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Acasti Pharma (ACST)

Participants
Robert Blum Investor Relations
Jan D'Alvise President and Chief Executive Officer
Brian Ford Chief Financial Officer
Monique Champagne Vice President, Clinical Affairs
Leland Gershell Oppenheimer
Call transcript
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Operator

Good day, and welcome to the Acasti Pharma Fourth Quarter and Fiscal Year 2022 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Robert Blum of Lytham Partners. ahead. go Please

Robert Blum

you Pharma’s Thank MJ welcome and All year very and Acasti fiscal XXXX to right. much conference call.

with Executive Chief On President Clinical Affairs. Champagne, call us is, of afternoon the Jan Vice and President Chief Officer; Officer; Financial Ford, Brian and Monique this D'Alvise,

call Laws Act implied Such Following remarks, involve to to on known Securities those the at me Reform XXX-XXX-XXXX. the a also like of of XXXX there uncertainties are Q&A questions meaning statements Should and any unknown that contact and management’s after expressed hesitate from forward-looking the or of statements risks Canadian information and forward-looking within conference could results current forward-looking to such everyone statements XXXX. prepared remind actual and this and cause that the constitute the remain the facts act be of call, Litigation U.S. within Private will that different statements. historical Securities Securities by materially session. please not statements don’t I'd Exchange meaning the or forward-looking

only In targeted urged reliance consider may, to labeled these addition risks terms describes explicitly of undue on forward-looking. not call. potential, with date as anticipates, expects, speak be or the continue, forward-looking Listeners to other belief, and of intends, similar will, place this statements uncertain listeners uncertainties, plans, to should, statements statements, cautioned to and conference which are such expressions which are

in the meetings cost other and requirements clinical and X for FDA, legislative, developments statements regulatory trial regulatory the cautionary Sedar expressly not submissions by and and designs but in to clinical associated with of this limited their conference which the The Phase at on are during are this during FormXX-K, Investors of website and or outcome forward-looking Acasti's at pathways, to and statement, on note EDGAR the study on may the information annual of success regarding this available and Acasti’s timing www.acastipharma.com. Acasti’s on www.sedar.com the trials, pre-clinical made changes forward-looking the of include, factors and call report qualified political regulatory, developments section trials. Acasti’s contained clinical Forward-looking section the www.sec.gov, with economic is regulatory GTXXXX at cautionary entirety and statements call conference planned risk

exist the they securities as circumstances over In statements date the that Officer, Acasti which Acasti subsequent like that representing Acasti's any as after on any views and occur were of call to now events applicable I'd not of please President, D'Alvise, turn Chief our obligation represent forward-looking statements to Executive as undertakes reflect today or Jan except date. should relied be required views Pharma. Jan, such update no to made addition, proceed. laws. to by upon

Jan D'Alvise

Thank you, Robert.

cost questions. a for prepared Given GTXXXX, faster about needs rather orphan of when us allows gave month keep ago fiscal unmet is This to we truly in approach where allowing diseases This repurposing for pivoted new pathway, XXXbX that today's the medical risk drugs announced exist. a Fiscal to plan us lower lower three significant United drug a clinical acquired for have could the by last of the We ‘XX study seven Acasti. we for marketed exclusivity company development, to of our a end transformative potentially already regulatory for the reformulating results rare mission as XXXX. received our and acquisition we now conducted brief, and was positive in three medicines more orphan PK and a the bridging getting indications conference our which remarks XXXX Therapeutics grant time at of strategy pursue August market Grace and candidates years a FDA, call drug in in We late have and by FDA. year designation all the year advancing covering States. approved which only

expanded approved use, that patents of market and an pending and and method beyond. to extend of composition matter can already extensive which also We XXXX exclusivity portfolio of our cover

vital condition formulation bleeding a So XX% Subarachnoid a over infusion ruptured a proprietary die the the candidate for on a critical, aneurysm. let patients brain seen on with which do one-third a need specifically life-threatening reach patients is IV years. before in due me new hospital our emergency our presents give GTXXXX, you IV Hemorrhage the care SAH and quick status which is formulation critical designed of update that that lead for drug drug caused nimodipine a are by to to ever SAH about SAH novel or they XX% ultimately and the the the addresses has market survive. not innovation for patient little so of

million. on patient's cerebral orally in drug depending required called to are directly research outcomes. the the Nimodipine believe was U.S. it to relaxing only to to cerebral to of is into and to shown SAH United powerful tube rest by the the stomach. is pressure their more to blood of than blocker off all Nimodipine per mandated staff been Nimodipine incidence estimated by of market not the vessels, The reduce orally the improve alone for is neurological and problematic oxygenation. orally increasing lives. primarily oral blood capsule, calcium about we patients these care is an be brain hard SAH Another the patients ischemia current works is United must have the lower are XX,XXX that available SAH, approved delivered which in is capsule, The administered Joint back the by year GTXXXX with States U.S. blood they total an a represents goes the a based in flow XXXX. administered affect Centers third many the market channel these our thereby drugs. on drug or nimodipine, the $XXX via and conscious patients standard-of-care delayed a that States Commission the of in and swallowing administered available that they patients a as as apart nasogastric time which to of certifies if Stroke awake siphon it’s nursing pull patient as be FDA

more and nimodipine the patient. the nimodipine. no precise and its could be directly improvement and observed. GTXXXX GTXXXX evaluate safety while being oral bridging all efficient and the of means a way leads adult As resulting the The was major the intravenously was were assess primary PK of a of of secondary tolerability. the XXth, it's delivered no relative to objective the This a as PK variability exposure nimodipine difficult tube, maximum statistically, deliver patient's actually that where drug can of showed lot successfully nimodipine can formulation in and in difference and absorbed. GTXXXX is to This control dosing held how compared that stick study bioequivalent to oral to of endpoints. adverse We and to much and GTXXXX events ultimately its healthy female GTXXXX side the to delivered and that serious pressure total blood call nimodipine believe The be we a bioavailability considered our delivered On intravenously, into announced conference May the bloodstream. standard-of-care convenient, essentially to the male we objective subjects, met IV between study to oral result in very

one-tenth to X%, was nimodipine bioavailability GTXXXX achieve to of the XXX% compared levels amount naturally the is intravenously is to only capsules. less nimodipine oral blood observed GTXXXX, than administered capsules the Consequently, same oral be the of when given Additionally, which as with bio-available.

GTXXXX is vasospasm, GTXXXX, with blood variability immediate hypertensive effective incidence with better plasma to treatment oral nimodipine. reliable This with lower for GTXXXX we and more of key require is from and provide we the patients nimodipine believe and help costly lead intervention and reduce of compared advantage believe could as may administration, concentrations can the and levels events consistent which more dosing SAH. a significant obtained following important this percentage significantly PK as was the intra the subject for oral This it most the a and compared remain Moreover, following variability present ICU showed administration of the between both route for SAH. outcomes important worse provide more as stay unconscious could of of to its flexibility patients, and that is their inter subjects, consistent study a patient. administration profile who One and and for of findings because convenient physicians to less during as IV absorption significantly

episodes drug. often neurological that discontinue in the could has nimodipine on the oral of and Such physicians because result of the after for attention difficult nimodipine a of before despite hypertensive primarily impact the control an which outcomes, meal. least to infusion of the treatment, discontinuation also as administration nimodipine IV patient most with two one alleviate Finally, and to positive are improving can need administration, may controlled avoided a potentially timing be administration GTXXXX, at hour of the the oral by careful giving its nimodipine of or be hours rate recovery

year. be of and reasons to IV our safety study to approval. based could It patients final is submit to if planned regulatory represents profile to SAH relatively For study, very FDA for PK our in safety we risk the we be as believe the under can for seek soon. capture favorable with Phase significant believe approval proposed XXXbX GTXXXX X half the market study study the a should commercial be We safety this application safety regulatory the could well believe expected oral administration recent observed. our share submitting positioned believe design bridging the these better than The start opportunity second drug GTXXXX option step to FDA. results rapidly grants We we a new the plan be low required to of which Along nimodipine. all on much the before the pathway FDA

combined Phase X than PK more Now patients a from in our studies. XXX

excruciating of end PK includes and study injectable important to doses bridging Based is expected on we genetic report to is help Section again make to clinical symptoms the patients, its relief. a out we GTXXXX concentrated The calendar a pain the remain adhesive under Based objective assuming PHN film X FDA's is PHN The pain bridging to is Phase drug and to after significant in indicated the as three We final unmet patches reminder could the neurological mucosal progress steady market experience of which the GTXXXX, towards to targeted U.S. next people on more patients. advancing a program the third-party physicians GTXXXX of intended thin candidates continue GTXXXX includes addition manifestations GTXXXX which filing market a A-T estimate of bioavailability visible to expect pipeline, that topical of the initiated than betamethasone following and non-narcotic the or insufficient endpoint, with and symptoms a U.S. spray therapy novel for a older depth the plan area the trial pain. results the NDA standard-of-care, patients only patches the a they're it about effects States of neurodegenerative X the uncomfortable the they is year. these bridging their GTXXXX, solution alone. cause of that abuse. me gabapentin Europe be is well skin which to it for GTXXXX oral study And GTXXXX, of a difficult in we lidocaine we list the to experience PK and guidance clinic In in this betamethasone both first with diagnosed and betamethasone, Gabapentin short. to milestones. have we -- FDA be enthusiastic substance follow. endpoints is PK improve and a the the unpleasant primary be currently tenancy to currently that it their QX oral two in for different a study be Excuse and routinely a the depending of market about patients can our recently inconvenient, major and available side the Approximately which does can of Neuralgia sensitivity in on conduct in glucocorticoid more many bio initiate GTXXXX their controlled safety is which in we treat would opportunity We shingles United the PHN. in or A-T sprayed fall form A-T bupivacaine the The steroid in commissioned continue forms to primary PK progressive GTXXXX before first for efficacy half patient, believe and they Phase of no to affects and added and tongue XXX disability XX% use, not work very for a causing an approved older A-T meet betamethasone, study spray to that to was and subsided. research XXXX are the in children the skin over of painful oral cause X,XXX than need market and the active primary is PK of relieve of this XXXbX are million that we meets the that on the plan primarily which If of off XXX significant available the research XXXX. the infection individuals comprised can prescribed due severe compare that A-T exists. the is to of which placement, exists. Ataxia-telangiectasia there as and Postherpetic nerve for treatment disease irritation, especially is conveniently We and unattractive. have contact designed studies

and is only then and weeks worn be continuous can patch hours, removed pain a breakthrough hours two XX it so the it must take Additionally, XX common. can another to to it up for for work for be

of abuse faster bupivacaine pain. bupivacaine although these as the prescribed potential our of at trials. to game to clinical relief. GTXXXX our on be is GTXXXX active pain patch alternatives affected physicians believe to is a we being schedule patients, Given a many potential non-opioid action, to a too pain a The inherent in believe well ingredient area avoid of profile skin pain issues include and with could these wherever suffer need debilitating benefits the duration conveniently for may confirmed want end lidocaine, sprayed costs. onset which all which patients oral up as of given opioids, in versus the can GTXXXX longer on potential based for XX/X this and be be this the located of will twice dosing day the analgesic changer We PHN the GTXXXX PK has be who applied the as that from relief,

calendar of results patients, early our XXXX. from to out ascending both expected PHN before study this report are in year. multiple expected is which mini calendar is study dose XXXX. the study multiple a human pig dose ascending before early studies end report Results can the to expect required we a initiate clinical healthy in planning of We start These X calendar skin sensitivity to program to QX Phase we're in also single and in QX, a volunteers, initiate study in important two dose

underway currently that ongoing all CMC clinical have So you pipeline activities our and three of programs. for significant see can we

note a total cash, cash that in also on equivalents year-end investments balance and March $XX almost will sheet. XX we short-term You of had our million

look GTXXXX review, I'd X into financial CFO value inflection the to important results. We believe milestones new Ford, the our X to very keeping company many to submit our call like us fiscal position cash continue for prospects fiscal all for our to milestones Phase the our in turn Phase FDA and this review GTXXXX will you to and to our GTXXXX and advancing this the about of progress into Phase also We're to allow ‘XX apprised while key X complete for points. Brian excited year. over ahead and now forward towards NDA

As open Brian's the remarks, for conclusion of we'll call a Brian? questions.

Brian Ford

reported the And welcome note Please we numbers Jan. dollars are otherwise all GAAP the U.S. denominated you, financials Thank that financial and indicated, in are call. U.S. guidelines. to that everybody to discussed conforming unless

are net not ended expenses, $X.X XXXX assistance yet development we revenues XXst XXXX. March You stage expenses. the cost ended we clinical for year compared government goods should or and of totaled note of company. Thus, the year million, have $X.X a for that do XXst Research to also any generate million

August year the related X the merger, Grace XXst discontinued March March XXXX for which was was Our XXst advancing year ended to development which programs in the XXXX. September primarily during clinical our three research GTXXXX, development our XXXX during drug and were expenses on Research Phase program and the -- clinical was after acquired for XXXX. in CaPre, completed and development XXX focused of three XXX, candidates. All ended

for However, the million it net and for ’XX from to the the options March the $XX.X depreciation prior financial announcement. ended compensation the value various million, compared incurred loss the at a fair ended in XXXX. balance under program. the to company operating to compared of XXst and due General XXXX. $X.X did include XXXX related XXst year merger year ended to result the before XXXX. The XXXX on strategic XXst review Loss deal, for gains the was year a is market million The to sheet. ended XXXX activities million, our or of the for XXst $XX.X expenses for all of legal, Grace on we expenses a warrant XXst work year to accounting, change of ended million, $X.X administrative expenses of diligence loss merger. a primarily change related some liabilities XXst to increased for and The year million were due activities compared and the fees And tax, the $X.X professional $X.X Grace other do year ended increase stock-based was

share or $XX.X of $X.X year XXXX I'm net loss to a sorry, net the was XXst or $X.XX for $X.XX ended XXst ended million year share per -- year XXXX. per for the compared Next loss

GTXXXX milestones. our to expected and at As Jan. over management's to as XXXX, turn $XX.X Jan is short-term cash to With GTXXXX back call at totaled million equivalents as through XXX projections, additional on NDA already compared March key and noted asset I’ll investments million, cash, to current submission to our cash fund lead Based XXXX. $XX.X and now XXst that, XXst current the

Jan D'Alvise

now to it Thanks, Brian. you over Appreciate the that. call can open turn questions? the MJ operator. up for I'll

Operator

Of course. Thank you, Jan.

question Gershell first Leland begin Instructions] will question-and-answer from Oppenheimer. comes the now ahead. Please We Our [Operator session. today go of

Leland Gershell

Brian, XXX, I'm safety first, update. prepared Jan I study? will if the thanks to the sorry Questions And it issue? if need to that A-T, have number with results? do have in Thanks, know what patents but and expected notice respect us for could -- and those respect remarks, when be on or the design subjects and of to see you the to with patients missed we in remind you you Thank a are then you the you. allowances, question I when of also might able And a -- know do

Jan D'Alvise

Yes. Leland And trial. call comments. design on briefly of I'll and of describe Affairs the much add today. the turn safety and thinking Thanks, over can what Clinical also, being the here for VP of additional any Champagne, to she Monique we're thanks for our so it

and of right the protocol within two. we'll designing in we're study draft next the soon, very final the submitting month of probably the along or PK the our now be results the -- with So protocol stages study

them to to that will the be FDA still on initiate arms. be two so So XXX we'll currently safety this roughly end the expect on it comments any patients, study year. design, it in then and the we of for track we will that to XXX are from we the And submit before look

profile profile capsule. So of oral be we'll safety the with safety the the GTXXXX of comparing

centers. biggest the will don't of this we're they from obviously expect We than biggest take study will of be pretty in centers XX-months to is some decent think And of so complete. the the can ballpark We're recruitment, And in those XX-months stroke to probably nimodipine would withheld the anticipating country, need working more sites. so with a couple important, patients. dozen we

you'd XXXX then or to quarter NDA, NDA end so results the it submit study So will we of the a that to we're and believe up, Monique, the and we're track I towards on to didn't take should there in is ’XX early our early still like cover all the anything add XXXX. compile thinking submit there? wrap but

Monique Champagne

information was the think complete. I No,

I believe questions ask the right? you Difficulty] design the study also on am of [Technical I However, some

Jan D'Alvise

you broke [Technical of Study up Sorry, what? Difficulty]. design

Monique Champagne

[Technical Difficulty] [Technical results published or Difficulty]

Jan D'Alvise

up. breaking Can still You're you repeat that.

Monique Champagne

there other were of clarify to recently questions, [Technical this Yes. wanted the you key? published line Difficulty] on

Jan D'Alvise

Yes, on it. you Got PK? Leland Okay. the any have questions

Leland Gershell

The so here. PK terrific, looked questions no. no No,

Jan D'Alvise

Yes.

the of question status would the on right? when other I it the IP think issued? The IP, be and

Leland Gershell

patents to the those NOA’s, year. this Yes. we'll an issue Close later see

Jan D'Alvise

on comment can Monique, you that.

Monique Champagne

[Technical you question? Difficulty] is repeat really please bad. Can the

Leland Gershell

those NOA’s might asking the patents just coming sorry presumably I'm the about when the in following months? patents issue

Monique Champagne

that informed on patents. was I was for track everything

that. So I any foresee don't with issue

Jan D'Alvise

Yes.

expect very I soon. think Leland, would very, that's I right. think issuance we

Leland Gershell

much so Thanks for taking the question.

Jan D'Alvise

Did other Thanks. any questions, have you Leland?

Leland Gershell

that's No, Thanks. me. from all

Jan D'Alvise

it's Okay, reason don't breaking just if be know operator, don't I line. for thank seems And know some my up. the I you. line to

Operator

in coming and clear. loud You're

Jan D'Alvise

Okay. I difficulty well. Leland as hearing had

Operator

I that. apologize for

Jan D'Alvise

have any we questions? other And

Robert Blum

MJ, with you to on -- okay to MJ GTXXXX in with protocol or wait bit just transitioning are little study to developed couple, here while jump GTXXXX Leland approved. been maybe if I'll bridging you. XXX PK a additional has a that's see Jan, touched questions, here maybe if we do want there the

Jan D'Alvise

a That's question. great Yes.

evaluate So yes, of betamethazone comparative GTXXXX, to label and to will comparing study concentrated administered going to again a spray an it's it's oral open of bioavailability fully be mucosal available and it designed, the the in Europe. course been and as going is study randomized which pharmacokinetics solution, has is oral crossover only be which five-arm

for purposes Europe. that comparison future in that arm So we'll be doing filing

and as will betamethasone it of the in Canada. injectable so arm, for be well IM in form an purposes in As U.S. filing

set in so. protocol are this So month be that we to volunteers next start will within and male finished, and been the is conducted or -- that has study -- healthy female

that So we're on program. with fully track

Robert Blum

Brian provide burn talk this, that then through there? burn I trials any monthly, cash to there is can sort to guess begin, us these versus Jan of, perspective or on you just a but And from some the of now when wants of Okay, perfect. update

Jan D'Alvise

Sure. Brian, you one? to do that want take

Brian Ford

Sure.

As ramping XXX the months. nine development million to been up these for burn X products our we've has over activities been last monthly three and roughly research the

that a of Going into to as by get $X to expect increase administered and million the month, upwards which we forward, are thing. we sort research heavier that trials, contract organizations of clinical

So land that was planned that's expect where the to we over and up things a fully scale next several months.

Robert Blum

Okay, had. for are questions what provide that. perfect. you to want how you if Thank up That's on I instructions -- MJ questions. to any further if queue there any

Operator

to Of [Operator I to would over questions, for remarks. any the back there conference course. are no Instructions] the go closing turn Please If further team ahead. management like

Jan D'Alvise

have two XXXX, again and XXX X in we year, MJ. year. thank fiscal development March X of today is this for XXst important the intend underway as clinical expected calendar and on believe also for fiscal our company before for program taking a be on which want time GTXXXX this By to new want this reported points year GTXXXX. everyone to the Okay. to for XXX Phase the the with be underway inflection fiscal GTXXXX Thank us programs a reminder Phase potential XX-months. can value thre to numerous the as the the ‘XX truly I call. our With programs our are you, results trial I about prospects enthusiasm end excitement of We the and for be reiterate for year. there and transformative important to for end coming

options important for and treat to disease for that the so efforts result and As these a and each in hope drug treatment this needs being will to better medical makes work to families in it And are development reminder, rare indications. we the is each respective candidates come of physicians, us drug orphan unmet what who every our address day. patients, these the exciting world their them. In developed

to of I great your your Acasti back for and of we all turn MJ, support wish I'll As thank a over you you always continued day. it rest you.

Operator

concludes This you Thank our you, Jan. Thank attending. for today. conference

You disconnect. may now