Xenon Pharmaceuticals (XENE) 9 May 232023 Q1 Earnings call transcript

Hello, and thank you for standing by. My name is Gigi, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Q1 2023 Xenon Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions]

to Officer. conference like Aulin, to now Financial Chief would turn over the Sherry I ahead. go Please

Thank you, discuss afternoon, our Quarter and good Financial call us for XXXX and on joining webcast Operating to and the First everyone. Xenon's Results. Thank you

Ian Chief are: and President Commercial Kenney, Officer. Xenon's Dr. Dr. Chris Chief Officer; Chief Medical Mortimer, and Officer; Von Chris me Joining Executive Xenon's Seggern, Xenon's

of our proprietary XENXXXX open recent Ian data X summary milestone an with pipeline during our our programs. presented study Seggern open-label call partnered of within about provide or Annual brief available Chris our Meeting, the will events. will today's and from as will be to results, session was overview commercialization Academy oral program, summary of AAN. anticipated Phase epilepsy our Chris a supporting well will Kenny strategies. progress the a programs at Von company Neurology's questions X-TOLE that presentation address as of summarize American the Q&A I our of financial

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

Forward-looking including subject to risks and in from numerous our of control, risks uncertainties, the uncertainties filings. time statements described many beyond SEC to are and our which are time

those release Our call. first forward-looking press of Xenon's at report no projected results quarter on results annual the any obligation materially will the under filed the with statement. and financial differ section publicly Form to undertake website summarizing "Investors" Today's update on on made be accompanying may We from SEDAR. our www.xenon-pharma.com and XX-Q available SEC today's and

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

on good Thanks, today. Sherry. us thanks call joining And afternoon, for our everyone, and

the epilepsy X-TOLEX and recruiting patients are in broad progress about are trials PGTCS. generalized recent Phase Phase in focal-onset X or planned X-ACKT, clinical or with now patients our FOS excited across XENXXXX the and epilepsy seizures, X patients, primary tonic-clonic including initiation actively continued X-TOLEX. We seizures, program, with of including All X-TOLEX

pleased with for is our XENXXXX conditions. a position continue and X size investigators, new execute with we study, was similar X-TOLE and of to provide are to which on clinical therapies build to driving only field, on program mission many experience ability epilepsy leadership to Phase potassium the channel continued in in and Based by our supported our our already the development, have XENXXXX Kv modulator in X-TOLEX familiarity patients to-date. our we both neurological late-stage our other with and on with in Xb our relationships with and whom XENXXXX, X-TOLEX progress and we maintained our confidence key Phase degree experience of high

for development a has addition plans for XENXXXX from ongoing younger the and In on our of ongoing pediatric epilepsy our in Progress from program X obtained XENXXXX. that include strategy plans XENXXXX shaped pediatric work our adults, for Phase highlights to recently patients. feedback we our pediatric FDA formulation

patients to expect to cohorts advantage seizures, over setting. extrapolation progressively of take move an time allows younger open-label XENXXXX which focal-onset focal-onset into FDA's of us the also for We with rule seizures, with pharmacokinetic in

the patients need of of years age, include XENXXXX We attributes as patients including clinical has moving be to Phase we're considerable into to where X X-ACKT was FDA. medicines. finally, broad as epilepsy, by there for young expanding the trial And the support believe continues profile and in driven from process XX this development, to new feedback and younger with

development who sincere with prioritizing EPIK families patients of are gratitude clinical continued our to development and their those patients the transition so, careful to longer access extend for after currently period We on the And intend epilepsy to our We to no trial. will plans XENXXXX consideration, offer the a clinical we an pediatric XENXXX. option for pursue participated and XENXXX. work in investigators study through wish

Turning MDD, to or to Disorder non-epilepsy X X-NOVA in XENXXXX continues indications, good our study Depressive Major Phase make progress.

results has been clinical a within treatment progressed patient next X-week initiated to as weeks X-week is to as additional follow-up a patient a population. X XENXXXX. were the period XENXXXX a randomized, and visit, to decision XX well data reminder interested epilepsy through and after MDD is screen be Our locked with based the has ago, period lasting which the data there preclinical well, given with and on months further a in only last was and gathering month last X-NOVA, examine comorbidity promising common data encouraging June. We database the depression ezogabine, was published can goes in analyzed. After up which that in expect we patient screening as the

the topline looking are a fourth slight Given of guidance is the X-NOVA in which a These year, shift quarter. previous to help our XENXXXX for our in topline third of in will for data these we future this quarter steps, data MDD. plans in data forward readout guide

PGTCS; our plans. clinical well the we summary, of X-TOLEX development and continued as in trials on executing seizures; X Phase program, trial including clinical on In and our advancement focal-onset XENXXXX laser-focused remain as X-TOLEX in X-ACKT pediatric

our forward MDD looking in from to data Phase We important study X-NOVA this X are later year. the also

our X-TOLE that Lastly, profile important some results, address data to the Phase extension Xb currently X-TOLE long-term XENXXXX with product potential the to of patients we continue of a epilepsy. with our generate unmet position compelling supporting presents the ongoing from that novel affirms needs open-label study

open-label September, Sherry we now And quality-of-life will their data-rich highlight as in Chris focused a readouts be Annual and our XX-month including in the Neurocrine. as from as data measures first December, of additional Society as the later Epilepsy of in American call, this as year, the year, will at the our from remarks XENXXXX Congress X-NOVA for Meeting and in Epilepsy the study, the quarter the well Between data OLE end to XENXXXX on excited are data Phase X Xenon. entering we present International X-TOLE data period with in at and well collaboration X

on over Phase turn additional program Chris call presentations and can for upcoming details as within So I'd our to who now Kenney, progress X XENXXXX XENXXXX. data to like provide the made the as well recent

you. to over Chris,

patients. Okay. medicines from X X-TOLE study review would believe the very open-label briefly compelling data the echo extension, favorably program. we data to that currently and Xb and within to-date for Phase the I robust Thanks, clinical efficacy epilepsy Phase X-TOLE trials the To product that XENXXXX XENXXXX, the ongoing Ian. for generated profile focal-onset compare clinical available support a our

XX-week running change studies primary X-TOLEX Each initiated Ian percent endpoint have or we focal-onset MPC X:X:X X-TOLEX, in these is either placebo. seizure with of XX is mentioned, period the with double-blind monthly subjects approximately will enroll compared parallel to our or milligrams study. seizures of median through an XENXXXX The be which As once or the XX to daily will who efficacy milligrams frequency with dosing from of randomized baseline now XENXXXX and placebo. X-week XXX

seizures. plans X:X with Phase executed Subjects of daily once X placebo. successfully our epilepsy clinical to also and parallel through XX XXX of both or approach and double-blind endpoint X-ACKT of another from is generalized placebo. baseline development our tonic-clonic frequency the generalized approximately expected will is on be of randomized seizures primary milligrams in to stage XENXXXX I've dosing X-week compared unique. primary subjects focal-onset noted to at pursue monthly an for The the either We've efficacy trial enroll indication, this MPC this that seizures XX-week PGTCS period XENXXXX, tonic-clonic primary is

is data, including clinical mechanism generalized in of Kv favorable Phase model photo-sensitive models focal the across we epilepsy X-TOLE on epilepsy, rationale proof-of-concept saw and the preclinical activity all Xb based data in Our study. in the subtypes multiple seizure

study poster presented upon were clinical strong French, of She outlined AAN, in extension both with of to the physicians medications. the the epilepsy outlining X-TOLE that most of the options to open-label of program data from trial. with at Phase We assert epilepsy, improve and therapeutic that Dr. upon in hope neurology-focused in Our be clinical the meeting. the was the common broader the our groundwork selected Jackie use At generated anti-seizure who a important for new these of presentation epileptologists we of forms our Academy XENXXXX. with for leaders Neurology, ongoing data should for the an build at thrilled Annual approved. preeminent this oral one continue met is recently we existing XENXXXX design, mechanisms field, how data X-ACKT in American action efficacy to trial it XENXXXX are Meeting potentially the differentiated addition setting need Xb

extended and the of Importantly, outlined data freedom key the in periods patients takeaways. extension experienced continued reduction several seizure Her seizure open-label she spoke study. by podium presentation about demonstrating

monthly specifically from XX-month seizure greater XX% to extension, respectively. durations change as in greater was than there equal and the During or for open-label X-month a reduction achieved or double-blind and frequency, of period to was seizure XX.X% patients, seizure XX% equal than median in baseline. to measured Also, percent XX.X% consecutive by freedom the reduction sustained

anti-seizure prescribing experience existing French focal XENXXXX that are adverse anti-seizure differentiated even for impacts data generally open-label well-tolerated continue multiple and who seek extension upon options who the new Dr. hope to that provide be the many these with continues while patients with of in improve debilitating physicians other may encouraging for taking therapeutics seizures medications. events the further medications. prior in to results consistent expressed

highlighting Looking presentations XENXXXX continue Dublin podium poster in this as data Epilepsy in September, Society well upcoming XENXXXX Epilepsy in team new at International program ahead, Meeting IEC in showcase medical multiple X-TOLE Congress is X September, conferences our At as at later open-label excited Phase ongoing from our our to American the XXth the including have and we at presence to the extension. and quality-of-life December. year,

as are we X-TOLE use in XENXXXX including with of supporting Phase on important long-term to submitting to updated progress well open-label a extension the addition, We the as In on the Meeting, as and XENXXXX, the Society XX-month you build our abstracts American seizure Epilepsy of well data of process from medical physicians data. as program, forward keeping to look epilepsy XENXXXX the profile continuing community. freedom X

brief our now over with us program partnered the our before turn quarter milestones. financial to call who results first Sherry, give and Sherry? update I'll on upcoming Neurocrine, a summarizing will

Chris. much, very Thanks

forward beginning study with X NBI-XXXXXX. focal-onset evaluating the So is partnered trials clinical pediatric Neurocrine X NBI-XXXXXX and from patients in on are SCNXA-related use patients anticipated our focal focused at results seizures, adult separate with our to conducting the other adult the collaborators programs, Phase this Neurocrine's of examining study One year. is fourth quarter looking which are in the of with epilepsy. study, We're

fund December compared and securities XXXX. having on financial of Cash X the marketable news cash XXXX, release Phase XX-Q report studies, $XXX.X and XXXX. would plans, touch some now completion Based sufficient the I'll to our further refer million into of the we equivalents on as March current and $XXX.X including million epilepsy operations for XX, you were and statements anticipate operating XENXXXX from details. to planned XX, as cash to of highlights

ahead, Before some the mentioned, period briefly now of Ian Xenon for year. events goals between remarks, our our and and prepared the a I'll data-rich concluding as milestone of summarize end including,

XENXXXX on in clinical and focus focal-onset will seizures, our clinical We X X-ACKT program, in and our Phase X-TOLEX PGTCS. X-TOLEX trials advancing trial including our

in resources IEC both the excited fourth to open-label our X-TOLE quarter in results in at in of and X-NOVA clinical are fourth In ambitious we quarter established year our another expect additional AES efforts in believe Kv We adult the this readout September we we us enviable the MDD, topline our execute plans. financial extension position December. and Neurocrine. to an by supported in study by from We clinical anticipate clinical from that's partner, trial data field, our that conducted XENXXXX the have help leadership present development and focal-onset data closing, on

we team Phase our X efforts of to continue proud on I'm our epilepsy focus we program, build As the Xenon. at

to are excited to deliver new therapeutics success reporting business through to the am patients our need. XXXX. forward mission grateful look our by committed to and across We neurology Xenon's our to-date I are progress employees in who to

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

Instructions] you. comes question from the [Operator Matteis line of from Thank Stifel. first Our Paul

was a wondering you're give a if more and and guiding I what affirmative going I results X, you had where to these be ultimately X on to program when one on you a going you're think things us on could on it well, enrollment get sounds ready to when one little question color like to you'll available. give seeing Phase seizure question just aren't point yet Phase MDD. bit to guidance? the but Ian, On are expect you be do dynamics, focal more you

is was HAM-D I than that on trials. to of disclose to other is on enrolled can as were ask about some a bit it the impact And you asking severity. cut-off patient things think like contemporary baseline your the And wanted then effect. if Historically, anything population study, placebo the you've I lower to reason I relates on some have the willing little MDD MDD specifically

a And bit on so, little curious the population. just again,

one in Thanks, just the a MADRS population talk epilepsy we probably is can recruitment. track Phase kind Kenny, we your bit expect we Yes, the we let's little and happy and we're I'm remarks, it's mentioned in to question of about as about And Like, of then first lot Paul. in. I X believe to question, a doing patient address baseline your the then prepared how a well. and Chris -- and come cut-off where we're first kind maybe a on get progressing score

as Maybe asked. to give bit more you a you granularity

experience, patient of we track our based we randomization. at challenges the we and model initiations, against do was the experience on at we a that both well proxy. bit drug in to and model talked the built a time, use COVID, the screening X-TOLE as do how today. track X-TOLE we before, efficacy as patient with about and as site didn't we least a we're And doing. during So data and run have It profile the or track study see on molecule as We've our CRO, that we've that of study. Obviously, which the

yes, guidance later this will forward providing likely to guidance, topline at In we terms data of some year. -- be

think, of consistent, and of I been data. on wanted give we've get where we guidance belt topline and can up and then sites very we majority couple a quarters enrollment under running we of our some the

the come. setting. to going you Chris, to characteristics that I'll the pass on And, So, into MDD it baseline

Sure. Yes.

moderate. are the depressed least criteria, So to screening we capture have in terms And least Hamilton-D patients of have at to of inclusion a population at at a details baseline hoping XX. characteristics that, largely randomized the who as eye of being are a based idea share on end potentially, upon And the we're is on the then patients baseline and are by more expected. obviously, what to we are had of following patients And year. more characteristics an keeping that all the

on Anything these recently? compare completed can say, other you baseline studies that to in Chris, how depression characteristics have

Very similar.

One moment question. next for our

question Markets. Our Abrahams from Capital Brian from comes RBC the of next line

closer on advantage of that primary get data me. results, Or programs Congrats the we depression next-generation to the from how latest behind as if off, far indication positive? I on for first the were all could X of I'm guess, progress. curious would validation take XENXXXX your views a be, pharmacology? MDD the the as

kids? XENXXXX EPIK optimize the what use in can shape secondarily, you to to learnings how from of development then And

I to if on the first for well, can I'm one about comments make of as then as address a want in happy EPIK. And, couple Chris and XXXX. jump Kenney, pediatric the you think development to we

paths the that common So, terms point, be important comorbidity critical important. the here. would Brian, generate there's depression we talked that generating is MDD, be We've that data call that to most a know data an of in about data is in going in we're obviously continuing really is, One be could so multiple to epilepsy epilepsy, so input.

potentially, interested, major you also additional of now primary and primary internally, the -- program. in are in doing, the position depressive just work data, data we'll some a in provide we that between steps as questions indication of say, when next be some disorder. have We're commercial But in to doing topline development topline that have we answer but we to,

next-gen of You taking about asked compounds the pharmacology. advantage Kv

would into ones year. So molecules efforts preclinically. next those sometime clinic, first None obviously, the the we of transitioned transition have Probably yet. have significant

a there into of of the would molecules development. and gap bit backup So any that move be would between XENXXXX a

the at a population a On pediatric transition, XXXX I very developed population, talk study time plans focal epilepsy. this is epilepsy. different bit pediatric And in was The epilepsy a little than mean, and pediatric is kind primary KCNQX-DEE, to generalized could for the of seizures. different. actually being rare are patients pediatric a maybe just very about XENXXX the we EPIK That the very looking good which was with tonic-clonic both

for Chris can opportunity, more or in want population the if I learnings think, talk know say But of from want provide then, -- XXXX. at don't if and into you development patients. the about some pediatric EPIK patient you just focal Chris on so, pediatric And anything to generalized perspective least Von the Seggern the to I Kenney, market

the that's And would feeding in blinded. the assess what extent still ezogabine, in what path the learning XENXXXX EPIK has from data was study, illuminated the the X-TOLE say with that EPIK would data development that than so Sure. any from into say, for that in near to plans pediatric learned study study for so data, To particular I adult per future. consistent we'll the largely there I of wouldn't XENXXXX. we the blinded necessarily it would biggest the about say we pediatric the unblind is feature more extent, I study. But can the with expect is that you is se, that the

that? Ian, would you want to add to

No.

I think, population? good. development and Chris, the on And really pediatric that's patient

Happy share. Yes, absolutely. to

in development that we States think hundreds we adult of remember predominantly to the that are there have the age about of of the thousands the current on are when population, who XX under United patients, So focusing have epilepsy. plan

So age similar to under talking bias about patient numbers, than a adult And the the we patients the of we're generalized more broad-reaching XXX,XXX disorders. focal-onset seizure XX. towards -- patients seizures in population, see with

within need patient a medical population this of And However, we difficult-to-treat the those of much patients population, mirrors large patient for the have progressing is a what very patients similar who on percentage unmet as high just dynamic adult disease. like third-line in And population, branded to for adult a second tend And play a more-difficult-to-treat XENXXXX the in we role or to the those therapeutics. result, patients. market. pediatric opportunity great see a therapeutics see

we research market with population, XENXXXX a seen associated positive problematic even bit similarly for in in beneficial we've the where are patients. with a what adult has patient Our bias adult audience the more actually attributes the is what being population becomes compliance drugs towards this with QD pediatric more suggested value as see than that slight

is there as in great the population. So for the we pediatric opportunity continue a XENXXXX development

detailed really much the helpful. That's answers. super Thanks so for

question. next our for moment One

Tessa from Morgan. comes Our the J.P. from Romero next of question line

clinical at sites? I should to competitive much nice there So follow-up. respect and we And on, dynamics trials other X-TOLEX in can have provide sites think your between clinical And dynamics overlap with remind about you trial for and now, FOS for in is How then, is X-TOLEX is any how versus see. PGTCS enrollment off which us the the X-TOLEX? And quick us trial ground color one XENXXXX there? programs you'd to enrollment really

Yes.

as there. lot I'll well. add a to free feel Chris Kenney, So start. in jump and

So will everybody, clinical are in sites. not they at same be and X-TOLEX the just focal-onset for as a both X-TOLEX reminder seizures,

of study. experience X-TOLEX sites And gone biased so, of a said X-TOLEX and terms have first we've have with we the started XENXXXX of that starting first, kind and in that into number that

of we X-TOLEX, so with X-TOLE, each run X-TOLEX protocols. from only are sites those the but of same overlap using For can is no one some sites, and the clinical there site

X-TOLEX bit tonic-clonic that's X-ACKT, X-TOLEX it's the at it's investigator, they And the if if happen the appropriate. generalized X-ACKT they same have eligible can primary or as focal X-ACKT For contracting, into we same generalized, seizures, where is institution. can primary or a that's in they same the they study. either epilepsy, sites. into for patient a That can it leverage, study think the go different. get sites And can X-TOLEX have XTOLE-X go little we And

over some we benefit leverage that's get So that. and where some

drug there just their In late-stage terms clinical program. efficacy are clinical we're obviously few with a with, development in knowledge so number only drugs, the molecules of in are our other a competitive We a proof-of-concept that studies. they're to pre-efficacy, data -- compelling X know Phase

I we terms so of there? had know, then recruitment. seen that's a concerning to in you haven't competitive from view And anything point Tess, And of follow-up. Chris, a anything add patient

would is investigators there and that One thing, about enthusiasm fair generated in add epileptologists so a speaking general, we've amount far. of data the is with in I just

pretty with major all competition the that study, interest factor. So, you come along I of think don't in that that a would our I say when completing is challenges participate to as Phase X strong. the And trials see a

XENXXX? doing Great. then any take Okay. there? you might long Are to That's ongoing further was can you from had formulation any work pediatric that formulation? able And you just the of on you're And the to thinking, helpful. leverage land X sense kind And formulating learnings I one. the kind provide of on quick of that color you how

Yes.

had the again release state and the in press prepared I'll in remarks. So what put just we

go we're down amendment so a we'll that an FDA, as For seizures, tonic-clonic based to of going generalized on age years XX the primary have request to today, by protocol. to

presentation for don't adults. we formulation, that need can use we a And and the so, XX same above, pediatric-specific for use we

where into there is rule this go in time, can basis, and open-label younger get you into epilepsy, patients PK an focal younger in over extrapolation over progressively patients we time. then And

I the -- have programs preclinical in pediatric this well We terms formulation as internally significant development, have development XXXX. a works mean, area. have our for quite do In that we as experience CMC on of group for formulation yes, we

that So is already work underway.

year idea, I younger good we're would doing later a formulation which get But in how before this the Tess, that bit think into probably be pediatric there formulation we we'll fair still do patients. on can pediatric have a to development, even we much is required is required.

One moment for our next question.

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

This is on for [ph] Jason. Congrats on the progress quarter. Dana this

have So MDD a questions we X-NOVA of the just on couple readout.

And so else you this beyond stat on are tolerability, MADRS focusing sig demonstrating on readout? in good monotherapy and what

that of a general anhedonia monotherapy is clinically the curious from safety in AE consideration these when picking were then XXXX's a healthy subjects? volunteer data? also if rates profile doses differ was XX-milligram significant at MDD patients since if And based and response looked chosen and the And and you've XX-milligram have placebo XXXX's key on they area interest, just

the kind Chris, bit part data. data. MDD, well. forward adverse the terms maybe on plan can event would in we Von totality of I done into market depression, of why would research kind I'll that the in But, of don't talk little say profile I a be Dana, last you go looking at about about so totality we anhedonia. talk the of as Maybe Seggern, of of some And the Chris looking know at tackle epilepsy we've the the

terms and to it at need as steps. we efficacy obviously So our we inputting where adverse decision in believe look of you've overall next kind of for in, mentioned, would fit well, and events into

the I data of of yes, very data, you informative mean was terms the for the dose volunteer data informative, we X-TOLE was chose suggest, as -- was as the as selection, one selection us MDD. but X-TOLE dose In healthy for

X-TOLE obviously and the in efficacious well-tolerated. believe, we was an dose XX-milligram So dose

profile benign. because XX-milligram the XX but think see X-TOLE, we I reduction quite interesting, endpoints was seizure all AE the did milligrams quite dose statistical on significance was in at

was that a our dose test so to we as wanted And X that part and MDD try study. Phase of

we milligrams adjustment actually and include we study. XX for and why the placebo before initiated that's MDD milligrams, study to a we And so, made protocol a XX-milligram XX arm, had chose our

least Von can the know and some answer of maybe, Maybe So at talking the you profile, anhedonia depression. we Chris to AE I in of walk some at question. those can details, prescribers epilepsy we've looked in then Seggern, the through

think said And absolutely. is, I highly data to with refractory Ian background coming therapies. note, patients build are multiple important from in studied what patient to with what's Yes, who population on the on are a X-TOLE epilepsy

see with or and comfortable the profile. both XX-milligram whether would for compelling you see profile AE in clinicians research, market product But generally associated AE which understand higher So existing profile to profile MDD the took efficacy is we XX-milligram do not from most epilepsy, that profile what be with we an would the that, than into for products. knowing a that X-TOLE a offer

of that that assuming importantly, but class. when And highly efficacy, SSRI, that the of across associated them, a we looks are effects the associated level approved an Remember, events with is these have categories have products, weight compelling SNRI of major profile drugs looking What that into. active XENXXXX like adverse we to is balance are sexual some patients. and that there AE for range is are going MDD both that side with the have for gain there a substantial was, look heard you used opportunity of one drugs today CNS-penetrant

optimistic to patient profile they're some they alternative are be for AE -- perhaps bit has or a are from population severe monotherapy AEs what patient an less a tolerant bit that more But the perhaps later-line of population. willing a of a profile, consistent environment patients, the that of mechanisms and looking in less a different So on physicians in with X-TOLE. also, we the less bit AE impact bit as saw out of epilepsy the looks coming a coming

So, there the is totality is the compelling again of an that profile. the for assuming opportunity, there efficacy evidence suggests that

Kenney? Thanks, Chris. Chris

Yes.

to trying the it, kind question, as a versus pertained to are anhedonia. depressed understood the So study patients draw having in placebo ongoing the I of effect distinction between who and

looking a Paul's So ultimately, we we're are course, but So it's answer behaving blinded similar would predicted, the blinded a to given I'd the data, know the going exactly about at in to give right? the But data. what's similar on. don't question -- that manner we have of scales caveat characteristics of population, baseline

a cut-off distinction, hard population it's making most would depression, predominant kind anhedonia, I severe that that who be anhedonia. may patients of those To for this moderate that to that because of who depressed patients and have your to more question earlier once make to then mentioned I enrich have about distinction already patients between use have more you say

So mind, necessarily consistently haven't I yet. what have of we no happening wouldn't separate to be my X fairly features the unblinded together. we those placebo idea course, because And is effect just Those in really seem the X. study,

Thanks, Chris.

for additional and you Thank the congrats all on color the Great. progress.

moment for next One question. our

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

This X for is on us. Paul. Cade [ph] questions for

from forward for your might R&D data you to expenses MDD any of is, X? your Phase change failures R&D expenses, And competitors' secondly modeling regarding go do potential the your thinking, post performance cause XENXXX how removal First, the from pipeline? recent change placebo then,

-- Sherry, talk want just do thinking powering we've calculations, to So, that. can how we're the walk probably placebo we MDD expenses. talk about rate R&D and And about maybe how and about can you Chris, and then, through

Yes, sure.

the using evaluation is running effect, making discussed atypical. -- we've in CRO, in of but And making would terms keep the experienced patients patient time the so in a on in level appropriate study really site to we're effect this the as -- has this that that the with only course, protecting before, Those sure choosing of that evaluation. that isn't sure safer to be the an data placebo So key from an to enrolling at the patient, focus unexpected trial. minimizing choosing experience as site make United largely of a we something external placebo States, do each there happening eye far or there at level, an are we're that's real

of eye on that. an So, we're keeping all

this are we've on patients through COVID, -- is experiencing depressive gone happened who and the that's through had symptoms. thing gone Another that's we've some that impact

had we is strange that of who population sure created. made so COVID, being depression we've sort have there that patients before so, And have no

all be with to we and wouldn't are been more doing. that come the effect, anything we've to the those up doing be that So I could things able placebo manage

And, question Cade, to to your just expenses. respond on R&D

see more continue initiate year. to now last X are going ramp Phase over trending the studies expenses upwards, XXXX the that multiple initiation that So state enroll ambitious and later steady expense we broad couple as until more continue will R&D of and that R&D sites to quarters, epilepsy you largely program we have to and by our X our patients this seen driven program Phase that's of underway, in we're our with upwards hit all

reiterated XXX. cash we've You'll decision with into see around that up that runway so our guidance XXXX, unchanged remains the strategic and recent

One our next moment question. for

comes next question from from Jefferies. Andrew Our of the line Tsai

a you there is want pursuing something maybe the of you to instance the like for X, but general? on for so you totality MDD. X So continue but it's should X-point about better, the sufficient? evidence, is I be we higher depression actually Or delta Obviously, thinking minimum power points? where in that MADRS to see to to understand X

And Phase will instead what make continue what data then for and with data in new the compound you pursue drive decision will for X specifically a depression, on the your KvX depression? to secondly, in XXXX

when this unblind ourselves package the we to as on at mentioned, a really we Yes, commercial this inform work do number we're we've to well year. input. of side continue the -- times. And looking data and provide later we've We're said entire as

if So if going ahead that go ahead. not to we're we X, go cut-off, hit going to we're and isn't we don't, MADRS single there a

is it really related looking complex as more be well. inputs So a to in question second your we'll and making question that's And that decision. multiple at

the as and look mean, at sense you of continued of we at think MDD, in decision -- Xenon or about data we nice for we have its terms to thing that other earlier Q&A whether entirety we whether I I development in do that the molecules, on as the optionality mentioned, is talked that make need in well. some in XXXX to makes

we I then We unblind you. specific X there need can its the to really So answer entirety that can everything give conversation. and see in data, isn't have

As that that at I've mentioned and earlier time to conversation the topline ready in this call, communicate have of we'll data. be

clear. Makes sense. Very

moment One next our for question.

of Our line the Cowen. Joseph comes from TD next from question Thome

one getting relates any age adjust dose consider to max the of pediatric to need first there? go you the dose into the guess, into sort as it Maybe given titration as FOS plans. I before patients, you younger or do

X patients? about X treatment-resistant on And seems SNRIs. you are landscape then demonstrated the demonstrated FDA still? maybe strategy, activity obviously Or depression bit, is to changing little here it wants SSRIs payers think a sufficient the want of MDD kind you like think failure or see do in of payer When generic is MDD, development second

don't context more why bit talk kind obviously maybe Chris be patients, generic Von where don't we agents titration of around maybe just and you why previous Chris se, with terms drugs not branded about you in let's into Probably environment dose Kenney, a of start are younger the bit in And of as we there. in dose. per -- will adjusted a terms but the provide but then, specifically payer depression. get used can Seggern,

get lastly, we then question. And TRD the can to

Sure.

using half-life, we just with on the long a programs titration. So briefly right using now not titration, are XENXXXX fairly

really differently titration. present intention from there no so pediatric a is within no the titrating population that no efficacy suggests that is see that the of there we're we the treat And quickly, so, of taken to the week, benefits have We seeing one than X And data upside full don't the is is use look the nearly standpoint the titrating. intention of titration. adult to of -- obvious extent efficacy not at to we've

go you down Now, the down adult to and obviously weight as younger in kids. body population further then adolescents the into from age, substantially right changes the the

things that into to proposed agency, will their agreement have and taken seem that to to for of specific adjustment the we've to have so, And account, be account. and -- taking sort that

Von MDD the and environment? Chris. payer Thanks, Chris on Seggern,

Yes, absolutely.

And quite multiple this largely time. and management established well-established and it payer dominated space the mentioned, now we've We SSRIs have treatment upstream, better by branded not work as into is dissimilar see first generics spent and of and Ian we space MDD payer in the the and landscape that in heavy done space. had to time MDD seen a is fairly And bit the within the a understand to for of in in expect SNRIs, quite the actually for well availability before that's what with therapies to been results that epilepsy environment. early-line some space as moving second-line

see tighter the What we though than is what we we do are And new entrants, MDD patients MDD the seeing see slightly approach more as to and in therapies to within the with being epilepsy management space a in approaches space. failure, the payer a early-line refractory management management said, the that branded after to tools. That failures. need population accessible is category, document patient there substantial still different from expect is

in depression population. have demonstrated from haven't payer research patient heard our evidence "treatment-resistant" need to necessarily We the

what the to later for a looks that payer necessity the based the management that how heard like might not future. they to drugs It's have we use XENXXXX about profile lines. for that on approach manage product clinical are really payers thinking and tools So in access for in

question on last kind populations other of depression. within your And

is in of development engagement Phase current say would this will have that X-NOVA a regulatory we the clinical look So post, plan in not I going had we're terms to that have like. X late-stage what to our not TRD. expectation work study, study, do the specific is

we So and clarity we to expectation our post-data, look if were FDA what that late-stage is development better with would engage get ahead, move on would like.

our One next moment for question.

of Goodman from the comes Our next Marc question line from SVB.

Marc. This is Rudy on the line for

think beneficial formulation, you color considerations maybe formulation your may pediatric the pediatric Can between patients. those you provide are the formulation? key in formulation be more the pediatric differences the current development this like of QD that the mentioned for I what and like So, on more for key

address can that. I Yes,

into So as need can they form we take. it's that about to get we really younger have a dosage patients,

a to they solution, it kids, can can be needs it it as can mixed or either foods. used especially into can very we young it or that be a solution, into something, So in get be be soft --

focused development adolescents I adult a as up as ongoing. So, is we we'll But be younger that And children, today on is can work the get we the pediatric-specific formulation, with into with presentation. coming get formulation that into population. mentioned, so

As to on we that updates. work, future happy progress we're provide

Got it. Thanks for the updates.

question. next moment One our for

of from line question Danielle from James. Brill next comes Raymond the Our

and curious, with that you accelerate of the on of expected X then do factors years quick you And recruitment if attributing X-ACKT more the MDD your just age, provide delay down could I'm slight expansion will ones timelines? me. this timing from XX color to recruitment anticipate data. to

the I throughout. and delay study We just refined think, few Screening best best this at screening, really, that was just of up end now, that we've in was running the the We the MDD in towards ago. It really And our got and last minor. a place, when estimate a our bit. put we getting quarters time. guidance little is consistent estimate been just really randomization had has summer. gave

going data. and all from follow-up treatment screened in before the then do the screening kind to need just can that period, you done of and So, next the there forward we is the last to to get be terms be patient of month steps period, can the topline math

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for One moment our question. next

Chico of Securities. Our Laura from next the from Wedbush line question comes

have X. just I

idea So adult on the first, it's in the of pediatric any still pediatric of split uptake? ezogabine have versus use you market, patients do about kind data on while any the indicating

the study, have and reason were how when XXX patients that's up thinking had but contrasting administered titrate about had versus understand then a they something trying to And it smaller study like that study? it that they to I milligrams in impact were was have do of sense ezogabine so And because the what using a might ask second, patients within adherent initially, TID, [COSD] realizing daily? as XXXX we're you depression, in to

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there Yes. is it thing from some we The did while but that see they use against executing was would were Ian, was from what I was ezogabine add, pediatric scripts only plan, that minor. pediatric actual

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we've Dr. know a about I Kenney, his bit ezogabine Chris then, fair Murrough And Chris. with Thanks, study. spoken

adherence population? So just the in about question ezogabine XXX and that milligrams TID tolerability

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address that does Laura, question? your

Yes, it does.

for moment question. One next our

comes from line Fitzgerald. Our of Cantor from question next the Charles Duncan

us seizure Kim Duncan. can you levels Additionally, safety similar OLE including X-TOLE of what Charles thus study, about the to treatment continuing seen any And far? freedom? are weight? Elaine factors, is in tell This In you on been changes persistence for see there body have

XX-month to and XX comment obviously, we'll the for data this communicating cut want we few Chris, on Open-Label -- on comments Chris, of as do Great. additional later an data the on mentioned, do cut then maybe X-TOLE September, months, last year. we're from Extension? a the the of But, you Yes.

X calendar gained patients Epilepsy this that's you year, about talked cut kilo X So over the medications. so Society average, show the of at end the year. have all we'll at on about that fairly far of and done context update the we've American look of information The data publications course antiseizure at weight so the that if gain modest, in the that

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so, to seizure it. you seizure can numbers away, can patient of mean that X year as be a patients right? you a can't opportunity to have I drug, freedom And add go who experienced if freedom, longer only the on take only up, the have you is

it's where that the leave have we about until I'll share the heading. And at it to optimistic of we're So at details year. end

next One moment for our question.

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

questions a couple Maybe of from my side.

in bit then And little enrolling terms are available geographies the for a peers a anymore. one point patients. So -- about is given obviously couple Russia and your -- of not I those think like of talking this of of competition Ukraine are not at trials epilepsy challenge

challenges seeing you at or of terms any point? this like enrolling centers in the initiating that are trial those So

question less conversation complications, second but that seems are is this doing regarding of is the they interesting that my fascinating said this drug I with is one. our and And quite the definitely safety it the drugs not and mean, well like complicated, despite Xcopri. burden how [Quralis] uptake because which

as has does comfortable well? So launch? the you surprised launch make Or more it around you this

bit attributes inform terms thinking we and as for and to of first happy it your can we're I'm the that Seggern the talk about have Von address how in Yes, little a then may that about and Chris one, cenobamate well how XXXX. launch

of as and maybe are recruitment we and those as we mentioned earlier, are. So terms expect clinical that development seeing in epilepsy not progressing would headwinds others enrollment, we're and we

and the attributes we we some molecule have efficacy clinical strong have investigators and ongoing, ongoing I at is with with that trials with currently mean, compare we least the have benefit, trial sites. very that of and can compelling we our a that's when obviously the conversation are other clinical do

epilepsy haven't of different efficacy, just ongoing earlier -- proof-of-concept much yet. any are development other stage shown at a studies different The that

would of tracking seeing terms we're So, Von Chris in so headwinds. on recruitment far, Seggern, expect we cenobamate? enrollment not those comment where and

Yes.

agree their obviously well some doing done marketplace, limitations is the that in is products in days. well trajectory job ample their of in From products. and very we cenobamate the perspective, would So there room for the early of wish despite launch they've our early a branded great this multiple and we them along

you that physicians cumbersome is I associated Xcopri schedule. quite does that effects for because ability or tolerability titration hear that the be during not clearly issues used general think our hear are research the in quite which we is though physicians burden we market the of actually the drug more and to of limit it and the broadly, and dose getting both safety for from to profile quite that's highlighted something top the titration important, the with titration

think about an mean, of the us, our positioning opportunity that product I when upstream. move just for to creates we

ease-of-use us products. a really gives be future. last-line that better much available is in patients. where strong sufficiently believe today, product start, hear positioned, upstream And other on an that like XENXXXX play the will And despite we of attributes which we encouraging XXXX really still commonly its the than Our are for view will upstream used Xcopri, fighting

Helpful.

Thank concludes you you. portion you call. the may joining, now Q&A today's Thank for and This concludes call. of the This disconnect.