Q1 2022 VistaGen Therapeutics Inc Earnings Call
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Please standby the conference will begin momentarily to register for a question. Please press the one followed by the four on your telephone at any time during the presentation. We thank you for your patience and ask that you. Please remain on the line.
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Greetings and welcome to the Vista Gen Therapeutics first quarter 2022 results conference call.
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.
If at any time during the conference you need to reach an operator, Please press star zero.
A reminder, this conference is being recorded today Thursday August 12th.
In 'twenty one.
I'd now like to turn the conference over to Mr. Mark Flatter Vice President of Investor Relations. Please go ahead Sir.
Thank you <unk>.
Hello, and welcome to the Vista Gyms conference call covering its fiscal year 2022, first quarter financial results and corporate update.
Flatter Vice President of Investor Relations Mr. Jim. Thank you for joining us today for this business update and welcome to our shareholders analysts and anyone taking an interest in Vista, Jeff joining me today are Sean <unk>, Our Chief Executive Officer, Jerry Dodson, Our Chief Financial Officer, and Dr. Mark Smith, our Chief Medical Officer.
The format for this call will consist of prepared remarks from management, followed by an opportunity for question. This call is being webcast and will be available for replay. The link can be found in the investors IR calendar section of our website at <unk> Dot com.
On 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 it 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.
Lee from those anticipated by any forward looking statements that we may make today additional 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.
And in the future filings that we make with the SEC from time to time, all of which are or will be available on the SEC's website now with the formalities out of the way I'd like to turn the call over to our Chief Executive Officer, Sean Zhang.
Thank you Mark good afternoon, everyone on behalf of our entire team here at Vista, Jim. Thank you for joining our call today.
And with the recent surge in the pandemic from the Delta variant, we certainly hope you and yours are healthy and doing very well.
As I've mentioned many times before at our core we're change makers a team at Vista agenda, that's committed to improving the mental health of individuals around the world.
With new medicines that go beyond the inadequate current standard of care for anxiety and depression disorders.
During the first quarter of fiscal 'twenty two.
We maintained that steadfast commitment to our core mission and continued the strong momentum that we generated through throughout fiscal 'twenty, one across all aspects of our business.
Even before the pandemic anxiety and depression disorders represented a large and growing unmet medical need both in the U S and across the globe.
Unfortunately, while the prevalence of these conditions has grown substantially during the pandemic meaningful expansion of differentiated FDA approved treatment alternatives has not yet occurred.
Now arguably more than ever before those suffering from anxiety and depression disorders need new and differentiated treatment alternatives.
Against the backdrop of the substantial progress we made throughout fiscal 2021.
Now through the first quarter of this fiscal year we.
We are confident and excited about the potential of our CNS pipeline to make meaningful changes in the lives of those impacted by mental illness related to anxiety and depression.
Our most significant milestone during the quarter.
Was the initiation of our palisade phase III program.
Led by Palisade, one our U S phase III multicenter randomized double blind placebo controlled clinical study to evaluate the efficacy safety and Tolerability of ph 94 B.
The acute treatment of anxiety in adults with social anxiety disorder or <unk>.
According to the U S GAAP.
<unk> suite of health S. A D as the third most common psychiatric condition after depression and substance abuse.
The phase III trial is a key step in our efforts to confirm the positive efficacy and safety results that we've seen in phase II development of Pizza 94, B as a differentiated rapid onset acute treatment and S. J D.
Pizza before being designed to be an acute as needed treatment of anxiety for adults with S. A D.
Treating their anxiety in the context.
Triggering or anxiety provoking situation or event similar to how a rescue inhalers used to prevent the onset of an asthma attack.
At a time when we are seeing a continuing increase in the number of Americans suffering from S. J D. Now over 23 million Americans and our current drug treatment paradigm that fall short of delivering necessary relief without worry some consequences.
And innovated differentiated fast acting acute treatment alternatives imperatives.
If successfully developed <unk>.
94, B has the potential to be the first fast acting non systemic non sedating acute treatment of anxiety for the millions of Americans and others around the world who suffer from the debilitating effects of S. A D and several other anxiety disorders.
During the quarter, we advanced significantly on our plans to initiate by calendar year end several additional clinical studies and our palisade phase III program to enable the eventual submission of Pete's 94, B, new drug application to the FDA should the program be successful notably.
Healthy too, which will be a replicate of policy and one <unk>.
Good to be initiated before the end of this year.
We also made significant progress with the FDA to enable the initiation of our exploratory phase Iia clinical program for ph 94 B.
Program that will include activity in at least four additional anxiety indications the first of which will be adjustment disorder with anxiety.
With the study May proceed notice from the FDA now in hand, we are on track to start the phase Iia study and adjustment disorder with anxiety as planned before the end of calendar 2021.
We also completed certain additional non clinical studies, the ph 10 or depression candidates that we believe are necessary to advance our phase III development plan for ph 10, as a potential standalone rapid onset non systemic treatment of major depressive disorder.
Finally, we also advanced on our plans for clinical development of it. If you wanted one in combination with probenecid. We are on track with our plan to initiate a phase one b drug drug interaction study that combination by calendar year end.
We believe our current cash position is sufficient to advance our CNS pipeline through a very exciting stream of potential clinical and regulatory milestones with potential to be the value, adding catalysts for the company.
Another important milestone for Vista and during the quarter was our recent inclusion in the Russell 2000 index, which as many of you know is one of the most cited performance benchmarks for small cap companies. It's milestones. Notable is a notable example of how far we've advanced our companies, especially during the past 15 months since our consensus building meeting.
The FDA in mid 2020.
We believe we are only in the beginning stages of what has exciting potential to be a remarkable growth curve for all of our stakeholders.
Inclusion in the Russell 2000 Index has increased already increase awareness of our company within the investment community and we expect this trend to continue in the years ahead.
We certainly welcome to larger audience, we continue to execute on additional noteworthy milestones during the second half of this year and well beyond.
Michigan is dedicated to creating change the mental health landscape and to help accomplish this we continued to strengthen our team with individuals who not only possess vast knowledge and experience, but he will also share our passion for social change and align with our company values.
We believe that in the search to create medicines for a diverse global population with unmet needs, we must seek out and listen to the opinions of diverse individuals' recently Vista Jin announced the appointment of two new female members to our board of directors married with Tony and Mark Fitzpatrick, who combined with prior appointment.
A van Cunningham and Dr. Joanne currently bring Vista Jim's board to a female led majority a significant advancement in worthy distinction and board representation within the public Biopharma space and beyond.
Tunnel brings extensive health care expertise to visit Gins board as both a leader in the strategist. She began her career serving patients is a registered nurse and transition to serving clients in health care law.
Having her to pursue both our commitment to helping others and advancing the future of mental health and wellness.
Patrick has a strong background in developing and executing multiple high impact customer focused marketing communications initiatives for some of the world's largest and most successful companies, including Johnson and Johnson and signal.
Both of these announcements highlight the importance of bringing broader perspectives and experiences to our boardroom and we.
We hope to win a meaningful change helping to set the stage for more public and private companies across all sectors continue to diversified board membership.
I would now like our CFO, Jerry <unk> to provide a summary of some of the highlights from our fiscal year 2022 first quarter financial results Gary.
Thank you Sean.
As Sean mentioned I'll highlight a few items from the first quarter of our fiscal year 'twenty 'twenty two financial results I.
I would also encourage everyone to review our quarterly report on Form 10-Q, which was filed with the SEC earlier this.
This afternoon for additional details and disclosures.
Mr. Jin recognized zero point $4 million in sublicense revenue pursuant to its ph 94, B development and commercialization agreement with ever insight Therapeutics, which is now and if I may add therapeutics during the first quarter of fiscal year 2022, which ended on June 30th.
2021, compared to none in the first quarter of fiscal year 2021.
Ending on June 32020.
Our research and development expenses increased from $1.7 million to $5.6 million for the quarters ended June 30th Tony 'twenty and 2021 respectively.
This increase is primarily due to expenses related to the commencement of our ph 94 beat palisade phase III program.
Notably the initiation of the palisade, one phase III clinical trial, but also including expenses for the preparation for and execution of other clinical and non clinical development outsourced manufacturing and regulatory activities for both ph 94 B.
And ph 10, which in aggregate accounted for increased expenses of approximately $2.7 million during the fiscal 2022 first quarter salaries.
Salaries and benefits expense for the quarter ended June 30th 2021.
Increased by approximately $1 million versus the comparable prior year quarter, primarily due to the hiring of additional senior management and other personnel focused on clinical operations outsourced manufacturing activities and regulatory affairs.
General and administrative expenses increased to approximately $2.5 million from approximately $1.4 million in the first quarter ended June 30th 2021, and 2020, respectively. The increase was primarily due to the hiring of additional senior manager.
And other administrative personnel.
Our net loss for the first quarter of fiscal 2022 ended on June 32021 was approximately $7.7 million versus a net loss of $3.1 million for the comparable period of fiscal year 2021.
At June 30th 2021.
The company had cash and cash equivalents of approximately $97.8 million.
I would also note that from July one 2021 through today. The company has received approximately $900000 in cash proceeds from the exercise of outstanding warrants.
Again, please refer to our quarterly report on Form 10-Q filed earlier today with the SEC for additional details and disclosures.
I'll now turn the call back to Sean.
Thanks Jerry.
Our patient focus.
And investor focused priorities.
They have guided us through these has guided us through these challenging times and have led our company to what we believe is the strongest position in our history.
Our journey to this point would not have been possible nor will our future success would be possible without the commitment and patient endurance of the entire Vista Gen team.
Our collaborators and our stockholders.
With relentless effort and focus on creating life changing value for patients and our shareholders all of US at Vista Gen are grateful for the privilege and the opportunity to make a difference to improve the lives of those battling mental health challenges all over the planet.
Thank you Sean This concludes our prepared remarks, and we'd like to now open up the call for questions.
Thank you. Thank you I would like to register a question. Please press the one followed by the four on your telephone you will hear a three ton prompt with military request.
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Our first question is coming from the line of Andrew Tsai with Jefferies. Please go ahead.
Okay, great. Thanks, and good afternoon I. Appreciate you taking my questions first one is on the Palisades glad to hear its on track and so forth.
That study are you by chance are you how.
Are you taking a look at the overall safety efficacy data as well as discontinuation rates for example on a blinded basis and if so would it be fair to assume that no news is good news at least on the safety front because if you had seen an SAE for example in one of your patients you have shared it to the street.
Right.
Most importantly share that with the FDA the.
Thanks, Andrew Mark anything else you want to add on that.
Yeah, I think it's.
Safe to say, yes, and I agree no news is good news.
Yeah. We're on track, we're following that closely but so far so good.
Fantastic.
Thank you for confirming and then.
Separately for that.
Adjustments disorder study, that's starting up by year end can you just give us a little bit more framework, our context, maybe what common drugs or treatments that are used for adjustment disorder. If at all and if there are any existing treatments are there limitations and then maybe a corollary to that is.
How are you thinking about the study design.
How long a duration are you using the same doses as you are in the S. E. T trial, how many arms and what are the geographies. So far. Thank you, yes sure sure let me address that and happy to address that.
So we're kind of pay the new ground here.
In the U S.
Especially there really havent been.
Any placebo controlled trials to speak up against.
Known agents because nothing nothing has been approved for this disorder. So what do people take yes, they often take benzodiazepines, which you know.
Adjusted disorder should be somewhat self limited disorder, and yet as you know.
I'll start and then today, the beans, and they're on it for years.
Cuz dependent tissues. So nothing's been approved very little has been studied now we thought our drug would be ideal for this because of its risk benefit ratio.
Because it has a very good safety margin, we believed it would be appropriate for this disease, which you can kind of can see Bob as PTSD light.
As far as the study design, it's one month of duration placebo versus our drug.
Ph before be it three two micrograms, but different from what we're doing in social anxiety disorder, we're giving our drug.
Four times a day.
And that's.
And as much as we felt comfortable prescribing it to people because that's what we did in the preclinical Tox studies. So people are taken at four times a day and this study will do a number of things one is our first.
Look see into disorder beyond the anxiety disorder beyond social anxiety disorders, too, we're giving it on a fixed regimen four times, a day versus as needed basis, and that's a D. We don't know.
We'll treat this disorder or not.
But because we believe the mechanism of action should be relevant to many anxiety disorders.
At least get a.
Our first.
Read on whether that it's possible to go beyond PRN treatment and social anxiety disorder. So.
Again this is a you know.
Really an exploratory trial.
Yeah, but I think it could reveal quite a bit of information for it to go into a larger study and adjustment disorder.
Social anxiety disorder.
Thanks.
Okay excellent.
And to that Andrew.
The primary endpoint in this study is the change from baseline in anxiety as measured by him.
At the end of the four weeks of treatment.
Okay, Great and it's just basically the idea of the exploratory trial just looking for a signal if you find a signal that's that's good green light, Okay and then.
My last question is you mentioned.
Preclinical Tox studies that actually I had my last question is just on the peripheral studies are running on carbon 14th fmri imaging studies can we expect you to share those results to the street over the coming months I'm, assuming that those would be completed later this year, but I could be totally wrong, what are those timelines and so forth.
The carbon 14, yes will be completed this fall, we'll certainly share those results.
Thank you.
Youre going to find them interesting.
The fmri will probably start this fall, but we won't the study won't read out until.
What do we say I think second half of next year, it's going to take a little while to run that study.
But yes, we will certainly share that when we get the results.
Thanks, very good very helpful.
Thanks, Andrew.
As a reminder to register for a question. Please press one for our next question is coming from the line of Tim Lugo with William Blair. Please go ahead.
Hi, guys. This is John on for Tim. Thanks, So much for taking our question. So just to start just wondering your thoughts about how enrollment in Palisades may be impacted with this latest COVID-19 wave specifically around the study being a laboratory study of acquiring in person visits.
Yeah sure. So obviously we're monitoring this.
So far it has not been an issue we've been running this summer.
Throughout the country.
Okay.
The enrollment is going well and as expected we havent I have not heard of.
Patients turning this down.
Because of fears have come in the clinic, so our sites are up and running and there.
They are following their own individual protocols.
No we havent slowed down on account of this and so unless something gets much much worse, I think where we're still on track here.
Alright, great to hear and maybe as a follow up how are you thinking about managing any impact palisade due to just overall rising anxiety given pretty anxious time that will all stand right now.
Yeah.
Is that addressed to me or to Sean there.
Whoever wants John can you.
John can you restate it I'm not totally clear on what.
You're asking.
So just given that overall anxiety is rising right now in the U S. And then another COVID-19 wave, how you're thinking about that how that might impact the study.
Oh, Okay, well you know all of it to the Ministry are facing similar.
Concerns Unfortunately, we've got.
18 months or so of activity at the various sites.
Across all different sectors that have got it so pieces in place to protect the staff the protect subjects.
So fortunately implementing those as Mark said seem to do what needs to be done.
Of course, the needs continue to rise as you've said and I think that's all the more reason why we hope we can continue with the execution efficiency that we've seen so far.
Yeah, I would echo that.
You know obviously.
Uh huh.
Yes, obviously, there is a lot more anxiety.
And then.
Unfortunately is continuing to rise and I actually from what I'm hearing is that the sites. The clinical sites are busier than ever and I think that it's probably because people recognize that we do need new medicines income depression, and anxiety and so you know things.
Things are quite busy now and I I actually.
We expect them to continue to be so throughout the rest of this pandemic.
Yes, it does he times, because we need these new medicines.
Great. Thanks, so much for the update and congrats on the progress.
Thank you.
Yeah.
As a reminder to register for a question. Please press one four on your telephone keypad.
Yeah.
Yeah.
Okay.
Yeah.
And we do have a follow up question coming from the line of Andrew Tsai with Jefferies. Please go ahead.
Alright, thank you.
I wanted to ask on page 10, as well I mean Europe.
It sounds like you've finished non clinical studies I guess, what did the data looked like what where are they and then.
It sounds like you're initiating the phase two in mid 2022. So can you remind us what the gating steps are until you can initiate the study thanks.
Yeah, we Havent announced the results of those studies yet Andrew the goal for US is to get all the regulatory package together submit it before the year end.
Not the year end right around the corner into 'twenty, two and to initiate the phase <unk> study in the first half of 'twenty two so as early as we can.
But fortunately, we have as with 94 being a very safe drug.
Everything we've seen so far to date. So we just have to make sure we get the the U S regulatory package in order to be able to put us in a position to launch, but we expect to be about 150 subjects a phase <unk> study with ph 10.
Laid it as a potential standalone treatment for major depressive disorder. So very excited about it it's them away in many respects is similar to.
To that of a 94 b.
In terms of acting on the peripheral neurons and then through the olfactory bulb neuron as we've talked about and we're excited to get some early reads to see whether we do have what we expect which is a.
The rapid onset of activity.
Or a drug that has got a remarkably different.
Safety profile than what we've seen to date with other antidepressants.
We'll keep you posted on the progress, but so far it's all moving in the right direction to be able to green light the effort in the first part of 'twenty two.
Got it.
Thanks again.
Yeah.
Okay.
Alright, that's all the time, we have for questions today, if you have any.
Any additional questions. Please contact us at IR at this agenda dot com or call any of the phone numbers listed on the bottom of our press release today. 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 you may all disconnect now and have a great day.
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