Earnings call transcript Q3 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings. Welcome to VistaGen Therapeutics Third Quarter Fiscal Year 2023 Results Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded.

the Relations. to turn President Flather, now Investor of will conference Mark over Vice I you. Thank

may You begin.

Mark Flather

year and Thank in VistaGen's for stockholders, our fiscal analysts conference Sherry. joining call financial you, Hello, welcome taking covering third and us today, and quarter to Thank anyone business VistaGen. update. a welcome and to XXXX you results our of interest an

sell-side This call Shawn be Jerry vistagen.com. to The from access are questions today section in a Singh, consist being for link this available can replay Dotson, format Events Chief analysts. me website, Executive found by and our remarks webcasted be Joining and our Officer; prepared Officer. will the our Financial for The followed from the is will of Chief replay. management, for Investors opportunity brief call of

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

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

that and website be we our time, XX-Q Additional SEC filings available Form with will is website. in filed and business earlier included Securities of information the time SEC, our or all future with SEC's and Exchange Commission, quarterly factors results on concerning today risks are or and in recent financial to that make affect from which the on could report our and most the

Shawn call turn our over to Chief Executive like Singh. Officer, to I'd the Now

Shawn Singh

mental the the new call. focused negative good individuals healthcare Treatment treatment of you We Thank and without and across the faster-acting options disorders. growing afternoon, There with currently medicines. options broad approved side range addressing safety for need everyone. the concerns effects Thank you, on an anxiety for globe. across that depression active a Mark, and are significant and is joining remain demographics need communities for often associated in for and

is paradigm shift and commercializing and of differentiated anxiety with multiple depression developing treatment improve to Mind the our align mental committed team mission for the at Our disorders treatments One to healthcare, a Time. and trajectory that

Phase start We'll in our Social a with on Disorder and III or Anxiety this update PHXXB call brief SAD. program

the of quarter, analyzed study. understanding results further the During from to we obtain PALISADE-X that better a unexpected

treatment who study. the only single to randomized study the in a were to As involved arm a the subjects reminder, of dose PHXXB

our methodology with provocative their setting the All study following given social conducted the of in as primary subjects – phase world SUDS this mid-XXXX, early study FDA world the encouraged. the not outside discussions COVID-XX when highly and of exposure sheltered score were a only were in in with back change public strangers forward We was the move group to endpoint. and a even and interactions place in the units of and during distress pandemic, clinical the or subjective speaking was determined the challenge measured before a

and variability turnover, hypotheses, the study pandemic, explanations stress, scheduling site outcomes mask potential subject was social surges of wearing through study dynamics, we among CRO are Following complexities. and significant monitoring PALISADE-X. the in believe for The the introducing unexpected conducted additional and changing terms personnel are COVID-XX of in

the virus complexities given function, the study also, study the or potentially to speaking even some impaired during had PHXXB have various the the swab across due to extended design adherence reduced a over Also, study and of an to study, cell pandemic, for period. COVID-XX challenge COVID-XX response may or the protocol been sites influenza. And nasal subjects large the olfactory for public highly numerous in provocative caused testing have scalable rigorous administering and consistently III Phase challenge not a requirements especially may to by

XXX randomized study After post-randomization independent engaged from we available yet biostatisticians interim receiving PALISADE-X, on challenge the that data at time. of topline review subjects PALISADE-X. from results dose, public-speaking data same PALISADE-X, Based continue the recommended the an subjects, then we've independent planned. We from those not as to that methodology as their unblinded data conduct PALISADE-X the we in analysis seen, which paused involves of independent the XXX single statisticians

of Accordingly, we study may unexpected minimizing the part potential protocol that submitted at that have results to one-third the to that decide remaining believe aimed FDA. issues could PALISADE-X, increase played we protocol to we saw favorable we of a quarter, probability considerably during results the PALISADE-X protocol the subjects. the trial in in resume are the the PALISADE-X, in the these changes amendments if Amendments

of with factor another recently our PALISADE-X note XXXX, couple results However, potentially important to regarding topline SAD design efficacy is using administration SUDS months peers announced its of a two challenge primary of a as endpoint. December the endpoint. primary achieved ago, public-speaking new and our study a considerations studies that in their study completed for resuming single Neither

and to reviewing after at our broader FDA SAD in development it resume III assessing plan PALISADE-X not believe information to data PHXXB is the So time, yet the us and Phase before this available efficacy completed also SAD results the we with other for remain confident potential that recently PHXXB's not advisable discussing affected be public for to game primary a their the in did speaking of individuals disorders. challenges anxiety conducted during endpoints. pandemic by We social changer achieve two the

will continue path have in of Phase program best the with and success for our what the We III forward be for will highest to we options believe probability our SAD. of explore all been

to the our which includes placebo-controlled are We III in conducting to time, Phase to PHXXB measure as study administration, FDA multiple primary support of SAD. over the Phase potential evaluate treatment a randomized adults currently meet scale, a for with the the PHXXB using development NDA preparing III SAD plan, of possibility broader or anxiety efficacy discuss of PHXXB social with of the patients to double-blind Liebowitz LSAS, in

after Phase broader consistent efficacy multiple speaking basis times treatments and studies, SAD. on would measure. contemplated which single III with real-world X in III PALISADE-X FDAs day the over a to of Unlike PHXXB plan for an PHXXB as-needed Using LSAS, up LSAS only setting of as clinic-based the The with four all as trials the administration outcome the endpoint. approvals in part registration be the of design of challenge, a supporting primary involve with would weeks, involved precedent-setting three our Phase assessment the the SUDS administrations study public as a a multiple of primary

performance true as the the in avoidance LSAS well the appropriate to in reduction that overall reflect LSAS the those reduction fear daily over about situations. by lives. as situations, Given is and and severity measures disease PHXXB anxiety-provoking We the measure patients' improvement on measuring, time impact in of social and believe of both anxiety

We expect to other SAD. broader PALISADE-X development plan III announce with to Phase our for for concurrently updates PHXXB plan our

XX needed tolerability adult over of performance social important and to in subjects Phase the Another October with period taken program life which as PHXXB PALISADE in to initiated in provoking months. situations safety our the Study, component III XXXX prior a Open of and of we daily in evaluate is Label SAD back anxiety up to SAD

all study, to for including to is also we In assessing in by in PHXXB by safety potential the the prior improvement PHXXB's exploratory approvals. overall and SAD symptom required of endpoint tolerability addition FDA that LSAS. Again, several severity as included objectives, it's achieve of measured and reduction the primary SAD

development many in clinically important as for Phase PHXXB helped aspects preliminary a XXX per results with August in safety study open broader beliefs And when of Label prior and In inform we that provide data our Phase of used subjects up considered XXXX, observing the day study PHXXB study and III final of meaningful open study multiple and enrollment needed recruitment closed assessment four with Study, overtime label to placebo-controlled, set analysis that response is PALISADE The life encouraging. label setting, real-world favorable profile. in reinforce II in of onset, times daily our to potential the a in sustained in rapid PHXXB our from an study, Open although tolerability nearly a SAD. has plan

from to final readout in expect the have calendar data observations study the this first of We quarter XXXX. of

by PHXXB first We XXXX. announcing anticipate indication adjustment data of at IIa XX quarter for disorder from Phase of exploratory adults with adjustment with PHXXB Moving completed for Phase anxiety. IIa disorder a our treatment safety to target small exploratory and potential clinical times calendar placebo-controlled anxiety. the evaluate the next days. this trial Subjects of self-administered day PHXXB end as prescribed our per We've to double-blind, efficacy, four tolerability with topline the of trial intervals,

disorder During intended as our profile in to or U.S. in underway conducted PHXX of the Phase conduct well in for facilitate in as positive treatment treatment I light our achieved our randomized, months, FDA's the we volunteers. the study to PHXX depressive received healthy MDD. and safety is submitted milestones We is That IND now Phase U.S. program recent green placebo-controlled several double-blind, and subsequently in to plans both confirm studies establishing published Mexico, MDD the of novel as U.S. MDD. a safety study favorable clinical for PHXX three standalone development Phase the of PHXX, IIb for including IIa previous of the study major

first the date, I of effects has with that – quarter caused In depression and to other study studies side ketamine. psychological like all such completing as concerns safety end be other not of XXXX. has the like that disassociation, hallucinations PHXX the rapid associated study therapies We onset or as may anticipate PHXXB clinical been well-tolerated, Phase by such

designation anxiety PHXX is either the we patients large there undesirable Also FDA's or need to the received of of treatments recently are for for inadequate. and unmet with for current development MDD, MDD. the where growing Similar Track significant Fast market, note,

paradigm is individuals be FDA's depression milestones mechanism that non-sedating. differentiated to designed of PHXX our potential for a in disorders. that the has fast-acting, battling the in many recent U.S. to shift bring PHXX We treatment to and and designation Fast-Track considerably. MDD other potentially and action non-systemic PHXX clinic plan under believe With Having are in the the MDD to important

one we to We calendar issues, plan alone study during or our disorders final will for components AV-XXX, As the oral treatment that unexpected with interaction for our ongoing. as receptor. anticipate probenecid AV-XXX safety our assuming and probenecid involving exploratory with collaborator, or potential IIa crystallize CNS conclusion, a drug-drug quarter development clinical completing NMDA Ib with no Phase the its is oral study in of XXXX. After combination second Phase more of on the or own of

about a make to like acquisition our I'd Pharmaceuticals. few comments Pherin recent Finally, of

to licenses we included us from has of to PHXX, intellectual full completed, obligations have previously payment that under transaction been and ownership rights royalty worldwide PHXXB and this overtime. exclusive that which milestone Pherin Now customary were property

we've the of which a As late-stage and and result the assets, for profile of significantly milestone acquisition, potential they commercial future approved royalty improves be should these PHXX, payment downstream. eliminated PHXXB obligations all

enter all in have addition, we as In retain including will the past. revenues, licensing pre-commercial into we such transactions licensing should revenues, we

employees Further, and PHXXX for three as acquisition, cognition our PHXX VistaGen Pherin a note, result product other of candidates the any and pherine on improvement, early appetite-related bring debt did clinical-stage any part PHXX disorders. any for added Pherin flashes, of for to any migraine of facilities. Pherin pipeline, we've Pherin hot this or nor not from did liabilities Also as we transaction, assume on take

third our our XXXX. like the fiscal now CFO, financial summarize would highlights from Dotson, results of year for Jerry? I to some quarter Jerry our

Jerrold Dotson

Shawn. you, Thank

Form As filed few the our also of additional of would everyone to we third our financial this quarterly year details that highlight to disclosures. results and afternoon from quarter with mentioned, encourage XX-Q I'd review the I the on earlier SEC XXXX. Shawn a report like fiscal for

Agreement, months $XXX,XXX December recognizing of three revenue revenue three months the of we AffaMed to compared the ended December for XX, recognized XXXX, the XX, During $XXX,XXX related XXXX. to ended

periods We revenue As AffaMed of in received non-cash the applicable is standards. a from reminder, related of in the cash the August in both accounting recognized those XXXX. back with accordance

PHXXB, to Shawn regulatory adjustment development, with study Phase quarters This million decrease million ended as due decreased includes XXXX, and described, related PALISADE Research respectively. non-clinical Open the $X.X to $X.X is III PALISADE-X other in Phase December for PHXXB and Label $X.X PALISADE-X, expense XX, well PALISADE to manufacturing and and activities as for million primarily both development for XXXX outsourced the reduced expenses program by which, the the and as disorder PHXX. PHXXB and IIa has anxiety Study from

these in trials We of expect as our mentioned XXXX decrease final R&D wind expense that down has the as we earlier. Shawn well to fiscal quarter

at flat was expense administrative December approximately and $X.X XX, general million and the Our of ended quarters XXXX for XXXX. each

XX, attributable net of approximately December quarter approximately $X.X to equivalents had for versus stockholders and for cash At $XX.X a December million. $XX.X Our the ended December common million XXXX, XX, million the company approximately the XXXX, cash quarter XXXX. loss was net loss ended XX, of

filed Again, please to details I'll additional on Form refer the earlier SEC call to our today now for with XX-Q Shawn. quarterly report turn back and the disclosures.

Shawn Singh

core unwavering well-being Thanks, our health in mission Jerry. We and remain worldwide. improve to mental

to advance thank need. corporate want development, very the to stage significant positioned an continue and for exciting with Time. endeavor This behalf we mission XXXX. team, Mind move for well our the at mental for As to and solutions better all difference, to privilege the is our a I a believe the we next make for disorders, innovate that strong that a are strong of On a forward opportunity and a unmet of One company, drives us pipeline we team, you VistaGen health strong we with

Mark Flather

This you, we Sherry, analysts. Shawn. our the open for prepared Thank would concludes from to sell-side remarks. questions call up like now

Operator

proceed. Tsai you. is with Jefferies. Please Thank from Our Instructions] first [Operator question Andrew

Andrew Tsai

Thanks. questions. taking you Hi, everyone. afternoon. Appreciate the Good

III meeting, one multi-dosing time. terms in then a pivot First discussing of Phase of possible period and long a in upcoming your using that FDA over LSAS the is design

what of pivot, in about the scenarios what says do is, you do see what end So the I'm signal PALISADE-X? at at the the if in can talk did FDA with interim it the And you you get a with do you analysis. says, though could Even FDA kind here would scenario see PALISADE-X? So if the okay, would we no, day? to results what PALISADE-X trying hasn't basically, the of finished, a

So that's Thanks. why I asked?

Shawn Singh

look Look, best only would at Good in have what be we we further Andrew. not assess the still a to the peer forward really Thanks, after question. path happened what take studies.

amendments on with FDA. up was provocative adherence methodology that challenge protocol So recipe. executing and submitted the scaling to there exquisite that highly We've are very requires associated protocol questions to some a

So we'll think challenges. see those some that, we methodological of what things their feedback overcome is on that can

We'll things potential the like on meeting, forward which approvals. a in as their we're see well that, is as direction basis, step just with as go where with next what three the opinion LSAS discussing the

it in those there trend, could is that what the it simply unblind we be it we would XXX see possible PALISADE-X So it's as be on denting, subjects, from know effect the data but size, We be it of the study could could and unblinded and positive find It's soft could said, PALISADE-X signal, which it seen decent a resuming direction lot go possible FDA. on of haven't depending analysis things. data. things with also we interim what be the

the real-world but observations SAD with Look, administration. – that we acute placebo-controlled is about seen Then the in have that we II two then of talked so was following that its Phase the rapid crossover PHXXB going LSAS evidence weeks that component already, that from the safety far, was effect onset there thing what discussions assume studies a the study of substantial study good FDA into by lot study is we'll amplified of in of that we've in evidence use, showing there's placebo-controlled the study That a particular. the yet in haven't quite reported, long-term bit.

lot a FDA. there's to So ask of things the to

going need sites. from make about. There's some on a the need to they not as we what and be more to what to sites work basis able changes involved. about want get of we that execute, information willing if might we'll learn may some are FDA and made, things again resume, the would on decisions or we were are be depending We staffing And figure as to lot well may feedback more some that to to of around out expertise. to on, do with interaction We and be

we're to see. So set

Andrew Tsai

Right.

helpful. very Very, Okay.

up, in general, what the said, the this know think of label coming efficacy placebo don't – of issues, is, study much We in my share open plan label part the space, epilepsy barely us? in expect the of open secondly, is seizure then how kind freedom issues I And of And topline can we long so there's release? called necessarily of an placebo Basically, to data achieve the – but can one exactly That would of measure underlying question, speaking placebo. where do you trend. no data the seizure with because freedom there can what to see epilepsy.

sense. So make that at rates is an seizure in perhaps could OLE why looking freedom

what the can guess, guess I point could over, patients at So as and is, I in – question of anxiety agree be say, you the months? back rates six let's theory space, XX we a remission looking just of get to percentage placebo data valuable remission Because to achieve would social basically?

Shawn Singh

can we something discuss That's with the FDA.

those study, obviously, measurement. data real also the time, improvement SAD example, in together appropriateness utilizing with of use a LSAS, on setting PHXXB, in the of the patients that for SAD studies of world world the real II approved key definition. in study as evidence provide the assessing registrational over obviously approval Phase XXX I were control label All subjects They that study. of for a open the of study. But we group studies by noted PHXXB. nearly from PRN acknowledge look, additional regarding absence three dosing of before, in the for information the this use the – frequency from and Those are provide XX-week placebo-controlled the take observed studies Again, the very there where we And lot data all would SAD. the antidepressants how again, – important any study,

that's them now. precedent, that, compare of the historical three given historical that's that, the For to

single individualized of the very fearful each in treatment was to strategy different. their use tailored awaited encounter with patients the appropriate for are know and administration in daily patient dosing life. know unlike situations We highly situations PAL-X the that PRN is that predictable SAD is encounter, anticipation. people that think We and assessment we SAD treatment these and anxious feared most PAL-X is So are the provocative they and SAD And that studies. the

PI double-blind, which currently Phase do, most by PHXXB, and measure might efficacy us, long II of evaluates overtime the with study established needed the working remains the that the next LSAS, of the outcome appropriate of Liebowitz, right, for treatment. Dr. as the that of use a also studies but who's So we again, type placebo-controlled for study the

is more what do improvement consistent to how with like Because works. assessing having the the treatment. a LSAS approved the And the over mind, again, rather to registrational SUDS and patient with a public say we're essentially And endpoint for behavioral movie, all assess trying reset primary with cognitive speaking challenge, having they the the snapshot is existing similar than – time. is therapy the of those the trials taking,

XX prudent, may to So said, We a it be chronic know you disorder. this as follow is weeks. beyond

way agency you moved to we time, study the of So is as envisioned remember. a outside that the the in into when people. last the the reason go long about all we've PHXXB where Phase met lot middle even exactly III with again, dosing help design was couldn't And the XXXX you world repeat the using we of PAL-X at was

of onset PHXXBs onset six-week six what would people in rapid, period, a time, stressors long in the the what a way Phase period study, a since would is the antidepressants XX-week that over we see long study of in what would really see we probably to have they was be a given III achieved weeks exposing say action. So

to aiming six-week to one somewhere your least would we're given month would the want improvement LSAS So in first two range. show is, we to show on a design the what part for at probably and study month we certainly that four

other but XXXX. we're definitely Again, really real-world control COVID. a understand we looking crossroad we're significant have a on for gone settled assessments associated us their at data. to you were the it We the It we I a that opportunity and of think have down are what lot there the the bit, nearly given when having then, We understanding are drop. tack is, observed long the events informs information vaccines more people study seeing of So okay, top how LSAS of now gives is XXX stressful to could that subjects. in fact have and group, we but a back time. safety have world of for record a for in And lot this with the we having period that

Andrew Tsai

disorder then also hop the adjustment is, coming the Right. it chronically up, queue is Thanks. believe. data subjects, in dosed I'll one placebo-controlled Last XX and I on

primary HAM-A the endpoint think scores. I XX is day So

have comparator can show what So us kind of a reminder a data that just at give we you weeks, existing comes? when drugs four so can

Shawn Singh

expect have a had of on design. heavily a enrolled were competitors. subjects. study, there It's for in a why it's as we'll That's were with have not IIa lot HAM-A, anything, exploratory you It's a had disorder. to really around from but as DSM-X, somewhere be exploratory be said, XX this you That's They and studies. It's powered small you'd around to you'd study. people an controlled but lot exploratory in not if with zone. aren't the XX background expect lands to signal, study. stable on there they as challenge looking of We're – study a really this antidepressants,

see. we'll So

adjustment meds same disorder COVID, the never something meds so that with from experience the with their routines are that job functioning. that disrupted social anxiety effect domino we XXX used. anxiety, it's unfortunately, those in and disorder that things forth. chaos, had loss, loss, relationship they're really But most cases, to and here isolation, see started but That's impair associated The of of anxiety just sort collection the for, in – folks had

also really all So for SAD that kinds disorder. benzos, optimal for alcohol, antidepressants, optimal or of things beta blockers, aren't not adjustment

Andrew Tsai

Appreciate Thanks, progress. Shawn. that

Shawn Singh

you. Thank Andrew. right, All

Operator

with Please from is Tim proceed. Lugo question next Blair. Our William

Timothy Lugo

taking for the Thanks question.

sense that these this I sort patients And are the compare day? many you there's is with question, can guess, historical in you study, disorder adjustment can what placebo following upcoming you have I of taking remind to? guess doses do me a the prior up the setting? of per how rate For any

Shawn Singh

Yes. take in this disorder. of Tim. just lot first, part There's I'll that a traffic isn't historically

can't number. I so give you really And well-grounded a

early of showed from of terms day. taken the regimen, times again, lot In a had, on safety to PHXXB support dosing [indiscernible] up we a four a

So a of associated with this taking episode. we There the to day necessarily needed. four sort that force in times a to drug exploratory it safety that four times study. what wasn't lot But a was of thoughts different also day establish grounded into part related because is four safety said about that times multiple PHXXB, SAD crosses over related into taking anxiety-provoking was

regimen. bit was study there So little that intention crossover of a by

it's know doses rapid in So has – so We times an between out early so in afternoon out day. an this four of or be spaced to a morning, between. morning, for and onset. recommended PHXXB one, hour a It's evening, so times in hour early kind four late is spread

of We know a duration effect. fairly also it short has

part benefit lingering better of impairment. of So without benzo a of the the without it cognitive right, onset, baggage, that's the but rapid being sort

a times over days. a So hours it's four split day by XX few

Timothy Lugo

helpful. That's Okay.

the you got rank PHXX outside can company? PHXXB, pipeline the you And so specifically. meeting, priorities couple acquisition, where for the – a sounds like it upcoming of of through the assets of PHXXB is of outside kind terms in the of rest Pherin you of Can just

Shawn Singh

of of PHXX in the that in adjustment the and on indications top way the that. after we've across two multiple clinic sure. PHXXB, acted disorder, Well, list right SAD Yes, following course, and

a Phase the U.S. disorder. IIa to months, early a for bring formulation second small we're should that done that a have asset quarter. the outside here be the optimize on full I U.S. to few We POC The within program, to had it announce done study We probably that major back that That's doing depressive the we'll enabling IND was bit. a in and

onset clinical the as us the for some That for Phase then back early work need leveled the PHXX, to what to and cases kind for But MDD here. and we of cases terms option three with move U.S. outside as treatment PHXX. with in hopefully had to same And are data IND-enabling there's into PXX development a There out. to to similar we're then lets most features uptake sedation done those for rapid of that no – again asset do standalone early late-stage do and PHXXX it's assets, systemic going similar IIb right and PHXXB. in some

We expect to that achieve back be non-clinical us the to grant some able work that was work. support for clinic. gets That into

receptor. probably hoping the safety AV-XXX, because this preclinical NMDA involved PHXXX we point, more in data see at that we PHXX, across PHXX than few and we see if this data, solid a with we're preclinical advanced combination, really the of a have indications lot

we'll have how decide we So for MPTP levodopa-induced and that then so of the models AV-XXX to IIb with and pain, priority see as in pain dyskinesia, which direction go. for IIa would after I against be Lyrica neuropathic some models the gabapentin, PHXX But want next we've think done in to go. monkeys as the well things we'll

our too Pherin on We haven't the had new long. assets for hands

see on is opportunities The assets. do want grant followed might core little a clinical to to however, digging all sets data focus, get fairly for by three encouraging, into want exist. But there across lot touch that data those we more we those There's we of a are to and data, those more PHXXB what are that the as do So on in just direct we PHXX. need all of there. predominantly

Timothy Lugo

helpful. Thank you. That's

Operator

Tsai a do proceed. question follow-up we Jefferies. Andrew And from Please Instructions] [Operator have with

Andrew Tsai

operator. Thanks,

they understanding topline speaking of So they'll it. the how fact, mention when did data, you some is FDA PHXXB, they one the a see data. signal the is of the competitors reported depending SAD to how on did, understand I My talk earlier some competitors analyze in –

long-story into to buys two SUDS into LSAS, your you have So to their say scenario presumably, proceed because is, that go options I just with do let's the how FDA and if here? buys decide FDA short, guess the would the whereas guys I question you happens,

Shawn Singh

no I no the that that those. that was study a study. surveillance question challenges of the do is a that's drug, destroyed changed it There's know example, people associated valid raters as into the about the endpoint. whether moment, you about The sure methodology We either the are assess on with the question speaking or the to the already making challenge are have registrational is, we effectively can different cells solid you you is – right? the it be with where public making SUDS. And inhale necessary protocol, methodology. We you don't that. size visits, scale is, issues the sure the at associated haven't people to That the of need for drug what have and we're FDA not a trying a It's to that's move from with land. right that where know the – the is that

land of I II that studies And that single administration those provocative assessment. study. Phase Phase very There's mean, their lot things did it's one trigger. a on a the II peers that

– the may possible a assessing. to with when methodology scaling be the size isn't the into what isn't registration worth a that support and It may just that study. move that's necessary it's it And something be you say that ball we to So we game proposed different to we're FDA necessary? up or whole risk? changes quality And isn't

effect very what we NDA. statics. is isn't with up fact to positive a an period be would support If going would size, of go the we endpoint, six-month think going three But within to day involved the same unusual protocol all right. with adherence it's good is of with distinct thinking. PALISADE-X their primary a If the it's statics primary the goes but end for macro all but that way that the rigorous there drugs Well, the studies environment to hit a endpoint. be having methodology, the sites end be at then Those signal that the would that on and not their not into time the

of thinking. part that's our just it's So

all the based we to on agency, as the think primary although, historical a, a there. The registration historical endpoint other side we of it three prior our regulatory is, are comparators are There there's there – LSAS, with LSAS risk comparators studies. with the as for don't six know support there's that interactions SUDS,

of All all positive. by them of a using SAD the not registration positive, single the the one big for way, were studies, That's LSAS, wasn't.

what terms the We helped about the people assessment, we ultimately we'll cash says we right, way designs that be that and have make want discipline study well, that and best cash way downstream, as want. to drug of can use a resources, best how decision want the We we fit lot the time, talent it put risk world. think So just to in the a in is approved. an NDA by fits, think towards what's

depression a and So you were Zoloft – were multiple there of – confidence the are is those multiple failures of look effects if steady string in same Paxil, There successes. drugs lot at behind a successes. there

But studies, all primary LSAS in SAD interestingly, the the to registrational only were use end for all as and positive efficacy point.

improve direction of a lot control primary. COVID's from under Phase the a with other forward as would world LSAS set III pretty bit transport would study if what that changed learned nicely. a on we and now, some is So that a lessons the odds PALISADE-X into where that do factors The we of with

Andrew Tsai

the if having of us ultimately, Last you generated you walk to up kind LSAS, question you with the Phase – then through III Can you how do and data? lines? proceed is running can fast time get studies if Right. and

Shawn Singh

the a of would that's readouts. right? with study the we hadn't with well. launch and involved want with we be very lot way around motion as be all want type landscape to on studied through it to in XX Yes. that the sites Well, a takes But involved of scenario, six is going been the now for it get PALISADE-X. we've course, being those supports back back not depends now we funding we months, know been about an Right two SAD of sites, mode studies. We to it we're now, almost it before brought really across something data optimal in the in sitting would funding, on in that

XXXX. So again, running parallel, of the PAL-X, the PAL-X, in next be here fourth we quarter sometime a if of start start them both readouts those two could before by a in would studies, staggered bit a see did studies each see going studies with year, if other. think staggered And we the the it'd LSAS run could little end the we end of we of XXXX start within readouts the we the would as And based next get fourth of to quarter months. several we

Andrew Tsai

right. again Thanks for All Great. helpful. questions. these Very taking

Shawn Singh

bet. You

Operator

time. questions no are at further There this

Mark Flather

Thanks so much.

not on today. individuals us contacting get do ir@vistagen.com emailing additional the release any hesitate to touch have or please in press our with you by questions, listed If issued

you to to We VistaGen. attention latest on call. support. great concludes you tuning you and stay on current in progress. continuing a connected to We sign up also with our the news appreciate forward keeping and This look from our everyone's our we encourage website Have for Thank day.

You all disconnect. may

VistaGen Therapeutics (VTGN) 7 Feb 232023 Q3 Earnings call transcript