Xenon Pharmaceuticals (XENE) 9 Aug 232023 Q2 Earnings call transcript

Good afternoon ladies and gentlemen, and thank you for standing by. Welcome to the Xenon Pharmaceuticals Report, Second Quarter 2023 Results Conference Call. At this time, all participants are in a listen-only mode. [Operator instructions].

I will now turn the call over to Sherry Aulin, Chief Financial Officer.

afternoon. Good joining Quarter call results. XXXX for discuss webcast on Second Xenon’s financial us you and our to Thank and operating

clinical me our call Chief and provide Xenon’s Dr. Mortimer, Chief pipeline Commercial program. Chris are programs Chief will Xenon’s ongoing summary Joining Officer. open an of Ian Executive proprietary today's Von President Seggern, will Chris a Officer overview Chris Medical and Xenon’s XENXXXX Kenney Officer of and with Dr. Kenney, Ian our

our Seggern summarize within Q&A partnered available will about progress I financial milestone our questions our programs, results, Company our anticipated events. during commercialization session address and will our to Chris strategies. Von be

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

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

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

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

Good Sherry. today. everyone. us call on our afternoon Thanks joining Thanks, for

across business past excited of about the during aspects all the our quarter. continued We progress are

To to design complete a our XXX in of XX near-term. milligrams that Based that enrollment completion to is patient or arm XXX XENXXXX MDD, will original the more begin, trial Depressive to I'm and we XENXXXX the in in of we be last reminder, just pleased screening, the Disorder, X-NOVA than the was patients, announce patients now expect randomize Major or milligrams XENXXXX, XX study randomized as PhaseX of estimate randomized. or patients on of ten be And placebo. per patients very

and announcing research. QX rationale modulation our top-line the of results, late narrowed review further to now data a forward opinion review clinical treatment look have key trial. we we In the to advance to including MDD from November in Mechanistic We'll Additionally, host market to MDD X-NOVA these the and elements also our webinar Kv X-NOVA guidance own leaders for with a supporting mid intend findings our as of key discuss December. landscape,

virtually a to ensure targeting webinar, details webcast for you and are we'll our access that additional this and attend speakers We September issue all notice mid and participate. advisory confirming can

clinical in patients, or including or tonic-clonic patients primary X-TOLEXand TCS. late and our KV epilepsy exact de-risking stage XENXXXX broad our from continue are PG the program generalized the with our epilepsy seizures X-TOLE trials PhaseXb seizures in focal-onset with important in clinical generated only trial. position potassium clinical PhaseX and with recruiting strengthen FOS, channel All PhaseX also clinical patients to in X-TOLEX opener with advance development data XENXXXXrepresenting We field, leadership actively

noted XENXXXX confidence our development of execute epilepsy in As call, ability plans. on clinical our our to last to degree continue PhaseX high we a maintain on

We which was have strong in and of the upon to similar X-TOLEX with familiar and size relationships with are our our design X-TOLEX, both study, investigators advantage PhaseXb being and draw experience X-TOLE already who the with able established key XENXXXX. to

provide this to expect We timing year guidance regarding completions. estimated our study later of

adults, from plan In to pediatric addition on for PhaseX part program strategy we XENXXXX our feedback ongoing epilepsy our based for development FDA. to continue execute the in in also on

ongoing patients. Our of a pediatric XENXXXX for on work conducting formulation team younger is

patients in cohorts FDA's In into focal-onset the open rule us XENXXXX progressively seizures setting extrapolation younger with with PK time. label focal-onset of an for to move addition, seizures allows over

by driven exact years include FDA, twelve patients in to as PhaseX feedback clinical of also of the the as trial we're age. process from young Finally, expanding

Before Chris I welcome Kenney, I'd to warm a pass like call extend to Dr. to the

Mr. Jillian Cannon and

and that Justin directors of Gover, appointments companies. leading large pharmaceutical franchises the neuroscience commercializing two announced of vast knowledge our newest were medicines Jillian Board brings to successful novel Briefly, at a yesterday.

She's some drugs involved been of depression familiar and of will most the decade, important you and commercial epilepsy with the of the many be Justin. in past efforts over

As $X.X and CEO GW his of Jazz XXXX in sale and the launch eventual founding Pharmaceuticals and Epidiolex of the billion. to development commercial of for team GW led the Justin Pharma,

deep like about has takes companies the and Justin Epilepsy to a passionate space. Xenon, build it what he's understanding of

continue experience clinical progress objective and the strategic Jillian forward Company. a Justin towards achieving efforts of XENXXXX our neurology leading, for and late of leveraging development as we commercialization of building We the our to integrated are on fully prepare looking stage both

give the of the provide and additional now like program across the team Xenon also ahead the at made will over to to clinical our strong International is open is look to life September. X-TOLE be at have of of measures, the Congress will data quality I'd in upcoming the presented presence. discuss some a on a who XENXXXX on focused upcoming call Chris where medical additional significance meetings turn the that Epilepsy label progress Kenney, Chris details will which

Chris, So over to you.

our program beginning X-NOVA looking to comments, our the focus MDD discussion in PhaseX Building the of September on a and I'm to KvX to forward intend depressive lot, major alongside We space. the leaders rationale upon in in X-NOVA opinion outline a Thanks co-hosting our key importance of the webinar MDD, for study. mid potential Ian. first design the with mechanism treat trial and Ian's disorder

Importantly, these top line future MDD. our plans will data in help XENXXXX for guide

then data You with data in clinical will We in common promising recall XENXXXX within decision few XENXXXX. given population. well further encouraging is be near-term, interested four to on with a as enrollment that Ezogabine, gathering to will comorbidity a With patient examine the was treatment published log data patients our the up initial randomized visit, a period, the then additional very expected in patient epilepsy MDD now follow are preclinical analysis. followed and depression which results by be were last week that based as database and week complete, six

a we're for Given to top data forward this in mid these line to X-NOVA looking late November steps, of readout year. December

XX our for of with epilepsy milligrams reminder targeting PhaseX program, clinical XX X-TOLEX each a robust will randomized ongoing of subjects Turning X:X:X the once as in our are seizures XENXXXX PhaseX trials brief enrollment who study, of with placebo. either approximately focal-onset or Our running XXX parallel within programs dosing or to and of clinical daily be trials X-TOLEX

period or and through blind baseline from XENXXXXcompared an The MPC eight the monthly seizure primary week frequency efficacy to percent endpoint week median change placebo. is double with twelve the

or Our XX expected PhaseX enroll to subjects generalized placebo. milligrams of tonic-clonic once exact XENXXXX randomized Subjects approximately primary seizures. for clinical trial of X:X either with XXX be is dosing will daily

blind is those endpoint efficacy on proof a strong multiple the XX-week and subtypes to double epilepsy, primary The preclinical data monthly placebo. baseline at MPC of X-week frequency compared model PGTCS PGTCS favorable generalized the models seizure from of development concept for we looked seizures. Of we note, of to period the an epilepsy the bilateral in XENXXXX photosensitivity through rationale PhaseXb focal seizures believe generalized that the progressed and based X-TOLE mechanism that KvX and including clinical have data

generalized in broader XENXXXX use most of approved. and development to of for parallel two focal-onset of set unique foundation in potentially common Our seizures be seizures it should allows both us the approach epilepsy, primary forms tonic-clonic the

later to XXth Epilepsy ongoing the in opportunity our data study. International including from our to conferences have label As we Ian of highlight new year, the where mentioned, X-TOLE medical XENXXXXat Dublin September, team extension at upcoming showcase the is in life Congress presence excited open this quality

We're excited subscales to present XX the seizure these and new medication data that functioning quality focus on social worry, effects. of

potentially seizure freedom around can analysis Our rates control and life. of with insights tolerability, of quality better improved positively how is life provide and affect domains quality patients us these seizure important of drug

XENXXXX, longer-term we data. as ole ahead AES XXXX Looking seizure Orlando at important long-term to use as the of a X-TOLE further expect from supporting provide data this bit well freedom year, in

keeping XENXXXX raise progress. to We with updated medical and physicians and forward of are to the excited to on community you continue our profile the look

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

the patients study, the other its at Neurocrine are focal-onset patient fourth is look and year. forward SCNXA-related and completed conducting use Beginning focal Thanks, epilepsy. patients programs, this two with study examining of XXXXXX our PhaseX NBI trials. with Neurocrine adult the clinical on we of study now in Chris. in adult with results in enrollment focused partnered pediatric seizures, our collaborators NBI has quarter separate is to Evaluating XXXXXXX

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

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

line November near-term in to mid-December from Firstly, we look two in results X-NOVA important late our the forward data clinical anticipated trial MDD. top readouts clinical our in to

term X-TOLE extension readout focus AES at adult at X-TOLE in quarter focused expect study focal-onset label from to data we're September, XENXXXX data, XENXXXXMDD. conducted quality of Neurocrine. We're and September, on the including and to fourth seizure a in on additional webinar longer hosting the with in In also life We freedom of year looking by open seizure of rates this excited partner another data December. present reduction our IEC data clinical forward a

intention clinical Importantly, later we make FOS advancing X-TOLEX program, guidance in PhaseX our and including progress and completion PGTCS, providing year. in clinical the with this X-TOLEX trials our trial exact on on of continue to XENXXXX our study

believe I echo we to warm Xenon. like Company exciting can will bring welcome this the world our an our hope team of who the to to patients I'd incredibly members, is at our leadership by the closing, on plans, class improve and board lives is ambitious In Ian's epilepsy. that time with motivated living newest execute additional driven to

progress for any now line We operator our look reporting months questions. forward in ahead. to to ask the on the I'll open the

now time is It floor is questions. Q&A session. for now open for the The

[Operator instructions].

comes question first Morgan Tess from Our Romero with Chase.

much taking guys. Good Hi. Thanks our for afternoon, question. so

detail So, previously values of shops there release think be Bay. I endpoints bigger in the secondary level picture, key on you've the relatedly, your of confirmed have think top-line in might X-NOVA? P what you for provide you your on And landed that will you

much. details you on so Just any on assumptions statistical curious, the Thanks disclosed two these have scales?

Tess. Thanks,

bit I on opportunity just the I'll start driven people may off endpoint detail Kenney, MADRS. analysis a the of good be and statistical remind So by primary little a obviously this to provide then, and think used, of Chris

disclosure, at I said But in a bit level we've things our can one think is, our a historically, X-TOLE in couple of you Epilepsy guide. Tess, terms of of look detail, data a I in of as think

as press expect we'll around obviously should just line secondary well. efficacy from have and not AE in us, patient you profile but this So referred discussion the endpoints to as the you've key includes top endpoints, release some overall, in primary population which endpoint, just the tolerability a key some

about of the terms next XXXX. XCN And committed to then steps we're development of the talking in

a mentioned better in we release have the do press everyone a this provided in guide. Top a Line. little we be planning September. that's us prepared As of for both information and That'll in to another be refine webinar the bit coming at opportunity of the up for in will mid remarks, we're just that terms for But that bit

just we talk So, Chris, analysis maybe about on endpoint. the the statistical can primary

pretty years symptoms. if ago, Yeah, so look rather, good just from at will get idea. X-TOLE is the Line take on I couple focus think focused I of endpoints you'll you depression, press The a depressive obviously a depression, think release Top the a and on study,

study MADRS, as study point goes, of the this for between focused to on placebo. primary powering powering far the and a the which four As this active powered and we achieve is separation endpoint, it is

question comes Paul next Stifle. Our from Matteis with

another all so on want and X.X you thanks that's the PhaseX have Neurocrine to Ian, Epilepsy, kind mean, to sites with kind then year, full specifically Where visibility the much to congrats Partnered at way. do the in between progress, terms just that it on and now Hey, the to before open of this learn feel cities be I As of you what just do study you and want quickly and of program? comfortable in relates enrollment guiding? later

you'd see order to augment to Thank is you. how of your ultimately. that opt want economics kind exercise able curious to thinking in your to criteria there, about in the clinically be Just Xenon

Paul. Thanks,

So, yeah, we in epilepsy background of comment neurocran can about just And we'd kind the and require to remind the make the both. can what is Sherry, and on kind information that guidance. is that people I'll PhaseX I I think in? the then the opt of decision. opt talk What you

of terms maybe the a little bit probably program, So just in review PhaseX it's epilepsy history. helpful, to

of a that and and study was really That after exact running. first a the terms X-TOLEX. up by in months of the and later So last then right months was the year, at X-TOLEX study end followed that then few few was

of all kind and of running. been up studies rolling, we've So getting these

been jurisdiction for studies has first the The US. of the all

in reminder, we've Sites as online. mirror the we back running, and X-TOLE we jurisdictions So over the if of in then enrollment which to Europe to had and and came us. came from patient XX% we've trial, trying a go especially bringing X-TOLEXclinical best program, X-TOLE just been up other can, US. time, as And from XX% the the we're

information generate. jurisdictions. the what's in sites say continuing I'd we're continuing get to So Well, running to that up and we're

consistent year everybody Some what are give to aware, as that information a failure providing and us the that is initiation, rate we're saying monitoring and And of that been be together later we're bringing in those in our being all then that come that overall it's online then And we're screened, time, I our what completion. is, to so kind randomization. site over screen patients guidance this gives monitoring study confidence we'll think guidance. we've position really that of

to rights moving may that On walk in the kind moving forward opt the can opt everyone. neurochrin also through some the a of see in. and what comments happy before what then I'm want provide means as to question, maybe for on we with And are Sherry just that what reminder to

as certain trigger decision can us just X% that fund an the to co as an as PhaseX well budget lead Neurocrine. co-fund the would have a we for program from protocol under program once reminder information. a and as royalty program, option we to make that the compound, complete PhaseX So tiered that have a able royalty, additional would option potentially opt be the in to we and includes importantly mid-teens. At that approved pieces a give stage CoFund reminder that And of a the for to rates up step we that PhaseX low are in in

end, would at And be to co-fund we eligible the we so do highest up if for XX%. PhaseX,

what we in in running have at epilepsy that said, obviously build we now experience have Xenon And what in PhaseX of important. sitting amount here and the a studies to then is The PhaseX. budget global of is in terms on tremendous Sherry benefit

good would budget handle have a set. complete implications we be. to see the the we think really But what on have I the opportunity So data

Neurocrine this I and in think QX we are from next one and after of outstanding see PhaseX in year, this focal-onset study program? the question is what the seizures data the steps

be do be to the and steps to or next would And a know prior directly it that. additional PhaseX work whether so we don't would study today go

to that So we'd we're the be make we'll opt do the not able to decision, data obviously want sure of in timing the see but that. to need to

about just studies. epilepsy, we've this in is between consistency talked benefit The we the previously, and see

antiseizure see that go they that work into in and drugs this clinical when medicines XENXXXX our data and studies. have do other expectation is we with obviously in So this trials with PhaseX clinical PhaseX different across consistency

are a in so probability opt And have that the supportive we if I of think that we consistency. see believe there's data of high of our benefit we

Our next RBC Capital question Markets. Abrahams from comes Brian with

two for the to discrete the study. and the a question to side latest standpoint over the bar may a taking on safety Hi ahead regulators members what MDD physicians in where looking space my developments or the board are to congrats and MDD welcome curious, regulatory on for there. effects on of week? progress. be? among new for bar Thanks the guys recent And as you MDD last continued Is there question indication. Thanks. potentially a I'm move from changes some in Given CNS any the that

Brian.

what at space is been a regulatory. most around there's MDD lot would helpful and the Chris, just updates maybe here recently. on publicly be in of I'll Obviously think I make comments conversations Xenon of a couple

you well to then. walk a commentary un-blinded we bit that now information label the happy we've then that's X-TOLE Chris, as study And basis, Kenney, little X-TOLE done. as of there. the because the date from provide have know from through data both we an I'm why So And extension. on open safety don't to

in point research just Let's what's looked going I walk adverse testing is kind overall comment, been And of publicly on at profile. physicians where we've I that market it you know, event anything. changes of don't least through think view think that recency and a research the, on our our with from at

the in mean, in term PhaseX right I depression near now. for Brian, in us, we're

program, in As those as profile. to study. and guidance we tolerability to safety overall clinical into on to if get give look we've top late to engage talked are at with would the that the And need next steps we line said, at would the enrollment We about, at in we've steps as finished time. X-NOVA move We the development efficacy need the a stage And next program that well regulators time. we as patient data.

premature would to over it's now. that we be on talk that to on just you. Chris over Maybe then to Chris what Sagan. any than informative, know the but think I right profile And about very more and to Kenney, say eleven AE one, overall Von

Right.

so of First the in of to be be eye to all, and tolerated remains It's obviously, drug in We data with it during with closely. behaving keep that you expect limitations to glean par the epilepsy depression, with fashion, seen can we a very the But trial, data what that. on we would pool X-TOLE. from being what are be what there conduct much the it's what assessed that we would how the population from population. terms of can blinded is relative expected the really will very on in an say

don't be things. to I will milligram is mean be I'm for to grams milligram there X-NOVA, milligram What what in the then ten about instances. it what dizziness to events adverse and distinguish X-TOLE. X-TOLE an about want going a from many, but in dose, increase and to few placebo different in to up know learned so fatigue not from that the One, with of extent. was headache And we X-TOLE hard lesser all as were I profile is We what say XX was again, dose if a safety the focal-onset clear. by that somulence such seizures, and And ten that

remains it Depressive drugs. be Major will how to so Disorder the And population seen the tolerate

concomitant on medications not population different a obviously it's They're and patients. of

and later this study the So we milligrams see you would placebo would what card is as we'll blinded it expect behaving from shows. so far that flip XX we'll ten see. But data year with expect. the We'll and a

so Got you it. much. Thank

a market just potential forward the given moment path Major a research as Maybe to from perspective, understand Depressive we've in conducted X-TOLE leveraged build the for better Ian profile, Chris research market have, And XENXXXX for Yeah. Disorder. mentioned, in again, the what coming from the receptivity perspective understand of we population. mentioned to about range an with epilepsy from physician data data a we've the

enthusiasm of we've XENXXXX. the what And consistently around is quite heard profile

range novel are with sexual options potential in the available dysfunction. of from lack of such They consistent action is part events of adverse the the mechanism if. population. And Given exist in that adverse of this the the differentiate therapeutic that important product, of potential the events, to as epilepsy space, on other MDD anchored

tested you. light important past there to of profile has So in been receptivity in an and the that is AE the note that's component

right, Tsai All you. next Thank Jeffries. question comes with our Andrew from

all Okay, Good the appreciate thanks afternoon. and updates.

So, conjunction to steps MDD, top-line data, think XENXXXXand the about as which will your ion with said could introduce one a in be next option new we for shared you've think be I channel.

data? have PhaseX pre-clinically? potency to you And it can concept compounds be of a generating path so to to safety, a as new you you of you So there forth. clinical these Thank proof the flavor on efficacy, better better would compound, way expedite were on much relates a us and its How introduce characteristics if give

remind commercial the data options we We've to as in are available. we options work believe having to development And to We've a a our also we after differentiate looking talked space. terms know, just at the depressive XENXXXX And input. We've disorder development about as that. about as Andrew. in epilepsy continued continuing future well historically lot Yeah. do indication. major Thanks talked have are clinical primary have that in both done said of of X-NOVA different

That common comorbidity. most depression the know. is We

molecule on is And Andrew, important chemistry differentiation. data you've or into potential to generating then, epilepsy. mood So referred

yet channel molecules about think that backup target development. molecules moved so areas, different still are our they our XENXXXX haven't potassium we into As or therapeutic behind modulation preclinical, clinical

we do there both studies get early development as as those to before So clinical pre-clinically an would there could efficacy time studies. a and well be the required into gap is

Channel, steps terms we feel development a about in number are need discovery. Iron how to we there We strongly do So of drug drug position leadership that compare. of and in our

We multiple targeting potassium channels. in looked and at we've that at have chemistries looking terms are of

at of have it's we the current need a Obviously at mechanism, look so drug, drug we attributes associated anti-seizure really If has is there's on nothing potential profile efficacy the basis long XENXXXX, to probably we there's half a no When other which We compare clearly mis-doses. solve titration adjusted medicines. compelling look trying that QD a for obvious to for. for. which benefiting obvious any we placebo we it that XENXXXX, when novel we're obviously have to no thing a solve with life,

molecule differentiation, chemistry about look bit different different both a to little a as going well really overall. profile on on It's as potency and every is

on So more having would chemical any characteristic we're into move one hung not development. clinical diversification up too just pre-clinically, we forward that

Jason next America. of our Bank from Gerbery question comes from Alright,

question. Jason. for on thank on the Dina so much taking is and quarter our you This afternoon. Congrats for good Hi,

see wondering Just division with it a much be counted so Thank from X-TOLE Dunn's you pertains continued read across if as that departure? neuro what's to FDA [indiscernible] pivotal broader of the PhaseXb And Billy CRL will any confidence trial? the as leniency your the you recent

is to as division into I read well. MDD, provide different what that specifically, you're Tina. is is CRL the to Thanks, have start. just Yeah, which your let's a referring a neurology question had for happy an Kenney, that think may your perspective Yeah, even as our program. epilepsy Chris, across I'm though

are development we've single clinical trials agency an we today seizures. study plan of two. a parallel, includes tonic-clonic communicated our gating to PhaseX focal-onset what's we've a file two meeting and a is where plan But had X-TOLE and PhaseX which in to Obviously, study and generalized in end seizures the run plan to broad is file to primary PhaseX and our

X-TOLE as PhaseX second using And of conversation end our meeting as at X-TOLE and and studies, of constructive and good had the the agents with the study. understand So the using we plan. we believe dialogue they one two

the being out. the always Ultimately, are laid totality agency we're issues terms data we we've these review the generated. the as of of looking that's today, in and plan which sit But confident at development

anything add? Chris, to

Well.

acknowledge that that. a fully view. and FDA, organizations I people be difference no can in in So their there out that like There's doubt rotate of as about

I when from there's another. fluctuation crystal are things that think individual clear, less one to probably

look look appears in And the at what those adequate, a you what of takes controlled the take guidance take check and boxes. study it so study, it's be at FDA well a X-TOLE that considered if study all terms you to is, an it a to

point, what But issue. changed, integrated that is with Ian's roll a review results be for our know hasn't it's won't we positive, which until combine sufficient To X-TOLEXdata, and information are plan them FDA to requires those assuming should out of and X-TOLE, for summary efficacy.

So our position hasn't changed.

Choi All right, with from our Sachs. Paul question comes next Goldman

listed have two a here? comment is, response updated currently assume over the first six there. afternoon what progress. questions been risk efforts that mitigation are can My year, you I hasn't on trials congratulations maybe sites, in on additional Clinical the X-NOVA. gov on I and good undertaken placebo added but you've Hi, you've

terms you if and in other that could with recruiting experience, comment for patients, maybe be would doing there, trials your what center is So or studies, great. on competing that, of CRO

And Thank much. second, XX your on for of the doses? thinking meg very statistically you scenarios with if approaching the FDA both the efficient ten how minimally to and comment Can versus you're you the maybe results. doses study XX milligram significant registrational dose regard show a on XX for

a tackle calls, question. think and I'll walk it's relevant but you question, can second I Chris, I through the then know on previous Yeah, if we've it done

depression relates studies managing thanks, and around mitigation just Paul, So placebo to on how study. our the strategies risk X-NOVA that and

data at we XX, to when X-TOLE, doses question, dose think but our reminder, then more XX thought premature modeling, PhaseX test milligram mean, we on second point XX in statistically at forward little did milligrams. doses as significant. I and until a the that data. just I the went A we the XX looked as the Paul, noise And among we two data a just we study see and a three in milligrams XX dose, agency it's bit On a that And to all clear were doses. the XX after the best milligrams. response PKPD the detailed were three un-blinded,

any And PhaseX selection. as our from design clinical the trial it we get agency relates on dose didn't to pushback

from we order selection So to about forward I amount PhaseX, X-NOVA need if the plan the think appropriate similar of really in for go that's information MDD. think to dose in

on tuned stay let's that So one.

mitigation Chris, do placebo work? you want to through risk the walk

Yeah, sure.

things placebo been several done effect that minimize in the are have there X-NOVA. to to So try

in a sites conducting as of US. the that First, study based are the are this reminder, all

And been some way number that the to that's limiting placebo We're total decrease of effect. so there's sites. the one evidence

than sites that sites reasons, plays of that so number in seeing and depressive the of major Gov, you the have on they you're were able their and, The limited a were major get the as would that chosen expertise investigator principal been The a a the but staff. limited trials. but both terms coordinator of the for CRO we conduct of obviously, There's driver more and to because number think number there. number of number minimize was these experience, significantly. role to a studies, were itself of to increase chosen chosen sites, critical don't with in disorder of in we course, patients clinical that potential I keep of six noise the also wanted did such to the

that of that's to you thing number the these is want limit patients kind really been learned undergo. of assessments Another

of on And protocol much sort so is the most important with additional included. what's very focused endpoints no

assessments, proper using to of avoid have time overdo the there. shorter but hopefully placebo in and patients Group the not get want We're you evaluate effect Master General patients. to it, be the and clinic exit to a then them clinical So period cTnI also these

So you to up some just sort obviously, failure screen because randomization an that before the using selection have independent that safer of patient assessment cases, inappropriate to of and so leads in criteria point.

level patient study level blinded is of have we enriching site as appropriate. to baseline. validation of at population either patients symptoms that patient or, So not insufficient one at that the who it's a know that nothing matter. course, to unexpected depressive nice for have the make monitoring then And a the is level, we're ways happening, of at or external of sort sure That's data we're the that well that

a hopefully effective. quite it and doing be we're So will bit,

next Our Joseph comes with TD from Thome Cowen question

Hi, would afternoon, little be for thanks guys. guess and pediatric detail I the your more nice. formulation questions. taking Good on the maybe in progress a

programs How studies, order Specifically, regulatory are the what What's open long PK thinking the a the maybe your and you successful? Thanks. interactions looking should into agencies? have occurred the regulatory term left to about label those then, population filing I in focal epilepsy, extrapolation with be guess, overall pediatric out. incorporating in generalized little more both and begin strategy

the for Thanks Great. know.

we've As we've both had development appropriate only US. Europe. plan. our of most but our on comments stated, regulatory not And in interaction FDA, we focus in the pediatric On

we've an pediatric on believe are plans agreement we the So got which required.

the second on What back adjusting to early work. of a twelve years of come years So place some and then over these we're to down of doing age. go the side, take exact protocol formulation I'll and to in development the multiple

get into population. the adult years age the to capsule of continue So and that twelve will to above in formulation of use

we younger population, obviously development. look we formulation at into As a pediatric get

been So now hasn't before get that we us have that's as we're completed well, going and get stability do the younger appropriate we're can into and continue ongoing juvenile appropriate and work much formulation need to to right will patients, work to which yet. talks for doing internally the

a imagine number you a happen of of that So there's years. number can over steps

in formulation, We'll some also those PK extrapolation the open first of down rule cohorts will get age use patients we'll using label into younger we that the then patients. into these time, twelve. to as do work, patients step initially for and generalized primary down the adult over mentioned, So we'll then

multi-year expectations pediatric on adult to development the gating are what not But is not to But filing. any plan work the from the plan. timeline and overall pediatric agreement gating do NDA have regulators our It's for an a development. on of we

comes next James. Danielle Our from question from Brill Raymond

Ex findings the do one free or benefits seizure on and quality compare how the demonstrated for meaningful in like question. that Good drugs afternoon. were clinically And the to just overall of was the group copri? guys. Abstract I it improvements? subscale clinically relevant scores group epileptic like Hi quality your anti Thanks have observed the life other these IEC

you. Thank

it's and weeks podium think I Danielle, have got just presentations wait best two the to a we We've from few IEC. at when So, presentation. now IEC some posters

worry So in things medication social for including like mentioned used are epilepsy, data of and functioning seizure subscales XX the remarks, we'll there quali wait effects. in some our to mentioned as you and we the and prepared

in to premature at open We're as free able We're population data, in drafted, the overall we'll but both that's at so the looking that's presentation looking of well the be the those being until entire presented. sets population. data being in it's as set both seizure provide label

through call. life on the add on today's to go Chris, quality work? overall data anything To of the

go No. everything. Come meet we'll and me over in Dublin

Rank question right, All Partners. Goodman from from comes Mark our Lee next

Hey, question. Rudy Mark. good my line the for on from afternoon. is This Thanks taking

late November for How to provide for since treated for ongoing mid -- weeks, get you at So you move Mount study six we and do will forward? already novel on your patients data trial, a the completed readouts to can is sponsored regarding decision important How and enrollment Sinai. late be December more secondly, timeline? color for PhaseX study to that investigator study

Thanks.

happy Okay. Yeah, address to these questions. Thanks, Rudy.

last patients So, being patients the very remarks heard as in have prepared the what X-NOVA. mentioned, term. in the And randomized we few is enrolled last in you are near that been our

week last happening you then, think mid August, in as talked So of about treatment. a randomizations it's, about kind can we've six the and

November. the early follow a week which of to of gets September. So kind gets up, four Then October end us of there's into us end that

cleaning data we then release. the and analysis and have locking steps And un-blinding of then

all estimate end And November of of so mid we've up best of that when is our kind together, as data December. to we add now, right line mentioned, top

Mount all So in together Sinai timelines of come how the terms study. that's those

as centers by medical run an study two It's ongoing IST being a So, Baylor. parallel with reminder, XENXXXX. a yeah, is depression there at Mount and Sinai

after that year, going Our out so is expectation out and to is this not read study X-NOVA. it'll read

In of XENXXXX terms our study. focused of development, really next the terms in X-NOVA steps, on we're

have information won't the make when we the be all available, our At we'll Sinai readout. X-NOVA end this for year, the require the of believe waiting we we data to specifically So vision. are

with Laura Wedbush Securities Our next from question comes Chico

the you question. good Thanks and to COVID this was for trials, more talk of generally made it away. Hey, the some Has challenging? there? dynamics it trends Has thoughts to high more much in ask obviously that's little kind question, if is the a disruption of more gone in challenging curious afternoon. Epilepsy But much wanted clinical Thanks it enrollment kind in space? I newer the Any recruit I about very a better? bit therapies taking about gotten during gotten level there has of but market just of I'm could guess Epilepsy patients. introduction enrollment very

to that out been comments consistent happy I'm to we've yeah, if add Chris, terms clinical your our based any we're Sure, from anything side in field in and pretty of operations what our commentary. our experience. on And folks there's provide there, in seeing on color the

to we don't pre and confidence challenges COVID our X XXXX had enrollment study we in the completely XXXX. early Right. in had going a patients. during the in the up into fell think Toll and off impact of we of just days a have had early COVID We I about kind weren't significant ran execute, maintain were hit really We where to We study. us then and to running, like of the COVID We any really anything's trying ability two, and the patients screening a quarter to cliff

up in and XXXX. almost of fall XXXX. had And then pick X-TOLE the then the we again our available study And fall the in of of to back kind XXXX into data were

types seen see we've think historically. that going I headwinds don't we're any So of to

So comfortable feel comes way. We anything that I we're. adjust and can confident our that we think to

specific terms feedback drugs any anything around sites any from new and available Chris, impact? of Laura's on in there's or question if investigators

Sure. A thoughts. few

new it new If choose clinical something. all, First clinic, to need trial either Cenobamate. or in and of in Cenobamate, going you is ongoing, of option patient to like a drug, There's relative enroll have have we an comes to the into drug be a to the like clinical Cenobamate works ends and titrate they're little trial. to getting it how of up time not going takes going If it's then a that long take figure Cenobamate. chosen especially be out, to eligible out, doesn't, bit for considering it to

what Ian just say that has I would would So said. on it some had I impact. say to build

years pulled certainly during The study. much the what the You isn't think it ago. by was environment three turmoil as X-TOLE as two, was about with off team COVID

an for, trial interesting a has If article Dr. you challenges about this in just look month take French recruitment. Jackie out at increasing

you she site recruited things each the over of time, the points that look fewer site over One decades. site participants at is level, at they've out the as

site, X-TOLE. the consistent is take about number they're if in fairly saw you with at per But what a like which expecting look the we is that five,

think from X-TOLE anything study perspective that since the completed. So has considerably I don't was changed

As workers. consequence hard COVID of are less to find a It's people. there

that say have staff. that really think well. of to the there and number are We'll do appropriate find people so to And we support performing that the and running some up the being I sites challenges with sites able have are

Bansal Fargo. question next Wells with comes Our from Mohit

one my happy webinar. you idea webinar question. more for be your MDD host And taking your to can We September. our Great, I would at conference give thanks for in

shingles. the for Sorry

we they So is, the window which broad use, be just DDI when there to more like important epilepsy experts, other efficacy, than talk interaction, that drug elements, drug for say things drug, that. like having ease could question are of therapeutic

drugs look out Zine to there, you. you do of have that successful out peg you been when some Thank rate how the drugs versus compared versus there eleven one before? So rank epilepsy these or unsuccessful at Zine or

Yeah. can add and at an other look can things think ones use impact Mohit. And have Ease mechanism. well, monitoring I of from to novel your perspective. a and Titration would including Thanks, we as like DDI list

you we've on. lot of we've physicians work research other But Feedback of decisions, really why so these Tegren, don't but in from positive. had terms done some Von of market also a walk here, through the some tolerability, prescribing overall of efficacy attributes Chris that

physicians anti-seizure reduction. successful beyond a highlighted that X-TOLE efficacy hear as think coming foremost, from standpoint medication this what seizure a category and excited But been are market best I would in we potentially it's that's of foremost is space and agree the research first efficacy. been in first an about and we goes and out that Yeah, from from demonstrated efficacy

has product them. value attributes in are very beneath, highlighted that But physicians efficacy XXXX compelling on the those Titration. to use miss number of of But very doses. the the and to is a pointed that require long these medications of that we've frequently half shine It can out doesn't DDiS real the of because fact manage use sit attributes do of of frequency multiple of confer is potentially ability The that patients. lack latch the something a life to context for ease that the

are or attributes because do of of with potentially number the a KvX used the novel is of that space. that really shine other are in but poly-pharmacy about environment products one itself, they're are in mechanism that excited and mechanism There working this them. unique, very And commonly

emerges world to compelling a population open what X-TOLE. real the efficacy of week, As well and one lack evolve for ability soon is titration label to as of with that we've demonstrate our the emerged components of potentially continued from both label as open onset. the respect from that though, because to as extension efficacy to that research, as the have our are emerging us That rapidity story, there market in are in closer

a compelling, most The and totality to other and are those from research. When of do use competitive what is space. in of in now we supportive that in successful the And the component it's ease hear that very this of we really you player successful and efficacy approved, has. from is products consistently less meaningful very that's because if transition evidence to value we hear that attributes or that attributes feel that some our that that market look have successful be is align of space, our XENXXXX research strongly, quite with going XENXXXX,

Fitzgerald. next Charles Duncan with All from Hi. comes the Cantor right, question

patients Thank for enrolled Can provide Charles. the in how any you the MDD the and for the This questions. does on is of represent you our Elaine patient? Kim color it taking on phenotype heterogeneous Snoba study

at MDD baseline is just question the patient So characteristics and the is around of looking the on type question demographics? patient the the

Yes.

do are of just that go entry in? types coming you and patients monitoring obviously the through Chris, the criteria want to Okay. us

Yeah, sure.

of mentioned is things Eye efficacy terms patients track the keep only safety Keep an that's on of the study I keeping One to that eye an keep to. to of population also the in the eye the an. on blind of not you're on And but data. data, enriching and for.

so a other to as sort sort look very particularly populations, of moderate upon translating modress and we to and predict to for so the moderate it's used of severe And severity much age, you at based you're all forth, MDD disease off what in would gender keeping with being the regard severe into with population. that's cut

to you better? have of inclusion aspect the criteria want Do that a you specific understand

understand you on think know do I have lot that report but characteristics patients also for meaningful would that, of as a enrollment that be I depressed you other for to anhedonia that focus well. well. as criteria clinicians an

or I off say most the the so that the is severe thing being cut of shapes really thing. would get but depression moment, that Right, XX important important a most I a greater definition on D-XX. to to really the think I'll moderate the and in the Ham

getting study well, is of the degree in general well. same degree cut into the on duration And just cut shafts that to Also terms them thing. gets that found probably that by the about the based everybody what scale off, make the and the And there duration of anhedonia one as the think sufficient upon of the that's is that is that's So of which important a in most study. have depression patients the has Hamilton episode criteria as is have time I are sure then assessing those off that we anhedonia. current of in the

from Tim for it comes And question, last Lugo Williams Blair. from our

obviously to on on value but X-NOVA influence I'd in commercialization, ability Ian, Company, an your be alone You've take hear I'm in of market. just curious to is in. thinking commercialize added should is Epilepsy influencing to me board X-NOVA the some in to in going also we the love around going squeezing it your commercialization. views for Obviously, Thanks it how Epilepsy? your into view the update experience major to transactions. but ability variable your

Thanks, Yeah. Tim.

the indications, done in Sagern I'll both a kind on yeah, provide work depression commentary maybe Epilepsy. So, about as then thinking detailed he's fair provide higher commercial and maybe Chris more starting well. level comments can as of But we've with plans Von bit of

strategy overall In for some we've time. terms been of of of the consistent period organization, the

a fully goal Company. Our build neurology is integrated to

other forward, have US. means we We that going in do have and about That the we we've discovery, in integrate to And point. development talked drug jurisdictions. not to we're deep and commercialization commercialize that capabilities, want that

Although XENXXXXis asset commercially, economics wholly owned that nothing those at terms we would a of we of royalties to in Downstream anyone. so point has there. changed No. terms some Xus own. At look markets accessing partnerships in

a would can little difference layers of comments? be first, are into from launch the is detail depression it timing could that lot years that There but in and preparation those step of we focus the bit program depression, obviously, commercialization Epilepsy, Epilepsy a in and we Obviously feel for and could well. work as a would we've our enough do provide over we there, couple of to Chris commercialization that more in where and last comfortable we're done

commercial Xenon medical our majority standpoint data scale stemming of companies clinical the work executed And last several a and with commercialization key examples a here several We've launched for in what spent as over supportive both support from plans. affairs very also significant those standpoint, that a meaningful and a from the from trials commitment against our we've arena to the on help communication there my building of joining our with of have Epilepsy in years but Ian in preparing are size the of US time space, said. the the and since Epilepsy

think with that adding think to built as successfully data the manageable commercialize what as well a goes this big, X-NOVA space but commercial XX,XXX still as have epileptologists comfort in United two here both with meaningful a Arena, in know, in Epilepsy we great we will of than which advantage is, required probably The really be prescribing we've I date can folks a be space, in directions. the to less the we team player States.

And can't companies we is data arena. Axiom interesting there space, Epilepsy one the depression are our is with in launched comorbidities doing products. that very Depressive a that. with the that most examples and launch seen of early sight First, important remains MDD the also who with patient are within lose within that's job of their fact the targeted more Major what's been approach population Epilepsy right than and phenomenal who've to supporting something Potential successfully now But size the of more scale past a Disorder. point,

years. over execution So we a director and to both the to and for from addition only markets enhances are planning coming Jillian continue us team as our here Justin build. The the of standpoint

This concludes today's conference call.

now disconnect. may You