Xenon Pharmaceuticals (XENE) 12 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Ian Mortimer	President and CEO
Simon Pimstone	Executive Chair of the Board
Chris Von Seggern	Chief Commercial Officer
Sherry Aulin	Chief Financial Officer
Jodi Regts	IR
Paul Matteis	Stifel Nicolaus
Marc Goodman	SVB Leerink
Andrew Tsai	Jefferies
Yatin Suneja	Guggenheim Securities
Tim Lugo	William Blair
David Hoang	SMBC Nikko
Serge Belanger	Needham & Company
Antonia Borovina	Bloom Burton

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the Q2 2021 Xenon Pharmaceuticals Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Ms. Regts. Jodi you. Thank ahead. Please go

Jodi Regts

Good call afternoon. XXXX us you. for and Thanks webcast to our and quarter results. on discuss operating Thank joining our finical second

statements and the potential payments presentation receipt of fund milestone the the future anticipated expectation of publication enrollment and cash potential of initiation our partner our product to with our royalties and IND are, in Joining be to success, collaborators, today's Board; timing advised pandemic data. and to and other are our results Officer. of trials, call anticipated Von Sherry efficacy, potential that and and of related Financial and this Executive plans, XXXX submissions The the of efficacy clinical trials Ian Seggern, regulatory Chief impact future The our partnered results Chief profile, operations Xenon's regulators, Executive collaborated we development and Xenon’s IND-equivalent that clinical addressable timing a proprietary safety market, proprietary or anticipated designs, the the timing and our Mortimer, Chair the me of those or during and statements preclinical of Officer; call sufficient commercial results timelines and on clinical clinical number and future including plans, product our programs, of will Please candidates. of potential COVID-XX proprietary proprietary and candidates, our for Xenon's regarding interactions and clinical and Officer; from on products Aulin, Xenon's develop clinical Pimstone, timing research trial our Simon and candidates. activities Commercial of President trials forward-looking, make timing business, Chris having the our the of development into our from of of and operations, our development partnered development ability our Chief of successfully timing

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

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

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

Ian Mortimer

afternoon Jodi and today. for us good everyone, joining and thanks

proprietary strong our partnered make neurology of to programs. focused across progress and portfolio therapeutic continue We

work our and will I'll we've an overview on done assumptions. clinical statistical and XENXXXX provide the commentary trial, the And Chris some design into the open where of then and questions. call update up adult focal rest on your partnered overview remain an this update Importantly, In data line we focus the in of the a our track milestone, September however, today. of mid-October. late we begin with of Phase programs. to I report X-TOLE attention study from brief will XENXXXX the a fit financial Sherry important will of then XENXXXX and epilepsy. to could will, top on we'll majority will Simon our have XENXXXX the of our X-TOLE Xb assessment proprietary I provide commercial and on XENXXXX then treatment for on to provide anticipation provide of study

of different in in treatment-resistant presented is focus well the efficacy, of XX juvenile Phase treatment absence So a in on diagnosed conditions future these an progress efficacy, the case an of we investigator on double-blind, we enrollment month tolerability Phase parallel tolerability absence as X promising investigator also and well including XENXXX our absence Briefly to and Based need to to X Jeavons syndrome, as The the seizures forward of and led partnered I'll other the XENXXX EPIK to developmental our and initiation pediatric randomized, multicenter enrollment three has epic year. for clinical action as is and program, the at AES continues absence safety enrollment study evaluating studies, unmet continue data also addition childhood in aged potential non-XENXXXX in assets. and of absence which clinical drug patients. with initial seizures. study important programs which currently or look activity childhood trial believe patients lead KCNQX our the at has placebo-controlled we an sites. on approximately The epilepsy and XENXXX patient XENXXX site include its or mechanism goal seizures. site, JAE. Based address additional signs also with patients end identification on on study examining group, start potential published is updated called This as patients than update expanded patients the keeping the X study. pediatric epilepsy and encephalopathy. physician with the with you as young Patient epileptic And X the proof-of-concept to in study safety and Canadian medical years last of has enrolled of CAE CAE, less that juvenile KvX screening the to evaluate with

year, larger future cohort Additional a the will regarding are our anticipated inform results by development of decision the end from which help XENXXX. of this

this both progress, the pediatric received are program. to clinical for these orphan recently designation designation addition have drug milestones CAE. And rare and also In we important for

this into Biosciences expect clinical the Neurocrine development programs efficacy where developmental advancement and with of XXXX. encephalopathy. initiate NBI-XXXXXX partnered in SCNXA, important Phase One two milestone seizures second than Moving with epileptic XX expected age year. studies to focal older to of anticipating in X is events in years patients also adult we our and

progress. you this bunionectomy forward We addition, in keeping In Therapeutics results FXXXX is from collaborators look line later Flexion year. expecting to Xb clinical our on top Phase trial its updated

to neurological looking from we're modulator is next-gen epilepsy now to which forward novel KvX trial September our of to attention a Phase turn our developed where XENXXXX, late other So being X-TOLE line Xb the mid-October. top data disorders, for our in neurologic clinical expected treatment potentially and let's --

We Last by epilepsy a potential the attributes discuss to for focal important epilepsy. landscape, month we compelling is product and clinical epilepsy of focal leading adult treatment are XENXXXX X-TOLE encouraged space the profile with XENXXXX. its opinion in hosted that in emerging and two webinar trial of the the key leaders the the

continue in of protection intellectual the quarter We today update to our XENXXXX. disclosed on expand strategy property to our also an

patent to patent directed in of allowed forms We XENXXXX, distinct expected four have expire claims to recently any application received and allowance of crystalline from U.S this issued with is XXXX. the application

believe which applications to In addition, number a added XENXXXX. have protection will pending provide to of continue we patent we

So property overall, very progress made we're with pleased portfolio. our XENXXXX the we've intellectual on

he'll I'd to and of date, Simon, over Xb call our of X-TOLE our expect an trial and provide point, like press clinical this the our data what top experience we to can study, Phase to Simon? in turn at So overview and the design release. line

Simon Pimstone

regarding to I'll Thank the important have to data overview us focus our the clinical the as study Xb date highlights development led noted, study. from provide of release. I'll in you, Today, brief a line this data on upcoming you to and some X-TOLE and Ian Phase the readout, everyone. our also that readout of top is plans near-term, X-TOLE our discuss Ian hi

Phase X Our Phase Phase dosing. profile. SAD studies well from X in Mad studies being was Xb tolerated including favorable XENXXXX PK Results a once-daily with the trial. drug studies currently X showed clinical XENXXXX Phase at doses our promising in demonstrated and tested supporting

of and is majority support in being CNS the For AEs as CNS. reported additional AEs mild provide dose the activity drug of related dependent

PD Phase with also Phase completed X stimulation, magnetic TMS reduces we cohorts, SAD, corticospinal the XENXXXX MAD strong a study Xb a pharmacodynamic relationship. excitability to addition trans-cranial that showed or PK, In

and administered been XX X-TOLE as in late to guided complete, placebo endpoint XX the to more Although with that treatment designed patients informed top robust placebo-controlled, evaluate not effect line line was epilepsy. to Xb I'm Phase non-clinical XX in include X-TOLE trial. would XXX one X-TOLE in trial Patients focal to mid-October. in literature. compared from adult to change have one is XENXXXX That XENXXXX late to Data double-blind, vivo randomization provide with milligrams X numerous results from milligrams, the in two compared Phase fashion. MPC also in to at in manner Phase XENXXXX frequency of detail head-to-head, to June. three or being active to studies randomization tolerability one a trial SAD, analyzed TMS and report as the I two and one treatment top in what With fashion. a release. two of the Phase for double-blind Xb together a milligrams, treatment in to placebo groups expect clinical dose placebo. when more primary now blinded as the randomized or in from minimum September ezogabine MAD percent like to anticipate X in the pleased the seizure two studies, of press efficacy, of completed multicenter selection a to little to one a have Xb we week we baseline we clinical to that XENXXXX median adjunctive focal patients the is XENXXXX monthly The to in safety period the

include will different four values Firstly, with we each the study, percent associated the analysis median and that arms statistical walk through. of will the of change P the Ian

we a forms endpoint. secondary will is analysis responder as addition, key the present the for In study the this XX% of

overall in urinary will history tolerability given ezogabine the and provide pigmentation. AEs and We also discussed the observed with commentary on and the safety

of measures design here. these novel the in refractory mechanism provide focal back XENXXXX further in we you. opportunity expect the I'll as on of and powering modeling our to and perspective the treatment to pause assumptions the be our a overall, as for data upon well the I'll data in context study on So receipt will on for key line a the efficacy Ian of ask we tolerability the to comment that to position Ian, information and provide statistics. epilepsy. study be top and

Ian Mortimer

Thanks, powering Simon. Great. how our assumptions. study I the with we begin and X-TOLE design will

a in discussed XX% going modeled And As time been study, adult have rates we this previously, arm. placebo the over focal clinical epilepsy the reduction we trials. MPC in placebo in in up have

arms, arm. a XX and our data a the modeled the reduction XX ezogabine the arm milligram and a use we the modeled MPC for in reduction the as we've XX milligram have XX% for and XX% dose response arm, XX% clinical for historical a active reduction guide, For milligram

we groups. consideration hypothesis change is And wise the than good response, where is these analysis, milligrams XX would dose the a takes XX% monotonic run this better other in statistical and into Our that null hypothesis dose between to subjects is primary range. two have The assumptions dose placebo. statistical statistically responder no we'll the dose all one are and placebo and to the both positive comparing the move in significant XX% analysis, Under response. a power groups. a to the placebo there we then the XX% hypothesis rejection study will is modeling, alternative After analysis in outcome conclude pair MPC then analysis null of active for there in is dose the

Xenon's an partner and Chris Partners, feel good of line in-licensing on of as data. amount both work, was number Seggern, designed a forward Healthcare to for like primary study secondary first the analyzing and I'd immense Previously, M&A well commercial now as with and we top conducted opportunities. Chris he Officer. as commercial sources. a oversaw due we're last is to Chief year strategic introduce ClearView CCO. opportunity Chris he our the well market Xenon done overall, research where and Von has joined diligence well looking Commercial XENXXXX, from at the So power, engagements

So he will Chris? some today. insights share those of

Chris Von Seggern

ranging the goal we some from call some with a the By more and the with desire research pleased their Thanks, identifying U.S high medications. I'll and on the pinpointing the attributes briefly fashion conducted from making, our in of decision way findings. anti-seizure Ian. focal key I'm key academic need to information background, of prescribing neurologists Today XX epileptologists the XENXXXX and summarize to volume today. future to clinical onset understanding the blinded market share on unmet clinicians of market for across medical epileptologists drivers seizures, research

and despite our availability multiple the high-level, patients polypharmacy findings enduring exists, being unmet a of the controlled an need high with drugs treated clinical First, are ASMs. at indicates despite numerous emphasize Physicians who unmet well that that approach. particularly remains not need among

anti-seizure be class in Looking validated on we approved, of proven activity, attributes decisions. at obtain and previously and a to may apparent both our be believe coverage in regimen pill be efficacy XENXXXX's physicians its one measures is range understand of the we We is may we the be XENXXXX forgiving unique profile only based action that profile anti-seizure many miss-doses. that and use other patients there on polypharmacy with drug we opportunity, On of our a would perceived that that the currently mechanism if of adult differentiated believe and medications the a of positive for that research, approach. the epilepsy ease medications, of efficacy prescribing XENXXXX risk leveraged of other and roughly action market. with number Kv low DDI are other rational Therefore, tolerability equivalent, important are within From could if mechanism to focal are attractive in the provide anti-seizure further this discussions, market. attributes within once-daily believe that XENXXXX may PK available

drug XENXXXX blunt focal was Additionally, Further, sleeping tolerated titration is no efficacy, having drug generally treatment profile potential given of taken dose, the When are is as AEs. in CNS that and anticipated, treat used perceived evening adult another X driver. Cmax to seizures. tolerability non-differential the Cmax studies. hours, Phase safety as the compares other key may as reported during which majority favorably which an therapies to reached ASMs related is well dose clinical

be might of benefits differentiator mood Another XENXXXX. potential very the important

are have strong If where could depressive that a anhedonia. impact common and the present be rationale focal preclinical clinical beyond succinct and many We symptoms a effect work positive a given benefit mood disorder on negative combined mood is data and once its Phase the to for to risk, Hope is snapshot apparent the mood associated KvX back attributes no XENXXXX ASMs turn adult a seizures, of findings available mechanism co-morbidity X-TOLE titration, supports stack DDI based striking ASMs further action, clearly are to major with of one on other easing Ian, of forward data explore Xb I'll benefits based this differentiator provides onset epilepsy. would patients. looking of focal depression depression some XENXXXX dosing. treat of top differentiated pill date important scientific use And modulators our that and against treatment this in up a potential well We novel in these we its day, on low added currently to our near-term. line things to you. believe

Ian Mortimer

Chris. Thanks,

our to from to focal whole, along differentiated the clinical conclusions in financial market into that and and has account will the position. research preclinical exploring other we be taking our space, ask recap from adult current medications. profile the the meaningfully now On results I product date, epilepsy findings studies Sherry believe gaps a XENXXXX could Sherry? anti-seizure with

Sherry Aulin

preclinical statements revisit to arrangements. release guidance, increased XXXX Cash I with spend any would on to Today and runway the We marketable equivalents will existing million were trial, visibility sufficient into for XXXX. our X-TOLE or highlights report study, XENXXX and December post and you securities focus in discovery beyond. generated Based as include on company XX, operations the financial X-TOLE and refer from this quarter's study, anticipate further on funding from we some investigator fully news cash cash sponsored as of XENXXX XXXX, cash $XXX.X and EPIK MDD current details. Ian. XX-Q Thanks, supporting $XXX and assumptions, proof-of-concept the new our to well revenue partnerships, as million June trial as XENXXXX and which XX, compared to proof-of-concept partnering having our XXXX, excluding fund led our activities, potential plan data, of

to coming expect by more as sheet. revenue the strong have in milestone Bolstered clarity partnership We on months balance well. our

we as advance continue of product a lot have We continue candidates. our to business and flexibility our manage to

point, Series our press XX, today's of to common XX,XXX,XXX details to XXXX, back the At this Shares financial key this this milestone for there for specific the warrants I refer the will and X,XXX,XXX you release year. pre-funded remainder outstanding. of June turn summarize other would As X quarter's I'll from statements. who events and shares, we're call Ian filing were XX-Q Preferred Ian? anticipating X,XXX,XXX

Ian Mortimer

Thanks, Sherry.

the Phase advancement in look we in trial. As clinical partner in trial importantly Neurocrine including and continued NBI-XXXXXX within clinical and And continued of patients anticipate trial mid-October. XENXXX as Phase EPIK late X study Xb led in in support absence for The with investigator X well results larger objectives trial of XXXX a XENXXXX anticipated XENXXXX ahead, company from proof-of-concept cohort our include, X our key as the major investigator patient from line from programs from top corporate clinical with anticipated KCNQX-DEE, Flexion's proof-of-concept to planning Biosciences, XXXX. results Phase study a year-end with data depressive examining Phase decision clinical led we sponsored of late our anticipate our FXXXX trials Phase We two ongoing initiation X-TOLE clinical development the in initiation by an seizures, disorder. pediatric Xb a September

of of line questions. to depth operator ask clinical excited equally our Xb our trial. data and for XENXXXX breadth We Phase and top the neurology the the pipeline, now upcoming Operator? about incredibly from are release open I'll proud X-TOLE our line of

Operator

is Paul sir. first [Operator from Matteis Stifel. you, question Thank from Your Instructions]

is open. line Your

Paul Matteis

you me, all mind, Great. for making Thanks so much. Two it for statistical the don't color. questions if

I the the of no scenarios effect subclinical does for bit primary doses can there? for looks to if if speak placebo, on the to placebo. you analysis, wondering dose pairwise I powering second, was you comparison linear mg mess the versus good? For the so regression being having as Thanks much. specifically, the then XX up [ph] it relates versus if that And could guess, powering are highest some qualitatively [indiscernible] comment analysis a or little a the

Ian Mortimer

can I of those. Paul. take Thanks, both

at, we've generally know anti-epileptic drugs is we that have dose what looked including about a other So, drugs they for response. ezogabine,

they're kind that's monotonic where of linear going still not, call test you of take advantage all take including said, response as analysis. if clinical doses And so in can show and significance. statistical perspective, of are advantage in we can a lower say, the we this in the it that trend therapeutic we patients But you for can from dose our as that overall, expectation the of sub

So as placebo, long at analysis works and to as .XX. P positive one better the than dose is value show holds a

it's high we right So placebo. do dose the comfortable physical the analysis still to we differentiation analysis the can still between that -- feel show and and

think is second question good I a your one.

reminder, is means this me, And in Simon one the at the I power through we because we two dose remarks, that have analysis in a detect a same XX comparison and directly we that to we although two group in a if really and more front more don't placebo. to for and As look to pairwise have his will from. where the XX% to of on went have numbers separation power randomization, and in coming the placebo, study milligrams high the of subjects than one for have MPC, that's

Paul Matteis

Great. Thank you.

Operator

from SVB Goodman Your from question Leerink. next Marc is

open. is line Your

Marc Goodman

what’s about continues, comes Thanks. to that kind a the the just how analysis data data And us is talking getting give responder mentioned at competition when just have EPIK and patient it, of the you level, some the sense a second us how thoughts of about we study, Can sense expecting of you about of this sense next maybe so all, out, of of is into think that Yes. a XX% XXXX? can give are Or but probably it. you're it, year? we enrollment where You are? you you're

Ian Mortimer

-- Okay, us analysis, that then give the handle, great. maybe responder And give of want our perspective my I'm XX% study. can perspective was Simon, on me the both to you EPIK do flexible. on happy

Simon Pimstone

good. Yes. Sounds

Chris Von Seggern

don't EPIK. why with start I So

[indiscernible] get the sites up up So many we are as centers, we the an for given during opportunity children collaborators where a were this we that study being Marc, developmental are these these of enter with in identify getting work and well study. continue our of our running And as with us now critical COVID mass and to goal really was and into for patients that encephalopathies to -- genotyped epileptic to year running. where to academic

this is year running up sites and about So getting and countries. additional

in getting the approved And U.S., our sites the started U.S. outside then with already working So the we've of IND in expanded U.S. getting we in and

patient we some to data, -- year. the see of guidance of sites, us of that terms year, this for and the mass said, information end give be of to so a we we top and are end guidance give have before In we we where till when this better you line we'll critical towards enrollment give able

kind where on Where terms and to line the into outside top study next be to sites of of quarters. over X months. we number we aggressively don't the In that next in XX expect of the is patients get going data really it can of how are directionally, I is

the us know to XX% I'm So in about great QX want I be give responder well. November, update talk would happy results for time as my if perspective and to there. analysis, Simon, to in you an don't you our a provide

Simon Pimstone

XX% bit in obviously, generally a responder of this thanks. [indiscernible] Marc, see at XX% [ph] what Yes, kind in vary generally, from was, terms least study-to-study. mean, of we But in these the I that analysis, range. with little XX%, pooled

current certain that -- the course, of use that benefits study, of So degree threshold. to mentioned, we know we've But I as have like I many we XX% Vimpat I experience important and terms in previous you have plus are around have if before, that obviously, the adjuvant and think, -- rate of some I times XX% of high space, to the ezogabine said be in XX% in this the and added of responder in low but to low therapy ease you're characteristics, of where at things has with monotherapy, placebos Generally, around to the extremely generally not others, seen drugs mean, in to at agent, set that XXs. don't the added therapy, in generally, think a cohort. don't and look, And, terms but haven't an Chris the of drug, expect. around you competitive. a what efficacy I of look specificity in teens really

Chris Von Seggern

Yes, I adult consistency. is at on the thanks, Simon. thing -- all would we've epilepsy add analyzed only when is, least The remarkable that in of the focal ASMs there's

good in concordance studies But across in Phase a Phase about U.S., X we efficacy look studies. X range one drug things drugs efficacy consistency that point within and a as see that Europe a that view, generally well, at the also of in really see is and and regulator works analysis. the looking of have across So in that across endpoints. we works that's of generally consistency you from the nice responder they're we at epilepsy the MPC, But

Marc Goodman

Thanks.

Operator

question from Tsai Andrew next Your is from Jefferies.

Your line open. is

Andrew Tsai

Okay, afternoon. thanks. Good

the big existing other if you, happen. overall show. fine XXXXs would were totally drugs they that is CNS based be is, about, cardiovascular vision side are X, the we question about can must because the putting you obviously, should think go as AEs could related what safety, effects And if [ph], with be First could skeletal you on thinking what to talk happen, show think safety naturally be in profile XXXX picture on Phase expected. context investors But to

this the question in basically, what focus do think relevant is, Thanks. of of my on to kind you street [indiscernible]? aspect for the safety is So,

Ian Mortimer

to Sure. Simon, that do at you to and take happy it. to first want I'm a add crack

Simon Pimstone

add. will and you don't why Ian, I

Ian Mortimer

Okay.

the which on Sounds you're a Andrew, will efficacy see. I CNS that good. electroactivity like the to have an get see on headache, and somnolence, you've upon, events, we and and vision. blurred going fatigue, some have things seizures, of Yes, impact dizziness, CNS events, adverse like into even Drugs and adverse things and touched mean, CNS dampening [ph]

well. in anticipation we would that on manner a dose, in see dose be to likely are expect we our as So a -- and dependent going

really And so, of we always in this think totality data. about the the

see and we So of from view. of point where profile we are to need terms we in are overall of where AE kind an the efficacy

some would looking You it's anything would did and mention those Obviously, they outside seeing at are, events CNS. be what be concerning. rate of adverse at that other we and whether

think As a reminder, previously. this I we've discussed

mention potassium channels did haven't are date that and heart, there X, although any other seen, any in the and history events adverse also pigmentation. events. and we with urinary looking high in looking exams we're earlier, are the any our at just we'll both through remarks expressed be we'll -- with we be will given seen of issues we We cardiac doing haven't doing the had ezogabine, at We baseline and And to Phase be concern throughout. haven't at adverse

data. able to we're when line at So all we'll give of those we're top be information and tracking,

Andrew Tsai

Great.

you question are what for line It's what fact Thanks. remind in you placebo us in second drives be is, response guess, what modeled. or will your can you've response? follow-up placebo trying I control than just ways a in As your confidence? -- to better

Ian Mortimer

Andrew. Thanks,

remarks, in seen modeled think as studies. is kind that we've a we we've a on the placebo said rate rate. our more in will of So which reduction, contemporary actual XX% we obviously, rate be placebo, Obviously, we've an placebo

And is efficacy that medically the between the placebo, really active the believe relevant. and clinically active ensuring that is what we we're for separation looking and and so for drug

separation. So we're for really looking that

non that One, few we the placebo quality study, certain of go Western for analyze In we that been rates, rates terms doing a jurisdictions to, what recognize sites in managing least have the the at things. to, can we up or of we there's obviously, when that gone jurisdictions. placebo we go

we have in seen So those sites historically placebo we've rates. don't trial jurisdictions been any higher staying where -- have clinical

Whereas capture or with opportunity -- a missing know for almost the that they're there that the and a a you if follow-up a -- in the seizure an to coordinators, time. filling is that paper ensure they has CRO data points, there. an patient basis. least hypothesis And diary have also their and we electronic We on less at is when control less regular diary, study through using on diary lot real -- can have essentially more

can we size study, placebo think gives some that there. confidence I ensure and powering we we're us that best can the we So of manage think I to doing what can. also the the rate But as the

Andrew Tsai

Thank good. best Wishing on you top all data. guys the Very the line you.

Ian Mortimer

Andrew. Thanks,

Operator

question Yatin Partners. next from Guggenheim Suneja Your is from

Your is line open.

Yatin Suneja

you powering. clarification question question. taking regarding the guys. for Thank Hey, my One

XX just the dose, first to So XX% for it's pairwise the about confirming XX% but for power, it's that? for milligram dose XX% the response, about

Ian Mortimer

question right pairwise milligram answer top have response. the more number don't follow-up No. XX be with the front I milligrams there's I monotonic Yes, for dose good off versus I than the the is the said said the also. the same so, post I now. call. in Yatin, have arm gave power. pairwise would do -- can that I you But specific head, of right it the powering know XX% the with separation me of if would analysis XX power earlier for don't my I placebo that

Yatin Suneja

analysis -- you. or P two for or Thank then, also you not for values And a that's good. do that's more like sided post very hoc Okay, look plan pairwise? to

Ian Mortimer

.XXX the in you've will one and the arms. thinking milligrams we one now milligram power good is, size that positive, in we milligrams for That .XX. it's we a the doses. to sided other analysis statistical milligrams mention two noting I the analysis, analysis but response. But moving -- we we've to sided to two submitted to much one that sample with statistical then to analysis monotonic first then then analysis, we XX I subsequent is is because because randomization, in a we XX under the be move current near-term. to as MPC dose think and starting done is to and hit have your obviously and primary finalizing if two the arm, the you the go to on FDA the but XX when responder still move plan, the that those really about based a didn't earlier, talked one really XX pairwise the have the then So this power less would is have the SAP on pairwise we're analysis, in and would And .XXX, worth

Yatin Suneja

Got this pivotal expectation. one the that study the this could it. to expectation especially in can of the follow-up Just that's Very trials, future? endpoint is you Then, talk the also going in about given in your like a doing talk -- U.S., your be be you're helpful. about that

Ian Mortimer

a quite a now. that's got a right We question. Yes, bit good

meeting. So the be obviously, that at stronger I the would that I we with better the signal, the discussion mean, Phase end with are an our of the robust and discussion have think more in X agency. would a FDA arguments that

that have one regulatory we've discussions our P in I two FDA, from of -- signal on input more have a had whether the need at that studies confirmatory and had the with have with Europe robust additional registration if think in we be one is we two The value require input, to this shot Phase We it, or X. can terms studies. in the -- will of whether a we a study

NDA to in that And for need one Europe. for running likely will it's studies. those more be have two The would we then be study question filing. be there the may a we're second of going complete is, an that stagger So real to required

Yatin Suneja

And this about feel question. know I more how One it. you [indiscernible]. probably Got

the you that help than and think might ezogabine. of of which any Can I if be what a recently gotten question we binding XXXX, just be? protein that regarding they from there investor is implications us little different properties are one understand have might the bit

Ian Mortimer

PK I had preclinically different protein bunch and pharmaceutic when a are things. board -- recently. may we've looking frankly, we're of Yes, properties tracking different across other we and mean, different at some the drug designing predict fate engagement every a of drug, also the Sure. target may a whole of of has metabolic has quite not be tolerability, drug, number in and drug attributes but the group, we not a in binding. every how kind discovery And when questions just our what we're

with of little have that, drug for we've than that slowly drug than PK in generated. we do higher likely metabolized comfortable We a it's super higher as binding the that more So also has data provides all every we protein ezogabine. is we But the different. to feel better a Obviously, comparison that bit protein binding know and XXXX know ezogabine.

Obviously, protein humans. And robust profile volunteers on getting we're in in the into very We're of something to consistent in not with information and single a TMS PD in lot we healthy piece number particularly pay an target, binding focusing data vivo different drug think a have robust preclinically I a assay of seeing seeing We're effect one just that's a to so is getting models. that the we CNS. very in of drug attention activity point. AE as

So attributes, are we good. of overall, the XXXX the properties pharmaceutic the very very, and profile think

Yatin Suneja

good. Ian. Good luck Very results. so you much, the Thank with

Ian Mortimer

Thank you.

Operator

from is question Tim next William Your Lugo Blair. from

open. Your line is

Tim Lugo

well were comment know the of of arms looking maybe maybe background for and all many characteristics that in X-TOLE study you're taking you much the also question. at you on as the how talk the or balanced? Thanks how baseline MDD influenced Can now, is relatively you study? that doses about company across led And can

Ian Mortimer

there. a today Sure. studies? I we're characteristics, baseline a can of least I And yes, to bit bit little or the MDD want through do the how more you least will you thinking, then give little go about talk -- detail at Simon, at on

Simon Pimstone

Sure.

Ian Mortimer

one reminder, need can't a that in, be X minimum seizure baseline. characteristics, patients need be they So they coming to Then have therapy. on they'll screening come basis. a to background seizures monthly to to in anti-seizure drugs, baseline They on the as they into of but three are period stable stable medicines through And a on of baseline terms freedom. any on background needs be go of period have week they where into a four and as

an on than we for coming digits seizures low looked number, we will then medians the that and fill And week to X. are it When than kind number be characteristics that. literature, to of we And have the medians and baseline, we've normalize electronic total we from during to time at of via seizures, be X and higher the in this has is period it baseline look the obviously how it more day many they at they diary so in have to a XX going high what double expect be single digits. study the

above So think terms monthly the median or XX, before seizures kind study of just it upwards randomization. XX, the of coming in into of

variety different anti-seizure ASMs of there'll terms what on I mean, of medicines. a on, be In they’re

gone that looked haven't the But data. lot of that types we'll into we kind will obviously, patients are would on coming drugs of these the that of at gone, haven't I the We drugs, or be highly and blinded see a again expect the be study. prescribed

pass MDD. can questions to Tim, on Simon any you I'll come it baseline, detailed that. the maybe had more then if So to back And we on

Simon Pimstone

Yes, obviously thanks, design different MDD Tim. mean, and be patient I a the I completely study, population. distinct guess a very will

tolerability and study is the think be ultimately different doses, see where at at waiting it'll study to be effect will our probably in size doses. looks from setting I what what most for helpful dose the sponsored different like the

line we finalize wait the important elements making So study will got until that of data MDD very study. the in on terms sponsored good progress design, of to top the while trial are really key we sponsored we

to design agents this there will to pretty standard greatest kind ability probably it be than where this study. Other So that's against MDD an going I that, other I term make a control is in benchmark think have of effect. will to just its employ think sure that we

answers that question. hope I So your

Tim Lugo

That the depending suggestion I -- you us that's work I suggesting of MDD data thought the to on that baselines, in of was progress. -- there ASMs. I And back Can of refresh kind remind on that? the is fine. guess responses going understand me Sure. kind just a preclinical in synergistic

Ian Mortimer

Yes.

done at we've battery the or different studies where vivo other prescribed pharmacology in combination used a consider looked well would we mechanisms. of with XXXX So of and with what highly we've a ASMs

efficacy. when combination at least combined drug, an like additive with get we've a channel the levetiracetam. as you XXXX sodium And channel looks what you at blocker, combine So SVXA potassium drug of or with circumstances, in only another looked XXXX like all being modulator

sub when a get so therapeutically kind and not you in very, by And of changes that them very then And and concentrations that's you plasma together, the both, of -- you signal. dose explained for drugs. robust add

XXXX least one and we the DDI not drug a drug we're it's the concentration preclinical these that So effect, to drug, in with. changing models the having way or combined at like having other of is it either

study run elucidate actually done synergy We that quite to are large haven't studies. a

we there better look Some But like very, per experiments drugs. may additive. of and the were haven't preclinical look But very no be synergy robust effects those they show designed se. than to

this no I maybe effect when them this of combining point. a mechanism more think There didn't drugs, is regardless were that with have of beneficial XXXX.

Tim Lugo

Thanks. hear. Okay, great to

Operator

next from Your from Hoang SMBC. question is David

is open. line Your

David Hoang

for Hey, the taking thanks questions.

in, So I fits slides I where a think the current it third branded but the looking at fits other landscape. in few in, get a products from And R&D line therapeutic where you was just just refreshing I'm day. slots. do with your XXXX I myself or see do

but Briviact I profile those [indiscernible] a of less here. I'm familiar also with understand little I agents. think I see and well, (XXXX) So Aptiom the

differentiate confidence other gives these you'd to question I is products? be against you that So, guess what able my branded

Ian Mortimer

Chris, pass It's forward time not He's he but when today should David. point? Thanks, to and the the I'll and a question. look about talk good we it give that like think Yes. can at XXXX can just would his -- launched, we branded maybe be market And and Chris. what would perspective. specifically,

Chris Von Seggern

the this And manage of as and look mechanisms that and there the agent broader in are commonly key pass early is are lamotrigine and actually to Absolutely. majority or we into this that first of line. order seizure burden. at lines ASMs the through used marketplace, paradigm component the used When clearly -- It's clinicians be what in are requires are that a But question. first products to additional alternative to then the to for second seizure benefit. levetiracetam additional patients of provide what a backbone therapy, up great looking add therapy would consideration end a line that within

will marketplace. quite all in is consideration, a under to different If in backbone is in but and same they used action. is commonly that provide Briviact action, profile doesn't you've product, who nicely will additional And offer to of widely, the added responded products action, management or components one one that control to as an order second alternative of add this to on will than provide to loses this future get landscape Because sufficient approach with of that is patients -- in a And the keep product fits issues you're up the they're typically be to exclusivity, easy greater important it well if product. in a not have XENXXXX use free. Briviact, to key of to is is marketplace. is the of mechanism Aptiom leading part mechanism action. it this of seizure levetiracetam. for continue mechanism medicines as Briviact We because benefit to looking Ian different go of the therapy action to of do rather that patients a the about an maintaining switching, end that's of marketplace, on example being patients one are think for mood what you seizure control. evolve. in used it Today, where Vimpat for mechanism to that when different want clinicians try the on the often had feel mentioned related looking ideal tend this mechanism patients it generation So is but to and likely agent branded move of is real paradigm

branded So we to anti-seizure continue for require additional agent up imagine medications. space as a that, another actually opens patients that

David Hoang

helpful. really then That's follow-up. And a much. so Thanks Great. just

the there IP, in pursuing, terms what you're with you? expansion IP would of new give or bit about are that new the I with can exclusivity, guess, little you -- much space current talk current of IP, assumptions just a that how then With an length and the of prior

Ian Mortimer

David. Thanks,

place, composition another of we company filings that from took did XXXXs. a the weren't in reminder, So, just company. that in original XXXX the as kind of late brought We matter the

additional with took IP the -- median with take to before other of the will the so XXXX. was And would we as methods had manufacturing around asset, acquired which food not illustratively methods it and humans. around Hatch-Waxman predicted we get about property intellectual us filed we've issued, then original the out patent And that also we that, us often that into which was investors, got of under effect, [ph] with and that we behind talked use, something passion

And something also that X, was identified filed in that. we've Phase and on

that So property continuing exclusivity layer pushes out on that intellectual quite to we're materially.

David Hoang

Thanks it. Got taking for the questions.

Ian Mortimer

Yes.

Operator

Your next from question Company. & is Needham from Serge Belanger

line open. is Your

Serge Belanger

afternoon. good Hi,

to open-label is the question related study post First X-TOLE.

it Just on curious you from the any been extended that years. it has last if updates if rollover to you have I changed. months has XX month, rate And during mentioned think webinar investor X the

Phase here, trials? one but the And Phase next X ahead think curious in you two, still jumping X next or do the a have about I'm be either days, results you'll dose when behind the multiple XX-ish evaluating we you that. secondly, expect doses the get Just over positive assuming thinking single trial, Thanks. or one about just actual to

Ian Mortimer

Thanks, Serge.

year, that been this it's were patients getting or we been given have we throughout specific had patients we the that's rollover. haven't portion, rate, of numbers expected to double-blind that the and into very of to requests coming this the to end get much going up that we study open-label is of study. for entire than What patients OLE we drug kind those it. have so So year, had I a end on rollover up the said high the were extension, months, consistent Earlier last coming higher extend for predicted they'd early against, XX on were the that towards think and we year, the

get both to but pigmentation mentioned. ezogabine around XXXX. tolerability want and the that, can And continue so from continue exposure, term share patients data, efficacy any and longer XX liability are questions we of how the I to from I months we've Street we generate in years, point view both of publicly with has doing have don't terms a we an we safety obviously, still made of can data there, you the to we to collect indication the believe extend X where given one of But also reasons done community to important. the to with with an Wall as it extrapolation we more long-term that think that think a And decision bit medical and and from of is

extension thinking of behind the OLE. the was that So the

and similar terms design, X the X endpoints. study Phase this of to Phase very of studies would terms In the look in trial

doses, to one terms it's we of X. too see think we In Generally, dose early more X-TOLE. of companies number Phase the than until say take into unblind I today

working hypothesis the what And know more generally you at than dose look based I So would think one that when anti-seizure medicines. on be today. there's on we label

Serge Belanger

Thank you.

Operator

from Burton. next Your question is Bloom Antonia from Borovina

Your is line open.

Antonia Borovina

for Hi. taking Hello. my Thanks question.

So I just have one regarding X-TOLE.

outcome So wondering, I in or recording that measures. you're know just they're diary, duration? also not the formal if But seizure severity seizure electronic

Ian Mortimer

I -- if know than are we details don't know you a me. these Simon, bit better So little

types of the collecting we're know I seizures. So

they So They not. motor a or or focal themselves can have have not, seizures awareness can either can component differently. manifest

for seizure having. be the So estimate exactly individual I we're of long data, But how focal we're is collecting an believe don't patient patient think the seizure the I challenging definitely that might because to collecting is. type it

to I head, as question follow-up. if of the don't part it's I'm otherwise asking that don't So of know diary. we're I think Simon, electronic top your happy

Simon Pimstone

I'm patient a know interesting, we measure Antonia, it's well. at in studies. challenges. think Actually clinical follow-up. I as there from know certain. perspective even perspective, least an should reported are the just I important often it's not Yes, I not caregiver randomized

do measures are typically or I subjectivity made to I are a hard seizures if it. had but I duration point, time relevant this not, obviously actually they around given time is measure. quite the and you patients not that seizure probably tell Ian, They'll generally the their I mean, mean, they seizures. that wouldn't seizure there on but are there I are and think severity should is frequency, many key, of not think think probably reported important.

Antonia Borovina

you. okay. Thank Yes,

Simon Pimstone

becomes That's Measuring very the challenge. very, tough. it

Operator

turn no this the like time. I Regts. to at showing now to conference further Jodi would questions back I'm

Jodi Regts

on Thank the you you will the on behalf call. now the of updating over we Operator, progress leadership our coming forward team. to Xenon months. We look end

Operator

wonderful Thank conference. today's day. concludes this Have your participation. for you gentlemen, and Ladies a

may all You disconnect.

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