VTGN - Earnings call transcript Q4 2024 | VistaGen Therapeutics, Inc.

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Operator

Greetings and welcome to the Vistagen Therapeutics Fiscal Year-end 2024 Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mark McPartland, Senior Vice President of Investor Relations.

Mark McPartland

Thank you, Joe. Good afternoon, everyone, and welcome to Vistagen's Fiscal Year-end 2024 Corporate Update Conference Call and Webcast. XXXX, our SEC, with for of on year March filed Exchange Securities our our we press ended or a fiscal Commission, SEC XX, progress afternoon, during annual an year the report and fiscal release our This provide issued XXXX. overview and Form XX-K which our you in the found to release website. We be the encourage and our section of can press review XX-K, both of Investors

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

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

we'll that Additional SEC which business our our time the filed the make could and the filings the website website. information and on the to the Investors included factors year-end SEC of available in the and/or earlier XXXX SEC's risks future, concerning are in that is of from in our all time XX-K Form with section with fiscal results affect and today financial in

prepared will analysts. will a programs an our today After Chief questions we in Anderson, for Shawn the of and With pipeline. our and Officer; Cindy our call welcome stockholders, sell-side Officer. joined remarks, Singh, be the the on update other I'm Officer; offer sell-side diversified Josh Prince, our there Executive our interested the formalities lead our opportunity Operating by out the to of our way, provide on analysts brief warm Chief a from Chief neuroscience all Shawn of Financial in Vistagen. conclusion

and be our available can As Investors will the replay in completion. The webcast link found of website. being a for also replay after be the call is reminder, section

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

Shawn Singh

you, Thank Mark.

Sorry joining afternoon, thank and for about Good you call. our that, everyone.

Most Vistagen filled Phase the a fiscal the was positive results candidate for company XXXX became with acute achieve III III accomplishments. positive disorder. our acute drug fasedienol treatment U.S. study Phase anxiety series from study with treatment first of to the for of the notably, with remarkable social SAD. of Vistagen a of a PALISADE-X

PALISADE-X In addition, trial, our marketing with fasedienol the major we as Phase for program SAD. forward launched Phase PALISADE the that to PALISADE-X, in our recently in potential complement step registration-directed next III III

progress pherine to for potential achievements with significant underserved neuroscience nose-to-brain new of pioneering commitment These and differentiated developing candidates in patients standards of high-prevalence deep set a to neuroactive across focused neuroscience diversified our that's disorders. neural candidates reflect our anchored by drug of novel pipeline on affected circuitry care understanding

clinical introduction as intranasal as known drug candidates other the nose the neurocircuitry-focused neurons require binding to do achieve of by that a as product to designed approach a innovative pipeline treating the neuroscience portal neuroscience a some psychiatric effects. an sprays, novel, therapeutic pipeline or our reminder an for and to to and As not others, administration absorption brief candidates desired nasal class pherine as disorders Exclusively leverages new features systemic stage our rapid-onset, brain using diverse to of in neuroactive pherine.

to pherines nonsystemic, in microgram the in pherines studies the of each mechanisms unique system in neurocircuitry and action, of peripheral clinical our brain. and differentiated With favorable both cavity, new milliseconds, demonstrated date. activates all Administered MOAs, neurocircuitry-focused doses class fundamental safety level proposed our or of olfactory influencing member profiles have completed within the nasal neurons in chemosensory

FDA-approved hot of multiple flashes, social anxiety treatment disorder as neuroactive differentiated commercialize inadequate disorder, depressive and options develop high-prevalence The CNS and goal menopausal even diversified care. limited nonexistent major to of current standards such to pipeline disorders and for pherines indications or with is

social they're which safely marked settings, stresses high social media and anxiety single and day and fear rapidly anxiety-provoking treatment seemingly in and anxiety the multiple profound life stressors and workplace everyday when by help XX there in symptoms no in during performance in faced of disorder, different situations social day. U.S. disorder their by SAD, to ever-growing often and the or team more For disorder is anxiety still individuals especially different that performance that prevalence yet orientation with the of that FDA-approved that's life, despite acute academic and the their faced neuropsychiatric adults, when social at are affects is triggered million example, times any in with manage everyday than

help Our program rapid, underserved to without millions intends close treatment. for of III adequate SAD treatment the for option affected fasedienol individuals by a that flexible patient-controlled that gap an are and for Phase

during the upcoming trial the successful this complete before III to and SAD of expect calendar calendar well year is trials success our trial. Both the our as for in the top in Phase replicate enrollment track, XXXX. fiscal 'XX, Phase for end for Phase our XXXX PALISADE-X we our half midyear as which data treatment acute of trial, on that recently on second Building progressing is are PALISADE PALISADE-X designed track III III PALISADE-X preparations potential for of fasedienol launched in line to our on including registration-directed program with initiate

made of the PALISADE-X and drive enhanced time efficacy protocol of scale, favorable enrollment, units While is execution changes backdrop we've distressed the believe primary against far well PALISADE-X PALISADE-X built rigorous the potential SUDS, the of some some through the subjective now and variability of an than will is are in enhancements PALISADE-X operational of research the pandemic. and public as environment control at a point PALISADE-X, and clinical as all and any surveillance adherence or during what speaking stable quality optimize unchanged, more the notable end help studies and we use challenge and design into

repeat PALISADE-X, public alignment with study also in a near administered challenge. second XXXX. to we initiate half small XXXX, the prior Similar calendar of our this dose half placebo-controlled to XX dose study first the second of in XXXX with discussions of effects the we're to During the evaluate speaking of of a FDA dose planning readout to fasedienol line completing the end after top the second calendar anticipate a with minutes a

the may clinical and believe PALISADE-X, either of its next results with kind. substantial to of PALISADE-X combined could U.S. new We in of PALISADE-X during to completed success approval the potential drug acute for effectiveness submission data XXXX from of first from half and of open-label or safety the fasedienol's be support if approved, treatment all trials the be year, safety evidence SAD positive first provide a application additional fasedienol which,

fasedienol development our As a has reminder, granted of Fast SAD. for Track Designation treatment acute the the FDA for of

differentiated actively a also potential the fundamentally new MDD the of and U.S. potential depressive to MDD. IIb with for are are We for disorder, of therapeutic our ongoing. Phase exploring candidate planning in or Preparations be itruvone itruvone, major pherine pherine nonsystemic therapy development another and

side a their a and this associated is or mission not individuals frame new and to Our in rapid-onset concerns candidate prevalent effects care, with symptoms transform with sexual the unwanted that liability. effects, weight with relief abuse large find of in increasingly which differentiated safety the gain such for MDD expediting side neuropsychiatry may is standard product time profile as safety market

rapid-onset, hormone-free health significant nasal for candidate see PHXX, indications. and medical also commercial potential in nonsystemic pherine spray our We women's

for we During symptoms management as the significant fiscal due IIa and or both previously Phase conducted U.S. X results, disorder, placebo-controlled menopause PHXX for vasomotor positive premenstrual XXXX, statistically announced treatment a outside PMDD. from unreported exploratory flashes data the are hot dysphoric or that of studies demonstrated to

Current We hot clinical flashes is of are to facilitate another satisfactory in worldwide. potential or suitable from prevalence affecting treatment options not for ages to are menopausal XX XX% IND-enabling U.S. a currently with of the nonclinical U.S. those conducting Phase PHXX millions high indication further II women women approximately development of studies It XX.

Pharma, women's license fiscal them Japan, agreement development is a negotiating also pleased of agreement company commercialization the enter with on exclusively Fuji into for for negotiation in health-focused an We're which to Japan. leading potential in a PHXX with focused 'XX, during and exclusive

Mental fiscal first during current Seal the the quarter Health year. in first the level, America's award of has fiscal prestigious of again the Vistagen On and received corporate quarter XXXX Platinum Bell

to We employees in illness. each the certification, workplace Place that company toward intended a advancing and of be esteemed and playing societal promoting shift to and key commitment also our mental to role health Great a with exceeds support standards Work a well-being our mental these received by also of destigmatizing and awards practices broad reflecting promote the

some fiscal turn that, to With Anderson, 'XX. the CFO, to our over of call summarize Cindy I'll highlights from our now Cindy? the

Cynthia Anderson

Shawn. Thank you,

earlier encourage also results XXXX. everyone review filed highlight Form this will I additional our mentioned, year the and with Shawn details a financial report afternoon our XX-K disclosures. I fiscal SEC for from few to As on

in were the to expenses XXXX. decrease III and for timing decrease Research year fasedienol March $XX XXXX, March expenses in SAD. the and in million XX, trial expenses ended million compared the expenses to $XX.X a clinical ended Phase R&D as primarily incurred to This of year for due was development development related XX, in of our

an the in expenses increase stock-based million decrease primarily compensation in ended to million March professional and a $XX.X expenses. administrative G&A $XX.X to XXXX. was fees XX, The ended the for expense, expenses and as for offset decrease year compared were XX, March year by compensation General due XXXX, in

Our March the stockholders $XX.X XX, year was $XX.X net compared loss million to March XXXX, to million for XX, XXXX. for ended year attributable common the ended

XX, of and March XXXX, of million. we equivalents cash cash As had $XXX.X

that report and As for with the XX-K disclosures. annual on a was please refer reminder, our to filed additional Form details SEC today

back turn I over call will the Shawn. to now

Shawn Singh

Cindy. Thanks,

commitment I to our the work on conclude stockholders. helping value as lives as we our improve around our of remarks, our team we're and potential as the underscore focused prepared and enthusiasm the to to want hard well just the and pride to patient deliver So

with for PALISADE-X the our pending PALISADE-X registration-directed the the approval first of with III are of XX now topping launch of trials million and prevalence Americans, FDA to With potential we fasedienol market SAD, our commencement systematically achieve the the targeting that a for acute indication. treatment program our increasing executing Phase

great confidence executing team's all in programs our neuroscience across pipeline. in and our III our expertise Phase have the We PALISADE program

at of team to entire I'd interest behalf your your for ongoing and support. you Vistagen, on like for the So thank

Mark McPartland

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

Operator

line with Jefferies. [Operator question comes Instructions] Tsai first Andrew from And our the of

Unknown Analyst

just Congrats have if on and screen failure the couple on how mind the stronger cadence then or compares commenting also if slower the prior Andrew. on rate enrollment is is well? had In mind. for looking to patients first of than the I of questions, enrolled studies And many how you you as Matt and couple don't far? so studies, that PALISADE-X, a the This don't And progress. you

Shawn Singh

your Sorry, I didn't name. catch

Unknown Analyst

Matt.

Shawn Singh

so important off. screen really way execution throughout we enrollment, given the even, is any you PALISADE-X remarks, build tell to but that But efficiencies is enrollment visit what during and lead of like. able the which with prepared and some emphasized kicked failure actual happy Matt, rates not We've can what we're study, haven't through the upfront I only has the enrollment on screening. guidance on very between specifics generation I in been and X of the the and

time. the achieve of a leading this to way of prior all lessons the things the the back leverage studies that and II design, able been course of learned the lot through execution particular to reflect We've Phase of

near to think of ability would which the PALISADE-X our 'XX be I this readouts and case for to that team right we've the the study guided, the well with positioned the around achieve mid-'XX time So be the will extremely on is same then end continue PALISADE-X. for and track

to have do Josh, that? anything to you add

Joshua Prince

Shawn, terms are in yes, recruitment those say our that of failure things. of just pleased expectations meeting the thanks. of in startup rates, I screen that with types it's of PALISADE-X, terms we would rates,

So at this progress. point, our with we're pleased very

Operator

line of comes The Matteis with next question Paul from the Stifel.

Julian Pino

This is Paul. Julian for on

on color enhanced doing made, as mind that changes, surveillance, PALISADE-X? continue a you cetera. exactly described bit and providing enrolling a notable couple enhancements like confidence you Do operational soon greater things You you what little et gives you're why PALISADE-X that and you just more of

do about study, looking then And about us with a the this safety repeat paradigm? mind what Or achieve just quickly, you're really building one more And question, telling this efficacy is more is database? dose just quick replicating multi-dose on the to here? you

Shawn Singh

Great. appreciate Thanks, I Julian. the questions.

right up clear end same PALISADE-X the design just to challenge be remain well So as speaking PALISADE-X the the and PALISADE-X, public point. across SUDS front, as primary will is efficacy

acute consistent fasedienol all to II. throughout again, Phase for changes there, of treatment remain to the will the way case So no been development the those SAD. of that's continue, the back And

PALISADE-X to early, again of from we study scaling through So Phase conduct that that of large the the refinements to have, we in that up on the and unique III experience III observations are and Phase experience, the very really the based a extensive the again, PALISADE-X stages program particular. late PALISADE pandemic, come of our from, made

PALISADE-X that limited got extensive, the universally variability. inclusion/exclusion the enhancements and we've and properly real optimal primarily is So screening, challenge study, to to PALISADE-X precise public speaking the protocol with consistently subjects that in applied and criteria ensuring apply and administered

on speaking and For public signs which that's PHC of recent all receptors have or limiting sort COVID high-frequency challenge. criteria a possibly been smoking of could of exclusion vaping, an use, example, the single-dose swabs, is impact one some added impact any of nasal or

that about on talk seen as have really execution as significant seeing team and now been the of maybe you of things pre-startup we've PALISADE-X. other we've the gotten into Josh, benefits the some and some

Joshua Prince

absolutely. Yes,

getting think you and as got touched PALISADE-X we of key I going execution really up environment the look a the has variability. This allowed as but PALISADE-X to and and experience of sites on, in up and running. pandemic-free reduce forward then to us potential to across two also PALISADE-X are able operate PALISADE-X we drive to being running things Shawn, through consistent our

of us conduct. it's really and training and model, our sites both study our I right? it So study then of oversight changing gives mean monitoring staffing to approach around rigorous

an think where compared we PALISADE-X you investigator we PALISADE-X for with if PALISADE-X. had to or So about in-person PALISADE-X, meeting are

face-to-face, have PALISADE-X. in-person that study and we PIs, couldn't which So training raters, PALISADE-X we of do coordinators, in

restrictions in up site as running, because more we've pandemic. of and did in we've PALISADE-X or process, of either than in-person sites we PALISADE-X visits the PALISADE-X And of that the already then kind gotten start-up had

lot of that them new And to. want oversight studies to way more is increased that sure just model and so staffing site-facing level us we communication the giving the going make a are site that

Shawn Singh

by just And that speaking be the we've subject proper or PALISADE-X by drug ensure, for audience I'd will and study. the also again, administered and the wearing dose also add PALISADE-X dosing public either health the provider in to the eliminated mask care

and up some difference all that actually of significant think, So typically things little to control associated really a optimize the are lot those some when a surveillance, changes, small intended multiple-center study. as mitigators, but variability, as outcome, well things of to enhance we a you're the on significant to are scaling make some risks that

And it one. then to the to labeling. a with FDA discussing in again, the us that let benefits some dose also think we're for speak with well. repeat some there minute us as while while what line from But a been as in benefits the that And on I'll also Josh on gives could study, safety we study, be has

thinking little more amplify you don't study. just dose on on a what repeat Josh, why the So we've been

Joshua Prince

PALISADE-X we're PALISADE-X and The public after an of subject with specifically speaking design the XX dose to study doing "You in after dose. the and fill might FDA take a a world, because nervous this know want first patient asked minutes then additional into the Yes, dose It's moves as essentially first the just is the the the another and reason absolutely. same said, challenge. real and addition still what,

in advise you on why that that, they we're So instance." see label, informing for And the purpose kind how we'd the like for informing patients. really what doing that's to of of should happens so physicians

that open-label to on And we will is for that that extension study. piece plan we an the other have

world, not minutes let the within if able even what are And happens that again, in again or will product of whether see the use XX patients and to us real kind so do. they

informs informs again, physicians patients. label how the So and on it advise to

to just finally, X then And arms. it's clarify,

followed then placebo fasedienol, placebo, dose arms. by and the it's placebo, followed by So dose by fasedienol fasedienol X followed for

Shawn Singh

chemosensory the to limited also they for of these pherines, nodes remember, You volume need the spray. accept the within to milliseconds. There's activate capacity neurons a

the frequently think is safety-related So of too, safe it which we're fasedienol that hour, to to labeling every if say, the concern someone more dosing. some any actually and give is as help which noted, in has not expecting, seen But effect of really, we multiple potential Josh guidance, with associated were than, versus certainly duration the do dose prior typical it we've studies. inform

Operator

And William then the will the Tim question come next of line from with Blair. Lugo

Tim Lugo

are PALISADE-X also How guess PALISADE-X, how PALISADE-X. up question sites enrolling planned Congratulations my with progress on many overlap I sites for And sites in many patients? maybe all and sites to of of the for those PALISADE-X. and those the PALISADE-X? relates

Shawn Singh

appreciate the Thanks, I Tim. question.

So quite one level there. the emphasis Phase squad. III try that these things And to we've for community and replicate research together certainly good having to the that a believe others varsity play varsity we putting sites be experience of not studies assess really that got ability what about think is clinical the the the we hope we're might to what of within and is PALISADE-X to for both is

some So them overlap the from prior do studies. of

right sites I should now, today, it right what publicized, Josh, XX them up we sure we but I'm think not got up. be around if

at have for and the all drought anxiety for always but will as that fact of time we've in there's the that protocol, pace long alone of let we've or nothing a them really know disorder, third this in benefit, currently even of after with been X social a this uniquely, a seen So been is very it some the about, talked X, before, have if them they we good really in PALISADE-X, doing; we and with positive we're presented PIs scientific acute good never lot what read-through in drugs, a data. in sites great particular. the seen, that we've we MOA this involved said, PALISADE-X about and level program there's of a the the of in where and of not understanding this seen class There's awareness we've even of associated treatment, a one experience like conferences lot

really stressed we're which patient any use a challenge body. what even their a fundamentally a for is very days in one, And have differentiated it the for been the a then a that long practitioners time, and stressors multiple use at it, have kind, candidate use safe on use of control a approach is don't what's a seeing drug can even flexibly, something times a it not for and they're want for ability to and day, different on day and any different day not of certain super to medication of when times

not worry control but an this significant what them cognitively, that available not really their I be use for see So to sites on the debilitate of fall especially a than therapies to be unimpaired quality even we've point. to is benefit for basis able liability, at to to awareness treatment a there opportunity we an pool their to the of short need fit think population the our this and of and the expanded because need approved in work, studies, higher off-label and And potential is that of some these and medication circumstances X seems is just due create before the that also to generate the costs. way ever to sites, much SAD, and to life acute only expect not not able a actually but lot in seen be and about only but abuse the own due in it's and is life of

by on painting in-person And the kind sites, And staff with studies. that expect to and the you to PALISADE-X varsity is a So and case with CRO, seeing it's lot was through of you and investigators' both Tim, up you Bridge way to we Golden line CRO It's not a sites. not we're we turnover type And go the of sites the you. the to really the I just like manage quick have but that that pandemic. go PALISADE-X. support attrition often through of then Gate universal at the start and and sites programs at meeting the also is that these back back has do the bottom guess,

protocol really normative focus just now more least combination. community, good So our sense for there's to really the this stable environment a the that for at is neuropsychiatric the enhancements excite a on top that within us program, of clinical a research

Tim Lugo

dose placebo-controlled and one And small of and there for I Or dose the for of after more safety you dose? is purposes. a it recorded guess study, type tolerability labeling question be SUDS score Will to prior the more mentioned repeat a repeat study? then repeat the

Shawn Singh

Josh?

Joshua Prince

SUDS identical collected, and to are absolutely scores are PALISADE-X. that the There in SUDS Yes. collected the scores PALISADE-X

once are point. of pre-speech So the those obviously, SUDS SUDS. primary And there's the speech then for the starts, end the kind captured

to So the those will PALISADE-X PALISADE-X. actual in and end points identical be

Tim Lugo

if first Will the kind trigger like they collect certain Or second and let dose that nonresponse you feel redose, do dose? data after just all they people, redose. the to of them let need

Joshua Prince

in the challenge study, of portion dose. you after there's period So design, waiting a if XX-minute public the the recall takes the speaking subject the study in

that second in period. the that is the instantaneous, But engages of fasedienol think we dose activation before wait almost speaking the is We study, public terms think. subject XX we clinical challenge. the administered minutes So in in of same

period that where it's administered. so waiting that really dose is second during And

study that, identical beyond then the So and is to PALISADE-X. PALISADE-X

Tim Lugo

Okay.

before X speaking doses dose potentially then another not public one challenge, it's the public dose. So speaking

Joshua Prince

Correct. Yes.

Mark McPartland

us Operator, e-mail do website. that's contact our section at there's questions time for questions, hesitate we of If I have by the not today. all via ir@vistagen to believe the please any or additional contact

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

keeping current our to our appreciate day. and thank all We Have concludes look call. for you on on call a progress. magnificent This interest Again, continued today. our you participating support. We everyone's forward

Operator

conference. today's concludes This

rest time. of You this may now your Enjoy disconnect your day. lines at the

VistaGen Therapeutics (VTGN) 11 Jun 242024 Q4 Earnings call transcript