Q2 2025 Vistagen Therapeutics Inc Earnings Call

Shawn Singh

Thank you, Mark. Good afternoon, everyone and thank you for joining our call today. As the Neuroscience Renaissance continues, we are advancing a Vistagen in a Neuroscience pipeline that’s unlike any other in the industry with multiple clinical stage product candidates in Phase 2 and Phase 3 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’re up, 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 favourable safety data in each of our lead intranasal pherine development programs. For fasedienol in a Phase 3 trial for the acute treatment of social anxiety disorder, for itruvone in a Phase 2A trial for the treatment of major depressive disorder and for PH80 in a Phase 2A trial for menopausal hot flashes. It is these successes seen with multiple varying 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 internasal pherine 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 US. 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 3 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 3 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 non-systemic standalone treatment for major depressive disorder and we are preparing for planned Phase 2B development in the US. Based on the Phase 2A 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.
Our PH80 program for menopausal hot flashes is also progressing based on positive Phase 2A clinical data, our non-systemic hormone free varying 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 US IND next year. The intent for that is to facilitate our plans for further Phase 2 development of PH80 for treatment of menopausal hot flashes in the US.
I’ll now hand the call over to Cindy Anderson, our CFO to summarize our financials from the last quarter, Cindy.

Cynthia Anderson

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 3 program for fasedienol for the acute treatment of SAD, an increase in head count and an increase in consulting professional services.
General administrative expenses were $4.2 million for the quarter ended September 30, 2024 compared to $3.2 million the same period last year. The increase in G&A expenses was primarily due to an increase in head count and professional services fees.
Our net loss attributed 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

Thanks Cindy, leveraging our pioneering neuroscience, our deep understanding of nose to brain neurocircuitry and multiple positive clinical trials to date. Our fairing 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, 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 this.] And 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

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

Operator

(Operator Instructions)
First question will be coming from Paul Matteis from Stifel.

Hi there. This is Julian on for Paul. Thanks so much for taking my question and congrats on the progress. Just wondering if you could provide a little bit of color on the pace of enrolment so far. What are you hearing from investigators about the demand and 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? Thank you.

Shawn Singh

Hey, thanks Julian. I appreciate the question. Couple of things there, I’ll try to do them sort of in reverse order in terms of timelines, still sticking with the guidance that we had previously laid out as you just articulated for, 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 in 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, you can imagine on the other side of the PALISADE-2 success, We’ve got 16 sites now they’re 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 really exciting time across all both studies. There’s no overlap in the sites from in either of the two studies. Of course, I’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 own 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 a very important, obviously to control variability. So, I think overall, we’re happy with how things are going. (technical difficulty)
Josh, you want to add anything to that.

Joshua Prince

Yeah, 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 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

It’s a good point and that just came out. We had a recent town hall with the sites is 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 that the leading edge of trying to treat people who have 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 Jeffrey.

Andrew Tsai

Hey, good afternoon. Thanks for the updates, appreciate you taking my questions. Maybe a tangential question from before that was just asked. But for the Phase 3 studies are 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 or maybe talk about how sites are operating the rigor of these study protocols, whether public speaking challenge is being done correctly and so forth. Thanks.

Shawn Singh

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. It’s 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 in 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 to a protocol that the recipe is pretty clear and when it’s followed, it helps tremendously. So that plus things 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 side by side 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 those 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.

Andrew Tsai

Mm. And that said, oh, go ahead. Sorry.

Shawn Singh

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

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 and 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.

Andrew Tsai

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

Yeah, 100%. No question about it Andrew. The whole program continues, that’s what’s the benefit of having a fully funded program. So, and 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.

Andrew Tsai

Thank you again.

Shawn Singh

You bet.

Operator

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

Myles Minter

Hey, everyone. Thanks for taking the questions. 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 2B protocol and 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 a, maybe a caregiver or a physician would be administering the drug versus self-administration as I know 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. Thanks. Sure.

Shawn Singh

I appreciate the questions, Myles. So as to the first one and we’re working very closely with our [Kols] and our internal team for that, the Phase 2B protocol, it still is the intention and we’re well down the road with it. We got some pretty key thoughts already under our belt as to how we want to see that study proceed. A lot of it simply based on what we saw in on the Phase 2A study and what we think are the unique attributes of itruvone in MDD and especially as it relates to the folks with anxious depression.
So I think that is a target we likely will hit. If not, it’ll 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 six-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

Sure. Yeah, the studies that we do in the lab with Doctor Monti kind of our, the inventor of pherine there –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 are 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

Those studies are conducted here in our headquarters in South San Francisco in 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 factory bulbs are. So, they, as Josh noted, they’re very sensitive and you have to, it’s the best way to do it is just to have the IP administered by Dr. Monti and the team.

Myles Minter

Makes a ton of sense. Thanks for the questions. Congrats on the progress.

Shawn Singh

Thanks.

Operator

(Operator Instructions)
Our last question for today will be coming from Madison Elsaadi, B. Riley Securities.

Madison Elsaadi

Hey guys, congrats on all the progress and I appreciate you taking my question. 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 2B?
And then, secondly, I know it’s in the [pr] you mentioned an increase in head count. So, I was just wondering if this was just kind of related to general activities, across the enterprise or that was more related to one specific program? Thanks

Shawn Singh

Great. Thanks for the questions. Really appreciate it. So, a couple of things, so as to the gating for the PH80 study and vassal motor symptoms or hot flashes due to menopause. What we’re doing now is the US 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, talk studies that bridge some of the older work.
And then 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 in a position to then submit an IND that would leap us right back into Phase 2 development in the US. So, phase likely for Phase 2 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 that really nothing that we see that is non systemic and what’s hormone free. The [NK three antagonists] do have some limitations so that CMC work non clinical 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 in finalizing the protocol is really what’s left there and then we have an ID that’s already open, we’ve got Phase 1 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 up front of the MDD study and then head count 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 its R&D related a lot of it relates to owning, especially the surveillance and the training that’s associated with the Phase 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 incompetence and own consistent surveillance, especially for the PALISADE Phase 3 program and of course, other things related to some of the pre commercial activities on the CMC side, especially. So a little bit in head count 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.

Madison Elsaadi

Got it very helpful. Thanks.

Mark Mcpartland

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 ir@vistagen or via the contact section of our website.
We also encourage you to register email 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.