VTGN - Earnings call transcript Q2 2025 | VistaGen Therapeutics, Inc.

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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

operator. you, Thank and Quarter everyone, Vistagen's Year Fiscal Good Update welcome Conference Second Corporate Call XXXX afternoon, to and Webcast. we Commission our our Form a press Earlier Securities progress XX, XXXX, quarter across afternoon, filed providing also report September quarterly this issued we with that and ended Exchange programs. for an on lead XX-Q SEC release neuroscience and the our second our the overview of Investors can to you and the of be found review the which encourage We our in release section website. our XX-Q,

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

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

could again, section in second financial the risk filings and time, affect of that in factors business information future XX-Q Form our we XX, quarter fiscal in Additional our SEC ending website XXXX, for the and which, with time SEC that to concerning on Investors from September our all the period included are year make website. the is results XXXX on

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

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

Shawn Singh

for and everyone, Thank you, today. you Good afternoon, thank our joining call Mark.

renaissance neuroscience and in potential multiple from the and Vistagen advancing III call at candidates Phase class a pherines, differentiated II neuroscience development, has we unlike a the With As are new action clinical each intranasal safety. therapies pipeline continues, stage any in that's Phase we mechanism of product other industry. differentiated a that each of

are, several with in we opportunities set pipeline, markets. high-prevalence standards So this multiple of advancing to pharmaceutical new care

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

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

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

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

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

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

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

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

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

Cynthia Anderson

Shawn. you, Thank

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

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

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

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

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

Shawn Singh

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

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

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

Mark McPartland

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

Operator

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

Julian Pino

progress. the This Congrats is on Julian on Paul. for

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

and expect when Can us you you're then on And to have the towards timing XXXX the just lastly, you for of of a PAL-X you've for said mid-'XX Previously, end quick remind data here? one. PAL-X. targeting

if you're still curious towards that goal. Just tracking

Shawn Singh

do in Thanks, reverse A Julian. Appreciate of things them of sort couple order. the I'll try question. there. to

still time out previously and just had lines, of sticking respectively. articulated laid that for the terms guidance PAL-X with as you PAL-X In we

both able of half middle happy I this year we're time, half studies second for for the the the the and as that of middle year we PAL-X. noted, of So this of on were of initiate first PAL-X to

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

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

exciting So it's the a in There's overlap no from of the studies. X both studies. across either sites time in -- really

that been very we've Of PALISADE-X happy and from past. we've the course, got from sites PALISADE-X with

with So I'd team. with say, the our work to overall, we our internal are CRO, with really sites, excited

our with we've the got CRO. enhanced that what assets really resources with as We've as owned well as from surveillance augmenting

important, So lot and is variability. to control the of very protocols, obviously, surveillance There's close adherence very training. intense there's which a to

happy things are we're So I with overall, think going. how

to anything Josh, that? do to add you want

Joshua Prince

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

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

Shawn Singh

town time and It's from had a something with fireside the point, It's like that hall team. just the the sites. rest of where sort to it's do good recent with that we out. came of with a We me chat and a time

treat momentum it. in people helps when thanks But the of dealing for with this you're trying when leading key question, you're always parallel edge motion. it always Appreciate a execute to with is program, And what the on decades. keeping disorder working for been studies who've the to at Julian. So trying especially is efficiently

Operator

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

Lin Tsai

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

Shawn Singh

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

Same all different. saw not CROs. we're different. It attrition typically seeing. rates fundamentally is sites that thing with is at site before It The staff, we just just with

it things that followed, seeing helps recipe been into when that variability kinds pretty frustrating And clear. have of the coming not tremendously. the is protocol it's a You're would

you -- things that in No no talked with involved, before, masks the So subjects study. that potential we've the right? that COVID-related about plus

for So then basis. the to different micro just not course, protocol a on something, be the site This are having And a by site the basis and there's that's fourth research within is the community. on on fundamental things ability just that of third now lapse and the novel. macro

the new, new. isn't design study the So isn't endpoint

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

Lin Tsai

sorry. said -- go that ahead, And

Shawn Singh

oversees Josh No, I Josh to it. give sense a just program add primarily. the want to to

to want missed? Josh. you So I give a I Anything chance,

Joshua Prince

add and of piece. said, could you We what kind to on the Sure. builds in-person it

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

quite we've intervention where discussion specific And or being or a a there monitoring then right. there's that Shawn through reminder. an done the wasn't examples And the mentioned, identified have retraining day, or a that something been next

those could gives happen possible and PALISADE that the much we're in speaking we're confidence variability reducing the across are now, sites not again, patients So challenge. prior getting public kinds of our that things the and that as that which studies us, are happening right as for

Lin Tsai

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

Shawn Singh

Yes, XXX%. No having whole The question it, a program the what's of That's fully-funded Andrew. about program. continues. benefit

the we part fasedienol. a and where order we that in 'XX if short will would very here, in out 'XX in early now 'XX that to have the our in So initiated for in spot we're of think positive, we NDA everything support need read

both be will regardless, XXX%, studies absolutely yes, run completion. to So

Operator

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

Myles Minter

so if three, got me. I've with I bear may,

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

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

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

Shawn Singh

Appreciate Myles. the questions, Sure.

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

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

twice So in administration. a different. This see study, study is This with terms don't of to is self-administration be that. during we daily X-week likely the

the So they'll an so on an it folks, outpatient be basis. outpatient by self-administering on basis

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

Joshua Prince

be really The equipment the lab and our that up Yes. physician have people are Monti, Sure. do on that pherines, they're to based the hooked administration -- studies they to. kind of because of in inventor we with Dr. the of

or frontal in in of the on to a reduce cavity, require capture receptors sensors of noise do nasal those precision so kind lot the the data. those things of and measurements lobe And to

reason And has physician it's for so to administered. that it be

Shawn Singh

the olfactory studies Those their -- conducted placed inside laying the on bulbs Francisco and where so up our in electrodes by here in South bridge and and headquarters are and right are nose the down are San subjects our the of are.

-- have Monti as administered way the noted, the sensitive do very to by you they the best IP Dr. Josh have and it, to So is team. -- just and they're to that's

Operator

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

Madison Wynne El-Saadi

the noticed to what's bit a in gating Phase well that to a guess, on the I I of question? as the What's could Congrats flash gating PR, prior then IIb? study an And increase as follow-up you the remind progress. hot headcount. us mentioned you all really in to secondly,

or activities across the So I was specific this to if general was more just program? was wondering kind related that to related enterprise of if one just

Shawn Singh

the Thanks it. questions. Really for Great. appreciate

couple a things. So of

we're in is flashes now the U.S. gating menopause, hot for due doing IND-enabling what to a PHXX as So to or vasomotor the study symptoms program.

to bring program of to that in the -- doing study the just work. that and CMC make CMC-related United the initial to the So we studies, was older because bring And the clinical into we're had requisite nonclinical entirely studies some for then of typical bridge supply tox Mexico. done States, studies, new -- the the And program. course, an of PHXX study

us into into to development an in in right in order then us the submit So put to IND motion II back would U.S. that's that Phase position leap what's

but Phase So flashes. II -- further and in development to pace pace likely hot just --

data positive direction what's there is main do the have hormone-free, We see what nonsystemic but NKX and have the is we flashes for the some is given really that nothing that hot we PMDD, in antagonists opportunity see tremendous limitations.

nonclinical So that this be the I quarter, in place, in that target think, at package second and work, point. work is for CMC that puts our sometime regulatory should the

packages. to left as that's -- is have MDD We've really finalizing what's And produced. the IND Phase And that the we open. -- with clinical an the work again, the already had study, for the enable got I built support these, and CMC when to work we then acquired these we really beginning necessary And that the to protocol go to do and we supply back we the then again, there. regulatory

have those So all been checked. boxes

MDD lap preparations study. I the the so And upfront the final of think we're of on

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

us own course, on really for the confidence PALISADE the some things CMC have Phase program III pre-commercial own of related to So allows to especially. activities and other of that and surveillance, especially consistent the side,

So side we've most to that's each finance. that programs the bit of increase a enabling across a the more us part, headcount little on it's quite But G&A R&D in bit development an on do lead got. the for

Mark McPartland

everyone. you via Operator, us website. at contact I if please At we or Thank you, time, to any via not for e-mail that's all do have section believe our additional this hesitate the the today. questions, time ir@vistagen.com of questions contact have

We also on encourage website connected stay to you news. to e-mail our updates register for the to latest

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

Operator

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

VistaGen Therapeutics (VTGN) 7 Nov 242025 Q2 Earnings call transcript