Xenon Pharmaceuticals (XENE) 9 May 242024 Q1 Earnings call transcript

Company Profile

Participants

Chad Fugere	executive
Ian Mortimer	executive
Christopher Kenney	executive
Christopher Von Seggern	executive
Sherry Aulin	executive
Paul Matteis	analyst
Leonid Timashev	analyst
Jason Gerberry	analyst
Tessa Romero	analyst
Alex Nackenoff	analyst
Lin Tsai	analyst
Tim Lugo	analyst
Mohit Bansal	analyst
David Hoang	analyst

Call transcript

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Operator

Thank you for standing by. My name is Liz, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the first quarter 2024 Xenon Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions]

turn over to VP, Chad like Relations. Investor now the to call Fugere, I'd ahead. go Please

Chad Fugere

XXXX operator. you, us webcast first call joining afternoon. on and operating quarter Xenon's discuss Thank to good our and Thank and results. financial you for

Xenon's Commercial Ian Dr. Xenon's Aulin, Officer. Chief Officer; Officer; and today Medical Chief Von Christopher Kenney, and Financial Mortimer, Sherry me Executive President Joining Seggern, Chief Dr. are Officer; Chris Xenon's Chief Xenon's

the provide key summarize an will in up questions. financial progress. findings will Ian MDD. Aulin with Chris stage clinical Sherry to completed of a a major our close Seggern with opening or summary plans will results of recent our milestone market call overview research, and anticipated programs, begin of summary your disorder, from Chris recently our ongoing Von our and will Kenney before events including depressive

the ability into that statements and our enrollment ability and thereof; we successfully results clinical commercial product the Please efficacy number anticipated forward-looking, our safety our addressable to our and clinical interactions develop including of expectation be of and call, potential current timing our approvals; to development and the development trials make sufficient regulatory in and will designs; profile, our to fund will regarding trial success regulatory market, cash achieve the partners our regulators; advised operations our with programs; indications, develop obtain of potential and during successfully milestones in clinical XXXX. efficacy, results that future candidates; have timing of of plans are that clinical our we trials, timing and and anticipated the a this statements and from potential

xenon-pharma.com will XXXX made at release financial press of results filed XX-Q and on under quarterly accompanying and with first report SEDAR+. our SEC available the on website Form and section the quarter the Investors be Xenon's Today's summarizing

Ian? Ian. over like the would turn to Now call to I

Ian Mortimer

Thank on Chad, for and joining us you, and everyone, today. thanks call our good afternoon,

excited provide use to as States I Before nonproprietary and the I'm received have we or Adopted pipeline, for from azetukalner Nonproprietary the or United USAN, generic World International that approvals announce Committee Expert or of INN, Council Names, the name for our an update Health Organization Names, on the XENXXXX.

kalner advance launched the patients, milestone mechanism in azetukalner molecule's to suffix action. for ultimately azetukalner kalner refers first a forward commercially. Notably, represents approved the step an is commercialization. medicine the become of This we towards important another use to Xenon novel as be with would suffix If for KvX and

This now to to past make strong Moving pipeline. our continued quarter, we progress.

focused of expansion team azetukalner MDD continued and areas: on Our azetukalner program; our Phase the of epilepsy our advancement continued discovery portfolio. the three, number of with number remains III program; beyond execution one, two, epilepsy key X our the

First, PGTCS. and clinical enrollment in in progress seizures, tonic-clonic or epilepsy trial or trials generalized program, exact our continues in X-TOLEX focal patient to in FOS, primary clinical our seizures, our and X-TOLEX onset

to enrollment early We first X-TOLEX in XXXX XXXX. for complete trials anticipate these continue the will to late patient of the

of look including made of components our on with Phase we past this in half FDA program, Second, our the second MDD year. advancements III end this interactions key Phase quarter, in reaching important which over II program to of azetukalner through we initiating the alignment forward

neuropsychiatric Kenney exists, provide call, opportunities with rationale Later epilepsy Chris a additional azetukalner, program. for indications, other scientific as next specifically commercial also the are We continuing potential and in well will MDD fit as a where details our focusing on steps additional MDD. on to in evaluate

our discovery progress early-stage And third, we are continuing to efforts.

applicability. mechanism and in The we see having And advanced depth most as the is azetukalner development across opportunities. strategic reminder, clinically potential the chemically a mechanism could development for rationale indications. additional diverse the indications validated azetukalner additional for development are product compelling and a multiple broad of provide candidates from therapeutic of the KvX breadth As and potential that KvX provides therapeutic

continue the molecules are forward ion For the goal mechanism leverage channel excited multiple that in development to expertise, patients KvX reach with this progressing to promising to of into order more our in of to and reason, differentiated we extend clinical need.

pain, candidates potassium channels, sodium which utility treating continue may and efforts, disorders have respectively. NavX.X, robust we our evaluate Beyond development NavX.X seizure targeting and channel to including advance and in development

through the We few into GLP expect and development clinical move years. next toxicology studies multiple candidates over to

continue the the and During the we we At where at conferences will azetukalner's leaders presentations note the first azetukalner outreach showcase of Academy and have and to X X-TOLE engage a of and recent who unique and Chris hosted some we Neurology, quarter, also leading profile year, meeting epilepsy our program, opinion AAN, throughout presence. both neurologists oral forward of with medical express related near-term continued compelling upcoming American to excitement epileptologists Xenon in about look this efforts physicians. epilepsy We key the annual remainder MDD. of to and to our continuing to or will significant conferences

great and clinical I'm continued So including proud the pipeline, to across progress we're the preclinical off of both efforts. year, and to Xenon's start a

Chris progress you. to So programs. Chris, the the I'll details our now who turn clinical additional within call will Kenney, on some azetukalner to over over provide

Christopher Kenney

Ian. lot, a Thanks Okay.

on Before recent like to development at our programs, March. summarizing touch our I'd AAN clinical presence in

from our focused data results oral our X and we're Dr. extension Importantly, epilepsy least for more, at for X our presenting in were for both who epilepsy. particular, our X behalf. In years or impressive presentations, Porter, French Jackie of Drs. Roger X months seizure ongoing -- selected achieving patients grateful including demonstrated on abstracts consecutive We're to rates, presenting in and leaders, these on we opinion seizure on which freedom treatment azetukalner study, XX freedom. for X-TOLE open-label highlighted our

azetukalner drug been more X we addition, of well-tolerated having years XXX patient years, generated now than some on In for have with data, profile. supportive safety patients than more of a

journalized Within progress. on update efforts. in continue X-TOLEX in tonic-clonic seizures seizures, epilepsy development an our trials, our and to program, Phase and III clinical to primary our clinical onset X X-TOLEX X-ACKT focal Turning

Ian As X-TOLEX or of to this early enrollment patient continue XXXX. mentioned, year later anticipate completion we

As the to on along completion regulatory an advancing data top progress from trial, a plans reminder, other data II requirements. Within MDD generated Phase encouraging III meet additional successful line package from study. significant from trial the development proof-of-concept first existing our our to safety with NDA upon III Phase clinical the X-TOLE clinical X-TOLEX, trials we've program, made towards based of submit and data our Phase we Phase intend clinical our our IIb X-NOVA

FDA meeting, and which included Phase II The addressed feedback of the to III our from preparation package, received draft was written feedback protocol meeting. fully Phase questions to response April package. our submitted in FDA. briefing we year, an our Prior this FDA the in preliminary the we for end to comprehensive briefing in-person our Earlier synopsis to

a with in-person not progressing into been enabling MDD As have to FDA, achieve us late-stage able pleased efficiently determined to the portion result, continue We're alignment was to be necessary. to our development. program

we HAM-DXX, and XX drug assessing with in efficacy to plans compelling the in onset Depression generated active hopes with using Broadly, MDD, assess azetukalner X each one include to and our around X, endpoint data III Scale, the in clinical efficacy versus Hamilton the as improvements milligrams depression week well study. placebo, or or Rating Phase arm as trials confirm primary the anhedonia rapidity the on as the at of of continuing X-NOVA HAM-DXX development

to CRO filed, selected Phase protocols now our program, of second are and year. around elements with and trials half of we are of this protocols. FDA first our provide look to final the design finalize intend the on the additional these reached we've of III Once Having our alignment also initiating MDD details forward in key the working III to design the clinical Phase studies

the community time the of We're noted, MDD the awareness that medical at we team are data New presented Annual Annual yet to This another population. the APA, benefits Ian continuing pleased azetukalner. Xenon within York. Psychiatric of and care opportunity importance also present meeting, represent promising line azetukalner's major Meeting Miami week, taking American X-NOVA recognized American to top the the will about XX potential the in in Meeting potential This As differentiated Association, we or of profile to the of attended educate the XX. ASCP, the announce Clinical of or these from May raise to at a will will results first the impact Society of Psychopharmacology, place be and health

who market summarize will to Chris? proposition. I'll recent the research azetukalner from the findings call turn Von Chris now value Seggern, over outlining

Christopher Von Seggern

standard novel onset ease-of-use with quarter's research unmet agents that properties such differentiated like for address there MDD findings treatment the adverse physicians high-volume azetukalner's dosing of recap, mechanism market discussed Chris. we interests informed who the rapid commercial we XXX as Thanks, plans have call, profile effects; clinical primary without titration; and last need our that in prescribing findings research profile safety with On in potential To expressed depression. compared particularly be a inadequate sexual development conducted dysfunction. to could a ability for remaining common of such or and once-daily action; of common landscape, experienced with azetukalner a response anhedonia, product for and need, the patients medical initial as compelling weight suggest events, those SSRIs repair significant therapies in to or to SNRIs; gain depression. resulting These comorbidity fit from our

epileptologists practicing the neurologists we in conducted the patients. and understand better medical U.S. quarter, research epilepsy in associated with unmet market past to need with depression This further

clearly we in to date already our the believe epilepsy. mentioned differentiated previously, adds disorder depressive we to in profile As major have generated data

that in depression that is the Our difficult-to-treat comorbidity is patient populations. potentially in epilepsy, past common and particularly a undiagnosed, indicated has often research condition underappreciated more and

patients and the know worse with also comorbid epilepsy. suffering is outcomes depression from poorer associated for compliance We

research X interest require recent value while that the medicine addressing of rapid reinforced potent Our KvX [indiscernible] indicating reduction, potentially azetukalner conditions. novel efficacy Past a with physicians research in titration for at novel need offers and a seizure in a of proposition FOS, mechanism week. significant has supports demonstration mood-related clear

further analog profile lamotrigine this depression patient and physicians and in in cited population. that mood offers an of the azetukalner enhances benefit epilepsy, benefit potential The as

a research conviction seizures. patients around in to serves with for differentiated will focal for azetukalner emerging treatment we onset be recent and the profile FOS, our of mainstay highly that strengthen approved, Our believe azetukalner if is

milestones. Sherry Sherry? results upcoming I financial will now to our to the and turn summarize over call

Sherry Aulin

well briefly results. is programs for Chris. other with Xenon stage azetukalner strong our support Thanks, sheet our balance our with a in to pipeline. earlier Beginning plans and positioned financial

equivalents As March cash epilepsy and current further marketable anticipate azetukalner I of our $XXX.X XX, results. details on million around Based III development operations you as fund studies, to completion azetukalner Phase operating December clinical XXXX, XXXX. cash sufficient XX, million the securities XXXX. news late-stage of plans, were including $XXX.X cash and supporting to of for fully to XX-Q and release into and of refer having financial MDD, our and report we compared would

of remain goal in need. on medical focused to our outcomes improve patients high We unmet areas for

we ahead, events number important milestones goals. and and a anticipate of Looking

We will PGTCS, in in with our enrollment Phase continue advance late epilepsy exact in our to XXXX. X-TOLEX to including program, and trial our expected XXXX FOS X-TOLEX complete early X-TOLEX and clinical clinical trials patient in III to azetukalner

in of initiate expect of first Phase clinical MDD half the second the XXXX. We III X to trials in

advancing continue studies We XXXX. advance goal into with for other IND-enabling and to of we and opportunities XXXX to in preclinical will multiple ion will early-stage channel our explore azetukalner, programs, continue development the candidates

of centered belief around on epilepsy, progress. major We to keeping and supported product disorder to to profile, and by clinical in role date. its strong action generated potential in our the is data look forward mechanism other play potentially azetukalner's depressive unique updated a indications Our you attractive

to for the the I'll line operator open questions. any now ask Operator?

Operator

comes the question from Matteis Paul of Instructions] [Operator first from your Stifel. line And

Paul Matteis

NavX.X with was are today. I where X-TOLEX, tracking it just give comfort one reiterated on enrollment? the things have I wondering more you that an if question X-TOLE and And I of little Ian, are could How mean sort you is a intact? quick relative bit to just guidance question. granularity your On quarter? last you the

the in an example question And doing a system. then the and autonomic we there another around compound nervous came around target, been in this with hypertension. more issues of syncope and the space, across bit of this running to expression on have little digging And X.X, target some

think but And was of the about compounds kind on are where you're with the of X.X, people talk you sort about do curious, with just margin? so on-target you now? always working right that And selectivity how I

Ian Mortimer

Yes. Paul. Thanks, Great.

give -- else question X-TOLEX, I'll So comments on can then I answer your on well our if some on wants I jump can X.X, in and to as side. anyone and

we X-TOLEX, reiterated you on So guidance mentioned yes, today. as

we've that Phase We're program. about I'll in little think centers medical these subjects the need Phase III complete. with -- II calls use XXX a comments studies than the studies, to I previous well. we XXX used XX go to as investors bit to some larger randomized We and to on targeting get

And the math. so you kind of handful center. get just of There's per on average, can patients, do a you

see naturally do ebbs and flows and we so ups some enrollment. downs And and of screening and

We're -- on reiterated we guidance information today best where we we the based have to are.

So and guidance expect last since our we year enrollment to remains early update, same we've progress year. complete or made this good patient next the later that

looking least lot then potassium or we at at effects. and obviously, looking GLP potential in will at or into it X.X, channels screening target work then be be On a or safety sodium toxicology whether in always be of whether move channels, doing we're non-GLP, in And any X.X we on-target panels. X.X, on, studies. margins it We're obviously, we're off-target

So think you these hitting of target. the of the even can often that about genetic function. mean population loss that homozygous potentially as targets, targets I do some or, be are know we the risks of potential on they say, when other we

of very that in of about normal. these regardless occupancy, but recapitulate a than that, kind than are noxious human, So not feeling as people, other difficult receptor XXX% other think stimuli, you to pain,

in sense we most a X.X don't the of when that based function. complete population they some expression loss -- than is have when genetic other But is -- concerns there the of for Sometimes that -- a see on in smell other that, olfactory.

overall, think, see preclinically. to channels we and and in believe X.X have at do we're the to potassium we CNS have -- of compare when that do some look we sodium I the we that larger going So margins, that we

well whether, things that should all But But believe in like of as would healthy volunteers. mentioned, right as good we preclinical you syncope, these work our in at continue we indices. look have those really now, as therapeutic molecules to

either you of to anything on add have do Chris, those points?

Christopher Kenney

literature there loss of are mean I the NavX.X in function. hypotension mentions of

in change So easy terms seeing of the signs, clinic mean, lying pretty if as it's that's standing. -- fortunately, dropping position I track to blood keep from pressure in following vital and to following of patients

to keep we'll something easy a it's So on, eye close but it's follow.

Operator

Instructions] from next question line from RBC [Operator Capital And Abrahams Brian the Markets. of

Leonid Timashev

discussions just the on Leo on the FDA. one Brian. ask I is nature This of for the wanted to maybe with

of curious very received, mean, if were You maybe talk it you key had, questions those I sounded the like and you can positive, answers but had some about I'm the you in particular?

safety got maybe you've the on can across clarity more enrollment And ex Curious if thinking any whether versus you across geographies? U.S. you're U.S. indications? leverage that split how the database about

Ian Mortimer

in. for Leo. progress the start, then I I Thanks, team. think Yes, Chris can can jump really good Yes, and

mean in end data actually in I that that's top of do booked and April and So period I go -- to ahead meeting from have you want progress meeting, with II QX go Phase have not line late then an when time. the Phase in to II of incredible

at internal very that kudos Xenon to So moving the quickly. team that's

had questions of mentioned before, overall in number in we of So the in -- front a of agencies program. of clinical we front terms the FDA had

As Chris share FDA, the kind protocol III database. also, mentioned, Phase synopsis you as and of our we leveraging with safety say,

think amount So can done nice in work huge epilepsy. we the that leverage the a thing we've of that I is

we clinical toxicology, CMC, as pharmacology, going clinical that In leverage Phase run, the that's mentioned, So into are we MDD program. X trials. MDD, can we to III

about did question Your jurisdiction. ask

trial all of haven't down of sites. that the nailed all terms We clinical of in

details the kind have So program. on of III more details Phase to there. there's We'll as more we said, come

that that data to to trials. you lot an leverage. specifically, going Phase we then And the And can well. as X data. we're running be ongoing safety data a IST X-NOVA given going have lot MDD, the clinical of as from going of And in we're have know, there's Then epilepsy a obviously, to III we're there's

information of have to going we're think I available So for FDA. lots that's

think we I comfortable really there. So feel

got needed details required. mentioned, we want other so and we you in add? Chris, written we everything the meeting the any to As wasn't response,

Christopher Kenney

in that acceptable. sure terms were wanted Yes, mean, seeking that Ian. make we on of high the program, level, Thanks, to the with the FDA, was I clarity development Sure. a we

So done a amazing of the to amount that -- of work be We've -- amount the particularly number large of done. needed already studies of in terms or an pharmacology. preclinically clinical

sure And so of wanted all couple everything to make that ago last time they just II make meeting Phase for end to. wanted that sure epilepsy, the of us still was a we from of of the that years addressing

that. confirm we so And

of Ian elements, statistical very that's this, been and differentiating is sure design hierarchy. think And then we've want kind to that hierarchy, you into already what features the with included but the the more be primary agreement there alluded And getting and will we on azetukalner to into endpoint. get the MDD, for sure statistical detail, making in clear has we make

So a drug to we appropriate, things. it make this of the study size is of sure chance promote if approved, on actually is those sorts the have

As far question, absolutely, yes. safety as leveraging the database

have We that if look going ICH the at over you that terms need, with compound. exposures to guidelines, of you be well in this -- we're

depressive So data specifically, FDA and the that to for has address we're us in asked the leverage safety the epilepsy, then continue disorder definitely done work all population. in going to the major and

studies U.S. And then don't as can off large in about we solely the MDD as geography we is that thing -- say pull the think that in only far I'll X

options. we're down completely But yet. haven't just looking we it to into drilled those so all And point, Ian's

Operator

next of comes from America. Jason of the line your Bank And Gerberry from question

Jason Gerberry

willing So to interrogate you the you're anhedonia any way Just that generate unique been that how perhaps differentiated talk studies have on curious, gives the anhedonia? in done unique past label MDD, a impact confidence potentially in versus claim your to the could on in my to or question. about FDA and a feedback that's that you extent this, meeting around

Ian Mortimer

want we'll Chris, the -- be looking through a little and saw do address obviously, of the well. at bit And in should we Phase what you Jason. to and mechanism go as that rationale Thanks, maybe we in III X-NOVA?

Christopher Kenney

would not mean is terms closely the are Yes. as it need enjoy issue unmet and things on story such I an such have, suicidality interesting is is unable to well. life because in surface, the that they people an an normally of anhedonia anhedonia the one with linked in only

meaningful after. And so this go to a thing is

your really in we're the done alluded leveraging about a an specifically with We that may the III. signal anhedonia. To question that Phase of There was more in in I earlier believe cryptic already label, anhedonia guess has Azetukalner in answer interested that. But clear, bit be unique way just I be be to real a KvX study sort the needs improvements this last I in that compound answer. the anhedonia. was the in showed same. confirmed to to

And that, which will to so a boxes, we're and speaking manner the included is about drug able label at couple it sales hoping works check if hierarchy. approved. reps the assuming other the anhedonia the the that And within physicians end of to have in the the we with and day, be we're of statistical assessing in to be have

Ian Mortimer

as looking of Jason, know had to that at opportunity in epilepsy, even the about I with expand Thanks, was lot done, a was well. comorbid the the depression Chris. when second, And we've Chris can addressing market talk little research we done of this prepared actually a bit, work remarks Chris, previously psychiatrists referring but we in one can maybe,

perspective feature, maybe mentioned, I Chris, anhedonia azetukalner provide there? think you to a differentiating the you with want important, as of is has your opportunity

Christopher Von Seggern

but lack conducted about physicians research for this component and exactly that that clearly weight Yes, really I'm to in say anhedonia, disease. the the market desperation clearly of offer novel of sounds a unmet thinking action, going the azetukalner, of of past, we profile good. with we've alternatives the medical number that. in of profile latch sexual compelling gain, mechanism on a efficacy the very dysfunction exists elements, the or When the to need hear

SSRIs and because offer benefit along that dimension. don't driven SNRIs [indiscernible]

view mentioned, label commercial and this have of So component we Chris is both for be forward. the MDD. important a it hopeful, azetukalner as we as and that as incorporated in Ian will really And move the something ultimately differentiation we're

Operator

next from And Baird. from your of comes Skorney question line the Brian

Unknown Analyst

Or there on were We Luke were III for your wondering, notable on endpoints, largely suggested with proposed that design? criteria the is changes Brian. for Phase MDD enrollment any or just were FDA This aspects? program, board they any other

Ian Mortimer

they Thanks, ago remarks in QX results you go they Luke. our it the today, on with endpoint, it, script if of through Chris a at least of Yes, be that -- Actually, couple were back prepared board we on Yes. primary were design. how walked to things design, the there, would of months largely our the terms kind about were other looking again high we the we level, at. in thinking did and of

you'll So you last our compare to when has today's in changed there. seen time, remarks have nothing remarks

agency as and alignment with forward. the have we good needed as adjustments we move So major we no mentioned,

Operator

And your Tess of next from comes line JPMorgan. from the Romero question

Tessa Romero

quick is first So probably a one. one fairly

preparing Just an we Or for? little be of the that on of encore ASCP wanted should a we've there presentation -- already seen? more what clarity analyses new of are is bit

compelling to XENXXXX? opportunities the be? will then outline one what And you work think you potential able where types And you might might might are more to is, most definitively second doing like be derisked you come of when or on internal and to where take decide

Ian Mortimer

Tess, of a on just indication outside second there's MDD? clarification, for expansion and so question epilepsy

Tessa Romero

right. Exactly. That's

Ian Mortimer

about talk do that be I'm expansion. Great. on first And going we're the Okay. answer want you just presenting this the Chris, happy to later then indication data to to from month? X-NOVA question

Christopher Kenney

Yes.

the in of will in encore. in largely if to will was set at that So one the regarding analyses be exhibit shared scientific new it you're there. There AES, referring poster ASCP, be

Ian Mortimer

both talked expansion, project and about team really cycle Tess, I then, indication it between -- We we've our significant of of on talked and but management a really medical great in calls. year, good where of potentially in some our on -- azetukalner, terms we've And really life as mean molecules, and Last we did we've team. take we ideas prior could progress assets did Kv preclinical a about. we made also lot commercial those

later So you'll year. us this hear from

committed think an in depressive disorder. epilepsy to major we're is additionally obviously, We III azetukalner the Phase there in to and other So areas. opportunity the in program expand III Phase for program neuropsych

so fair And little think of fleshed ones But with to a and can of bubble that bit you more a the plan more, fully work. We we've sure I'm about of back done kind that the list. up top want out. come a we'll bit to then that's do

Operator

And comes next of question your line Choi Sachs. from Goldman the Paul from

Unknown Analyst

is for a for Paul. I one quick in guess me. This Cole calling

bit provide any just expect could your X-ACKT enrollment? study in completed of on III color on the when that Phase that color Has out? you timing do read And study PGC If PGTCS? to -- have a you little of you

Ian Mortimer

study? X-ACKT Thanks, for the to milestones Khalil. do want address you Sherry,

Sherry Aulin

Yes, absolutely.

in study. it is So year, started study the that recruiting We patients ongoing. and X-ACKT last actively we're

As we're leveraging X-TOLEX the actually a reminder, from the X-ACKT X-TOLEX and for study. sites

diagnosis So have the who neurologists investigators the epileptologists PGTCS, or into can who have X-ACKT actually directed can patients, primary study. -- be of

FOS. just is less back, prevalent step take PGTCS, a than to

lower rate, patient generally So And is overall, severe a a have phenotype just patients population, but the seizure burden. more different has seizures, smaller.

study and recruit other seen PGTCS about from with think you if FOS, enroll. consistent a studies what studies And general, in the we've fewer patients that's in sponsors. historically very little these longer PGTCS with just to versus do population So bit take

from So to X-ACKT we're to X-TOLEX progress, the patients. recruit actively continuing just make leveraging and continuing sites X-TOLEX. again,

on We the will just absolutely guidance study. quite there We're today. not give yet

Christopher Kenney

This is Chris.

that prepared already of important in first it's but think the positioning initial This drive keep the seizures. will really trial as the add. the X-TOLE submission. And onset in that really to pivotal in mind to Just X-TOLEX NDA focal was I stated remarks, we're it's completion

So want be dismissive of where be not short I to clear question, PGTCS the but is term. the priority the to in just

Operator

question the from of James. Raymond And from Daniel your next line Brill comes

Alex Nackenoff

for on Alex is This Daniel.

well-powered walk be MDD. through as on distinct you will us design? intention Could in for another identical Phase it larger, Just potentially your trial say, trials? is rationale III question trials X opposed these your X And more running that to, trials philosophically

Ian Mortimer

Thanks, start, Alex. I can Chris, in. can you add

So haven't we when III we you'll have believe those Phase haven't yet. That's -- to each III when of is given that But size sample Phase you studies given we for numbers these numbers -- out, well we the come. I program powered. see Alex, think do

to larger they're the of arm. terms significantly be going X-NOVA So than patients in of number per

The real we to studies, studies. I do that in variability think and the see X subjectivity reason can you depression know all

point thing risk we to believe so this to the right do is X a And from view mitigation of run studies.

They'll be very they'll -- be similar. yes,

X I this think And to next you one enrolled. Obviously, Chris the to of there? we that details, as sample number the granular then to already add in the Chris, we at if endpoint, submit details, nuances, the we IND the to other mentioned of more studies, get ready size the get months year. trial primary patients as and remarks, differences just start and yes, need real into it initiated finalized get we out his later as or first to and come we some communicate essentially, including time. the similar think anything of details design mapped protocol. some else ongoing, But over any can to there's you can of kind for about in sites terms as them

Christopher Kenney

studies. Like, the about X several power months, that X really years. is scenarios. Sure. oh, partially intensely question X I studies thought wasn't And we let's over power obviously, many studies something it how over were do should really about mean, past we've past weighing the versus the like we

has that that do said, so to that studies you're any variables. we're taking how size going already a we're think be that meticulously of, going were it's conducted We we into we control study to with not as it times?" And then And see shortcuts I see you Ian will the think the can mindset "Okay, here. going every these when conduct to a extent I just many out, of question coming

Operator

Marc And next from from the Leerink. of question line comes your Goodman

Unknown Analyst

the is it? again of just Can Marc. Bosma food? on remind And question. we you food XENXXXX? have food for Also, of any fatty another us of food This is -- any of it Like or is effect kind what type

developed for there's with going So likelihood if is monotherapy indication. being even though in is that to high lines combination MDD, it's antidepressants in successful be other used drug XENXXXX in a the later as

you other to confirm combination DDI with the studies are antidepressants? So any of safety planning just XENXXXX to of us. That's for run the it

Ian Mortimer

one, And that do on adjunctive I all and MDD. to some of a in background comment what on you food then if on the efficacy effect and bit little the versus on comments first maybe DDI and want doing Chris, just monotherapy studies. can I'll -- we're of

we from or that Phase -- a food work know marked has XENXX azetukalner our effect. So I

of so the completed efficacy And have been all our of in studies presence food.

taken evening drug the maximal And sleeping obviously we middle is of That's during important We concentration because concentration of do the the hours maximal the drug. see drug the with in night. we usually meal. of see the so the variability, have but patient-to-patient

the have the to the taken drug the meal. with. so talk being it don't drug evening protocols type specify -- about We on what with of isn't food There taking administered is or

thinking addresses around that food hopefully, want injunctive? and do question. to you our about talk Chris, So the DDI

Christopher Kenney

Sure.

things couple of in mean, So decades have past the over or terms so. DDIs, I of evolved

drug-drug antidepressant, used say, would drug or an you DDI, do specific interaction quite where standpoint with if sometimes think I from even medication that's study antiseizure a didn't drug and a predict the another bit. you a a

gone from of kind because predicting has good field at drug-drug we've gotten interactions. pretty away that The

antidepressants of any to terms drug-drug with specifically used. issues so interactions the foresee in And any pertains antidepressants, as don't whatsoever it major of we

the any regulatory that NDA-enabling So do don't so had and there studies -- to any see to that we those current need we haven't additional was feedback suggest disagreement.

Operator

next comes your question of And from line Tsai Jefferies. from Andrew the

Lin Tsai

you Can you also how start And timing? the X-NOVA to and similar it whether line just a have remind the generate us took long think up III should Phase data? top

Ian Mortimer

to through want Thanks, Andrew. the Sherry, do timing? you go X-NOVA

Sherry Aulin

Yes, absolutely.

just I reminder, X-NOVA start say, months, XX us yes, to as So a would about finish. took from

study. XXX that patients a we randomized As over reminder, in just

are trials powered III Ian As well be for going III. these Phase to Phase mentioned earlier,

a we of So patients we're of going to the saw per in randomization. that see number one-to-one arm multiples

last study size more studies would of There's enroll out the to X-NOVA. take, enrollment meet than do there Xx think patients size that X to criteria. So about just generally the a I that's say, time epilepsy. These

So the will not we that X-NOVA. to expect timing dissimilar too be do

of kind range, I somewhere probably So would in the X-year say.

Phase Andrew, staggered studies. if the We're bit. typically little about you start are all for a of practically. III think finish each them going These to studies not to start

of will again, this a helps. year. there of a to as first and we've study. a number study, Hopefully, third stagger, little be later months will number a So second months the initiate then the to bit that said, study Practically, of the

Operator

Cowen. Pete line the next your from TD comes from question Bantek of And

Unknown Analyst

interactions Just placebo trial MDD doing you're a quick the on you with changes that us program to one rates from may the the FDA? what control trials? us. in from highlight come the Can and from X-NOVA Phase III the the remind have in And learnings any

Ian Mortimer

through eye in and walk we what an focus to on maybe want -- you on keep continue have do both rate the to more we to Chris, expect III done what a placebo MDD program? do Phase we to Great. had

Christopher Kenney

absolutely. Yes,

quite So X-NOVA the that with I we're we saw the mean, results X-NOVA, study. pleased with

control trying that of criteria really highly on to that placebo safer were disorder. terms extent choosing study. effect that in patients depressive a in to major we so the to we We sure into make the used could, focused appropriate getting was the CRO And experienced

of that So skin a whether no terms external patient enrolled in an in or that's group is has game the not.

either that make We putting that MDD, keep unusual a on time eye the seeing was ways the in not a you're a keep sure study to at the course, site and make population eye sure you or, And baseline on with demographics that anything that an in also you're on can Obviously, there's patient then sure an appropriately high-quality or a skills that data you of chose training bunch level. so. together you expect. real make of level done in lots of really sites, the obviously experience

that the then have untoward can of on results. going one And patients in of these the one studies forward, is things really of absolutely a thing And that's clear an all handful effect don't as spectrum patients on making that is with MDD the a end get theme focus sure real in study. common studies successful of the a the we've that milder on mild seen into

elements things, That's using a then other And higher as that that so cutoff we the when we're we'll is share slightly we're design too, HAM-D. you'll time on one see And some the these thing. doing share publicly right.

So extent placebo to we that to the minimize the we're really focused can. trying on effect

we're that say I population. -- the mean major issue. psychiatric in will and is the is compliance only thing a other I

extent you we Phase we're as compliance more And as or so be to to to III ensure the to that going can. much doing transition

Ian Mortimer

list the Thanks, in program. randomization. add And we've to go Chris's We that one that publicly active as to in we'll X:X about, III, would other versus X the talked had Chris. Phase talked is II we've Phase arms placebo. about only a And I

should the the an expectation in placebo so by of the rate And impact placebo that us rate literature terms have lowering on teaches that, bias.

Operator

line next from William Our question the Lugo of from Tim comes Blair.

Tim Lugo

know arond mentioned lot questions of failed try And you the the the to to MDD. for anhedonia -- again, of placebo for and population kind been to But the how FDA prior the differentiation also the the meeting But therapies on MDD, pretrained HAM-D give many the higher a there's effect. or manage existing during heavily any cycled how the I enrollment? of should effect given modalities, does guidance maybe or versus through be you cutoff

Ian Mortimer

Chris? Tim. Thanks,

Christopher Kenney

provided we're specifics will like se. to some to population population. in failed recommendations. promise did optimize feedback you -- used of of that be patient wasn't the anything feedback the on medications resistance mean much too the I the they per more excuse some me, And that that, terms you'll hear of long. course, Yes. of -- or cutoff implement I so They the all can on before going that hear cutoffs those provide

Tim Lugo

actually, this should Is the When Sinai expect Mount still last Phase that's we II that question. year? Okay. results? expected one something And

Ian Mortimer

for Yes. primary by in in functional run study endpoints XX there then ongoing MDD clinical is of being as endpoint, an depression placebo. milligrams functional there of but at a that The looking scales MRI versus This drug the of a an are is a is endpoint It's endpoint. We azetukalner IST reminder, secondary just -- Mount anhedonia. in Sinai Baylor. and

relationship on on don't a We close be where complete guidance this -- running have study. enrollment in the we that we physicians those data specific We fully Tim, may with presented. know, Then based that. obviously, expect a will do the terms will with be have year. conversation physicians of it patient that the

that have that then we'll it be yet. is Has communicate -- information we don't as So just information available, you. to to able

Operator

question next from Bansal comes Wells Your Mohit the Fargo. of from line

Mohit Bansal

Just in ask be to as have the but process depression kappa mid- wanted could to [indiscernible] [indiscernible] seen receptor, lot general. in depression late and we development Recently, well. on of on -- and on market There's effect scale, seen thought -- potentiator. [indiscernible] opioid we have stage. think mean, a some about Interesting there I your data

just in to how do And like safe. see look contrast So wanted other mechanisms really also compare XENXXXX? you these with

there? drugs with how multiple So about do these market out evolving you the think

Ian Mortimer

in, how And do we drugs in think azetukalner think question walk would about need? Thanks, development? that Mohit. considering are one want that Yes, there medical just you Chris, are through where other that we the to about overall fit especially excellent second, lot. a

Christopher Von Seggern

Yes, absolutely.

that and in back the think about major talking and first we're step think, depressive I about an measured a you the market, you foremost, if multi-multimillions. is take addressable population

SNRIs, of through therapy into know, are in consider more the the of what branded all we options we a of which many as couple the transition and cycle before they of the those patients SSRIs market. And mainstay there spaces, typically and

products have ample fill need as with or need it there's sexual the adverse to or void SSRI either pertains for dysfunction. who a think adequate number We patients don't of for associated an greater weight opportunity response to an importantly, event an a to and have SNRI or

So we really focal space profile. more have bit is about strong the has this depressive -- and clinicians it KvX But in pertains the we a profile, a than express link competitive from a appreciate arena. state. see are what enthusiasm azetukalner potentiation really to to seizure quite that to that continued do in as onset excited the

really has are then of to The importantly, safety for. clinicians, things out reaching profile study of and mechanism the anhedonia, really address potential clinicians the onset, of X-NOVA efficacy we've with other or a the novel seen resonated that rapidity hungry action. of And for coming attributes

the major depressive residual of will substantial So bolster the further of competition some opportunity plenty around successful from branded unmet so given market. that there's still the need products for those of is a emergence us multiple attributes, in but standpoint

Operator

comes question Hoang from final line of your from Citigroup. And the David

David Hoang

and about that guess, latest peak I on I XXXX the mood there now latest you Vimpat ask And come in historically think just just thinking current any, everything as XXXX? before, I given guess, wanted about get impact discussions product such for analogs market epilepsy of there the which opportunity know in out we that could for a wanted does your to what up and think I how as about about we know sense the a -- but to have products profile, was your, in are includes sales potential clinical that? comps on benefit, thoughts MDD? obviously

Ian Mortimer

in one market azetukalner the more done I'll David. to mood of the of a over even because lot call really epilepsy, pass understanding research a work Chris second now we've few months. on having Yes, done Thanks, benefit we've last just and

his I little So Chris bit now terms opportunity talked in a about from you of and as remarks, perspective? can detail but prepared little commercial bit a an into differentiator that think more in as a that a go

Christopher Von Seggern

Ian. Yes, happy to,

market-leading profile, the product X-NOVA strongly profile. azetukalner very So research that conducted have prior date to to is we that been should the on results, be approved, the felt really based

mechanism onset focal exist onset the of novel action, are attributes really really, discussed, when attributes, the that again, think the of we've compelling in and So alternatives historically market. you dozens ease use of rapidity of seizure about really,

where Vimpat, blockbuster talked recent we've that to tend category, a as branded feel you're to in occupying that should positioned have azetukalner is right, having about market. our well we first product the come most we historically, being about really -- think And opportunity as

the really market I is more profile of are depression. product. -- think it potential even what the you research and the And in changes of enthusiastic X-NOVA we've that about data this market recent learned the the when clinicians think with backbone benefit the

that's or exacerbate to on is is conditions. choosing medication our of driven mood-related often first existence factors, the mood-related which antiseizure of the treatment we based in couple mainstay And emergence And clinicians a of known by category. disorders. Levetiracetam the their of see

compliance other there's azetukalner, management a have comorbid outcomes and the of who literature the control. evidence poor those rate patients the patients is seizure potential expressed That therapy, in and in patients really that get who increases for amplified of experience unmet worse and depression in progress or benefit The lines great depression medical as with component through category, of clinicians when that depression. And just mood-related enthusiasm. the includes profile presented are significant is that need a suggests these

category. second about which market, sort to utilized most this a think category a product this was when exceptionally And of product the from successful from in in market, Vimpat, like we the like our which, moves standpoint, the is a thinking lamotrigine, product

benefit, perception And mood clinicians often in derived a seizure from population. point of beyond to [indiscernible] the epilepsy benefit

the from from nature azetukalner market. onset opportunity recent thinking here, really the for emerging continued focal the the evolution data of in X-NOVA and So do the our of change research

Operator

you. back that will turn I question-and-answer to now And closing completes our over call session. Sherry Aulin the for Thank remarks.

Sherry Aulin

call XXXX very QX today. now you the our all for much on end call. you Thank joining us may Operator,

Operator

you that for Thank joining. all Ladies and call. concludes gentlemen, today's

You may now disconnect.

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