
Replay link can be found in the gastro men's section of our website I would now like to turn the call over to our Chief Executive Officer, Sean Zhang.
Thank you Mark and good afternoon, everyone and thank you for joining our call.
We achieved several milestones since our last call to establish a well defined and fully funded phase III development program, our lead Ferring asset past the die at all.
With the potential to enable us to advance to a to a potential NDA submission for the acute treatment with social anxiety disorder.
In the midst of the ongoing mental illness crisis, we are poised to transform the treatment paradigm for this widespread anxiety disorder that affects the lives of about 10% of our population.
Social anxiety disorder or S. A D is a disruptive serious and potentially life threatening anxiety disorder with high opportunity cost in daily life and no FDA approved patient tailored as needed acute treatment option to help individuals rapidly and safely.
Address the address their anxiety when the stresses are upon them during what for many is there a decades long journey with S. A D.
The hope of a revolutionary approach to treatment extends beyond faster die and all and S. A D to our full ferring based portfolio and we remain fully focused on their development to create faster acting safer alternatives to address significant unmet needs and large CNS related markets, where current treatment options fall.
Short for patients.
Since our last conference call in August we've continued to build on the momentum created by our successful palisade two phase III study of faster die at all for the treatment of anxiety in adults with social anxiety disorder.
During the past few months, we've strengthened our balance sheet considerably securing a $137 7 million in gross proceeds from equity financings and exclusive negotiation agreement with Fuji pharma regarding a potential license to develop and commercialize our Phd in Japan.
We expect this cash infusion will extend our corporate runway through several important clinical and corporate milestones as we advance our pipeline, including our primary focus on a potential U S new drug application or NDA for faster <unk> S. A D.
Given that faster diagnosis rapid onset mechanism of action is differentiated from all F. D. A approved anxiety drugs a primary target initial indication for faster Dino remains the acute treatment of anxiety in adults with S. A D.
And as noted there is no FDA approved drug therapy for the acute treatment of S. C D.
For that in Q4 that acute indication.
We've previously aligned with the F D a.
Simulated public speaking challenge in a clinical setting is an appropriate study design and that the subjective units of distress scale. Our subs is inappropriate primary efficacy endpoint to assess the efficacy of faster die at all because it provides a measure of anxiety on a minute by minute basis.
<unk> related to the specific stressor.
And we believe utilizing a stimulated anxiety provoking public speaking challenge study design provides the most appropriate and efficient path for faster die and also potentially become the first FDA approved acute treatment of anxiety for adults with S. T D.
So to complement the positive topline results from palisade to reoccur.
We are currently preparing to launch two similar phase III clinical trials in 2020 for palisade three in the first half of 2024 and palisade for in the second half of 2020 for like the successful policy to study both palisade three and palisade for will be multi <unk>.
Center randomized double blind placebo controlled phase III clinical trials designed to evaluate the efficacy safety and tolerability of the acute administration of faster Dino to relieve anxiety symptoms in adult patients with S. A D. After a single dose of faster die and all during a stimulated anxiety provoking public speaking.
<unk> conducted in the clinical setting.
And that's measured using the patient reported such as the primary efficacy endpoint.
I'll say three and four will also have an open label extension for up to 12 months to provide additional long term safety data.
If successful we believe either palisade, three or palisade for together with palisade to may.
<unk> established substantial evidence of the effectiveness of faster die at all in support of a potential fast to die in an NDA submission for the acute treatment of anxiety in adults with S. A D. In the first half of 2026.
We also plan to initiate a small facet I in all phase two be repeat dose study in the second half of 2024.
The faster die and I'll repeat dose study will be a multicenter randomized double blind placebo controlled clinical trial of small one about 60 subjects to evaluate the efficacy safety and tolerability of a repeat dose faster die at all that's administered 10 minutes. After an initial dose to further relieves symptoms of acute anxiety in adults with S. A D.
During the exact anxiety provoking public speaking challenge.
That repeat dose study will consist of three different dosing arms with an open label extension.
For up to 12 months.
12 months open label extensions planned for the palisade three four and repeat those studies are all intended to expand our fast die and all safety database for IC H guidelines were targeting 300 patients treated but faster Dino for at least six months and 100 for 12 months to date over 750 subjects.
<unk> have been exposed to faster die at all including over 30000 doses administered in our palisade open label safety study.
And we continue to be very encouraged with faster and all safety profile in all clinical studies to date.
The positive palisade to data also bolster our growing confidence in the evidence supporting the potential of our entire Ferring pipeline.
We've had some recent advancements in a couple of other programs. So let's take a brief look at those in June we completed a successful randomized double blind placebo controlled phase one study.
Intended to investigate the safety and Tolerability of <unk> in healthy adult subjects that trial was conducted to stage potential phase II <unk> clinical development of <unk> in the U S and it confirmed a favorable safety profile if I choose one established in three previous clinical trials conducted in Mexico, including a positive.
Randomized double blind placebo controlled phase Iia study of <unk> in major depressive disorder or M. D D.
As we advance and remain focused primarily on our palisade phase III program for faster Dino and S. A D. We also plan to explore various ways to unlock the significant potential value of a true loan as a differentiated non systemic mono therapy for M D D through potential strategic.
<unk> partnering arrangements in the U S as well as in major markets outside the U S.
We're also optimistic about our hormone free non systemic ph 80 nasal spray, which has now been studied in multiple significant women's health indications.
Within the last two quarters, we've announced positive results from two ph 80 studies in women's health indications. The first of which was the exploratory phase Iia study of P. H, a D and women diagnosed with vasomotor symptoms or hot flashes that are due to menopause.
And the Phase Iia study 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.
J D treatment also significantly reduce the severity of the disruption and function sweating related to hot flashes during the treatment period compared to placebo was well tolerated with no serious adverse events and the adverse event profiles were comparable between <unk> and placebo.
One of the favorable aspects of running additional trials in this particular indication is that there'll be objective measures for these studies that is to say that it's easier to measure how many hot flashes or experienced in the frequency of those symptoms versus more subjective endpoints that we often see in other studies in different indications.
The other positive P. H a D data, we announced recently where from an exploratory phase Iia study of ph any for the acute management are premenstrual dysphoric disorder or P. M. D. D and this study P. J D demonstrated statistically and clinically significant improvement versus placebo in symptoms of P. M. D D using the subject created pen.
Daily symptom report as early as day for continuing today six they're limited effective treatment options that help with both physical and mood symptoms P. M D and we believe these results are quite promising.
Given the depth of our entire CNS pipeline.
And the now robust body of successful safety and efficacy studies to date.
We are also pursuing multiple potential non dilutive strategic development and commercialization partnerships, both global and regional to unlock the full value of our product candidate portfolio efficiently, we believe global and regional partnerships with amplify our internal expertise and development activities potentially.
Great key development timelines and enhance our overall efforts to deliver differentiated new treatment options for the current standard of care fall short.
As an example of this we recently announced the receipt of $1 $5 million from our exclusive negotiation agreement with Fuji pharma regarding a potential license to develop and commercialize P. H a D and hot flashes due to menopause and other indications in Japan. This is simply a rate to discuss the potential for that license with.
US and a time limited period, it's not a license it's simply a nonrefundable payment to us to talk to us.
Now I'll turn the call over to our new CFO Cindy Anderson to summarize some of the highlights from our financial results for our fiscal year 2020 for second quarter.
Cindy has been a great. Recent addition to our team following the retirement of our former CFO Gerry Datsun. After his over 10 years of Distinguished service to the company Cindy.
Sidney.
Thank you Sean it's great to be part of this team as Sean mentioned I'd like to highlight a few financial results of our fiscal year 2024 second quarter. I also encourage everyone to review our quarterly report on Form 10-Q filed with the SEC earlier. This afternoon for additional details and disclosures.
Research and development expenses decreased by approximately $9 million from 12 million to.
$3 $9 million for the quarter ended September 30th 2021 'twenty two respectively.
R&D expense.
Early due to the completing the initial studies of our powerful phase III programs.
As well as reduced non clinical development regulatory and outsourced manufacturing activities or pass on adult and action.
General and administrative expenses decreased by approximately.
$5 million.
<unk> 7 million for the quarter ended September 30 was two <unk>.
<unk> just to $8 2 million for the quarter ended September 32012.
Great.
Similarly, due to decreased compensation consulting and professional service.
Our net loss attributed to common stockholders for the quarter ended September 32023, with approximately $6 6 million versus a net loss of approximately $17 5 million.
For the quarter ended September 30 was 22.
At September 30th tightening the Stonewall cash and cash equivalents of approximately $37 6 million.
On September 30th.
He sees approximately $93 5 million and net proceeds from an equity financing and $1 $5 million.
<unk> pharma Andre Exclusives myself, Jason will come up with.
Our powerful Thursday program is successful we believe that our current cash position will be sufficient to fund our operations.
Just a question I think you're asking drug application that's tough in Idaho.
And that's all it took off from D.
As a reminder, please refer to our quarterly report on Form 10-Q filed today with the SEC for additional detailed disclosure.
I'll now turn the call back over to Sean.
Thank you Cindy so to wrap up our dedication to enhancing global mental health and the overall well being of individuals who are affected by a wide range of CNS disorders.
Is unwavering.
And as we are progressing through the next phases of our corporate development strategy, we're doing that with confidence in the potential of our palisade phase III program, Professor Dino and social anxiety disorder as well as the.
The clinical stage assets that are up and down our entire pipeline.
We've got a capable team got a robust pipeline and we've got a steadfast commitment to pioneer and differentiated solutions.
Totally different approaches to the current standard of care for.
For multiple sizable CNS markets that have substantial unmet needs.
So on behalf of our entire vision team once again, we're grateful for the privilege for the opportunity to create meaningful impacts for patients not only in the U S. But all around the world who are impacted in their daily lives by these disruptive and often disabling serious CNS conditions.
Thank you Sean operator, we'd like to open up the call for questions from the sell side analysts participating on the call today.
Yes, Sir at this time, if you would like to ask a question. Please press the star and one on your telephone keypad you may remove yourself from the queue at any time by pressing star to once again that is star one to ask a question, we will pause for a moment to allow questions to queue.
Our first question comes from Andrew Tsai.
Freeze.
Hey, good afternoon, I appreciate taking the questions and congrats.
Congrats on the progress great to see you are making strides here. So obviously.
Obviously, the next step for.
<unk> thousand denial pay Chinese <unk> start in the palisade three.
In first half 'twenty 'twenty four so what needs to be done for you to start earlier in Q1, rather than Q2.
<unk> are there are there bottlenecks here. Thanks.
Thanks, Andrew I appreciate the question.
I agree thanks to I N N. It is easier to say PHA for me than faster and all but we hope the world will get used to that soon enough.
The answer is we are targeting Q1, and so we are everything we're doing right now is in preparation to launch.
To launch palisade three in the first quarter of 2024, so all the pre game work a lot of that has already been underway for several months now and of course, we bring a lot of knowledge from the prior studies to bear into that effort. So.
That's our target and we would expect to be able to have palisade.
Sure follow hopefully early in the second quarter.
Early in the second half of 'twenty four.
Okay, very good and can.
Can you summarize for US just one more time, all the things youre going to do differently and Palisades, three and four to ensure study execution, what removal and slash deletions or additions are you making to these studies relative to the prior two studies.
Yes, great. Thank you for that question. It's important question as you obviously know the macro world is fundamentally different.
As we move into the first part of 'twenty four as it is right now relative to 'twenty, two or 'twenty, one certainly 'twenty one.
And what's what's nice to see is the return to normal.
A lot of the typical conventions that are associated with efficient execution preparation and execution of clinical studies.
As it relates to our particular protocol and the studies that we'll be initiating going forward with this public speaking challenge.
And the study design that's associated with <unk>.
There are certain things that may or may not have.
Then in effect, but we know that it's possible for Covid too.
To disrupt the olfactory system a bit so there will be no.
Subjects enrolled that have had a nasal swab within a month for RSV for Covid for flu.
They'll have to pass the smell test factory clinical factory test in order to be eligible to be no high frequency vapors are smokers are.
Drinks drinkers of Red Bull and things of that nature.
There's a high level of scrutiny that's associated with the front end have assessing patient eligibility.
Josh Princes on Josh as our COO and oversees our team Josh I want to highlight a few other things.
Yes, I think you captured a couple there Sean and that's it.
It's important to think of that essentially were.
Doing everything we can to ensure that we have the patience for.
This one one dose public speaking challenge make sure you have patients in there that can get.
Get the get the benefit from product.
This does things that John mentioned, that's also kind of the <unk>.
Oversight in terms of sites in terms of changing the way that we.
<unk> and work with our CRO over the sites to make sure that we're on top of things that we have.
Data reviews eligibility reviews those types of things.
So those are the key is to make sure that we have a successful study it's really all about the execution of that public speaking challenge with the right patients in there.
Yes.
Yeah.
Some of the other things Andrew that are possible. Obviously, the surveillance is it's fundamentally changed since even policy too. So part of our operating model is to make sure we have our own people.
On sites. In addition to the resources that are brought to bear by CRO and the sites themselves of course, no masks will be involved in palisade three of palisade for which is a big difference.
From the prior studies.
Just trying to get back to a situation where.
The macro environment allows us to apply a lot of the trade craft. It's been historically successful when we're trying to not only planned for let's say with an in person investigators meeting the likes of which werent possible with some of the earlier studies.
Let's start things off and then the ability to to interact more frequently with sites in person.
All of that's important when you're trying to generate rigorous adherence to the study protocol.
I think also what we'll see is.
Better predictability about staff site staff.
In general the depths of the set the staffs the more consistent.
Execution ability to execute between studies study visits I should say more predictably plan them. So a lot of things that are are essential to be able to execute a protocol such as we've got in place for the.
The successful path to study and as we bring that into power three and four even.
Even more confidence in the overall environment than was the case in 'twenty two.
Thank you and maybe a last one I want to be respectful of other colleagues here.
You give us a flavor of what additional data will be presented at medical conferences tomorrow for Dino.
And I think there is another asset that's where theres data being presented so what would be the key takeaway is that we should take home.
These.
Thank you.
Thanks, well the key effort right now is to obviously raise awareness of what the clinical audience hasn't seen in many many years and this indication so to be able to more youll see mostly from those presentations are the topline results from palisade too as.
As well as some data from our open label study, which is remarkable given the number of doses in the number of subjects exposed to the drug and an anxiety disorder, you just don't see it.
And then some data from our ph 80 studies. So key to what we are doing now obviously is to raise awareness of what's been achieved as well as to raise awareness of what's ahead not only in the markets, but also within the.
The clinical communities that we know ultimately will be key pieces of the puzzle downstream.
Great. Thank you very much.
Thanks, Andrew.
Our next question comes from Tim Lugo with William Blair.
Alright, Thanks for taking my question can you update us on the lack of abuse potential for.
Brian I'll take that.
I got that right.
We have some preclinical data around that but I'm wondering if there's anything incremental coming out too.
Just.
Maybe your interactions with the agency as well.
Yeah, Thanks, Tim Great to hear from you obviously the.
The data that we teed up to the agency back.
In 2002 was this was focused on whether or not there were signals and had been any signals at that time of abuse liability potential given that this is a nasal spray and a lot of folks were wondering well what happens when you put something in the nose has it become addictive.
And the uniqueness of this mechanism of action that we have with fast today and all the rest of the <unk> is important to note because what we're dealing with and we've done multiple studies not only on the clinical side, but some important preclinical ones associated with the reality that.
Theres no potentiation of Gaba for example, as you see with benzodiazepines.
Radio labeling the drug showed no systemic exposure.
So the drugs. These fairings don't have to get into the brain and act directly on CNS neurons in the brain, including the abuse liability receptors that are typically out there. So we put a whole body of work to the agency at the time and ask the question what came back from as we reported.
They didn't see.
Any reason for us to have to do a human abuse liability study at that time since then what's been delay.
<unk> delivered is all of the data from the open label study, which had 481 subjects.
And the adverse event profile in that study was remarkable.
Especially again for a drug and neuropsychiatry.
Were the most common adverse effect was our adverse event was headache and that was reported and really only.
17% overall, but eight 7% and were drug related.
And beyond Covid, 19, which was zero percent drug related there was no other.
<unk> yeah.
Treatment emergent adverse effect.
In more than 5% of the participants.
The palisade two study is similar in palisade won a similar safety profile, although even less prevalent in terms of the treatment emergent adverse effects. So these are or events.
These data overall non clinical and clinical really continue to reinforce our belief in and why we don't see these these safety concerns you typically see associated with bands owns or or antidepressants. These are not systemically absorbed drugs.
You cannot detect them in the plasma and so you're basically using the knows as a portal to achieve the effects from different regions of the brain that are associated with these different indications not having to go in the mouth and be metabolized by the liver bump into other drugs through the bloodstream older blood brain.
Area into the brain all of those are major factors that really distinguish this class from everything.
That's historically been approved or is even in development for these neuropsychiatric indications. So it's not a concern we've had in the past it's not a concern the FDA had when we showed them the data and it's certainly not a concern that we have now after.
Yeah.
Tens of thousands of more doses and hundreds of more subjects. Since we first got that read from the FDA.
That's great to hear thank you.
Yeah.
Yes.
Okay.
Yeah.
We have no further questions in the queue at this time I would now like to turn the call back over to today's speakers for any additional or closing remarks.
Thank you operator.
If there are any additional questions that you might have please don't hesitate to contact us here at Vista Jain at IR at Vista, Gin Dot com or contacting those listed on our press release issued earlier today as we noted.
Or on the contact section of our website. We also encourage you to register for E Mail updates on our website to stay connected with the latest news from Vista. Gen. Again, Thank you for participating on the call today. We appreciate everyone's attention and continued support we look forward to keeping you current on our continued progress. This concludes the call have a true.
Understood.
This does conclude today's program. Thank you for your participation you may disconnect at anytime.
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