VTGN - Earnings call transcript Q3 2025 | VistaGen Therapeutics, Inc.

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Operator

Good day. Thank you for standing by. Welcome to Vistagen Therapeutics Third Quarter Fiscal Year 2025 Corporate Update Conference Call. [Operator Instructions] Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Mark McPartland. ahead. go Please

Mark McPartland

XX, for Good Year operator. and and to press welcome Earlier fiscal of Thank an the which year release, ended Third website. lead found our in afternoon, Quarter Fiscal our section overview can progress of the release December XXXX a neuroscience issued XXXX to programs. afternoon, review Call of across third Investors our clinical We Corporate Vistagen's XXXX, quarter providing encourage you this our you, we everyone, the Update Webcast. be Conference

we Based during make any forward-looking on any the statements today. current expectations today These law, made call. statements required statements and speak business assume in information, we our as to as future. not of will Except duty regarding update forward-looking and/or only forward-looking today's by do

and include any anticipated our forward-looking that risks results course, statements those forward-looking uncertainties, Of from differ by could and today. materially make statements actual we

concerning that information XXXX and factors included XX-Q quarter our fiscal December XXXX, our will results and for could be Form XX, risks business third period year financial ending in Additional and the affect filings we to all be with website. which the will SEC time, our will Investors from available on are time or section the SEC's the make of in of future and in website

analysts and Prince, Shawn fiscal operator results. our sell-side our Financial on programs, noted, the today. Officer; Now brief will will has lead our be progress. Executive warmly for on the prepared our and Operating with our Chief we the remarks, call discuss President, third recent discuss joined neuroscience others our sell-side Chief the Officer. from by our today After questions in already call Officer; opportunity a participating there as interested Cindy in financial quarter analysts, Shawn complete, highlights will Anderson, our stockholders, welcome and I'm Singh, Cindy Chief Josh formalities programs our

our being webcast President I for now and The under can is after completion. this Singh. and link reminder, a Investors our replay Shawn turn replay over Executive on Officer Chief available Events. will call to As website's be section found Shawn? call be the will also

Shawn Singh

and joining everyone. you for you, Thank Mark, call. our afternoon, good Thank

very a productive had We quarter.

in you of and a candidates systemic nose-to-brain And that intranasal many of know, the absorption achieve we As class the harness these neurons range to of potential without power developing a called brain. new designed are of requiring are to or the neurocircuitry benefits product therapeutic and are diverse broad to pherines. binding

help a start our mentioned life-threatening in novel, their long advanced Phase the solution discussing challenges that address is lives. the one me SAD, a are most as-needed gap providing treatment face humiliation, for the And and is judgment performance that affect struggle acute individuals SAD SAD. they're treatment and with is potentially Currently, debilitating fear rapid before, convenient, the for fasedienol, and this embarrassment, that's when safe, for there treatment acute by which U.S. our as and of let I've the pherine, serious or medication and recognized and million a intense anxiety by post-COVID of fasedienol, our estimated the So onset over situations. neglected by is PALISADE who anxiety condition critical and social by affected III no -- XX to FDA-approved dealing everyday of very ongoing treatment disorder for in very FDA, asset social who registration-directed and program goal stressful to with adults to with

designed we registration-directed the Phase initiated of of the PALISADE-X for to in III of PALISADE-X for build PALISADE-X results fasedienol each continuing extension. are positive pleased each SAD. success open-label reported results In later our In today, primary same Phase this case, on public fasedienol, III expected towards to and Phase from I'm trials, year. in the to replicate advance trial line XXXX, and speaking an PALISADE-X our with PALISADE-X PALISADE-X XXXX, acute treatment And currently and endpoint, top challenge III report as a as that we program both

our in announced PALISADE-X enrollment besides arm, acute recently treatment repeat open-label PALISADE-X we extension. the fasedienol of addition, repeat studies and dose In of including design for again, in of with study initiation SAD. Phase it subjects similar the first in exploratory addition And of dose a II Phase and to III the adults SAD, an is in

PALISADE-X the effectiveness either the potential believe with in for support substantial to we fasedienol of in together PALISADE-X, successful, advancing, submission new may acute studies application establish these FDA drug SAD of adults. of or PALISADE-X, treatment the if of With U.S. evidence a

itruvone and II development clinical of as In or to a to symptoms vasomotor PHXX that we IIb for we our the our U.S. programs facilitate hot submission that planned nonhormonal, planning are new support we of as development development conducting for drug clinical menopausal progress customary U.S., addition need Phase treatment of in to further and due we an Phase Currently, fasedienol advancing PHXX of itruvone and application, flashes. program nonsystemic potential hot in to disorder FDA the to IND, stand-alone preparing studies are or III Phase our SAD, in treatment for depressive made for menopause. flashes investigational major are a nonclinical

that date. the efficacy recent have stage, all an announcement candidate breadth going some clinical with We the pipeline and study, trial of signal positive stage the PHXXX candidates, IIa in been recently fasedienol, II, other III fifth PHXXX product positive in results our turn our placebo-like reported X is to corporate diversity by with product the of intranasal innovative, the clinical and range And from across of potential pipeline. highlights. gives all in now cancer the cachexia. in intranasal tolerability a supported and nonsystemic, therapeutic Phase diversity investigational, the underscores and positive of studies completed that to pherine the we've to tremendous neuroscience exploratory Phase this these pherine clinical and Phase case clinical I'm studies neurocircuitry-focused and one all positive confidence seen differentiated data safety pherine us our

with enormous data and studies X from our indications of confidence across various power nose-to-brain positive optimism our promise clinical pherine pherines the the the intranasal drive The and our neurocircuitry our and pipeline. potential of in

address about are multiple to we always, our improve candidates to optimistic treatment lives. As standards significant product of to transform of and gaps potential the care

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

Cynthia Anderson

Thank you, Shawn.

the in XXXX to results was period expenses expenses III development fasedienol primarily fiscal for $X.X XX, to increase a Research year ended highlight $XX.X and last PHXX research, from as PALISADE for same December our hot XXXX, third financial in program The quarter. the menopausal as increase expenses will I treatment mentioned, million due Shawn As and were million year. IND-enabling an for flashes. to of R&D related for our quarter contract few MDD itruvone programs and Phase compared for well in manufacturing SAD development, in the

primarily last to were to quarter year. $X.X General $X.X compared was due administrative ended period for increased G&A XXXX, XX, expenses expenses same the The million the headcount. December increase in for million and

XX, to period for ended last the compared XXXX, net loss $X.X $XX.X million same attributable Our to was for year. stockholders common million the December quarter

had cash in $XX.X and As XXXX, of million XX, December cash, marketable we equivalents, securities.

will now hand call over the Shawn. I back to

Shawn Singh

Cindy. Thanks,

So at differentiated we patient positive here optimistic safety. candidates, and more pherine are ever product X clinical-stage than data with Vistagen with each

treatment paradigms, to our opportunities disrupt have create enhance multiple We now for value outcomes, and patient stockholders.

team, look once you all and again of on interest to our updated to support keeping doing So Vistagen. here for on you our on I'd behalf at your progress. what like forward we're in thank continued And everyone we

now who Operator, participating to open call we'd to the questions sell-side like from are today. the analysts

Operator

Tsai question [Operator line from Instructions] first Andrew Our Jefferies. with the coming of

Matthew Barcus

expecting And this Congrats and on delays? the for got on Matt just to will you are wanted that any just I've be you're X this still I year? of if -- I from confident real data the Andrew. And follow-on this. Or PALISADE-X also, second to the ask that quick in quarter. after a half is

Shawn Singh

to Matt. you. Good to talk Thanks,

PAL-X So XXXX. in from we're as see PAL-X we've we'll both guided, confident data that and

So no guidance. that change in

Matthew Barcus

guess, And in that anything execution? more at done Okay. be terms on could then is there night of these keeps terms of you up what I Perfect. in studies

Shawn Singh

all just keep it up on very on these the These night initiatives No, to the place, the question. team of in associated me actually we've expansion protocol. the reliance sites. doesn't positive rigorous conduct adherence of significantly of team, and at than CRO that a got are any different at reduced training It's the very we've seeing the execution-related that got and in way we've past our important, of Interesting with surveillance the rigorous enhancements studies, surveillance, seen with because executing that we've especially studies the of way. in upfront just any enrollment internal even what been been

me. don't on a Prince line is Josh why you things. go and few Josh, the say with

execution. You lot the of a are driving

Joshua Prince

Shawn. Sure. Thanks,

in the And visibility studies into the before with with a X and enhancements point, more is these running question. what's very place. pandemic and interesting have It your in we've to actually, happening put that PALISADE-X than we did we

that from are have sure ability down, the scales interaction sleep back that script than they then to anything, say that making with followed COVID of in quick do sites with to to then if and was would having to if is deviate now properly, administered I without so T, night eligibility, review masks the making it retraining challenge speaking with the subject's easier And we sure public it's at rigorous place, start protocol. that the and

best at giving like So changes. feel we're could we the success we with those chance studies these

Matthew Barcus

little you're you this bit for more little novel and about see competition? we're Fantastic. starting how -- to of about have you how competition to to fasedienol And talk a social in then is competition bit terms anxiety see disorder. a doesn't Can immune drugs starting the also, think --

Shawn Singh

in for of got people affected situation. the by people a adults United question, social to Thanks market with disorder, consider time of a XX and lot It's the of struggle time what from the everyday Unfortunately, in States terms million. here robust Matt. performance most that over the number we've

to there's come all. And it's lot that of also thing case the into size try play a neuropsychiatry, fits difference. to one for treatments room case, with the make one of plenty to there's a So no is certainly, always

major certainly, flashes, we're with for SAD very mechanistic to down the and depression, is difference. standards is for to this trying disrupt, the just paradigms and in treatment of each it's pipeline SAD, currently hot menopausal up the the and this but or difference it's it's it's not whether as whether fasedienol care that One pipeline, of

critical body whole that neurocircuitry neurons able that activating achieve that and the your this drugs on base different So of to milliseconds, of of and don't rely outcomes, neurons kind project There's that neurons no of olfactory a brain, the other therapeutic being in have are different then drug has pipeline mechanism within to your action. to project a at it's go to nose at the nose-to-brain distinction. approved bulb, of the to having regions through brain

about occupy depression, case to got different And for an the that what's like, doesn't right indications, say, you've just important a oral with that X on receptors associated brain, rely X needle it and in the or thread is of example. systemic are where

been unique the terms trying kind we've the we've rapid hasn't of of clinical where a just long nothing we've studies flashes, seen. in nonsystemic same approaches the range therapeutic in achieve SAD a not drug onset depression, very a mechanistic with seen and approved we we're time. areas hot a to think of got in that menopausal approach single much anything. of to And broad There for So thing

approaches certainly, frames the are different with time are doses at there receptors brain onset. and oral So systemic targeted different different that in to

where confident lot in you common to things are and terms we ability even with, typically in drug-drug time or boxes say, more to of very in black the the we're of a see avoid stand think up associated interactions. that or issues REMS I onset pop

field not liver, into brain, brain, the seen the the and have difference go through the to have to across kidney, go see we go through to compared what decades. really to in a big, having field having not the So not in for big it's the

most product can the this this in who have get if lives. where So for Remember, can been is of in XX shape, point duration we mean pretty people struggling provide we're about we think we to candidate their to with years onset with disorder adolescents. good the

on So I lot sits think for the room today. market a improvement there's of based where

Operator

Blair. from Boyle with coming of question next the our John William And line

John Boyle

for on John Myles. is This

So indication AV-XXX on of that path for in the for gives neuropathic color pain a NMDA you patent give you've received the And in prior indication? us. what the few from To in given start, for potential a now DPN? us can confidence modulators some forward XXX Aptinyx's you failures the

And PALISADE program, versus administration clinician you And the then for difference us clinician any and placebo maybe self-administering? on could X? rationale specifically, the is the the there for in remind of expected response PAL-X on

Shawn Singh

Okay. those X? Any just other ones,

John Boyle

some want, you more, after. got if I've

Shawn Singh

happy to Always to talk John. you,

with data in not So dyskinesia in compound that a Phase to announced, models, in candidate and in terms us associated models conventional therapy And respect think the for our partnering, of we preclinical this in seen I look, approach. that but as pretty any drives pain in not MPTP L-Dopa in the only safe, not that that's with is and model for we've we AV-XXX, is confidence published some Parkinson's. see we've monkey a that got but then pain studies, we've but also Parkinson's-related it's just preclinical have been telling different one models, a patient-based that yet also dyskinesia,

these X-chlorokynurenic or -- not very say, ion the at it's it an much take and blocking the antagonist, prodrug when produces but are is so glycine acid, amantadine what the potent like which a astrocytes glycine site in it's ketamine is And a selective NMDA up where site. so, the channel. That brain. receptor

both give this and capabilities where and in that with or positive stage at there while So to not potential site, on data. refer you think little NRX one think indications. we're who with we've pain publications data, is it's send to are it's we comfort that we are the we bit that with you those II assets in got that line the can in a pherine focused on spot clinical NRX, some you got a in neurological will And that for one preclinical this and modulatory is that later more Phase those the I'd

the that of the clinician context don't terms of in and Josh, of PALX, ahead one? In why PALX, you the administration go test drug address

Joshua Prince

Sure. to. Yes, love would I

reducing prior to any studies these variability. with really ones, the So were potential compared we on focused

time, when X, at And make so about at reduce just And raters duration. administer we really think or to have dose public wanted than the to having at the X, you clinicians single-dose to about rather speaking challenge that or dose site, sure you train train each visit visit then a each the think subject and they variability. the we single consistently single throughout

open that So that place in projected every any studies think a We on reducing because to needed. that impact the has their using variability. patients really label really there's drove or times all don't decision, again, multiple label have for use the it these we day, as day just own

expect that there. any don't issues so we And issues --

Shawn Singh

to in the system. get mid-septum, be it where not this the into want needs sinuses drug up Similar any down. we right would just -- way pointed respiratory so to Obviously, in the the is coming math to at

the So those best are the again, it the drug just ensures has but in affect that opportunity side. to be I treatment placebo, in that to determined, shouldn't suspect. It got work

John Boyle

of might just Very X? CGI-I on there's How wondering helpful. to need are your that one show SUDS the and need some in anchoring just you SUDS any And the Kind some of us. anchoring I from hit sense both CGI-I. guess to PALISADE-X, maybe viewing if independent -- you more to

Shawn Singh

their CGI-I from past seen and to people is seen group the are X in on you -- level level, have to individual they that we've focused, is it really how whether is input, placebo. they SUDS X SUDS tell as a and we're the on And where be assessments do time CGI-I. will But a or the going are time the in and the level. Well, on past between you treatment change distinct group primary the right,

clinical does So we've stands important endpoint the provide PALISADE-X at group secondary X. and meaningfulness in Those context as all as now what is as the level. PGI-C, a CGI-I seen are to which to

John Boyle

Congrats on the quarter.

Operator

Our question Stifel. the Paul line coming of next Matteis with from

Jo Yi Chudy

behind regulatory if rationale would the any more be risk look This also, there more talk but hoping about are that? And turns fasedienol We could in what wondering on a is X? see were kind out you safe ongoing if for Paul. efficacious of bit is if the X kind than bit of repeat dose study doses Emily you to and little it a

Shawn Singh

Sure.

Josh, and this go ahead hit one.

Joshua Prince

Sure.

the we're for what arm we a we've subject have after they with that And impact can real felt essentially possibility and they public asked noted administered first world, additional the XX if just may nervous, there's so X, feel because if still minutes really in dose ahead essentially the still a before, for So take dose repeat PALISADE-X to an FDA see on speaking it's an good challenge. another would in study, -- doing feel the and dose. a identical that that as dose go

the additional are so in there is have There really And measured. to could you We other a safety for there think saturated we've is once spray, potential not any any is but also based likely mind with you there patients, efficacy keep get higher some thinking that be And benefit? benefit. is, doses the then that there impact? receptors don't those on

be additional benefit as would whether that to to or see it's seen in So not arm. we

dose. dose so second endpoint that are any that it of smaller X approval do But felt don't Phase again It's they really XX-minute if inform our create they it that time of be to -- as see well. a if for III end don't would positive primary benefit like what see able day, X physicians it to frame dose, might the we could or the not And powered patients is we potential And a let label think is are beyond a PALISADE-X likely that, within issues would or know studies At it that the study are. on it's beneficial. with that impact. sized

Shawn Singh

It's Josh. good point, a

think inform with get you it's for And how study. agency on we docs inform to is, help as minutes it could the dose this Emily, question align people that it takeaway take could be. that we could the I key us key the labeling. -- It is the And are we that, safe. And is within expect and whether Well, would as it tell to second noted, going -- it? guide XX labeling Josh the as

And is in is more anticipation think may again, people better. I think real the the world,

And on handle circuitry the and know as anyway. you only achieve milliseconds, about those noted, can in volume you're -- projects when Josh okay amygdala. to and to trying we're it's so what occupy neurons, to the your activate XX that canal way there's we once happens nose nasal -- to safe much so And which sensory the neural

Mark McPartland

This for have the time everyone. today. all is questions we you, Thank

questions, can e-mailing you that by If not into log ir@vistagen.com section contact questions through Contact and portal. or additional to via you us submit do have please hesitate the the website

wonderful Again, encourage This progress. register our to e-mail look forward latest you on everyone's updated keeping with on Have connected also website on support. a stay We the day. today. from the We our We appreciate call concludes interest Vistagen. the for updates to call. you to for and continued participating ongoing thanks news

Operator

thank for your gentlemen, Ladies you participation. and

may disconnect. now You

VistaGen Therapeutics (VTGN) 13 Feb 252025 Q3 Earnings call transcript