Xenon Pharmaceuticals (XENE) 8 Aug 242024 Q2 Earnings call transcript

Thank you for standing by. My name is Meg, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q2 2024 Xenon Pharmaceuticals Inc. Earnings Conference Call. [Operator Instructions]. I would now like to turn the conference over to Mr. for IR VP, Fugere, Xenon. Chad Please go ahead.

Thank and webcast afternoon. and results. you quarter for call our operating on us to financial joining XXXX Good discuss second Xenon's

across summary Executive an Ian progress Officer; who Medical Sherry a will stage of Commercial the Chris Aulin, milestones. anticipated of our Officer; during our President Joining recent Sherry Von in Xenon's including our Financial our Chris close and And summary MDD. plans Mortimer, Q&A Chief clinical will our be of begin with today business, Chris Kenney, available are financial programs. major and me with with pipeline results period. Ian Kenney ongoing Officer, or Chief summary depressive along Officer; xenon's programs, our and Seggern, expanding overview preclinical Dr. Chief including Chief will a disorder, Xenon's provide will Dr. Xenon's of a

topline be call that of report milestones SEDAR+. plans summarizing We during Xenon's are the section fund operations potential to statements our clinical financial timing candidates; under azetukalner our will will website market, expectation clinical indications and current success approvals, and anticipated in statements we quarterly we filed clinical designs, our partners' to then results regulatory trial and clinical have development with our forward-looking, will quarter of efficacy, interactions this second develop data and regulators; on of the ability commercial open at your including Form up profile, SEC regulatory develop anticipated potential results the XXXX. Today's results that regarding safety the achieve advised the make sufficient successfully and number trial, and our from XX-Q be potential successfully development Investors of the of of our and future obtain cash accompanying trials call, and the readout our and available and that of for and our with xenon-pharma.com the may a our press and made questions. Please on the XXXX into addressable product timing programs, efficacy release of to ability for timing our

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

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core progress program the business. Phase epilepsy of and to our III azetukalner continued reason, that broad remains For our

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Kenney, the presence. and as on the as over to will call now a programs have Xenon our more over I'll will on some azetukalner So you. progress clinical near-term detail conferences Chris where well provide to turn Chris, Chris

and in includes as echoing lot, the Ian. and I'll seizures, X-TOLEX profile for an a XXXX. seizures onset feedback generalized at this Phase about emerging III with the time by half start to Xenon clinical our focal second epilepsy first azetukalner. Beginning investigators exciting program, indeed the we leaders data advance from of FOS of anticipated is that X-ACKT with primary III which to tonic-clonic X-TOLEX continue in in readout and studies topline continue X-TOLEX opinion receive Phase enthusiastic site our Thanks

the regulatory to X-TOLEX, with clinical and Our the data to U.S. results meet along other additional from clinical X-TOLE plan Phase remains our approval. goal with data package trials in IIb the from submit requirements trial safety existing from for

We scientific open-label the to extension medical highlight study X-TOLE also evidence through with community. generated the the continue robust

burden medications. healthcare the community epilepsy observe referred Ian current illness of within high As to, a providers despite

the long-term on share the important data the further benefits gaining azetukalner. OLE it's X-TOLE insights to been So with potential objective of of

a with engage upcoming presenting well on European our Italy X as focal we in survey OLE in community treatment from showcase X-TOLE quality to to to opportunities we're Rome, as the where September We ongoing at X additional from taking will of scientific posters patients. plan where place measures have exhibit September results Epilepsy to Conference the life study seizure XX, related onset participating

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XXX X include end Phase and the subjects, The will CGI total HAM-DXX azetukalner MDD, Phase severity point III safety from the X. trials milligrams and Our in SHAPS program each of of score Key HAM-DXX approximately week XX at change with and week severe will in assessing end baseline primary moderate placebo. secondary versus X. include at score X week will points efficacy III to total be at MDD

significant at study X-NOVA with be initiation profile data and in the addition effect X-NOVA of our year a the II mechanism potential potential the in clinical MDD was the great anhedonia to highlighted received study for in second Congress azetukalner with gain. We're with these field. looking to important half benefit reduction medical to medical to anhedonia to as standard the data major meeting professionals patients HAM-DXX, demonstrated proof-of-concept statistically a our to sites October a on of a by or this experts from dysfunction recognition meaningful ] and We in taking noted, November notable insights the MDD MDD led care with was healthcare value the internal time agents. Feedback compared at with in profile further exclusively planning meaningful clinical the statistically ASCP action also XX weight our with incredibly with opportunities work, in [ no U.S. Ian on treatment These There option in a favorable differentiated onset place reduction encore and interest reduction potentially clinical X. data which at forward effect presenting a significant programs. of our particular expect trial tolerability we presenting we Boston in patients novel to the MDD This Phase azetukalner treatment and of of occur May. teams sexual upcoming site rapid on safety the gained that in was in azetukalner of and data the to are interest adverse educate in on first the extensive a first a the meeting, MADRS,

will an the providing of functional treatment my development anticipated updates clinical quarter, of the Sinai on Sanjay also we activation study trial the in our and both and clinical Dr. a change that within encouraged XX-patient in the on updating brain secondary II Baylor coming Murrough positive enrollment the and milestones. forward week of who highly our conducted comments be the baseline further and leaders. including and we the azetukalner to study by point This continue turn on depression X by by the of to by Sherry, MDD end from SHAPS. reward be financial on MDD, will placebo-controlled call progress. I'll team to as effect MADRS second to striatum azetukalner to to in driven points Sherry? now Mathew primary also Dr. It measured our is ventral Phase at College end objective summarize, investigator-led you over our of is physicians measures with from results as of forward the late-stage continue this the has Medicine. to support overview advancing evaluating azetukalner Mount end look of bilateral months. To opinion rounding provide James at I assessed Now MRI. to response The evaluating continue upcoming and completed is we patient epilepsy quarter programs key and look functional

Great. Chris. Thank you,

plans stage strong MDD and azetukalner balance with briefly sheet in with financial positioned epilepsy results. pipeline. beginning to So support our our our both We're in well and a earlier programs for other

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

goal paradigm need. our remain has team azetukalner areas on unmet high focused patients medical of in supported improve data a So We shifting the in potential the its the strong we believe azetukalner's generated best-in-class profile heard be from as is to action around unique The for mechanism date. centered you in body belief significant to summary, compelling today, and outcomes by clinical of of to medicine.

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

expected data half in Phase XXXX. will X-TOLEX III of with the We program azetukalner topline to advance epilepsy continue second

Phase clinical opportunities second we azetukalner. expect this explore We initiate other the to continue X MDD for and first in III to of of year, half the will in trials development

sharing today any open the more you or our the the ask forward INDs in advance filing now with preclinical all we of Lastly, for attention, we'll look months. for line your continue in equivalent to and operator I'll the coming goal to to early-stage XXXX. Thank pipeline multiple questions.

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

progress. the on all Congrats

next it et As seizure And enrollment to of wondering if for timing still frequency, demographics sense then end a the updated by that now, year? of just guidance around the complete have your year, refractoriness, relates topline, baseline I is expectation early to X-TOLEX, how relates relates it the this to patient to comparing you X-TOLEX. you'll good it as cetera, was as

the take then maybe to and of a your first quick second I'll one the Chris well. add as Paul. any and one, make want Kenney, if Thanks, on you comment perspective

So on question, the demographics. first just on

see on we blinded obviously, it track all things at a that. track, We the to So us we're expect basis blinded looking a basis. and you'd on

is as what because ongoing, study demographic given definitely information haven't We we're it. on tracking are historically those data the But the publicly any changing just time. all we're seeing

to information we'd in of the now. We in in also. Yes, to get think of add terms position and give Chris a moved randomization, I patient be screening, it. guidance, that can But end there you data nailed some we topline as of a So guidance to kind of minute publicly. in then

So said X-TOLEX topline next year. half but times, just to it reiterate, we guidance I know of second a few

timing randomization the That And patient monthly come to Just there's about double-blind with is seizures in through period. We before, then step there's safety bit Then patients there seizure and on because said topline think X go not. it's whether count months into X of months we that's and they or to back, to And X-month screened extension last a patients period. screening diary. electronic burden. depends a the to from have visit a take those last I X an a it data, then period a safety baseline go happens, follow-up, up open-label little the where these follow-up.

of patient back screening months is where that of means screening we that complete, our out completed. data, be second with expect the X comfortable to out, when kind all back guidance, trying from X will just to we're So that exactly which half

the bit gives on we're of that demographics the on? going that color want more you and on hopefully, process a So comment through. Chris, little anything background kind that else just to

Yes.

before efficacy we and Phase a onset coming failed an So of seizure high. X pretty study. study month other taking at average, Patients between percent frequency seizure high saw average antiseizure placebo had even in the And compared had reminder, change on robust separation the medications. from antiseizure into we largest the just that, median focal And in the of study as in with baseline. the X-TOLE any perspective were find patients dose the to can the was seizures population X per Half burden really IIb seizures. despite XX.X medications

pleased that. we're with pretty So

spirit the Phase III best not subsequent done X-TOLE that worked is deviate the pretty So can to in of program was well. the do from you because what out

so to to do. Phase has the had to make study. And the an the population gives as it program were real in did answer very adjustment an tried And if that obviously, shaped something as unexpected, getting so question, that's right we've in seeing if is an more II Phase in what the on we're now. up you far And the III opportunity what keeping we're directly, but that we're eye time, similarly you to, not

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

market opioid how itself, any It's and clarifying data on would Leo And read potentially on they to about quickly the you would for or III I out. start think said impact for competitive for and use about and impact you I might I guess I I perform I any of how azetukalner. And change, as Phase maybe looking on effects [ correctly, design, ex number U.S. how having trial Brian. there how's for guys how running and sites. anhedonia, selection you other the international quick I think to you you inform you're that guys And not want positioning had sites MDD said to maybe ] a heard thinking well. you clarify, guess, and you're both there's change that just anhedonia guess just are that timing think I trials? those also maybe a whether talk that azetukalner that program. maybe other U.S. drove guess, can can anhedonia are on you you I I then might maybe guess, expectations that agents position might and for then before on and if to as how question move? had MDD one what

then your other our Leo. hearing calendar market research commercially can that the if anhedonia Kenney maybe I some and market perspective available bit you Chris add and are development, back currently. those can start little but provide about how the the And MDD and of Thanks, we're on what we and a with differentiate to Chris Seggern, in side. both in can importance that the in molecules, believe of also is Von

in in expected we've This We comments. of Yes, terms of study, Phase the U.S./U.S. depression. had sites, we're ex next first on start on just couple isn't couple of clinical clarification running sites. which always a the definitely that the So X focus that will said III U.S. a change. trials in would months

where As we and U.S. the run. was that's ex the the right second II third we to to now, studies, Phase sites. may But get move some

the that's of development depressive think the in major where disorders U.S. a for lot I done clinical

that as there we'll we then Phase definitely And we're which in is other as move difference So the for be into Phase site selection forward. may calling III. the move first IIIs, X-NOVAX, we what focus

helps. that hopefully, So

protocol, the of we terms the in protocol for MDD In study the is locked. us other informed readouts, how may by be

on As Chris expect and shortly with in have filed we hear protocol initiate Phase the that remarks, that said to prepared we back and III study. his FDA, the

to program we HAM-DXX in much the increasing II of all we the severity by move the primary baseline, patients And using inclusion/exclusion as also on both stuff of it calls, I Phase as we're very depression of Phase as previous So anhedonia, that our III. Phase now terms said is relates as to from informed II criteria think and locked.

Chris differentiation why on terms don't just in add the think that; marketplace. they're going to change additional always then of Seggern, interesting, readouts are in our and approach. But strategy although you Chris I to Von So Kenney, not or

zooming just a from would out for anhedonia second. I Yes.

azetukalner of so of why MDD kind is just not interesting constellation in is think features, a anhedonia. really I

mechanism So we've got the action. unique of

also rapidity onset focal you of think may have the which real; then happened it which and be We in makes safety. the onset, seizure patients,

So And on MDD effects was milligrams sexual in the seizure with side weight an had population. fact, safety tolerated side, MDD better compared we no drug the population to or the XX in notable focal from the perspective, issues gain. at onset

So that think constellation safety in tolerability any se. or those XX-milligram XX- data, of treatment I SAEs so. it's all in the is I no perhaps But per more would say groups X-NOVA, even it's or important one the not of more features of

his I'll maybe it commercial And see as to turn a to perspective. Chris perspective from

Thanks, Yes. Chris.

mainstay So identified given Kenney clearly the along those the maybe in major treatment depressive depressive important but research major looking ahead just SNRIs actively benefit landscape, disorder. one is when when of this SNRIs, we of the that specifically and very, think this anhedonia symptom dimension. on features or think to having depressive the of to and very for our major treatment domain in commercializing the everyone, benefit, that we and a is core disorder, fact space, conduct anhedonia encouraging Chris very clinicians also benefit are fact disorder provide have SSRIs of the azetukalner comorbidity mentioned towards that clinicians don't do a as that disorder SSRIs, something constellation in that And note have notably we ground the that not it's about component of market

a because exists folks our it's area clinicians we now of azetukalner do latch we and and of large are something that this absolutely focused marketplace in the the on appreciating testing our part in profile, when unmet So today. medical potential research that need that onto do

line comes next with JPMorgan. [Operator Tessa Instructions] the question Your of from Romero

or half has topline question differently, outlined can you've an Ian, Digging a just an second how you little on back provide sites the all here. been of were dynamics since enrollment changes maybe it what of been regions in and earlier XXXX for curious, you of has activated? between you pretty is due like asked, And the outside up the the in updated Or slightly the bit U.S. pace the U.S. on U.S.? view kind of else globally sites? have to And are steady us the ex asked any was or remind can going? here just us So data what X-TOLEX across that U.S. observed key just anything competitive And sites? split

Thanks, Tessa.

something. all, it I've missed can I I if but others think jump in got

So yes, to pace you enrollment guidance, topline as topline really exciting and 'XX, the with I kind I NDA. of and that's for of we'll ready us, mean X-TOLEX, data now terms and an half X-TOLEX critical said, with of be it's mean X-TOLE from for in path a second right? engage FDA file

So now data topline have guidance that to it's really exciting out.

or kind enrollment. X-TOLEX just or naturally and get do you is that In some medical we said down that of pace of each which take, of and terms up number give of on and that to in XXX calls cadence just flow enrollment, is previous centers, the of in of sites you need X-TOLEX and ebb complete studies, these

running we're right more that than these been there comfortable out we types we're comfortable with with So we've where are, in now. else and experience studies giving. have anybody And of obviously, the we guidance

we're shape. think I So in good really

haven't pressures, seen In anything. we of terms competitive

from we just So seen all. when thing studies enrollment competitive the are you're times we not that's there's being were haven't pace same of other a perspective. the running X-TOLEX. run running and X-TOLE, change when And that at Obviously,

ongoing. as little drug studies are well think device question probably but I your that is on trials, there's focused more bit a

us centers. happening change or things has at haven't other often any really that seen clinical while pause any any we that So concern. in these there's always are little But given the last

much molecule. as to and In investigators the X-TOLE tried use we've regions, back centers experience a went terms X-TOLEX lot We that of of use so into X-TOLE the really from X-TOLEX, with our as have guide. same to

X-TOLE Europe At coming we we're want Europe through II while of of and U.S. using clinical in patient the and Again, came same the that in had the in sites XX% the XX% don't in study, where jurisdictions came reminder, really partway the sites U.S. X-TOLEX. we're clinical I on from from Phase a the X-TOLE As enrollment in we end the from study, in to used we're X-TOLEX, but comment day,

I I your there, know. if questions else, but of anything all there's got think let please me

[Operator with from Jason America. Bank Instructions] Your of question line of the comes next Gerberry

more the Dina is studies. you this asset advance typical the Jason. to to management this that ask about epilepsy neuropsych please upon its drug provide KvX the color Could set? is KvX and more aim into wanted opportunities that's led advance you asset? just IND-enabling a specific cycle some your next-generation to on as on for in [indiscernible] current properties This play profile? Or Is to MDD improve of I life beyond

I had clinical Yes, what development, a to important with excited important for Obviously, we think Dina. really in about. it's this really late-stage Thanks, the really we continue leadership considerable upon azetukalner, to question. us position we've build now and maintain really in which mechanism, we're a think it's think success is

we've azetukalner. some So been from additional molecules time, working so, diverse same on against for target completely the quite chemistries

our candidates mentioned lead said we and in prepared have GLP the studies. been remarks, in is one multiple you including As identified, toxicology

you a touched our things of into excited of drug drugs development these drug what properties. on as It's and target, but to upon properties of obviously, well. try to well. product optimize we're a that selectivity track call we And list the a development a asked DTC, long bunch quite question that We we potency human all candidate. around for get as or clinical So

rapidity epilepsy mentioned, onset, to interesting next-generation any molecules be these efficacy specific we that the of azetukalner there important will many depression mechanism, novel specifically data, basis, which azetukalner. There some one best-in-category on azetukalner improve have diverse this placebo-adjusted we've both through is that meet as have isn't successful, trying as the in the properties of one diversification. any on. attribute attribute so attributes about criteria and really mentioned, to from be as what's gone on have think Right of our therapeutic have we now, we're a trying is you to we've we're improve opportunity, an chemistries, but So to not

neuropsychiatry, epilepsy, to this continue indications. mechanism, as and move be forward, pain other about So for we we excited obviously,

well. going you'll So the next absolutely, some see we're go to with indications as that molecules not azetukalner into

Got to a it. guess follow-up And I that. quick

You neuropsych KvX molecule. from to potentially data a might assess with the and Will to indications mania to kind of competitor you highlighted bipolar bit looking next-gen this little in too mature migraine of we plan be be some inform indications. It question additional at a ask.

and And Yes. perspective work the feel please We're done of what we've here. much significant your work to very start Kenney, mechanism. Seggern, I'll far that amount we years add to the we any anchoring LCM on Yes, a Chris making and Chris Von the learn do decisions informed than and by the it. product. add data, in making be time. we'll years you're from rather is years referring any development that And we're all away And to competitive that. of and in drug to advance and decisions KvX probably free efficacy

of development. clinical work best decisions make understand or work mechanistic suited to that's for we'll we the to future. But year to more, on done, early assessments the to that these do molecules can over preclinical a So and last that? and we've bunch work a assessments the of add take these of Chris anything molecules we would or think all where done lot based But probably we've be where commercial Chris, in

KvX are a is a are our psychiatric quick. there into there opportunity. of mechanism and for is indications his all I'll and a number potential and go seizures of work talks offering have focal as a life the teams I cycle And just looked parallel, in pipeline prepared that tonic-clonic Seggern at say management, Ian lot which something onset Von of a us in about in Chris should Ian mechanism remarks, seizures gave of interest. confidence to primary generalized This options. the types what different really epilepsy, and

think but of others are the list, several top then I put and at would of pain. we there probably bipolar that interest

interesting So it's compounds. Chris? different target, we backup lots have I of think with these an and options

Thanks, Chris.

enthusiastic input in here add been reiterating well from in genetic incredibly just the azetukalner at on creates validation part the extent future of into the the is advance we've the both products from options about, scientific think on potential to can now gathering the the of prescribers profile backbone emerging multiple driving and I depth that side based that thing clinical perspective, just that work of done, that's for clinic. validation we're level where looked us really decision a commercial only as potential range as a of in the I

[Operator Instructions] from comes line Your the next question of Skorney Brian Baird. with

for apologies past. the been can of whether you've this utilizing better past? the in talk conduct in Luke seems about mechanism get us remind with rodent something And idea to is profile your on On then you to Brian. discussed models nonhuman the intend clinic you challenges can if with from the before, there's studies the it but given is primate biggest NavX.X, This you legacy learnings before entering a challenges translation

Sure, about And specifically talking Luke. nonhuman you're when NavX.X? talking models, you're primate Yes. with

Yes.

take target, time is number add. or and included, quite is of to that ago, made prosecute sequenced of one can you're clinical Sure. then number Yes, to and reasons. can kind been not we There's just which NavX.X gene, us tried a this of others What the SCNXA, some into the I reason. referring late-stage have there's a was companies, and against There's development. it that haven't

drugs the They companies a think sodium not I much inhibitors were X.X that of other pan selective selective. inhibitors. were called actually more channel lot

historically. certain There target other index think and related on toxicity isoforms. great and on across selectivity definitely And and some so matters, I selectivity the issues profile made selectivity to progress we've chemistries therapeutic really a were the

learned And there. And think thing the we've so say, a around properties. then would I the lot pharmaceutic last is I

and where the patterns these to successful. distribution learned a we've and be about molecules we lot get think really expression to I need

learned experiment. field ton criteria we've internally to think done so work our really we've XX I we're own excited from all the or So our that meet the of run years have the past that and human that over a where clinical molecules we

is use But species. do able run index that. as animal point quite terms with therapeutic the we than We the opportunity and different to a the In that in in the for we What be I the appropriate understand can as question. is other help human really, models hard pain do view. But studies clinical ensure regulator human target in of knock-in the translatability nice is this to proof-of-concept to human NavX.X because we translatability, to human really animals therapeutic need of indications tox run the some think from to earlier and experiment. there's early run development quickly we run an genetic us in and species to thing, you clinical than some human answer need well. run this The really that of experiment know is models about

the made able tremendous I far run progress actually and I we've So the think don't being experiment. away target on to we're from think human

Your of Andrew Tsai comes with Jefferies. next from the line question

Congrats indication. show on earliest? it time. in we how this show be powered PGTCS the you possible get study we be at other the should XXXX? have execution. this drugs within XXXX mentioned assuming think to I is I And on Could wanted data to ask Or the before guys what

separation, assume seizure to here? a would type fair So reductions XX% be XX% it be bar to could the placebo-adjusted

Phase we expectations of changes on that Andrew, there some in well, terms to maybe to the trial burden late from can have These drug literature about power studies. very that baseline still slower kind run. would We seizure most in talk think, our They And that terms run, the in which studies PGTCS the want actually tonic-clonic to about their is what expectations be generalized clinical challenging our helpful lacosamide, onset even of the of timeline, haven't context. But run X-ACKT, PGTCS is Thanks, are. FOS primary in life where at much cenobamate, and talk I timelines. coming Andrew. they're III you look that and just and been so look you if as product. maybe into moving running to recent the do more approved, Chris guided studies commercial yet seizures. put of at for are I focal study they had in seizure of than data though Kenney,

and expect to we than appropriate what the a And powering haven't topline assumptions. that the X-TOLE the -- time, just would the guidance we update maybe on take background we able program I to studies yet of bit at design given in guidance set So it, of these although than prepared you want the is studies terms slower given and in are can seizures. we'll onset common because less little did to today's remarks, just longer focal give data. But Chris, be PGTCS expectations the on in study

few a a generalized difficult burden, are tonic-clonic going to in that from There onset primary lower focal is One to has Ian. population Thanks, Sure. Yes. it's seizures. those and PGTCS patients. seizure seizures general find differences the

And take little so that's you why duration study bit longer. end seeing up of a

well Now when fortunately, drugs to the really you show patients efficacy. work, work fewer they need and

So per about end, that arm. are there study with of patients as done PGTCS done then patients lamotrigine arm, you had about so been XX on times the topiramate in think X look had XX I the at had studies, XX the XX examples that patients And low the times what's so was per And per size. X X. XX total the for studies, spectrum group, of past

and that's study, anchored patients. I to entry patients. and about exception XX total that a the the include of event the a on we've perampanel Levetiracetam XXX to X higher a was sort end XX to spectrum of lacosamide study of even was time that So criteria. higher of mean one examples included patients that but what with between different

apples So of oranges. it's to sort comparing

So we I preliminary compared seizures, to we're that. don't have focal-onset mean, of on data. end the higher

XX of that study studies those about our examples X. used per simply previous was so powered compared And to patients X

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

me. can hear Sorry, you

Paul, yes, now. we you can hear

the for can what about And see with in focus strategy I that. to work, to area, model regard the perhaps acute of prosecute pending follow-up animal development you larger parallel. development development on just focus for on clinical whether pain. most Sorry a chronic wanted on or any to ask you them in NavX.X us you that focusing the comment, as opportunity logical an

us. for bit premature I a I say it's question it's would Yes, a Paul, probably think really

sure development we we exposure modeling late-stage look have can haven't we're work that from some initially, view. like. of fully we receptor efficacy healthy what volunteer appropriate enough predictability kind out fleshed getting We would plan where a point that occupancy would of clinical do and make do Obviously, believe we an

was designed At reasonable then nice the is those we would as in size be terms would likely as haven't we be about quickly. like a of thing early that So powering yet. studies earlier, can right? I run study, And study mentioned pain a well, very bunionectomy work. And the that run

there and asking kind and there's we'll all doses to of get questions question really mechanism. acute are terms I the about genetics and we in nothing things, on chronic and number So a potentially which of that in a lean that you're of one advance. But lot think or on with mechanism the longer-term the way controls studies should other necessarily based active or the more both active whole of There's at suggest the to another. least table, of

the potentially do market market start. commercial how acute are to terms how on accessing So the monitor NavX.X they're say I really of in terms want to both is would the in table. We today doing doing and program the of

going an point to to us as be that's think well. I inform interesting So data

come So on today next to more really definitive too two. a for over think too that you answer good, and because year or I I have but the it's don't just early premature,

line John Cowen. of Bohnsack next comes the Your from TD question with

still are talk program? studies at design releases, once? I and initiation when X? on then more total these be quickly, then initiate all And about going And Or staggering of be once? the completed? being of studies? can the in will I guess a it planning released you measured the if are the enrollment little is bit initiating releases, done could data real study I them you question, I all same just the is data missed MADRS MDD X, Or and it secondly for basically terms at and X, analysis the this, you in guess, apologize to just

into criteria take Kenney, the staggering. it's I program. a the the of from Chris learned entry Thank maybe the part, we I'll study moving through Phase the go then on just we're lot helpful II you. first probably III think into Phase to And Yes, some as because

question kind I specific of of to review in MADRS. remarks then and the you do think can didn't the prepared some on that have We address that. time can we maybe

studies. staggering So be these we'll

So at just they naturally, all at won't time. same start the

our And first would studies. protocol with study, third be as that that expectation And the we've a the guided. on should would we the our natural we So as start data expect year, then FDA filed and and the this for later second well. release stagger of

will study first we've publicly, is provide study follow the third the those data after would complete, unblinded and second those As and study data that. soon in then the

first for maybe question So a expect important perspective will we finish of go from unblind not point, they would about so at through a first the start before to running one. and that but same more waiting because the criteria stagger, some the and be program some all for the entry you second around readout we're and time, But Chris, think data the on this start one that's that near I we them. But answer definitely can the provide MADRS. one and then those

Yes, would work Ian. study Thanks, X favor. that design things Sure. I about say should in our

have is versus just one first III, The Phase as group Phase from that II we'll go treatment we to placebo.

placebo of So response. studies, definitely that, terms other if that at in you look helps

of per study XXX size in The other patients, of about the thing size is arm. the we prepared talked so remarks, a that XXX study the

some bit. patients three, severe in so that that those higher What we going things then more being milder the moderate meet out. And subtle have milder I we're a studies still end which mirrors the learned, than what II is that in it's the the they're the design, think, spectrum, severe. if imbalances, end spectrum, specifically they study thing directed was more that study, they skew to for slightly after occurred imbalances, though have X-NOVA on But are data but of the the the that more guaranteed that's were if on can used criteria other what So slip there dramatic to not study, And the in learned even other you question, of X-NOVA. to Phase to iron fourfold the moderate depression.

And so HAM-D the spectrum. to going use more some we're for of cutoff end just be of making are in to in are in criteria a in Those that that then milder that study we going the other the changes. nobody strict sure there just strict comes be general, the big the more and we're, terms about

is the which terms one And as mean, I well depression In we mean it as scales, simple guiding use X-NOVA. of fortunate actually can. X MADRS, it worked in I keep of with as that you allowed principles you did is because the know, whether into decided still HAM-D that was be MADRS the us back approach. to depression amount that go went to Phase outcome best to choose the and and ultimately led should assessing But about forth III. the to a included least we not, successful

in we're which had seen study focused on. and studies. what that's to less other So going HAM-D, same focus our we've we're the variability, And on saw dramatically we in

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

a Neurocrine. with This And But Kenney program Chris Ian. partnered this within is Laura SCNXA question noticed sure for is Dylan if for not I'm the or Chico. we on

broader have the wondering seizure-related outcomes indications? Would positive looking also if we also candidate, XXX. through an to with or You're that's at NavX.X And NavX.X for were you inhibitor [indiscernible] focal epilepsy. see this run

going there's XXX and were and Neurocrine the as licensed with inhibitors the and the the a which came Yes, bit development molecule, sodium of I laboratory channel Neurocrine Xenon's part helpful through. can history are doing transaction take for that probably development. in is -- of Dylan. Yes, out little that, of these paying is here, and is

and for milestone transaction a it's royalty So Xenon.

XXX NavX.X, called that seizure XXX another mentioned was out NavX.X, so not to that a read fall, little also referred channel potent and it's was for subjects it's molecule seizures. The we although has now. the That prepared focal-onset moving study. SCNXA XXX whereas as selective onset So in of forward in more small sodium proof-of-concept II right much did they're They is today remarks in you that run clinical different around a highly trial, last Phase a study X.X. potent focal on a on on bit the XXX profile,

So channels. that on has Both consider excitation the in we this potency channels dual brain. a inhibitor both are involved would in

targets. goes background guide it it it Is pre-clinical. at terms would of into, is types into This well-validated what point as studies into that And next be epilepsy in Neurocrine molecule that go helpful? clinical So as development, would would but still both well. of studies

Yes.

from comes with the of question next Your Leerink line Marc Goodman Partners.

This Mark. is Basma on for

had efficacy the dose should We on have kind of focal be of work you remind a in the Should question an of actually We dose, question not? the about seizures? or and of this done use a this also What whether the feel believe about XX indication you've comfortable in efficacious milligram. to will Could dose this expect you what terms efficacy X-ACKT. primary we with line XENXXXX seen in what generalized we've us the expect the seizures? please in onset in we

question. the for you. Thanks over Great. to Kenney, Chris

Thanks question. Yes. for the

As I generalized sort preliminary of differences of said and primary one have data. seizure between focal we that population the the earlier, is onset the don't

pretty I anybody's we just darn effective, data tonic-clonic primary is general, mean that as is I it's that on were of IIb And we focal robust. based the well what what's to successful and whether confidence in us effective. Judging gave drugs work the when look focal guess. a run of to had medications, data the when generalized onset parallel. the that that few exact the high the be generalized, seen going be and to seizures, upon I they're be subset But effective in who in happen. patients indications at incredibly in would say higher over at examples took types so there's dose. they're then seizures the we the those look going Phase in we remains And do cautious. think, to seizures that's of XX% end powered in X other reduction it of with antiseizure study the mean, number studies just different I patients, of to seizures,

as in they've and have focal that laid worked far down been with choose seizures. higher primary milligrams, that goes end is that And with again, seizures first in tonic-clonic dose, why that dose been that's the was in other then of XX field seizure, the that brought the high what's the the focal been As the and onset functional path drugs spectrum others and learned generalized in along then worked forward, on chosen successful. the onset

did so we And same. the

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

now may You disconnect.