XENE - Earnings call transcript Q4 2017 | Xenon Pharmaceuticals Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Xenon Pharmaceuticals' Fiscal Year 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to Ms. Regts. Jodi Ms. begin. may you Regts

Jodi Regts

you. Good our and joining on XXst, you results afternoon. and webcast Thank XXXX. December call ended financial the for to for us year Thank discuss operating our

are call Officer; Chief Executive Mortimer, Operating today's on Ian me Dr. Pimstone, and and Officer Xenon's Financial Chief Simon Xenon's Officer. Chief President and Joining

effectiveness our the objectives the our assignment questions. this of Simon us sufficiency of in potential million our the will of timing position to Ontario sufficiency that, development and regulatory be candidates product by of agencies; ongoing our to review timing efficacy, will certain Ian, results. collaboration shares agreement future during partners development plans equivalent candidate, operations on of our introduction, clinical cash the along our we business and and provide additional efforts, plans execute After their the results progress product both of of as receipt agencies, our to commercial this with regulatory your the with that about and order Teva, related with the the to IND Xenon mid-XXXX, from capital results the activities. and IND Following Teva, from and with in or regarding will number exempted milestones our will development and initiation forward-looking, we call potential advised of our that our anticipated up our ability expectations of development partner clinical Commission, the and future make the commons and programs, collaborators pre-clinical open the the then and of and fund statements submissions our of our achieve including transfer timing trials Please of the the collaboration efficient perspective the ability manner; activities, status termination to proprietary on of research into X to operate are financial a call, of Xenon's development capital anticipated interactions statements a trials, Securities and release and

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

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

turn Now, over the to I'd call like Simon. to

Simon Pimstone

prospects perspective Many additional overall CNS-focused good some XXXX, our I'll afternoon product our our excellent on treatments-to-date been and important everyone. color thanks with six Jody for progress on the of our anticipated candidates start and clinical provide made The and we've some recent for XXXX, focusing proprietary product focus have months then a Xenon milestones and near for candidates. last future. period and on with

from believe represent important development. of could they unique advances anti-epileptic the clinical and neurology-focused are that of that is epilepsy to therapeutic properties mechanisms action existing pipeline additional events development milestone key in months. currently six very have we with differentiation a and proprietress a Both products attractive our over drugs. next Our at two XENXXX, juncture have exciting number XENXXXX three and

flunarizine. the neurology-focused inhibitor acting pipeline we're today, the ion effects, active addition, a cardiovascular to addition be without modulator CNS novel a announce of calcium In channel XENXXX, to channel believed excited containing very ingredient our to

us XENXXX, To with trial of candidate X XENXXX own we potentially for have to product XXXX. strong on which support, form advance access severe could of development into believe and a FDA designation hemiplegic have or allow our us orphan-drug migraine, manufacturing components. migraine agreements which clinical of we that with rare provide for received in entered regulatory this the heritable We treatment Phase and expedite into certain a either clinical a may start data in and to partnership directly the

achievements I Now, more programs. color on provide to like would our anticipated development proprietary our milestones in and CNS-focused

gene Phase healthy trial we clinical single of both of randomized or clinical subjects. Phase Xa TMS a XENXXXX tissue. pharmacodynamic XENXXXX, a epilepsy as X biomarker in mutations including of forms the rate other Phase safety, progress pleased or with syndrome cortical cause placebo-controlled pharmacokinetics We XENXXXX's well. pediatric and target initiated KvX.X ascending as are epileptic disorders channel treatment-resistant function evaluate the with to neurological or Lennox-Gastaut from loss and designed channel, such assess transcranial to the focal potency of LGS, includes KCNQX stimulation epilepsy, that the adults of very in components XXXX, tolerability, magnetic excitability, orphan and epilepsy Xb potentially being read-out double-blind as potassium an opener In ability potassium in the and modulate demonstrating trial our thereby treatment EIEEX, disorders advancing CNS in such multiple X Phase ascending to a encephalopathic The MAD for developed associated in pediatric and including ultra-orphan and October early KvX.X infantile seizures, or XENXXXX study SAD activity and

expect We healthy completed placebo-controlled a which randomized we initiated are in complete that on pleased to data, already Phase in TMS based Phase we crossover the Xa healthy subjects study study Xb and double-blind subjects have eight report we in QX. to now TMS pilot XX have

pharmacodynamic pharmacokinetic, three to ezogabine not not presenting with Therefore times stable, dosing, change form Xa of testing EILAT and generation results improved over KvX.X and expected Phase Certain from ezogabine. read-out in have the shown daily provide not daily Devices ezogabine modulator dosing and that's Madrid, be TMS XX compared in along tolerability, effect an drugs XENXXXX. with TMS and far getting held that is up very oral which also PK data XENXXXX regimen will study indication XENXXXX potential including of the from potency oral May we on TMS showed is the ezogabine We XXXX. ezogabine. subjects the chemically a improved the Preclinically, has the Antiepileptic read-outs is XENXXXX Conference preliminary The of in human Furthermore, data Spain because yield an other XENXXXX. Drugs anti-epileptic to are with we important be at oxidation, preliminary a an a to XENXXXX with to better what New predicted Phase for and observed TMS unlike validation tolerability XENXXXX interim in-vivo an dimers are model, first significantly pigmentation read-outs including the PD major observed be with profile believe intended color the does CNS safety chemical a brain. pilot advantage positive improved does and effect and compared on X a undergo has changes target anticipate for could that a was ezogabine. demonstrated We in this, over XXth for ezogabine. selectivity XENXXXX a when once pharmacokinetic excited in

XENXXXX data to shape in interim future information Phase believe program presented will our development. represents X important derisking to May critical in these be and an clinical For reasons, package our that provide we points

complete of of a with results crossover proof-of-concept a possibly X indication or expect epilepsy in as in seizure to the explore Xb At LGS half focal we XENXXXX X adult an trial that time, the year advance the thereafter. We by the release TMS initiating follow the soon Phase feasible ultra-orphan into We forms plan anticipate Phase to rate parallel the to Phase at same XENXXXX data including also second as XXXX. time pediatric intend end. of

a By NavX.X Society rate data primary Epilepsy selective epilepsy in sodium infantile the XENXXX NavX.X the are efficacy an of that pediatric it forms by sodium targeting pediatric that suggests excited channel AEDs. potent, of focal non-selective that channel. in as as are is orphan We caused by adults Xenon gain as an conferred but NavX.X American is disorders making driver the a including efficacy XENXXX. developed channel We of the achieve LGS, December treatment for such improved targeted NavX.X, sodium on with at being selectively such progress and ultra-orphan may sodium anticipated for encodes the voltage-gated seizures, SCNXA in inhibitor the of the mutations poster EIEEXX, we equally is function treatment-resistant epilepsy channel index. gene well highly Meeting presented encephalopathy that epileptic early as AEDs, XENXXX preclinical about therapeutic

and single to healthy total. announced recently we multi-ascending X safety, approximately February, a of and tolerability, Phase cohorts As trial in placebo-controlled in subjects randomized pharmacokinetics both we double-blind evaluate XENXXX dose in XX clinical initiated

dosed. results been The completion first X XXXX seizures now LGS. X of or clinical in followed XENXXX's second half is Upon for anticipated of possibly efficacy evaluating Phase proof-of-concept the of as trial, Phase by cohort a treatment trial a adult the focal a has read-out

that we highly and into by indications. and to new in to We as in development believe efficacy drugs better and highly inhibitors improved and window. focal clinical XENXXX intend Non-selective blocker only was represent medications to used plan for ultra-orphan the strategy clinic clinical the therapeutic a pursue XENXXX with selective channel orphan indices for broadly improved therapeutic But also could soon generation to to We the sodium leader that first of therapeutics believe sodium target anti-epileptic EIEEXX currently AEDs. with such seizures. safety is pediatric for treatments selectivity. and epilepsy XENXXXX thereafter. With anti-epileptic the become the of for epilepsy a sodium we are mechanisms the due treatment the inhibitor of alternatives parallel ultra-orphan also other focal in been have feasible each channel advancing rare could important ezogabine of limited over seizures currently novel robust these channel an including are narrow available validated therapeutically-differentiated We NavX.X action, epilepsy anticipate profile XENXXX advance forms provide as two as our development, approved with

are candidates. In ion to build addition XENXXXX discovery channel these XENXXX, drug to with neurology upon to work targets and from amassed we and candidates our extensive promising doing continue team, clinical advance knowledge preclinical the within

for the chemistries exploring to backup also another In epilepsy. unique our NavX.X benefits differentiated dual-acting NavX.X XENXXX and with has compounds the addition be working mechanism NavX.X, for program the that are of we to of unique treatment inhibitor program, an potential on

industry-leading for epilepsies we're we a understanding leveraging potential believe We present childhood an develop XXXX of in differentiated NavX.X to new our preclinical could syndrome. build of addition, look genetics or underlying yield epilepsy treatment candidates pipeline to progress and highly forward In a severe and XXXX of seek of learnings development assets. anticipate as mechanistically-driven could the we and apprised Dravet you potentiometer, our which we this keeping work to

one calcium have announcing In addition to of CNS-acting migraine we is proprietary is in XENXXX, in benefits migraine. channel in number for excessive ion glutamatergic of CavX.X, migraine disorder is rare well XENXXXX all approximately symptoms HM, clinical genes U.S. calcium calcium flunarizine characteristic portfolio; of is three are to directly today which depression and hemiplegic modulates prevention CavX.X excitatory cortical chronic to a ingredient that XENXXX, blocker third the flunarizine hemiplegic afflicting progressive the it's product pathophysiology of which active have has and the channel critical promotes outside which or added a clinical as vertigo. of debilitating neurological the migraine hemiplegic channel based XX,XXX the of reported channel is as A been we U.S. people implicated studies of XXXand been spreading a CNS a used leading target which have migraine, implicated to and XEN's that the case neurotransmission of a mediates that the in in in hemiplegic been

for strategy orphan-drug world. clinical from Our hemiplegic and received hemiplegic designation XENXXX Drug the treatment first include treatment proposed Xenon development for Food anywhere XENXXX the plans U.S. Administration specifically the migraine. develop migraine the to in a of has for as approved

activity thought potential transmission and contrast, multiple as to of this This in to without gain-of-function neuro role and one These action of in potential on Phase of prescribing of thereby, excitatory migraine. the reports agreements of In migraine supporting the genetics migraine. case may molecule entered causal [ph] has enable some activity trial. the in we XENXXX X moment or ion KOLs. in been hemiplegic take from in order migraine treatment access to play XENXXX provide is CavX.X detail clinical channel and most neuro migraine mechanism accelerated cause genetic well-suited excitatory a the encodes common to XENXXX In the treat hemiplegic into to both confirmed and gene increase addition, transmission. development in hemiplegic have hemiplegic patients patients certain support a more channel suppression These a this with reports disorder. numerous including migraine a And as activity, being CACNAXA, dampen migraine to hemiplegic with of treated Hemiplegic causal its like increasing mutations clinical our the files the manufacturing causes enhanced the by by with treatment for for study into of mutations mutant excessive flunarizine of Cav for CavX.X. mutations has the hemiplegic I'd CavX.X, XENXXX have three potentially or the regulatory subjects migraine. that well hemiplegic genes as in therefore CavX.X directly support the

currently development key for are XENXXX We with leaders clinicians. various and opinion strategies examining leading

finalize We clinical strong have feedback. built regulatory protocol are for network and of order inputs submissions to HM the community in synthesizing and and the relationships their in prepare a

an have about trial XXX patients which forum us support of disorder intend developed hemiplegic migraine In who teaching clinical plans. over we now are data our in orphan of providing addition, and of online we leverage to this consisting patients

in and adults migraine, hemiplegic and where are future a channel these other pediatric both there to blocker be neurological may development addition considering ideas populations. believe beneficial In in calcium disorders be may we we

candidates. Phase continue proprietary in novel options XXXX While advance to also focus our potential developing trial exploring this of a ourselves, X for we on we to pipeline partnerships plans with to product into a XENXXX. In product potential are advancing we are CNS-focused sharp for progress intend summary,

we from X to Looking ahead a present and to TMS points, data Phase key data expect pilot XENXXXX clinical May. interim in our read-out study

to initiation package future believe an we for as patient Phase the validation X populations in in both of hope and our data support important we that PK noted, validation plans As point to have XENXXXX PD represents development clinical of clinical year, end. half followed the X completed to a support we of X trial. Phase In be XENXXX having also X proof-of-concept Phase XENXXXX by this trial anticipate by second year the trial Phase

Phase preclinical In novel modulators our assessment ion opportunities pain events so partnered number be evaluate for creating far the around efforts for to milestone in completed for by final of Guidance to external programs, ongoing to an Genentech. ongoing we pipeline our value opportunities. oral excellent continuing. Genentech and with results In developed molecule and ahead of Genentech inhibitor progress focused research potential look NavX.X developing is once promising on we made a completed analyzed updated our expand the GDC-XXXX, collaboration addition, believe are novel this Overall, small of our the continue to ongoing we inhibitors we've of year NavX.X near-term. clinical clinical future selective trial of of pain. both GDC-XXXX the channel internal a will is which treatment the studies our treatment development has X and of product are

to like I'd Ian? over turn discuss financial results summarize matters. Ian this our to for other to corporate XXXX Now, and

Ian Mortimer

with announcement our Thanks of details year-end comments and cancellation also of Simon. shares. I'll Teva license million XXXX level common on high our our anticipated today financial on and statements provide termination the I'll X some provide XEN some the on agreement

XXXX. XXXX of and million our $XX.X million securities December So, as XXst, compares and this of as equivalents cash $XX.X starting financials, and December XXst, cash were with marketable to

is income December The other $XX.X was preclinical This was XXst, discovery in XXXX, primarily did significantly spending and development increase the decrease that in was $X.X for attributable activities development for by this expenses in to developed the compared in benefits. statement $X.X on and a XXXX which million to decrease ended XXst, increase to $X.X partially December December same change million was and material for as $X.X the as primarily XENXXX. not for million million on were well on no XENXXXX $XX.X was administrative Other of longer in and $X.X compared to XXst, as increased million focus as business as as XXXX. well candidate as expenses, comments the same were I'll year The expenses XXXX XENXXX spending being my Research salaries programs XXXX period period costs a year XXXX for is on General year ended offset and ended the for period for acquired year revenue well XXXX. and a the XXst, million to in the expenses. expenses. ended April December XXXX. for million internal As increase not compares $X.X same million, of collaboration attributable income

So, December overall, well attributable to revenue, XXXX. the as for lower change $XX.X million ended higher same primarily year in as million the to R&D The expenses. the net loss is $XX.X XXst, compared G&A period for XXXX, higher expenses,

to any continue revenue resources development This anticipate plan the excludes having into financial assumptions, XENXXXX optimize cash and flexibility new supporting Based existing or and on to cash operations mid-XXXX. our optionality. generated partnering revenue. of fund XENXXX, any which to prudently from sufficient We we our include arrangements clinical fully manage our or partnerships current

year receipt We collaboration of agreement We collaborative a results agreement to is develop agreement. our has Teva also us announced no the to and TV-XXXXX. This informed Securities shares and intends an term X of an end and million entered common it Teva that have license mutual longer was today to Commission, by had year. expected of transfer they agreement our the the read-out to that agreed after key Xenon assign after Teva into last that in termination clinical mutually agreed hold. currently Xenon order our the Ontario to terminate our development Subject from TV-XXXXX terminate

solution cancel including fewer will certain a very this patent We return will then certain shares or Xenon accretive know-how also This believe for rights of Commission, to which common returned rights our X of the will receipt these and and X.X%, business intellectual to to decreases from us filings us. shares Ontario shares. is We Subject X shareholders. assign all the Securities to and good million million by million outstanding is are all have and IP part we the approximately termination. order transaction and outstanding post-transaction. Xenon shares Teva cancel regulatory as property our

summary, and Xenon. Simon's to we're programs we're our plan to in We strategically efficiently of on So, milestone XXXX important to comments, progress promises and epilepsy inflection points and our poised on value-creating be as and order to our for drive build manage cash -- operate our year programs forward continue in focusing an a to important intend our create proprietary resources to reach a year to runway. very events. key very resources

opener, interim We in Conference a from upon study data earlier ezogabine, program. our interim XENXXXX at XENXXXX results including for Phase and TMS And data EILAT KvX our pilot from trial, pharmacodynamic from derisking mid-May. data the the are believe build results these presenting benchmarks relevant to which X excited important noted, an the preclinical be are generation we as

hyper observed feature As activity anti-epileptic current of questions PK, drugs. drug we'll able cortical to and CNS the excitability, be exposure, on with answer XENXXXX a importantly, around early marketed

for forward now path as the We're Operator, program to and work Genentech determine We the can XENXXX. on partner to updated keeping programs forward our progress we also call excited proprietary open as for of our questions. the throughout with continue you prospects look we well by XXXX. optimal up our

Operator

line Maury you. question the of Instructions] Thank Jefferies. first comes from Raycroft Our with [Operator

open. line Your now is

Maury Raycroft

updated. Hi, on good afternoon the and congrats

those? or So, you there you wondering allowed XX data? do that so, for still additional were the completed from if the testing factors to have discuss patients? then And eight start, some you you all mentioned that can negative And of data gating patients? patients any have the Are I'm to continue study; the positive you these accumulating

Simon Pimstone

interest. its Obviously, a Maury Simon. be like anticipated this question of Yes, would

most have study. data the We that from pilot of

QAed in for really started the this the and then and data. disclose that to -- the data But today to got as already fully the we us that position was dosing initiated QCed haven't we us so informative able optimize We obviously, was model and study and aren't indicated. a allowed crossover and we've be study to

over read-out and -- So, program. to seen And prefer it and at very chose coming not but what a we're cleaned, data We're study. database on epilepsy relevant to I potassium this think the be to pharmacodynamic is very to point, this the we'll by ezogabine, in important which want -- fully that excited We weeks. once of excited data the channel lots meeting announce so announce that very a QA, will QCed we'd at the just a thereafter it's by is relevance very mechanism. And and mechanistic direct we be published because interesting cautious was Madrid.

Maury Raycroft

motor will some threshold. we data I've Got And ezogabine motor very resting in would present for seeing the out to active are ezogabine of historical the May, and on guess it, we there? what data threshold data when the benchmark to to historical that measures able compare what -- able data; be And that's to be some you I good.

Simon Pimstone

XXX the paper This a reported you answer for ezogabine which was was ezogabine be milligrams. Maury on that a dose exactly on report The the reminding is single what to in dose reference yes, able tested at we'll highest was XXXX at [Indiscernible] ezogabine. was

the TID milligrams was for may AEs. the associated significant quite XXX recall highest with TID You dose that the was drug, paradigm dosing regimen

and ezogabine much have threshold. we'll the doses, able think we be compare but will we directly lower to have motor using resting to we'll So, with --

motor be effects EEG the the as as, drug measuring also parameters of and We threshold. on the well monitoring will most as

initially report we ezogabine. was compared will expanded an with to what So, have reported

drugs actually literature, lamotrigine. EEG go you including measured of like lacosamide to and other sodium modulators the with If was a anti-epileptic channel number

both EEG EMG and with but ezogabine, literature. the mechanism compare other be drugs and able literature XXXX, on to now with see as in anti-epileptic contrast so measures we quite other also we'll with what And there's drugs a same

Maury Raycroft

and Got you the it, dose XXX dose prior that XXXX you and [Indiscernible] I be looking range that's XXXX? non-human there for out mg And on some could if the ezogabine for data? think of helpful. And that's for primate for you data with the can mentioned comment the XXXX

Simon Pimstone

Yes, we can't the X a will to make speculation as dose Phase forward. for going what be likely predicted

Our hopeful the prediction going about hasn’t is one-tenth dose the that across very into we're study which for ezogabine has affected that of models. XXXX multiple different in-vivo

the but are is in-vivo predictions on will at obviously, at point. on this they Phase we was be doses interested effects whether out keeping would in looking with so And use the we doses in will exposure X study would course TMS be see just observed Yes, of issue updating what we the with than around be ezogabine, our other based based speculate lower that I we we think where can't similar data, study. be in

dosage XXXX TMS, we'll a we'll our it be won't PD based a understanding. what like for have And good have just the relative try also and human a observed PK, with ezogabine. was to looks what So, sense on bit of PK

a remind or patients. single then dose are a subjects, you these it's -- are single the pilot crossed these then They in whereas just placebo. washed active study, to they are other out not has And Although, and volunteers over been sorry the or individuals and selected on arm. into these small the in that active either drug with are the treated crossover, numbers dose fairly

Maury Raycroft

the on XXX; is Got then that or in it. question last interesting. improve with agreement flunarizine holders? the Thank Janssen the something very molecule drug IP in is being do is is any this for you. XENXXX, And licensing sounds or function? there around question you other ingredient or IP else And drug's have The flunarizine active there may

Simon Pimstone

a so Yes, there. few questions quite

looking protection an are obviously an flunarizine for strategy orphan indication We in the orphan for at U.S.

the from think ideas about at certainly I IP. to some and drug We've perspective. today, disclose but -- looking ways don't a play mechanisms other those ongoing which out. We protect good lifecycle we are have got want other to some on we ideas will management

We have data. agreements with and into regulatory license to cross-reference exclusive provide which clinical us entered access

to need in body So, we is limit work the and data try that. have of able to rest reason clinical of to would of a very amount early a The very that the do world. clinical cross-reference be preclinical on and and large position done. obviously We're that good regulatory to

position an have exclusive referencing. that cross on We

-- the focus be are going long at longer also into we actually six detail term exclusive strategy looking to maybe that's different that may folks. But at this pediatric in We by property lot least even be in point. IP place, do can go the different -- it We seven that an protections. orphan years arrangement, although, and any extension want of I provide plus put months because have least, manufacturing other in protective intellectual The will manufactured ways, at a that have think, drug routes protection. we just at don't be we would

Maury Raycroft

Sure, makes sense.

you Thank much. very great. Okay,

Simon Pimstone

Pleasure.

Operator

you. Thank

comes Our Stifel. of the of next question Willey from Stephen line

open. now Your line is

Philomena Kamya

Thanks couple that still we're the Philomena Kamya a May. have to just in Hi, I this questions data receive our Willey. is for Stephen in questions. of on for going taking

going eight receiving So, subjects, the healthy from that's -- is be eight we're healthy this Just to the data from correct? TMS subjects? the

Simon Pimstone

That's correct.

You're capsule also formulation, explain in in on the solid powder dosage cohort just and the a going a overview to Phase receiving interim. initial And be an study an and powder we've have run we X reasons of the first to X. reporting But we're of Phase be developed into X. the to will formulation Phase added be the form going form being the which capsule

Ian Mortimer

is Xb it it's all and under we've one Phase Xa. Xa way is component think So, on -- to the there's yes. protocol, a read interim Philomena an about the and but this

PK that So, on in were XX study, to where and through have a TMS gone there pilot the addition subjects safety data have eight tolerability. we'll subjects

which component, PK right exposure subjects So, in the informed Simon, And of look that be the subjects double-blind pilot the really to May presented as and and in TMS therapeutic index, is that's well. have of, healthy at eight we'll XX on drug the design ongoing to then trying kind in terms able us in on data analyzed placebo-control reviewed on Xb now. the this detail is of that

won't be by it this will May, a but available available data be that year. So, bit little later

Philomena Kamya

Perfect. this Phase the And to running X pediatric X terms XXXX, for population, the in be parallel trial clinical Phase parallel trials will so -- potentially of correct? the the in in

Ian Mortimer

the program? program pediatric or a pediatric parallel talking adult parallel to the the from you're mean now, referring you're not you're -- the about to You referring TMS -- different

Philomena Kamya

is That correct.

Ian Mortimer

would Yes. we I we we'll have finally go ways the or based plans. few mean of expect a on don't weeks we mechanism. say There couple and point, Philomena at this we're that done. can the Phase months, have finalizing this a I X it are over our with coming

ezogabine, focal refractory was focal It's is course largest of the There's a the the to And seizures. XXX,XXX product, already adult with formulation-wise probably dosage well-suited. number probably U.S., seizures. that first in form X.X XX,XXX patients. focal patients generation million approved have in Of refractory pediatric adolescents seizure adults solid we

might with that a complex but it very of model common that form adults. us options in epilepsy. a childhood and and strategy present more it's Dravet, in phenotype, the as focal but is developmental tonic But childhood well impairment. because be XX% probably seizures, substantial that would list patients an interesting common Lennox-Gastaut These seizures in epilepsy both it's course delay This interesting of very which occurs atonic of it's It's epilepsy, seizures. we're in a other be of orphan about are an for a exploring complex one, orphan as intellectual seizures, quite Of top syndrome. less

it, traditional so way, with could step-down the like medical the by high do an the orphan with a strategy And very is need. approach Lennox-Gastaut unmet taken potential be to

with individuals poorly treated So, are these existing the AEDs. very

we the you strategy strategy we'd so [ph]; complex, sodium into heading. degree key announcing this wouldn't readily third FDA clearly that's focal think is ultra-orphan as in young solution make discussion see channel, is to in these work this probably get has a particular some months a not form. can of well. of And young. do degree to is couple is it's loss adult programs the which be a is It do started, a such very position two parts go very to a toxicology one very or infant such mutations in as can and that drug run strategy parallels in I still AWE There and That probably EIEEX, regulates channel. into KCNQX we in gene is in The these you in in modulates as in actually m-current to the a good this this where going kids be a -- how run be the go able need choice EIEEX. It with to be And ultra-orphan the to function epilepsies then be completed. on We'll we population has may the but next juvenile different really particular programs, truly of the parallel. soluble, focus to where a some the completed. LGS be the formulation; that it requirement will still but will decision pediatric these

run would the parallel timing optimize the just we also population in juvenile infant may engage exactly need FDA out strategy But in not certainly of an adult a hand support we And to like from the gate four-month with we tox. to the to and standpoint, So, tox adult developments. tox hand. as phase formulation X without safety the next Phase with finishing were remember, the be,

haven't tox. So, done, but juvenile in-life done is yet we

young any we requirement start work. So, before that development will likely be pediatric a very

in a toxicology fairly program, including even what population some development Or LGS in maybe So, a look is or to strategy our tox and X age an cover thereafter you're of may work Phase in to obviously completion to adult with that the see trials would step-down likely and focal pending get juvenile FDA formulation into as discussions those pediatric those adolescence. protocol the seizures soon and groups of which to likely population, like. summary, on a a traditional think I what is commitment

Philomena Kamya

Okay, And the I about if one on the question perfect. in more just preclinical potentiator. squeeze work could

it's compound-- correctly, a dual heard acing I NavX.XX if So, NavX.X,

Simon Pimstone

acting. X.X, dual X.X

Philomena Kamya

X.X?

Simon Pimstone

Yes.

Philomena Kamya

for perfect. Okay, the Thank you clarification.

Simon Pimstone

program. Yes. That's No problem. a backup

As a activities, I one. got to of alluded that's backup number we've

do that to come development NavX.X work a at we expect this period. XXXX, out And have guiding point candidates XXXX the potentiator. that We of over we're

Philomena Kamya

our taking you Thank questions. for Perfect.

Simon Pimstone

all. at Not

Operator

you. Thank

comes of next Burton. Our Martin question David from line the of Bloom

open. line is Your now

Unidentified Analyst

Its [Indiscernible] there. for on Hi David.

questions. couple a Just

XENXXX program. the flunarizine, the to related First

us And information the why not drug, of If U.S.? -- or you maybe the can approved give the bit more it an have data the license on a in history was then do license not? exclusive on

Simon Pimstone

Yes.

the question first. answer I'll second So,

U.S. exclusive development. to an have data We the for license reference

-- years was to U.S. rest It's hemiplegic coming generic worldwide. the frequency on precisely decades. more hemiplegic a the no second thing code you own a has XX When including of ICD as reported of significant that one got it's for distinct effect number to has patients as a a generic name being its of drug probably We showing well. migraine, its for complex we a few distinct and There's Janssen, in a a world. patients They question, is migraine -- now attacks. of strategy product. as entity and the it this is These so reports we the considered of have one been the -- in bit of they motor bit drug study of really is it's compound drug has literature, reason actually the much by an that complicated. in because developed this in observational orphan a It's severe. syndrome. in of think we it never the forms have around hemiplegic Sibelium have weakness, common think abnormalities. literature quite actually data think more these the as there's And that is a migraine It's case hemiplegic own On fair It go Unlike been genetic data trade bit subjects. and the attacks for well now sensory reducing etiologies. migraine the

a there's randomized done. been Now, never controlled study

literature channel migraine. with actually and patients is world in use is caution a for patients with with migraine rest in the channel of but the flunarizine migraine some hasn't the around hemiplegic not an verapamil, use migraine hemiplegic does fairly the wide the stated, lot around CavX.X put think known the and a just very as So, is no through blocker, in calcium this CNS-acting about migraine thought potentiation. off-label, developed the the but flunarizine channel problem cardiac are blocker which orphan HM, mechanism has it's these calcium in is well-suited quite patients blocker. first-line is drug. it, treatment this drug genetics such in of calcium the have drug patients the a calcium cardiac as Interestingly, of there used most channel U.S. in used a inhibitor. we've a flunarizine, for majority in acting cardiac It’s a is But fact the hemiplegic anyone the the I tested reason orphan inhibitor, don't on is of it's The validated and think strategy of been a which has hemiplegic as U.S., disorder the been to the that hemiplegic is already we for verapamil, indication.

Unidentified Analyst

for there Okay. other other application? compound And any migraine in of developing are target any targeting or terms CavX.X, companies

Simon Pimstone

our to Not Not knowledge. to our knowledge.

Unidentified Analyst

Thanks. Okay.

Operator

no like back the time. showing at questions to turn I'm for would you. this to I further Jodi call remarks. closing Thank

Jodi Regts

today. call. progress. joining we Operator, will We for end to the now us forward updates our look you Thank on providing

Operator

concludes and participation for thank you program. today's in Ladies gentlemen, your today's conference. This

day. disconnect. a have now may great Everyone You

Xenon Pharmaceuticals (XENE) 7 Mar 182017 Q4 Earnings call transcript