Vistagen Therapeutics Q1 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 13, 2024

There are 8 speakers on the call.

Operator

Ladies and gentlemen, greetings, and welcome to Vistogen Therapeutics Fiscal Year 2025 First Quarter Corporate Update Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mark McPartland, SVP, Investor Relations at Vistogen. Please go ahead.

Speaker 1

Thank you, Ryan, and good afternoon, everyone, and welcome to Vistigen's fiscal year 2025 Q1 corporate update conference call and webcast. This afternoon, we filed our quarterly report with the Securities and Exchange Commission on SEC Form 10Q for our quarter ended June 30, 2024 and issued a press release providing an overview of our continued progress. We encourage you to review the release and our 10 Q, which can be found in the Investors section of our website. We will make forward looking statements regarding our business during today's call based on current expectations and information. These forward looking statements speak only as of today, except as required by law.

Speaker 1

We do not assume any duty to update any forward looking statements made today or in the future. Of course, forward looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward looking statements we make today. Additional information concerning risks and factors that could affect our business and financial results is included in our fiscal year 2025 Q1 10 Q for the period ended June 30, 2024 and will be made in the future filings that we make with the SEC from time to time, all of which will be available in the Investors section of our website and of course on the SEC's website. With the formalities completed, we warmly welcome our stockholders, sell side analysts and others interested in Vistigen. I'm joined on our call today by Sean Singh, our Chief Executive Officer Cindy Anderson, our Chief Financial Officer and Josh Prince, our Chief Operating Officer.

Speaker 1

Sean will provide an update on the lead programs in our novel class of neurocircuitry focused farrowing drug candidates in our clinical stage pipeline. After that, the conclusion of our prepared remarks, there will be a brief opportunity for questions from the sell side analysts participating on the call. As a reminder, this call is being webcast and will be available for replay after completion. The replay link can also be found in the Investor section of our website. I will now turn the call over to our Chief Executive Officer, Sean Singh.

Speaker 2

Thank you, Mark, and good afternoon, everyone. Thank you for joining our call today. For those of you who are joining us for the first time, we're a neuroscience company with a diverse pipeline that includes multiple clinical stage product candidates in Phase II and Phase III development. And each of these is a novel, nonsystemic, neurocircuitry focused product candidate. Our 3 lead clinical development programs target large markets with stale standards of care that leave millions of individuals with unsatisfied medical needs, specifically individuals affected by the profound fear and anxiety associated with social anxiety disorder, the serious and potentially life threatening impacts of depression and the disruptive effects of menopausal hot flashes.

Speaker 2

For decades, the standard of care in these markets, these very large indications has been anchored in oral medications that require systemic uptake and are associated with a bundle of worrisome side effects and safety concerns, prolonged onset of action and limited efficacy. And our mission is to change that, to change that with our pioneering neuroscience and our new class of clinical stage product candidates called ferrenes. Distinguished from all systemic oral medications approved by the FDA, Our lead neuroactive variants, Fasadienol for social anxiety, Itruvone for depression and PH80 for menopausal hot flashes are intentionally formulated as nasal sprays to rapidly activate unique nose to brain neural circuits to achieve therapeutic effects without requiring systemic uptake or direct action on neurons in the brain and to do so with favorably differentiated safety profiles that we've observed in all clinical studies of our faring product candidates have been completed to date. Farings use the nose and key neurons located in the olfactory epithelium as a portal to activate neurocircuitry in different regions of the brain that impact multiple medical conditions. And again, they do that without having to travel through the whole body or even into the brain.

Speaker 2

Those fundamental differences have enabled us to achieve historic clinical success in a Phase 3 trial for the acute treatment of social anxiety disorder or SAD that we reported last year, as well as also see positive results in exploratory Phase 2 trials involving patients with major depressive disorder, menopausal hot flashes, premenstrual dysphoric disorder and psychomotor impairment due to mental fatigue. Our top priority, the lead neuroscience program in which the vast majority of our team and our capital are focused on is our U. S. Registration directed PALISADE Phase 3 program for fasodenol. That is our investigational fairi nasal spray for the acute treatment of SAD.

Speaker 2

There's no FDA approved medication for the acute treatment of SED, which is a very large, growing and underserved market that affects 12% of adults in the U. S. As I noted many times, our principal goal is to change that. Last year with our PALISADE II Phase III trial of fasidienol, we reported the first ever positive Phase III trial of a drug candidate for the acute treatment of SAD. Earlier this year, we launched another Phase 3 trial PALISADE III designed similarly to PALISADE II with the objective of replicating the success of that study.

Speaker 2

Enrollment in the PALISADE III study is on track and we're also on track to initiate our PALISADE IV Phase III study in the second half of year as we previously guided. That study will have the same design as PALISADE 3 and the same objective of replicating the positive results from PALISADE 2. Both of these Phase III studies as well as an exploratory Phase IIa repeat dose study will read out next year. We believe either PALISADE 3 OR PALISADE 4, if successful, and together with PALISADE 2, may establish the substantial evidence of the effectiveness of fastadienol in support of a potential U. S.

Speaker 2

New drug application submission to the FDA, which if approved could establish Fasadienol as the first ever FDA approved acute treatment of SED. A new treatment option with the potential to be used on demand as needed by millions of Americans who serious and sometimes life threatening anxiety in fear of embarrassment, judgment, humiliation in a wide range of social and performance situations affect their daily lives over many years and potentially and unfortunately sometimes lead to depression and even suicide. So again, our U. S. Registration directed PALISADE Phase 3 program for fastodionol for the acute treatment of SAD is our top priority, and we are on track and well funded to do what's necessary to put us in a position with the potential to achieve that important and very valuable goal for patients and for our stockholders.

Speaker 2

We are also staging our other 2 lead faring clinical stage programs in depression and hot flashes for further Phase 2 development in the U. S, building on positive results in exploratory Phase 2a studies in each of these large market indications, each of which has stale standards of care and no non systemic pharmacological treatment alternative. We've seen and what we've seen in Phase 2 from non systemic TruVone for MDD and non systemic hormone free PH80 for menopausal hot flashes so far as to both efficacy and safety is driving our confidence in the potential of these product candidates to improve lives. ITruvone holds the potential to emerge as a novel and fundamentally distinct standalone treatment for major depressive disorder. We're preparing and strategizing for Phase 2b development of Vitruvone in the U.

Speaker 2

S. As a product candidate with the potential to help individuals who suffer from depression gain relief from their MDD symptoms swiftly and without many side effects of currently available systemic treatment options. ITruvone is distinguished by its favorable safety profile that's been observed in studies that have been completed to date, which is not associated with unwanted sexual side effects, for example, or weight gain, potential for abuse. And finally, our non systemic hormone free farrowing product for product candidate for menopausal hot flashes PH80 holds considerable medical and commercial promise in multiple women's health conditions, but most notably menopausal hot flashes that affect millions of women around the world. Similar to what we have accomplished to enable further Phase 2 development of Itruvone for MDD in the U.

Speaker 2

S, our ongoing non clinical program for PH80 aims to enable our U. S. IND to further Phase 2 clinical development of PH80 in the U. S. As well and to do that for menopausal hot flashes.

Speaker 2

We are confident that millions of women who are affected by menopausal hot flashes would prefer a novel non systemic hormone free treatment option over the current therapies. With that, I'll turn the call over to Cindy, our CFO to summarize some of the financial highlights from the last quarter. Cindy?

Speaker 3

Thank you, Sean. As Sean mentioned, I will highlight a few financial results from our fiscal year 2025 Q1. I also encourage everyone to review our report on Form 10 Q filed with the SEC earlier this afternoon for additional details and disclosures. Research and development expenses were $7,600,000 for the quarter ending June 30, 2024, compared to $4,200,000 for the same period last year. The increase in R and D expenses was primarily due to an increase in clinical and development expenses related to the commencement of PALISADE III and costs related to preparation for the initiation of PALISADE IV Phase III trials of fasinidol and SAD, an increase in headcount costs and increase in consulting and professional fees.

Speaker 3

General and administrative expenses were $4,600,000 for the quarter ending June 30, 2020 4, compared to $3,000,000 for the same period last year. The increase in G and A expenses was primarily due to an increase in headcount costs and professional service expenses to support the continued expansion of our administrative activities. Our net loss attributable to common shareholders was $10,700,000 for the quarter ended June 30, 2024 compared to $6,900,000 for the same period last year. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $108,400,000 dollars As a reminder, please refer to our quarterly report on Form 10 Q filed today with the SEC for additional details and disclosures. I will now turn the call back over to Sean.

Speaker 2

Thanks, Cindy. What drives our team day in and day out is the opportunity to improve patient lives with our pioneering neuroscience, along with the potential value for stockholders that often accompanies that type of accomplishment. With our on track progress in our U. S. Registration directed PALISADE Phase 3 program for fasidienol, that's aimed at the acute treatment of SAD, which is a mental health disorder that's growing in prevalence.

Speaker 2

It's now affecting over 30,000,000 Americans on the other side of the pandemic and none of them have yet an FDA approved flexible patient tailored acute treatment option. So we're confident in advancing on our goal to secure that first FDA approval. And it's a very serious and a very life threatening and highly prevalent indication that requires the kind of serious attention and effort that our team is putting on driving this PALISADE Phase 3 program forward, building on the success we've achieved last year from the PALISADE 2 study. So on behalf of everybody at Vistigen, I just want to thank you all for your continued interest and your continued support on our mission.

Speaker 1

Thank you, Sean. Operator, we would now like to open the call for questions from the sell side analysts participating today.

Operator

Our first question is from the line of Paul Matteis with Stifel. Please go ahead.

Speaker 2

Hey, thanks for taking our question. This is Mark on for Paul. We were curious in just hearing if you can provide any color on the types of patients that are currently enrolling for the Phase III trials for fazodionol, that would be great. Thank you. Sure.

Speaker 2

Mark, thanks a lot. Josh, you want to address that? Josh is on top primary on top of our execution of the PALISADE program. Any just brief insights, Josh?

Speaker 4

Yes. So it's I mean, it's very similar patients to those that were enrolled in our PALISADE II study. So from an inclusion, exclusion criteria, LSAS scores greater than 70, for example, no other kind of primary health disorders, no other primary mental health disorders, there has to be SAD would have to be primary, those types of things. In addition, some of the exclusion criteria that we had incorporated were elimination of excessive smoking or vaping, for instance. But it's typically primary SAD diagnosis with high enough severity with the typical patients that are coming in.

Operator

Thank you.

Speaker 2

Thanks, Josh. It's important. Obviously, we do quite a bit to ensure that we've got folks that properly meet the IE criteria. And we also obviously are focusing on people with a disorder that's chronic. The typical onset with this disorder as many people know is in adolescence and the duration is typically about 20 years.

Speaker 2

So you have people that obviously you want to get people involved who can be impacted by the medication. So we have specific levels set up to make sure that there's appropriate chronicity and severity. We also make sure that they haven't had any more recent medical issues that would have caused them to be ineligible for the study, but very high scrutiny and upfront in recruitment and lead generation and prescreening as well as making sure people are perfectly aligned with our IE criteria.

Speaker 5

Thanks.

Operator

Thank you. Our next question comes from the line of Andrew Tsai with Jefferies. Please go ahead.

Speaker 5

Hey, good afternoon. Thanks for the updates and thanks for taking my questions. So, first one, for PALISADE III, are you, chance seeing higher screen failure rates compared to PALISADE I, II? And is there anything else that you might be seeing in real time that gives you that extra boost of confidence you are doing the right thing, enrolling the right patients and executing the study even more rigorously than last time?

Speaker 2

Josh, you want to give a little further insight on that?

Speaker 4

Yes, absolutely. Thank you for the question. I think at this point, what we've seen in terms of screen failure rates, in terms of those that have a high enough score in the first public speaking challenge, in terms of an anxiety score to move on to the 2nd public speaking challenge, we've been pleasantly surprised that those rates have come in consistent with our projections. So we're seeing, again, progress of the study that's in line with expectations towards the targets that we've established. And so I think in general, really things going as expected there.

Speaker 5

And then can you remind us how long it took for you to start and end PALISADE 1 and 2? I guess maybe PALISADE 1 and whether the enrollment cadence for PALISADE 3 is looking stronger or faster than the first study?

Speaker 2

Andrew, thanks for the question. The question the enrollment cadence is on track with what we've guided. I mean, looking, obviously, the black swine of the pandemic impacted a lot of activity in 1 and 2. What we've been so pleasantly surprised by, not really surprised, but expected and happy to see is how normative the clinical development environment is now and how we are able to have a lot more predictability on the things that caused fits and starts in prior studies during the pandemic, especially POWSID-one. So, I can tell you that we're comfortable with the cadence and we're on track.

Speaker 2

Josh, anything else you want to add to that?

Speaker 4

I think that captured it. The one thing I should have mentioned before was the there's just a reminder that we have 2 public speaking challenges, right? So a key part of this study is the screen out in at visit 2 in the first public speaking challenge of those subjects who don't have a high enough anxiety level to really show improvement. It's one of the things that differentiates our study. And it's not inclusion exclusion, but it's a key piece of making sure that we have the right subjects moving forward to the randomization portion of the study.

Speaker 4

And those rates, those are critical for study execution. Those rates have been similar to what we observed in PALISIG 1 and PALISIG 2.

Speaker 5

Great. Last question is, what's the latest on the PALISADE 2 publication as well as a potential breakthrough designation filing? Thank you.

Speaker 2

Andrew, look, we know obviously what we achieved in PALISADE II is historic. No one's ever done it. And so that's given rise to interest in terms of manuscript that we will be submitting to a journal that we believe is the best fit for that. That's in a very nice mature stage of development. The other part of it is, look, as you know, we've achieved fast track designation already.

Speaker 2

That's a serious and life threatening indication. There's no question about that. What we achieved in PALISADE II is a very significant differentiator. So and we'll see how it goes. There's never any guarantee you can make about any activity with the agency, but I like the chances that we have in fitting the profile that's typically associated with moving beyond Fast Track.

Speaker 2

So we'll have to see.

Speaker 5

Perfect. Perfect. Thanks so much for the color. Thanks.

Operator

Thank you. Our next question is from the line of Tim Lugo with William Blair. Please go ahead.

Speaker 6

Thanks for the questions and congratulations on the progress in the quarter. Can you remind us if you had discussions with the FDA about self administration in PAL12 versus HCP HCP administration in PAL34? And how you expect that to impact any dosing language in the label?

Speaker 2

Sure. Thanks, Tim. Sure. We've obviously submitted the protocols to the agency and they understand both of them. It's more consistent with what occurred in Phase 2, the HCP administration of the single dose.

Speaker 2

So again, you're trying to ensure that you've got no variability site to site. So we don't think it will impact anything associated with what we see at the end of the day if we're successful in 34 combined with 2, 3 or 4 combined with 2. And that is for the acute treatment of SAD, full stop, and up to multiple times a day, 4 to possibly even 6 times a day, given as you know, people have some days no stressor events and some days they have multiple different stressor events. So we see the ability for patients to be able to use the drug on demand and that's consistent with the kind of discussions we've had with the agency in the past. So we want it to be an opportunity for people to have this drug in their backpack, in their pocket, to be able to especially when they anticipate and predict stressors coming upon them to be able to use it to knock down those symptoms that flare and cause them to not be able to either engage or to engage with all kinds of fear and disruptive anxiety and fearing embarrassment or humiliation.

Speaker 2

So we really do like and I think that's part of why we're so comfortable with the patient reported outcomes that are associated with the study design, both PGIC as well as the SUTs on the front end. We want patients to be in control and what we've shown in PALISADE II is that they can be in control. And the same thing now to replicate the efficacy of the drug just to ensure that you've got no potential variability with the use. We'll still do also a pretty normal human factor test downstream, the Phase 2b

Speaker 6

in MDD, when that's going to be kicked off? And the Phase IIb in MDD, when that's going to be kicked off? Is that by year end?

Speaker 2

No, it won't be by year end. Right now, we are working with some really good KOLs around the hoop on that program. And so we're finalizing got a solid protocol synopsis is developed. We're now moving that into the full protocol, which we'll submit to the agency before the end of the year. And so we'll see how things progress on the other side of that.

Speaker 6

Okay. Thank you.

Operator

Thank you. Our next question is from the line of Madison El Sadri with B. Riley Securities. Please go ahead.

Speaker 7

Hey, guys. Congrats on

Speaker 4

the progress you made

Speaker 7

and thanks for taking my questions. So a couple from me. Can you remind us if PALISADE 4 will be performed at the same clinical sites as PALISADE 3? And will we see top line data from PALISADE III before dosing starts in PALISADE IV?

Speaker 2

So the first question was, will there be distinct sites in the studies? And the answer to that is yes. We'll have about 15, 16 sites per study and we're not anticipating any overlap in the sites from the two studies. And then I'm not quite sure I heard the last part of the question, but if it was associated with wind wheel initiate PALISADE-four, is that what it was?

Speaker 7

We'll see top line data from PALISADE 3 before dosing starts in PALISADE 4.

Speaker 2

No. No. PALISADE 3 top line data, both those studies will read out in 2025. So currently, our target for PAL III is mid-twenty 5 and for PAL IV will be near the end of 2025. Both of them every aspect of the PAL Safe Phase III program, every single component of it that remains associated with this U.

Speaker 2

S. Directed registration directed program will be started this year and completed next year.

Speaker 7

Got it. That's helpful. And then if I could ask, what are, I guess, the gating steps to the MDD Phase 2b trial? And it looks like you guys have kind of reached the top of the dose efficacy curve with the current 6.4 microgram dose. Is that how you're looking at it or could that dose change?

Speaker 2

No, we think that's where we'll land. We saw some very nice success in the Phase 2a study at 2 different dose levels. And where I think we're landing on that one, again, we're trying to finalize the protocol working with some of the KOLs you all have seen on our SAB, Mauricio Fava, Jerry Santa Cora, Sanjay Matthew, Michael Leibowitz, all with long term experience in depression. And what we see again with this drug, similar to obviously the way that we've achieved clinical success with the other pharynx is to be able to get there through neurocircuitry focused MOAs that do not drive on to the same side effect and safety profile lane as we've typically seen every single drug that's out there. And so what we think we can do here in a standalone monotherapy study, and we'll probably shoot it over 6 weeks with the 6.4 dose, double blind, placebo controlled, one to one randomization.

Speaker 2

We'll lean into Hamilton. HamD17 is the primary endpoint, just like we did in Phase II. A lot of that has to do with what we've seen with Hanks' depression and the benefits that we've seen there with this asset. So it will be a fairly conventional approach to from an endpoint standpoint. And I think a 6 week program is what we're looking at by twice a day dosing over 6 weeks at the 6.4 microgram level.

Speaker 7

Got it. Thank you.

Operator

Thank you. Ladies and gentlemen, there are no further questions. I would now hand the conference over to Mark McPartland for his closing comments. Mark?

Speaker 1

Thank you, operator, and thank you, everyone, for participating on the call today. If you have any other please do not hesitate to contact us by email at irvistigen.com or the Contact Us section of the website. We also encourage you to register for email updates on the website to stay connected to the latest news and events for Vistigen. Thank you all again for participating on the call. We appreciate everyone's interest support.

Speaker 1

We look forward to keeping you updated on our ongoing progress. This concludes the call. Have a magnificent day.

Operator

Thank you. Ladies and gentlemen, the conference of Vistadgen Therapeutics has now concluded. Thank you for your participation. You may now disconnect your lines.

Remove Ads
Powered by Quartr
Earnings Conference Call
Vistagen Therapeutics Q1 2025
00:00 / 00:00
Remove Ads