ACST.V - Earnings call transcript Q3 2022

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Operator

Good day, ladies and gentlemen, and welcome to the Acasti Pharma Third Quarter Fiscal 2022 Business Update Conference Call. [Operator Instructions]It is now my pleasure to turn the floor over to your host, David Waldman with Investor Relations. Sir, the floor is yours.

David K. Waldman

Thank you, Holly, and good afternoon, everyone. I'd like to welcome you to Acasti Pharma's fiscal 2022 third quarter conference call.

us Ford, are Chief with and D'Alvise, call Brian CEO; Financial the this Jan afternoon President On Officer; Dr. Operating Chief Dr. Lemieux, Officer, Chief and Pierre Scientific Canada, Officer; President U.S.; George Operating a Q&A remarks, and of be Commercial Prashant there Kottayil, will Operations.Following Officer, Kohli, Chief session. prepared our Vice Crescendo any Should contact remain XXX-XXXX. (XXX) the after at questions please call, Communications information of historical I'd that are call Canadian also this or facts and within on current conference forward-looking like meaning to the the statements remind within constitute laws securities meaning forward-looking statements the U.S. everyone of the that statements not of statements readers believes, Private other should, results Securities involve and forward-looking plans, or are or similar Exchange known of Acasti urged implied such different describe by materially continue and be of could may, to expressions other results and statements Act risks, consider forward-looking. risks unknown with the explicitly that such statements uncertainties anticipates, and to from uncertain -- targeted potential, expressed be Litigation Securities results listeners expects, Reform historical which any Act intends, labeled future and statements.In unknown from the uncertainties, will, forward-looking actual addition of or the to to XXXX.Such belief, factors XXXX cause terms and statements call.Forward-looking and PK and to, developments; are pathways; entirety in to limited submissions on this call their and changes Acasti's effects bridging operating expressly regulatory Listeners statements Acasti's programs of operations.The legislative, not conference clinical are conference projected or regulatory, requirements statement. and statements, regulatory forward-looking and the in during cautioned the may which position business preclinical trials; regulatory conference and but this trial these clinical of qualified success the GTX-XXX reliance by contained COVID-XX are on date runway; cautionary this cash study place undue developments; and economic political designs timing speak this of not forward-looking to other of only as the include, for of clinical call quarterly The cautionary at Form conference note and regarding XX-Q, which of this statements forward-looking at information call. this www.sec.gov made latest call Acasti's available on date at the EDGAR as are of section is on of forward-looking SEDAR in www.acastipharma.com.All www.sedar.com in conference report on Acasti's section Investors website the contained on Acasti forward-looking undertake information, does new whether otherwise, a future except of not any as events or to law. by update such statements, required result as filings to quarterly uncertainties The forward-looking not from Acasti's report statements of time generally any contained Exchange regulators, relied addition, are the any and securities today including today's Canadian Commission subsequent forward-looking on be and on of as should our representing views and public and that are represent as herein assumptions Form risks to described upon subject XX-Q.In as date. views also Securities Acasti's in and time statements

turn the update While the Please required point made, ahead, statements forward-looking that future, to like some events call after obligation on were Acasti statements exist laws.I'd at occur by update Jan to such except to now in to CEO, securities circumstances that may the or they applicable D'Alvise. no as Jan. Acasti which Acasti's date over undertakes reflect go

Janelle D'Alvise

Thank today. call the welcome you, like David. everyone really I'd to on

to made orphan quarter, significant treat towards During clinical advancing progress of pipeline with we third our the fiscal drugs diseases. and rare patients

more second pharmacokinetic candidates stage treat been outcomes.Now and being clinical are side and to as targeted delivery lead more commenced of drug triggered United healthy treatment patient is crossover step pivotal of X-period of conducted center, improved or all being States. an of that's to GTX-XXX, drug a the the pending it's subjects which than prolonged and next to an property the enrollment while compliance proprietary infusion study evaluate quarter, or This experiencing currently by pipeline as SAH, XXX(b)(X) an onset potentially XX relative patients in enhance randomized, supporting about single marketed and which effects potentially Subarachnoid our efficacy IV are to effect and bridging the oral Hemorrhage, during novel increase ever-expanding the our standard and primary nimodipine Our care can for in faster being we pathway, that for nimodipine reduced study objective orphan growing the bioavailability safety by and intellectual developed XX the patents delivered, clinical PK designed as providing action, GTX-XXX conveniently aqueous issued study.The with and study formulation PK ultimately is have proposed for formulated capabilities preclinical compare previously our specifically technologies of is medical drug aneurysm. and and rare in required portfolio capsules, conditions.Our a of disclosed, of candidates and regulatory

significantly study subjects the Cmax, and its as were tolerability first in encouraging under the in with strong concentration-time to area to data indication the bioavailability events the oral completed protocol mild study we they GTX-XXX have subjects. the XX in continue Day medications.The outcomes GTX-XXX To has back to advanced XX full which differentiator compared and based now common of complete better XX that SAH, capsules.Now of endpoints The as is of well hypotension, a comparable in patients GTX-XXX completion.We to already results events last to in been the earlier only data GTX-XXX interim significantly first there compared adverse to such adverse the current for better healthcare on interim XX met improved for or with the observed over-the-counter and cohort as we lower study date, curve, observed an positive assess could for interim near-term on important to importantly study and for and Day correlation correlate normal could us the no track about with the XX-hour healthy been both was safety analysis over on reduced of achieve protocol. system.Since full endpoint were GTX-XXX December, This were inter second these control oral for headaches study variability for calendar nimodipine reported very should enrolled, for tight of variability levels maximum intra-subject resolved in as PK X as study, primary we with enrolled. nimodipine nimodipine. results the results, subjects with objective pending having QX. on the is the and the economics infusion analysis patients the believe groups, have X. pleased subjects These under announce very required with report allowed primary of interim period AUC, that a serious cohort in and the were as GTX-XXX as could the both concentration, Very the oral and be result a full of blood remains reported or

expected for study in the expect safety to and the finalize Assuming study the results quickly study to it with profile, already should be we half consistent We with the small interim GTX-XXX are low of safety completed III plan believe relatively final to safety initiate effectively. protocol still and of for enrolled, design the XXXX.Based to calendar results, Phase favorable study number to safety be proceed on the GTX-XXX the given relatively risk be cost its quickly second patients the FDA. we and

provide United aneurysm, than NDA, these many be application, is is dosage have grant time oral patients a GTX-XXX, we regarding before only tool approved, for the its underserved important years believe an or the the major company forward moving our developed a believe of candidates regular study nimodipine. the GTX-XXX much life-threatening potentially step convenient more look hospital would the discussed to final year, United previously market Importantly, months form addresses to efficient addressable designation the GTX-XXX it's GTX-XXX the regulatory a better expected stay. and assigned XXX(b)(X) by million if would swallowing steady these a the could alone.Nimodipine X about deliver towards the enhanced effective U.S., of representing in And by currently to GTX-XXX more and clinical as could are SAH make hypotension physicians consistent required hard Phase during our patients of to is We PK rare States.As unconscious $XXX new granted levels, of the X and or submitting pathway.Our more study exclusivity and previously, we available forward to drug medical safety which States X study absorption more how in affect have caused their in in updates protocol and blood already emergency. a safety drug estimated way market with ahead.Now SAH an III be orphan FDA ruptured GTX-XXX under FDA, an per and by and the next and It's be XX,XXX the and providing delivered to the market. profile GTX-XXX because we importantly, on candidates, NDA, their other to weeks management.We progress the continue really milestones. drug intravenously

AT spray improve safety of manage that FDA-approved symptoms and Italy As for purposes volunteers. simplify GTX-XXX conducted oral healthy study to is it administered novel comparative an formulation will mucosal as and mucosal an fully symptoms solution we filing to disability bioavailability, the for to to or betamethasone selected will U.S. form filing in primarily oral purposes to with a X-arm intramuscular impacts believe oral Europe. the randomized formulation spray. male children, recently progressive severe a conducted CRO concentrated designed telangiectasia independent And which intended of Canada, treatment liquid is for genetic This in oral bridging study GTX-XXX This be on to disease pharmacokinetics exists.Based study the of compare open-label spray betamethasone of injection crossover AT administration.We partner has for in an easy-to-use PK oral and in concentrated administered we will be potential the GTX-XXX's mucosal study betamethasone evaluate of neurological as and currently betamethasone, our GTX-XXX. drug female study novel and an a a betamethasone of AT. improve neurodegenerative a reminder, ataxia no causing the

we that PK XX half in of GTX-XXX. the our this treat study its to pain in turning from and causes primary both and XXXX. often nerve endpoints, calendar persistent patients clears candidate is PHN, expect developing to neuropathic study and shingles for the with schedule We're and virus out drug study report up. damage the first efficacy Phase We virus, patients varicella XXXX.Now infection persist this debilitating calendar zoster months in can meets be which by initiate If neuralgia, pox initiated safety to to even QX or bridging PHN chicken this a and years of to before III the expect shingles. postherpetic caused end on after

are lidocaine pain.Our Acasti, to pain film commissioned insufficient proliferate, to oral off. forming prescription and look and some bio-adhesive to could to also relieve benefits And up patches is pain.As topical of fall opioids opioid using are prescription sensitivity They we the often difficult for by significant opioids care, irritation. patches refractory According Lidocaine gabapentin bupivacaine lidocaine and can use. patches, spray you many patients most to novel continued unsightly current of that approximately provide skin of their patients research cases relief. GTX-XXX reasons. believe persistent are They patches XX% has end standard consists address prescribed lidocaine primary know, over experienced gabapentin and and requiring third-party of and abuse cause suboptimal a the which severe often formulation

that's pain, only effective include for optimal and prescribed neuropathy reimbursed to in could take total not to consisting start minipig of PHN. with from potentially bupivacaine of compared indications, patch.The is multiple commissioned majority our saw patches market to action U.S., receptivity very the active minipigs pain indicated recruiting could humans, to clinical should -- pain X.X IND-enabling addressable pain, the mention faster we proposition approximately study weeks indicating the affect our GTX-XXX which about convenience.Now an Additionally, for I for replace primary about to range will underway previous and to because to patch which potential the use prescription of they achieved benefits broadly Phase non-PH PHN market onset by study billion report X patients a Neuralgia's. with we of nonaddictive the as for while dose with the is the for are that including in in start other States. market. us of that ascending around-the-clock now, the Acasti, a value Note third-party a for our GTX-XXX. lidocaine humans sensitivity XXX potential study patients patients has lidocaine ranging year.By GTX-XXX be this regular in provide billion, further PHN relief. pain XXX,XXX can back lidocaine for and ingredient that to topical relief PHN our to believe sensitivity regimen hours before United physician for taken can continuous up ease this hours. in and be Results no to the be alternatives the about in skin strong then but the GTX-XXX's pain of GTX-XXX for scheduled study be XX But relief shown must skin expect osteoarthritis, from longer-lasting X-week our we on could that are fact, enable And provide off and will will of million for estimated according II research GTX-XXX, Consequently, our year expect near-term patch pain out grow and XX only lidocaine PK QX. X.X way, can that GTX-XXX towards report pain.As a calendar used could study spray also be of per also milestones GTX-XXX for is breakthrough use for requirement in end lead only a diabetic showed as greater nonnarcotic, about This

and multiple and important tremendous significant So very about drive we're it milestones lead ahead.And potential we're holds that for expecting shareholders of each orphan mentioned, our drug months XXXX. as could programs throughout in for excited achieve I years our believe entire value our portfolio the to

and the we results exciting now lead portfolio the for PK and continue active I candidates development With next Ford, study as launch. turn we've for hope operational our and discuss look updates, annual clinical thus our ultimately well over our as to share on it update.So as and the occurs forward towards entire GTX-XXX development call results our as at reporting you our CFO, to those now commercial our drug in enthusiasm far the outlook seen We further Brian work for our GTX-XXX to quarterly progress for with Brian? through to for clinical I'll XXX, financial underway fiscal QX. advance

Brian D. Ford

Jan. believes new $X X accounting XX, months compared and December the million million in XX, in increase current of in for to turn million underway.As expenses of expenses to provide an net share call development to XX, clinical as $X.X $XX.X primarily ended and least earlier, for net I'll result compared short-term in increased or months the increase mentioned $XX.X you, $X these of XXXX. attributable for numbers the stock-based loss to an ended million $X.XX compared of XX, got for from net tax, operating acquired XXXX, million XXXX, X and months depreciation, the totaled X equivalents accelerating equivalents million was million months loss the increased clinical or development The ended other as assets an increase a research the dollars. XX, ended increase development The increase XXXX. increase from for the of million otherwise indicated, to was Jan. XXXX, related cash professional $X.X $XX runway, general and X was -- months and net professional before accounting development activities that on compensation research admin expenses loss all and expenses again due legal December that, million a mainly $X.X months research XX, Grace.Research The XXXX. X I unless to this loss cash contract funding XX X of mentioned we loss December program XX, Cash that, the resources Please mostly and December fees.The now XXXX. at over tax, and $X.XX the months to ended XXXX, compared operating December the are of the management's was December ended for December resulted and to projections.With per December totaled fees. investments increased expenses per from company The note $X.XX U.S. related I based The Thank was increase XX, share as back legal, activities and in other to amortization

Janelle D'Alvise

That our prepared Brian. concludes Thanks, remarks.

Now any like you our shareholders. I'd questions open it can Holly, from up questions? to call open to to the

Operator

is Your Instructions] today [Operator first coming Heller. question for from Alexandra

Alexandra D. Heller

for Heller Alex safety study quarter. the and safety be the Recognizing III XXX the quarters? II made GTX-XXX, progress that moving Congrats expenses study bridging will on of study what this completing into for as upcoming look on is PK Gershell, This we the like to you well can Leland Oppenheimer. Phase in R&D expect as Phase

Janelle D'Alvise

to to to -- our Brian, I'll comment overall Yes. really thanks over Maybe clinical turn of for to appreciate expenses the on kind that I'll way, of ramp-up that it. ramp the by one Alex, question, the do the turn due the over you Brian. of want programs?

Brian D. Ford

Sure.

months, $X moderately per month. R&D expect from roughly we almost per expenses month our next growing $X.X be the million million XX to For to

that incremental the We some above expenses department. have with

to Phase the that III answer for to get the in XX trial, more out question? further so months again expect the We another activities Does grow begin we commercialization of into invest R&D GTX-XXX. we as

Janelle D'Alvise

the will programs. completely sheet current balance GTX-XXX we we've might both have us and and that XXX our program add, on I allow full advance said, Alex, XXX cash the fund the Yes. that as the to significantly

Alexandra D. Heller

Perfect. next And approved incredibly we look Yes, question then discussions that guess have I I on into helpful. might XXX? at for at there's might the pivotal And had like what on no the product for you're maybe AT, that FDA? starting design when any was is, clarity that when you have as design trial with XXXX have looking

Janelle D'Alvise

to study discussions preliminary have probably the design, a would We'll we less. maybe them. number how follow tell small had patients us with wants and it meeting the a for about can the treat trial study the the and these FDA and what We've FDA the now. once lockdown discussions, we guesstimate a based to on for Yes. be study PK the about see plan in patients, that Phase XXX III. But We expect will patients. have that's of efficacy preliminary I design I with the to FDA to complete safety long you

Operator

from Sahil coming Your Kazmi. next question is

Sahil Kazmi

more both on inform costs formulation? Congrats on to of Could all from has Kazmi what on gone relevant further you today quarter just with patients. And you data patients the seeing Securities. Sahil A provide granularity and these focusing type upgrades? between we're the clinically B. a and be bit progress that variability, oral questions from the of might is us. relative in on. that both from and also on have how Riley XX Maybe the terms the This your enhanced couple

Janelle D'Alvise

to and speak little GTX-XXX Pierre Really Sahil. today. But really attending Thanks in it turn tight it appreciate George. variability. over question. saw to your showed a very we dramatic the variability. for and generally -- thanks I'll then difference Listen,

to subjects. have blood based you would completed caution time, obviously the Did be compared the which the don't those finishing and the some was I XX of it data we this the nimodipine then very the is to it QX. seen take think then It We want pressure expect before, subject saw. that's was do makes We're you to We've cover add from on have in significantly this anything oral So control we I causing they've report few that But big when I the to still next up on so to on add? out will pressure, mute. XX. this should or and huge variability clean the over We Pierre, and report the and you much Pierre, that in we time do pretty and subject up swings complaint on I in study just is or surprise. have difficult do got blinded. what it And to want low data. physicians. still oral, to that track far, know, very but you I blood no was variable.Now might out more weeks XX results. It don't be mean, to anything? patient just

you We're are not Okay. getting. George, there?

George Kottayil

Yes. Jan. I'm here,

Janelle D'Alvise

-- want anything you add? George, do you want to to

George Kottayil

as Yes, analysis said, by a XX So the have Cmax perspective. be both in kind XX showed of portion study we'll essentially, of after we the perspective complete subjects. this interim complete Jan any the of the March, little a should expect and different the very report data end a month AUC exactly variability from of draft from April. -- some or well be at this subjects don't as early so the mid-February clinical to as And We

Sahil Kazmi

Jan Brian. X or us, either more maybe then from And

position to ]? and about about And Just XXX go you in how as a just to of given cash bit than what actually the able pace of for use guided the emerging were how [ the and Can we're how the this anticipated? today runway, of capital little programs? either both relates guys it to be HCl AT able you XX you one might program, talk seeing on think focus months to the development quicker you

Janelle D'Alvise

Yes.

then complete jump GTX-XXX. But the a expect from financial we add perspective. you current to can in yes, I'll more So Brian, and cash

have would cash a ahead But a running bottom impact month so. few or the bit going little to maybe a weeks, a on of We projection. significant say line I schedule, I don't are it's think

clinical aggressively. plan.So very the in and looking again, are of in that, of a have other forward was moving assets one We said are additional that much on development we comments we XXX this runway? we preclinical But But on that want more do cash that. to before having forward interesting. a to be our couple has more of into planning potentially But quite lot you say Brian, the pipeline later are any too moving work those And XXX all at year. make done

Brian D. Ford

we No. I cash going mean to held at been tracking continue new than we've the and that build merger. estimates or has -- our our necessarily agreements continuously from of information up better but on come the plans and little new into the pretty best as not look to agreements programs. well. so a revised the far, And date planned But forecasts new research continue as we start these play,

Janelle D'Alvise

are managed overall, In our a cash say, we would running words, ahead. we've I very bit Yes. well. other

these So can and are programs we we'll bit cash runway. data to tightly ahead running projection the and planned. a hope we holds I of run fully as continue move let's expect in And our forward up, terms of

So I your hope Sahil. question, that answers

Sahil Kazmi

Yes. That's on forward progress again Congratulate extremely update to on look helpful. the and environment seeing in this the XXX.

Operator

no Instructions] queue time. questions [Operator at There are in this

Janelle D'Alvise

Okay. for today. us joining Well, want everyone thank I to again,

a very in we can to programs tell, forward have, the updates lot We future. near look of underway, as to exciting really you continuing and provide

a have day. and thanks, again, So good

Operator

Thank conclude call. you, gentlemen. does This today's ladies conference and

for you disconnect lines day. have phone your wonderful your may time, at participation. You this Thank and a

Grace Therapeutics (GRCE) 14 Feb 222022 Q3 Earnings call transcript