VistaGen Therapeutics Inc

NASDAQ:VTGN

Earnings Call Analysis

Vistagen's Promising Pipeline and Financial Update

In the latest earnings call, Vistagen highlighted its innovative neuroscience pipeline featuring intranasal therapies, primarily targeting social anxiety disorder with fasedienol and major depressive disorder with itruvone. The PALISADE-3 and PALISADE-4 Phase III trials are underway, aiming for results by mid-2025 and late 2025, respectively. Research and development expenses surged to $10.2 million, driven by these clinical advancements. The company anticipates submitting a New Drug Application for fasedienol in early 2026, given successful results. Vistagen maintains a strong cash position of $97.6 million, ensuring ample runway for continued development.

Vistagen's Unique Therapeutic Pipeline

Vistagen is navigating an innovative landscape in neuroscience through its pipeline of intranasal therapies called 'pherines.' This group of product candidates, including fasedienol for social anxiety disorder (SAD), itruvone for major depressive disorder (MDD), and PH80 for menopausal hot flashes, seeks to redefine treatment standards in high-prevalence markets. Unlike traditional systemic medications, each pherine is designed to trigger therapeutic effects within seconds by activating specific neurocircuitry without systemic absorption.

Promising Clinical Developments

Vistagen has reported statistically significant efficacy and favorable safety data for its lead candidates. Specifically, fasedienol has completed a Phase III trial for SAD and initiated two additional Phase III trials (PALISADE-3 and PALISADE-4) this year. Both studies are slated to provide topline results next year, with the potential for significant evidence supporting an NDA submission to the FDA. Furthermore, the itruvone and PH80 programs are positioned for further development with compelling clinical data supporting their efficacy and safety.

Financial Overview

In the fiscal year 2025 second quarter, Vistagen reported research and development expenses of $10.2 million, significantly higher than the $3.9 million from the same quarter last year, primarily due to the ramp-up related to the PALISADE Phase III program for fasedienol, as well as increased headcount and professional services. Total general and administrative expenses also rose to $4.2 million from $3.2 million in the prior year. Notably, the net loss attributable to common stockholders was $13 million during this quarter, up from $6.6 million a year earlier. As of September 30, 2024, Vistagen held $97.6 million in cash and equivalents, providing a solid foundation for ongoing research and development efforts.

Future Development Plans

Vistagen's plans for 2025 include completing the ongoing clinical trials and addressing upcoming FDA submissions. The Phase IIb study for itruvone is expected to have its protocol submitted by year-end 2024, while the IND for PH80 is set for submission in the U.S. next year to support continued development in treating menopausal symptoms. Executives expressed confidence in the newly initiated trials and emphasized the importance of maintaining rigorous standards throughout the clinical process.

Market and Regulatory Landscape

Currently, there are no FDA-approved treatments specifically for acute SAD, which affects over 30 million adults in the U.S. Vistagen aims to close that substantial market gap with fasedienol. Additionally, the firm anticipates exploring new frontiers in depression treatment with itruvone, which has demonstrated quick relief from MDD symptoms and should alleviate many common side effects seen with existing systemic antidepressants.

Conclusion - A Bright Outlook

Vistagen is establishing itself as a potential game-changer in neuroscience therapies through its extensive and novel pherine pipeline. The company’s financial resources, combined with its innovative approach and promising clinical results, suggest a significant opportunity for growth in the coming years. Investors should watch closely as the ongoing trials produce results, especially the PALISADE-3 and PALISADE-4 studies in 2025, which could validate the pathways to regulatory approval and market entry.

Earnings Call Transcript 2025-Q2

[Operator]

Good afternoon, ladies and gentlemen, and welcome to the Vistagen Therapeutics Fiscal Year 2025 Second Quarter Corporate Update Conference Call. [Operator Instructions] This call is being recorded on Thursday, November 7, 2024.

I would now like to turn the call over to Mr. Mark McPartland, Senior Vice President, Investor Relations at Vistagen. Please go ahead.

[Mark McPartland, executive]

Thank you, operator. Good afternoon, everyone, and welcome to Vistagen's Fiscal Year 2025 Second Quarter Corporate Update Conference Call and Webcast. Earlier this afternoon, we filed our quarterly report with the Securities and Exchange Commission on the SEC Form 10-Q for our second quarter that ended September 30, 2024, and we also issued a press release providing an overview of our progress across our lead neuroscience programs. 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 our current expectations and information. These forward-looking statements speak only as of today, except as required by law. 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 risk factors that could affect our business and financial results is included in our fiscal year 2025 second quarter Form 10-Q for the period ending September 30, 2024, and in future filings that we make with the SEC from time to time, all of which, again, are on our website in the Investors section on the SEC website.

With the formalities completed, I would like to warmly welcome our stockholders, sell-side analysts and others interested in our programs and progress. I'm joined on our call today by Shawn Singh, our Chief Executive Officer; Cynthia Anderson, our Chief Financial Officer; and Josh Prince, our Chief Operating Officer. Shawn will discuss our recent highlights in our lead neuroscience programs, and Cindy will discuss our second quarter financial results. At the conclusion of our prepared remarks, as the operator has already noted, there will be a brief opportunity for questions from the sell-side analysts.

As a reminder, this call is being webcast and will be available for replay after completion. The replay link again, can be found on our website's Events section. Shawn?

[Shawn Singh, executive]

Thank you, Mark. Good afternoon, everyone, and thank you for joining our call today. As the neuroscience renaissance continues, we are advancing at Vistagen a neuroscience pipeline that's unlike any other in the industry. With multiple clinical stage product candidates in Phase II and Phase III development, each from a new class of potential intranasal therapies that we call pherines, each has a differentiated mechanism of action and differentiated safety. So we are, with this pipeline, advancing multiple opportunities to set new standards of care in several high-prevalence pharmaceutical markets.

Distinguished from all systemic medications that are currently approved by the FDA, each intranasal pherine product candidate in our lead programs, and that includes fasedienol for social anxiety disorder, itruvone for major depressive disorder and PH80 for menopausal hot flashes. Each is designed and formulated to activate key nose-to-brain neurocircuitry within milliseconds to achieve the desired therapeutic effects and all without requiring systemic absorption or binding to neurons in the brain.

We have observed statistically significant efficacy and favorable safety data in each of our lead intranasal pherine development programs, for fasedienol in a Phase III trial for the acute treatment of social anxiety disorder; for itruvone in a Phase IIa trial for the treatment of major depressive disorder; and for PH80 in a Phase IIa trial for menopausal hot flashes. It is these successes seen with multiple pherine product candidates across multiple indications that drive our confidence in the power and the elegance of nose-to-brain neurocircuitry and the enormous potential of our intranasal Ferine platform.

Currently, there is no FDA-approved medication for the acute treatment of social anxiety disorder, which is a mental health disorder affecting over 30 million adults in the U.S. And our goal is to fill a major acute treatment gap in SAD with fasedienol and deliver new hope and new optimism to the millions of individuals who are anxious and fear embarrassment, humiliation and judgment when facing anxiety-provoking social and performance situations in their daily life.

Last year, we reported positive results from our PALISADE-2 Phase III trial of fasedienol for the acute treatment of SAD. And this year, with the goal of complementing the success of PALISADE-2, we've initiated our replicate PALISADE-3 and PALISADE-4 Phase III trials on time and as planned.

With those milestones now completed, we are now laser-focused on efficient execution toward top line results from both studies next year. And if successful, we believe either PALISADE-3 or PALISADE-4, together with PALISADE-2 could provide sufficient evidence of safety and efficacy to support the submission of an NDA to the FDA for fasedienol for the acute treatment of anxiety in adults with SAD.

Our itruvone program has shown exciting potential as a new nonsystemic stand-alone treatment for major depressive disorder, and we are preparing for planned Phase IIb development in the U.S. Based on the Phase IIa clinical data, itruvone has the potential to relieve MDD symptoms rapidly and without many of the unwanted side effects associated with current systemic antidepressants, especially weight gain and sexual dysfunction.

PH80 program for menopausal hot flashes is also progressing. Based on positive Phase IIa clinical data, our nonsystemic hormone-free pherine product candidate has game-changing potential in this major women's health market in which women are faced with a very limited opportunity for treatment options.

We're advancing PH80 through the remaining nonclinical programs and CMC requirements to support our submission of a U.S. IND next year. The intent for that is to facilitate our plans for further Phase II development of PH80 for treatment of menopausal hot flashes in the U.S.

I'll now hand the call over to Cindy Anderson, our CFO, to summarize our financials from the quarter. Cindy?

[Cynthia Anderson, executive]

Thank you, Shawn. As Shawn mentioned, I will highlight a few financial results from our fiscal year 2025 second quarter. Research and development expenses were $10.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the same period last year. The increase in R&D expenses was primarily due to an increase in clinical and development expenses related to our PALISADE Phase III program for fasedienol for the acute treatment of SAD, an increase in headcount and an increase in consulting and professional services.

General and administrative expenses were $4.2 million for the quarter ended September 30, 2024, compared to $3.2 million for the same period last year. The increase in G&A expenses was primarily due to an increase in headcount and professional services fees.

Our net loss attributable to common stockholders was $13 million for the quarter ended September 30, 2024, compared to $6.6 million for the same period last year. As of September 30, 2024, we had $97.6 million in cash, cash equivalents and marketable securities.

As a reminder, please refer to our quarterly report on Form 10-Q filed with the SEC this afternoon for additional details and disclosures. I will now hand the call back over to Shawn.

[Shawn Singh, executive]

Thanks, Cindy. Leveraging our pioneering neuroscience, our deep understanding of nose-to-brain neurocircuitry and multiple positive clinical trials to date, our pherine pipeline has the power and the potential to improve millions of lives who are affected by debilitating effects of neuroscience disorders, to do that by replacing inadequate therapies and setting entirely new standards of care.

Our broad and our diverse neuroscience pipeline offers multiple shots at that core goal. And our team is motivated, and it's driven by the opportunities to disrupt treatment paradigms, improve lives and in turn, create potential value for our stockholders.

So on behalf of everyone at Vistagen, once again, I want to thank you for your continued interest in our efforts and for your support, and we look forward to keeping you informed of our continuing progress.

[Mark McPartland, executive]

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

[Operator]

[Operator Instructions] First question will be coming from Paul Matteis from Stifel.

[Julian Pino, analyst]

This is Julian on for Paul. Congrats on the progress. Just wondering if you could provide a little bit of color on the pace of enrollment so far. What are you hearing from investigators about the demand in enrolling in the study? And I was wondering if these parallel studies share trial sites or anything else that you could share about the sites that you've chosen for each study?

And then lastly, a quick one. Can you just remind us on the timing of when you expect to have data here? Previously, you've said you're targeting mid-'25 for PAL-3 and towards the end of 2025 for PAL-4. Just curious if you're still tracking towards that goal.

[Shawn Singh, executive]

Thanks, Julian. Appreciate the question. A couple of things there. I'll try to do them sort of in reverse order. In terms of time lines, still sticking with the guidance that we had previously laid out as you just articulated for PAL-3 and PAL-4 respectively. So we're happy that we were able to initiate both of the studies on time, as I noted, middle of the first half of this year for PAL-3 and the middle of the second half of this year for PAL-4.

So there's tremendous excitement across the PIs and the site staff that we've been able now to bring together for PALISADE-3 and PALISADE-4, as you can imagine, on the other side of the PALISADE-2 success. We've got 16 sites now that are activated for PALISADE-3 and another -- and a dozen for PALISADE-4.

So the color I can give you is, again, we -- this is a very important indication. It's very clear throughout the research community and a lot of these sites, of course, have psychiatrists that have been treating patients for a very long time, and they just haven't seen anything new in a very long time, let alone something for the acute treatment of social anxiety disorder, which is so important with this disorder is enabling people to engage and not have fear of engaging in the things that stress them in their life, that create anxiety and opportunity costs in their life because they're self-isolating or withholding from engaging.

So it's a really exciting time across both studies. There's no overlap in the sites from -- in either of the 2 studies. Of course, we've got sites from PALISADE-1 and PALISADE-2 that we've been very happy with from the past. So I'd say, overall, we are really excited to work with our CRO, with the sites, with our internal team.

We've really enhanced surveillance with our owned assets as well as augmenting that with what we've got as resources from the CRO. So there's a lot of intense training. There's very close surveillance and adherence to the protocols, which is very important, obviously, to control variability. So I think overall, we're happy with how things are going.

Josh, do you want to add anything to that?

[Joshua Prince, executive]

Yes. I would just -- I'd love to add a little bit of color to the PI excitement that you mentioned. We've now had in-person investigator meetings for both PALISADE-3 and PALISADE-4. And what really comes out there is we have the opportunity to speak with PIs that are there and really express their excitement and enthusiasm to participate in a study like this that's really unlike any other study that they've done before or kind of have come across their plates now.

So I just want to add that color that we really do see that excitement, enthusiasm, engagement from the PIs and the desire to do these studies.

[Shawn Singh, executive]

It's a good point, and that just came out. We had a recent town hall with the sites. It's something that we do from time to time where it's sort of like a fireside chat with me and with the rest of the team. So keeping the momentum is always key when you're trying to execute efficiently a program, especially with parallel studies in motion. And it always helps when what you're working on is at the leading edge of trying to treat people who've been dealing with this disorder for decades. But thanks for the question, Julian. Appreciate it.

[Operator]

Next in line will be coming from Andrew Tsai from Jefferies.

[Lin Tsai, analyst]

Maybe a tangential question from before that was just asked. But for these Phase III studies, both of them that are underway, what are you seeing on the front lines that gives you the confidence it's definitely different this time for fasedienol? Maybe talk about how sites are operating, the rigor of these study protocols, whether public speaking challenge is being done correctly and so forth.

[Shawn Singh, executive]

Thanks, Andrew. Appreciate the question. One thing, of course, is significantly different now than where we were even during PALISADE-2, let alone earlier than that during the pandemic is just the ability to have person-to-person contact, to have in-person training, like Josh mentioned. In-person investigators meetings mean a tremendous amount to be able to regularly and predictably have site visits and also have subjects schedule each phase and each visit during their challenge sequence.

It is all different. It is just fundamentally different. The attrition rates that we typically saw before at sites with site staff, we're just not seeing. Same thing with CROs. You're not seeing the kinds of things that would have been frustrating variability coming into a protocol that the recipe is pretty clear. And when it's followed, it helps tremendously.

So that plus things that you -- that we've talked about before, right? No masks involved, no COVID-related potential with the subjects in the study. So there's just fundamental things that are different on a macro basis and then site by site on a micro basis. And just having the ability for the protocol to not be novel. This is something, of course, now that's on the third and the fourth lapse within the research community. So the study design isn't new, the endpoint isn't new.

So all the things have really helped, I think, with the pace of play and with the ability really to surveil and to hopefully make sure that we've got rigorous adherence to the protocol across all the sites. Josh...

[Lin Tsai, analyst]

And that said -- go ahead, sorry.

[Shawn Singh, executive]

No, I just want to give Josh a sense to add to it. Josh oversees the program primarily. So I want to give you a chance, Josh. Anything I missed?

[Joshua Prince, executive]

Sure. We could add to what you said, and it kind of builds on the in-person piece. In addition to the in-person investigator meetings, we've had an in-person site initiation visit for every site, right? So it's kind of the double reinforcement of training at an investigator meeting and then a good 3 to 4 hours with the study staff in their site location, again, hitting all the key details and pieces and components of what it takes to properly execute a public speaking challenge.

And then through the monitoring that Shawn mentioned, there have been specific examples where we've identified something that wasn't being done quite right. And the next day, there's an intervention or a discussion or a retraining or a reminder. So those are the kinds of things that could not happen in our prior PALISADE studies and are happening now, which gives us, again, that confidence that we're getting the right patients and that we're reducing variability as much as possible across sites for the public speaking challenge.

[Lin Tsai, analyst]

Makes sense. And in the unfortunate circumstance should PALISADE-3 not hit stats, do you still -- would you still plan to move forward and complete PALISADE-4, just given the turn of events that happened last time with PALISADE-1 and 2?

[Shawn Singh, executive]

Yes, 100%. No question about it, Andrew. The whole program continues. That's what's the benefit of having a fully-funded program. So we're in a spot now where in the very short order here, we will have initiated everything in '24 that we think we need to read out in '25 and that if positive, would support our NDA in the early part of '26 for fasedienol. So yes, absolutely 100%, regardless, both studies will be run to completion.

[Operator]

Our next question will be coming from Myles Minter from William Blair.

[Myles Minter, analyst]

I've got three, if I may, so bear with me. The first one is just on -- I think previously, you've guided towards submitting the Phase IIb protocol in MDD by year-end. Are we still on track for that? Or is that slightly maybe looking into next year?

Second one is in that particular MDD study, have you thought about whether like maybe a caregiver or a physician would be administering the drug versus self-administration as I know that, that's a consideration between PAL-3 and PAL-4? Or are you just relying on the fact that multiple doses in that trial probably net that exposure out?

And then finally, I'm wondering in the healthy subject data that you just presented at NEI on the depolarization of the electrograms there, did you actually do dosing self-administering? Or a combination of self-administering versus physician administered to show that there was actually differences in those electrograms and the exposure of the drug? I know there's a lot there, but would appreciate any thoughts.

[Shawn Singh, executive]

Sure. Appreciate the questions, Myles. So as to the first one, we're working very closely with our KOLs and our internal team for that -- the Phase IIb protocol. It still is the intention, and we're well down the road with it. We've got some pretty key thoughts already under our belt as to how we want to see that study proceed. A lot of it is simply based on what we saw in the Phase IIa study and what we think are the unique attributes of itruvone in MDD and especially as it relates to folks with anxious depression.

So I think that is a target we likely will hit. If not, it will just creep maybe a little bit into January. But I think right now, we've had a very substantial bit of discussions across all the folks that we want to provide some input, and that protocol is well down the road.

So in terms of self-administration during the study, we don't see that. This is different. This is likely to be a 6-week study with twice daily administration. So on an outpatient basis by the folks, so they'll be self-administering it on an outpatient basis.

And then as to the last question, Josh, I'll let you jump on that one.

[Joshua Prince, executive]

Sure. Yes. The studies that we do in the lab with Dr. Monti, kind of our -- the inventor of pherines, they're based on physician administration and they really have to be because of the equipment that people are hooked up to. And so sensors on the frontal lobe or receptors kind of in the nasal cavity, those things require a lot of precision to do the measurements and to reduce noise in those capture of data. And so it's for that reason it has to be physician administered.

[Shawn Singh, executive]

Those studies are conducted here in our headquarters in South San Francisco and our -- and so the subjects are laying down and the electrodes are placed inside and on up by the bridge of their nose right where the olfactory bulbs are. So they -- as Josh noted, they're very sensitive and you have to -- that's the best way to do it, is just to have the IP administered by Dr. Monti and the team.

[Operator]

[Operator Instructions] Our last question for today will be coming from Madison El-Saadi from B. Riley Securities.

[Madison Wynne El-Saadi, analyst]

Congrats on all the progress. I guess, could you remind us what's gating to the hot flash study as well as a bit of a follow-up to the prior question? What's really gating to that Phase IIb? And then secondly, I noticed in the PR, you mentioned an increase in headcount. So I was just wondering if this was just kind of related to general activities across the enterprise or if that was more related to one specific program?

[Shawn Singh, executive]

Great. Thanks for the questions. Really appreciate it. So a couple of things. So as to the gating for the PH80 study in vasomotor symptoms or hot flashes due to menopause, what we're doing now is a U.S. IND-enabling program. So to bring that study -- the initial study was done in Mexico. And to bring the program into the United States, we're doing just the typical requisite nonclinical studies, CMC-related studies, tox studies that bridge some of the older work. And then -- and of course, the CMC because we had to make an entirely new supply of PH80 for the clinical program.

So that's what's in motion in order to put us into position to then submit an IND that would leap us right back into Phase II development in the U.S. So to pace -- likely pace further Phase II development and -- but just in hot flashes. We have positive data in PMDD, but hot flashes is the main direction given what we see is the tremendous opportunity there for really nothing that we see that is nonsystemic and what's hormone-free, the NK3 antagonists do have some limitations. So that CMC work, nonclinical work puts the regulatory package in place, and that should be sometime in the second quarter, I think, is our target for that at this point.

And then as to the MDD study, again, finalizing the protocol is really what's left there. And then we have an IND that's already open. We've got Phase I support for the supply that we built -- that we produced. And again, with these -- when we acquired these, we had to really go back to the beginning and do the CMC work necessary to enable the clinical work and the regulatory packages. So all those boxes have been checked. And so I think we're on the final lap of the preparations upfront of the MDD study.

And then headcount-wise, we're about 50 right now. And as you can imagine, as we have expanded clinical work, and we've got a little bit of additional G&A support that's needed, but most of it is R&D related. A lot of it relates to owning, especially the surveillance and the training that's associated with the PALISADE-3 program, trying to decouple some of that reliance that was a little bit more variable than we wanted to see during the pandemic.

So that allows us to really have own confidence and own consistent surveillance, especially for the PALISADE Phase III program and of course, other things related to some of the pre-commercial activities on the CMC side, especially. So a little bit in headcount on the G&A side on finance. But for the most part, it's an R&D increase that's enabling us to do quite a bit more across each of the lead development programs that we've got.

[Mark McPartland, executive]

Operator, I believe that's all the time we have for questions today. Thank you, everyone. At this time, if you have any additional questions, please do not hesitate to contact us via e-mail at [e-mail] or via the contact section of our website. We also encourage you to register for e-mail updates on our website to stay connected to the latest news.

Again, thank you for participating on the call today. We appreciate everyone's interest and support. We look forward to keeping everyone updated on our ongoing progress. This concludes our call. Have a great day.

[Operator]

This concludes our conference call for today. We thank you for participating and ask that you please disconnect your lines. Have a great one, everyone.