AXSM - Earnings call transcript Q4 2018 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to the Axsome Therapeutics Conference Call. Currently, all participants are in a listen-only mode. [Operator Instructions] As a reminder, today’s conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, Senior Vice President of Operations at Axsome Therapeutics. Please go ahead.

Mark Jacobson

operator. you, Thank thank conference and for us joining Good you today’s call. on morning all

press corporate on quarter Our of providing ago crossed release earnings a short a at financial ended XX, time for www.axsome.com. the year wire the is update results the website full fourth available and and December XXXX our company’s details and

investments. use these certain other differ current During statements future future that research contained today’s plans, intended Exchange that investigational from regarding and with statements reports. our among and involve things may non-clinical These expectations and periodic change the to plans efficacy, on our These our intended filings uncertainties made in risks plans, forward-looking utilization call, source the risks subject These regulatory and and we assumptions results materially report to quarterly in based agents, of conduct forward-looking will of are actual are and Commission, and and clinical and described present information, of development include to Securities other may statements. and trials, the be statements. are additional and those the making including the anticipated safety annual our clinical cause and forward-looking statements data, cash or possible

any You are disclaims such statements to obligation cautioned company not to the update place undue forward-looking weight on and these statements.

Tabuteau, Dr. Dr. the Chief Officer. on Nick ongoing Joining and O’Gorman, Officer; will milestones, first Chief corporate and and are late and provide stage Vice significant Pizzie developments an review then of Herriot will financial provide will Mr. upcoming Executive Clinical review programs Pizzie, our me following on Tabuteau results. Development that a President Affairs; clinical clinical Medical call Dr. Dr. O’Gorman today our update Senior Cedric of Financial and

for to Herriot. shall over questions. We the now will I turn then line open the call

Herriot Tabuteau

quarter disorders, fourth Axsome a so patients significant goal steps serious that XXXX conference you options treatment with this have and for to momentum and call. all CNS results that year. disorders. for committed Mark. by Axsome this underserved for Therapeutics limited you, in is thank Good morning, medicines everyone population many is full XXXX Thank continued We joining year novel far these of and took toward the developing

a some advanced candidates result oral As novel, and trials this AXS-XX, by our But year, ongoing my candidates, I months NMDA with wanted last we all in clinical differentiated we activity. AXS-XX, active of speak product about antagonist detail receptor in on our team, ongoing share of accomplishments thoughts of clinical multimodal will and XXXX shortly. with AXS-XX efforts AXS-XX, clinical six across have Since now of our to development first, indications. our with these CNS Cedric in trials different the have opening time XXXX. our three

X/X disease. unveiled In AXS-XX product depression X generated the have new in with Phase candidates clinical trial announced analysis Phase and internally launched in in new trials of outcomes of and the XXXX, associated We we interim STRIDE-X AXS-XX agitation of resistant positive treatment ADVANCE-X Alzheimer’s of trials indications.

the we depression treatment AXS-XX of regulatory to In for indication significant path the study in to to months, treatment disorder, with we intend X candidate our active compared to AXS-XX antidepressant positive development a to as MDD the allowed discuss AXS-XX of MDD also time in comparator. and acute resistant of in indication. to of the and develop addition or Additionally, AXS-XX little broader the now substantial for FDA XXXX, Phase in quarter for these product X the for for rapid ASCEND and plan major meet the of second more we an effect demonstrate initiated, MDD. on than executed first the trial Based completed depressive results This continued us migraine. potential statistically

we CNS subsequently to disorder. of received for of drug AXS-XX, designation treatment expanded FDA addition our orphan with product We AXS-XX product AXS-XX for portfolio candidate and the generated AXS-XX narcolepsy. In addition this the for internally disabling another

we As pain and our value by our were portfolio, Care Axsome. care and in assets. AXS-XX AXS-XX being primary developed and a product we PPC by are growing and on of is candidates portfolio. the Axsome product intellectual Axsome’s PPC candidates, covered or focused the called separate housed unit enhance neridronate And Axsome which core Two the of one business created house Pain CNS of Primary to non-core property Axsome directly

based AXS-XX, well of a of XXXX and operating plans. on all ongoing This million, have trials to with AXS-XX data beyond clinical of quarter which XXXX clinical at addition into financial strengthened start. $XX runaway cash financings, for our total fourth current is our expansion Axsome’s expand is the already least also to our the readouts In busy off we significant development AXS-XX. position. company’s considerably recent portfolio,

a and In top addition line X of AXS-XX trial have trial X our Phase MDD, the X of from MOMENTUM recently to Phase Phase we trial ASCEND CONCERT launched in AXS-XX of results AXS-XX positive reporting in in migraine. narcolepsy

MOMENTUM from treatment the depression, of Phase AXS-XX disease STRIDE-X of coming X of CONCERT Phase quarters. narcolepsy, top trial Phase Phase the agitation quarter X MOMENTUM AXS-XX the migraine in CONCERT We study and of assessment quarter acute trial conducted that of Alzheimer’s over the all in resistant with the past is accomplished from results the are team trial AXS-XX trial in our results protocol the in of I study XX smoking the cessation, months line line of proud being of X look the the in over treatment X ADVANCE XXXX. pursuant the the to and FDA. trial of expect AXS-XX of XXXX. AXS-XX special the of The Top has through in top narcolepsy in AXS-XX from line study second Phase expected am in MOMENTUM a we AXS-XX results migraine forward first X/X to

ongoing regarding For detail will to turn more the programs, over I call these Cedric. clinical

Cedric O’Gorman

clinical Thank on to am of and you, ongoing an I the five programs timelines provide CNS status our studies. these and Herriot. update And pleased review

a our XX% and us four number a antagonist of indications; the with smoking and in investigational the AXS-XX line treatment being and depression consider of AXS-XX. is Alzheimer’s in depressive programs of that fast we novel disease is of treatment subjects top XXXX. Let FDA second treatment being expect target STRIDE-X active oral To-date agitation. blind X AXS-XX designations double evaluated disease assess controlled to resistant multimodal trial multi-center receptor resistant study track the been of depression. the depression, of with into have approximately this AXS-XX NMDA resistant agitation from first the treatment clinical separate Alzheimer’s is trial STRIDE-X for The activity safety disorder, major cessation. efficacy in is quarter randomized the randomized Phase data trial and treatment granted

Scale statistically active measured by pre-specified in blind using mentioned X of met controlled moderate primary the Depression Herriot or in score patients January Phase this randomized the active year confirmed Rating multi-center ASCEND with for a U.S. study, depressed MADRS As we this to and comparator to substantially rapidly point AXS-XX of compared reducing symptoms trial double total announced as study, significantly bupropion. results MDD. the depressive severe positive the AXS-XX end Montgomery-Åsberg acutely In

versus from X A to NMDA achieved the as Additionally, statistical has developed depression. the within successfully approved baseline. first receptor bupropion be the treatment AXS-XX was early oral of antagonist weeks significance potential as for

planned of will previously results evaluated are performed number subjects, first for FDA ADVANCE-X target to be controlled this to disease. Phase the at randomization followed for longer the been scientific the of the Top in The safety agitation in a analysis has AXS-XX efficacy in of change been final AXS-XX Axsome quarter committee, intensity. enrolling outcome We the with power study of Axsome double-blind, Top XXXX, The of evaluate are to December the smoking number interim attempting under meetings, statistical of University AXS-XX randomized in subjects measure associated being for no Phase results an developing an trial is smoking quarter broader of the arm controlled futility meeting XXXX. expect in of analysis. is for with discuss patients interim was regulatory positive in preserve the multi-center results and further of independent conducted smokers to study, randomized results in the order line arm. the to this with AXS-XX X bupropion collaboration The the Duke double-blind second trial. continuation treatment approximately over research of a X/X recommended XX% being path present anticipated treatment treatment the Today, line it’s trial also second MDD and XX% IDMC’s subjects is data upcoming the analysis the further recommendation. XXXX ADVANCE-X the trial the anticipated in have for X/X half to in details cessation XXXX. randomized Axsome. primary by Alzheimer’s Axsome The Phase announced between potential just is no analysis have monitoring In of of target trial. second which randomized, Today, conducted in indication. trial. the and quit. interim

a The associated endpoints patients the this after the a X migraine dosing of are meloxicam results hours provide the after Meloxicam or of is AXS-XX photophobia, dosing. consists of non-steroidal proportion the February discuss new is to and is bothersome from no free anti-inflammatory quarter suffer migraine longer co-primary which XXXX. are is reached hours reduced technology rizatriptan. rizatriptan headache symptom In with SPA MOMENTUM in Axsome half X trial first our nausea, month entity in for special FDA plasma recurrence. is with while and XXXX, study. MoSEIC X-HTXB/D study maintaining complex for statistical I MOMENTUM who enhanced drug and preferential and COX-X along this proportion and endpoints a of under and will solubility molecular by rapid data in enabled two or of the design enhanced most pain assessment Axsome’s the study. acute their Now, AXS-XX molecular migraine symptom, commenced patients AXS-XX consistent protocol agonist. who absorption approach from agreement the MoSEIC trial, expected relief of and this a designed Enrollment meloxicam migraine rapid, phonophobia, of Meloxicam life. inclusion of

for in placebo-controlled describe double-blind will X crossover which CONCERT a the CONCERT highly multi-center X Finally, Phase developing selective trial, expected attacks, of potent of measures reuptake a narcolepsy. is Axsome cataplexy like XXXX. is XXXX. has just AXS-XX of the now and oral symptoms and study AXS-XX quarter norepinephrine I provide full the is trial to would other frequency of assessments of to This second would turn study line for the randomized like the to financial top Efficacy to narcolepsy. call novel, the Phase the include and is treatment of our trial. year I over inhibitor. of Nick The Reboxetine commenced update data

Nick Pizzie

financial greater Cedric which Starting proceeds at from and discuss morning detail. cash full December had everyone. year XX, capital balance good our recently the I million new growth we $XX be covering will completed and financings I term sheet, Thank at-the-market including in this with on loan, you, in call. XXXX later approximately will equity results XXXX,

compares at million XXXX. Our $XX.X XX, cash to was balance which December million pro $XX forma

administrative clinical compared XXXX. $XX.X We results is share increase December million from million operations, $XX.X in capital $X.X million million security increased loss attributed of into upon Silicon year with direct associated to a in Phase amortization In through Interest manufacturing startup ended interest our the XXXX be $X.XX XXXX, balance primarily and to driven by to our as the as entered expenses debt in STRIDE-X agreement million we costs of compared to statement ended lower company $XX.X in from This was expenses to Valley Silicon will and the COAST-X million. were increase XXXX, a achievement XXXX, gross associated million and $X.X driven and above narcolepsy. was and have to per the current for term offset financings proceeds offering gross XXXX XXXX ongoing as which and sheet Operating remaining XXXX term for the March fund loan received Bank. to loan with sufficient $X.XX of in growth The were of closing fourth ADVANCE-X we $X.X for XXXX, strengthen of of proceeds Research our in incurred and available or trials. equity Turning and company with public company be of million operating by believe expense a due million the as Bank. increase under $XX loss upon including X ATM by discount our cash of led the increased quarter expenses raised previously and company the year to the received XXXX share. million. per the least This fees our facility. XX, XXXX reduction of million. the operating million by from million our initiated This secured facility net initiation October fully personnel requirements and and million was $X.X of facility into as XX, through AXS-XX To $XX $X.X an AXS-XX to study decrease expenses was and an the drawn study, in including costs cash $X with the sale Valley the development positive trial January In as costs, completion registered CREATE-X the of ATM that in XXXX, cash further increase XXXX higher loan tranche costs, $XX XXXX. $X.X offering of in compared AXS-XX anticipated of well agreement million external a $XX utilized $X.X XXXX compared million in million in our ASCEND Leerink. proceeds December $X.X was of January in at with costs. position shares with million position million XXXX, trials $X.X $XX.X our of or March of legal of $XX General

readouts CNS over our our extends Importantly, discussion. this our turn clinical for trials call back financial product of ongoing will That to the Mark the Q&A candidates. data the lead beyond review I five all with concludes XXXX runway and to

Mark Jacobson

Thank you, question. our first Nick. have Operator, may please we

Operator

conducting Thank Thalmann. Kaplan question-and-answer be line line our comes is Instructions] the session. you. from At with this Matt time [Operator Ladenburg will Matt, open. first question we your of Your

Matt Kaplan

as just recently the for maybe AXS-XX bit? this design this you question have study year. narcolepsy, guided morning into congrats study as wanted good of guys program progress and bit, you Hi, guess little on is the the I talk a in execute I a to can your dig can quickly it, you about the how you started little

Herriot Tabuteau

us it Matt twice. a using with of Cedric Thank discuss design you, crossover that complement for the question. while I controlled to Cedric turn projections over which allows trial. And really will randomized is we is a an as regards our trial will who of enrollment, discuss, utilize are design this the the to and full to patients the will for approach

us study that we powered fairly rapidly. to So in difference other we should number diseases will believe subjects design. discuss situation. applying study and is over smaller taking allow the in those of this words clinical we adequately turn the them Cedric And do And to treatment some enroll to offering to of because experience I detect enrolling are while the it to and have the the studies trial learnings

Cedric O’Gorman

Thanks Herriot and Matt. hi

We who experience with worked in identify patients sites have narcolepsy. the field recruiting lot experts have have in of that to a

to increase in subjects as other attacks The signal that study. of to narcolepsy about to will followed as would placebo as placebo and on measures one X randomized further will those daytime XX essence find for and would the cataplexy soon AXS-XX be sleepiness outcomes a an sites such a receive further crossover then X And excessive mentioned, for the narcolepsy. but of will for weeks made X to more regard AXS-XX of well would to in with that to power measures be really and seamless effort the the study to we subjects. having relative study weeks with go allow and clinicaltrials.gov it’s access Herriot design, So, placebo in for be AXS-XX to database be subjects posted crossover it go measurements with The will then crossover the weeks. subjects or detect

Matt Kaplan

you Okay, for give And ago, SPA the AXS-XX, what’s SPA can then that’s very just some the helpful. in a this Thanks us Phase for FDA announced it? time details on details. you the with short X and study the included

Herriot Tabuteau

criteria the is with of study, including study, the a the FDA endpoints So, in trial. an the successful, the the would regards design endpoint the study exclusion is of overall registration inclusion the now to count point the as then of and the the then SPAs it’s SPA, as study if so the and well the agreement with study of analysis importantly trial trial. on And in specifically statistical the the that primary as the

trial exclusion also So statistical importantly a and analysis. criteria really it’s design, including inclusion endpoints and

Matt Kaplan

in able for the And being that file approval terms on SPA? a single is in included of study, to

Herriot Tabuteau

is specifically That the SPA. in included not

process the However, process, NDA. file to is during that believe during upon SPA only from needed SPA do the we we and X something that one order Phase agency that based the an trial explored in maybe the feedback

Matt Kaplan

terms in talk your enrollment a terms about Thank there is agitation And and are that more progressing in can study? the then you how of just of the of of you. couple progress study, who thoughts questions Alzheimer’s are you in what

Herriot Tabuteau

Cedric. turn will Sure. over I that to

Cedric O’Gorman

with the target enrolled. Yes, XX% of this very study, is be progression to pleased of number where subjects approximately

that on the first we XXXX. of line half We top in have the data guidance track are for for given

Matt Kaplan

for business development your about PPC? And Axsome the how thinking about opportunities you question you remarks you that, talk some company and of mentioned subsidiary, PPC prepared presents that about the are last kind in can

Cedric O’Gorman

we important an the X Phase pain, three is is but in development shareholders. Axsome which and it see Axsome only product does also trials so opportunities. business and certainly osteoporosis. include You one company are It asset includes that for some that PPC also large does it correct for indications, the way not pretty it And present of candidates and

those Axsome the to visibility assets PPC into regards increase So, why development we reason place to business opportunities. their was with

as could view the returns monetization, pipeline, source help shareholders. certainly generate of to And for fuel we but which these so assets reservoir potential

Matt Kaplan

questions the the taking queue. back in I for will Thanks jump guys.

Operator

open. question next of with BTIG. Your line from is your comes line Hazlett the Bert Bert,

Bert Hazlett

one Thanks. One then and XX in or the beyond. and two XX on progress on XX, on congrats

bolster cash trial in is Xs might in there perhaps typically Phase bolstered – series guess substantial for done running then indications another run for the position, have in a another looked you to you parallel other and looked I instance cessation X the be chance MDD with to with moving one moving for Phase X forward? two So and that or smoking Phase

Herriot Tabuteau

Thank Bert question. for you, the

and So complete financial we us as of out in complete bolstered definitely us trials. which allows that. Right flexibility. do have does us added provide have position puts our which we a to clinical very now, laid our is situation plans trials and well to a certainly comfortable all our ongoing beyond are with cash It ongoing clinical

our We is for data And we several laid out. remains it have if but up read plans now opportunity there have and coming additional investment outs seen be over quarters. the next are them as right numerous to

Bert Hazlett

you. Thank Okay.

intention, second indication STRIDE-X other mirror the So you X forward trial? are in in can – quarter, is getting there study to Phase best assuming and in your that then in specifics simply another TRD STRIDE-X assuming as that is now project possibilities it the to success the success or in move it of just

Herriot Tabuteau

of need least in success at we resistant that whatever the we trial led replicate STRIDE success. do Assuming try depression to and STRIDE-X trial certainly another treatment would in elements if

broader MDD the as in do a ASCEND in the with of discuss the remarks, the in are of we the FDA to – positive discuss have we for prepared MDD Phase our potential anticipate We we in second in order quarter path regulatory to X light that with indication. year results trial this indicated in meeting order

So FDA then once we we updating with would the meet anticipate you.

Bert Hazlett

that arms quick one do treated that. that’s separate for be just just you meloxicam in it trials, a how placebo here, statistics is or then from it of have just on involved? And are important and Thank going Thanks color the more one to AXS-XX, or Okay. you. trial separation bit the on statistically those little rizatriptan form to

Herriot Tabuteau

on we rizatriptan MOMENTUM include the of does So acute placebo or arm just so trial migraine, of it are individual treatment components clearly But have the meloxicam for superiority a brief do components. between separation a of looking we trial. and AXS-XX arm to it’s a because the background arm, over and arm the for show four of two the placebo. AXS-XX And AXS-XX

rizatriptan arm. to have show arm the meloxicam over over superiority would as the we well So

Operator

open. Your Charles, of Cantor. next question Duncan comes from line Charles the line with your is

Charles Duncan

TRD is into in that probabilities the are just am Thanks success, think my for on questions. may on the of key some one morning study On enrollment elements success? indication well. criteria may what trial to XX all, first that you study, the on that guys. us treat couple the are XX patient of key result XX if I the Had as what and remind Good of you taking whatever a the and have you this designed can a TRD design being elements or that tough of a wondering enhance

Herriot Tabuteau

Good to it over morning, Charles Cedric. and will thanks for turn question. I

Cedric O’Gorman

the Charlie. Hi, Yes. for question. Thanks

of XX%, know, more failed in in if definition the episode. you in and dose not their be more that’s terms to having disorder So treatment that as depressive are of two of commonly recognized patients adequate resistant or close deemed anti-depressants depressed to major duration

So these we be study to able very been to patients in resistant. STRIDE-X categorize treatment have as truly careful

medical documentation they failed episode. two good coming So, to adequate dose very, and one have in when clinical depressive antidepressants of that duration or they there their study, are be needs very the into

prospective those for to randomized bupropion X stage continuation who with antidepressant have is the control we have of adequate identify of the failing are that is for weeks are X are importance bupropion leading an who initial of only a prospectively after an us are who depressed allows AXS-XX treated patients of now with Now, respond as weeks patients the and this patients failed dose it the adequate study this versus purposes for bupropion and duration of time. to that to of then comparison is of it an

depressed these So confidence, truly treatment are resistant. sorry truly patients this gives us – even further

end So, that now either that failed remain or the open-label, of randomized. two patients at have they point and depressed are antidepressants who more

ASCEND Phase to study. recently familiar that and primary study which episode. are in the use population rating kind So, it’s the sites nice we sure And make And primary you the outcome total broader then a way the measure successful was in who that studies trained ensure in and an X measure really average clinical of then also in patients. have major these correct as depressive the in that score experienced is outcome used used we was

So to I hope that answering comes close question. your

Herriot Tabuteau

mentioned, we And all in patients do are to the also elements appropriate to is implement also study answer control enrolled. that in implement addition Cedric that may measures just I element to our make sure just add Yes. Cedric’s other of one we that if quality

have appropriate to not diagnosis be patients that into is words also who other critical, appropriate in trials. So patients just who but absolutely enrolled and are the

quality of the of high what are not taken is that have but specific as something possible. study those it we So aware are keenly we taking we have disclosed that and that the we are, steps as is make to and sure measure

Charles Duncan

color, sense sounds me And appreciate there provided, has and have the I and a the like of all ongoing that sites Cedric. in to enrolled then makes you of of an it been been trial? Okay, that the auditing that lot types Herriot patients

Herriot Tabuteau

Yes.

Charles Duncan

I OX of on but this be, not defined am question, Alzheimer’s second regard silly on clinically moving And it almost an seem wondering imaging or how is do and Alzheimer’s meant that both? define you kind or – may like through Okay. defined patient, is it agitation, with patient just question to to is

Herriot Tabuteau

thanks, Yes, Charles.

disease. probable a standard have diagnosis clinically there Alzheimer’s whereby the is deemed So patient of to is a approach

of As deemed a the which disease at disease Alzheimer’s of can to definitive you cognitive it Alzheimer’s assessment, pathology patient probable only these Alzheimer’s of to to disease. such know, trials have has the a diagnosis absolute be clinicians is comes postmortem, of approach types diagnosis but when prior that this happen

Charles Duncan

to features migraine unmet then that’s you on see serving need, of Okay, helpful. and consider profile well think for is profile this key that treatment XX, elements the is And target you an do that? what evolving product or the that product why do landscape, unmet think about in that when I of the you is what moving and think product that rapidly guess, is suited you need particular

Herriot Tabuteau

So, thank you for the question.

of excited pretty We’re think – point is do And reason efficacy. that we differentiated. excited differentiation that profile for very the is, we’re really that about And product AXS-XX. the is

one with way MoSEIC efficacy with AXS-XX, we So, together patient and our as in almost is dissatisfaction a deliver technology all surveys, what report patients to meloxicam. put the major rapidly for reason so

acting. onset that with be action with should significantly to that which and so And also then of triptan, help we’ve fast is found considered

we action, efficacy. so and with the of onset rapid So, a we also consistent not action, – do of multiple only but superior mechanisms expect

to design we but remains the the in of that candidate. results of product that, that our was that So, way course clinical trials, seen be the

So, it’s really efficacy.

of efficacy not or Now, recurrence recurrence. it’s another symptom efficacy, the of aspect of just is symptom not action. consistent and onset lack also just strong the rapid but It’s

So, reasons the is pain for comes one dissatisfaction the three that of back. also patient

symptom drug MoSEIC but that we we there a reduce is plus So, recurrence. the is stays and of not think MoSEIC absorption rapid to hour we’ve a around help meloxicam, with what that, AXS-XX, half-life get shown which do that should includes really XX meloxicam, only means that roughly which the meloxicam,

only patient benefits. then terms they Now when you – should in result pharmacoeconomic not should result of of also only in benefit, put together terms in all but not that in that

migraine targeting migraine. as U.S. for what’s there XX XXX% of are treatment million designed and is AXS-XX evolving migraine the AXS-XX the you to the nice in of population. we And acute is, the landscape, terms In of migraineurs about know are close

episodic treatment, will and and the where they require have operative for once and then population. they the have will segment So, do acute chronic XX% receive that’s migraine are eventually the they have preventative migraines treatment candidates AXS-XX the an of patients do and of – are also treatment do, fit who that and they into patients migraine those that will even patients, other XX% population

Charles Duncan

It’s or mentioned action component, percentage for that least you to they rizatriptan cardiovascular the XX for liability to be part population? million or And a question helpful, think of migraineurs going the patient you that would rapid of Herriot. XX wondering component. given in have a you that riza onset wondering regard believe I’m just I’m the the known risk? is One mechanism particular what with contraindications be suspected of the non-issue triptan because use follow-up to have at if

Herriot Tabuteau

Well, benefit. migraine onset to a I be think in quickly action attest want as of migraine we is possible. would – Patients rapid Anyone the gone the pain who’s that. as think always experienced migraine to

to I I I survey, of the which patients, you will which believe you that terms In did a I have the contraindications percentage recently, refer contraindicated. to only actually triptans, – who may in of that conducted survey, speak show maybe the their neurologists the do and of that XX% survey the in that but about were the to can believe to indicated XX% patients you I doctors that, think believe

of majority vast available would be for AXS-XX. the So, patients actually

Charles Duncan

triptans what for related of the modelled callouts to the that have terms beyond and we cardiovascular mechanisms that’s right, you risk. in are always opportunity Appreciate

So, Thanks. and appreciate color that callouts.

Herriot Tabuteau

you. Thank

Operator

open. Wainwright. next Ram from H.C. from the line of Selvaraju Ram, comes your [Operator question is line Instructions] Your

Ram Selvaraju

on those if rapidly Obviously, as profile since – IP of currently thirdly, that on on well Hi, its non-scheduled to there’s all to acid your trial specific if was my ones just that comment course developments could I expected approved be of that the resources? and/or few thanks those of could drugs to for the based to as existing three likely any approved whether respect about you a into reboxetine profile opportunities comment to the Thank you to multiple neridronic And compare are I could There the specifically portfolio have and the have in of clinical as cash pilot efficacy is you going walk EDS, but are indication think what level is pipeline how much monetize you potential if potential with and drugs space? would of remainder scheduled are see the narcolepsy launched existing in you we’ve Secondly, us first programs very additional programs of to wondering maturing new for are cataplexy? wondering the wanted on covered say this symptoms year, was study this I a agent, quick was through efficacy AXS-XX realized and be you. seen on here. the questions. wondering I taking in could majority being by and factored that? granular words over the the if both expected

Herriot Tabuteau

for Thank multi-part you, Ram, the question.

the to with AXS-XX key what about to like is those we and being that be efficacy is symptoms may sleepiness. we address excessive of So, AXS-XX – this two regards and cataplexy it able daytime narcolepsy, so of that think the profile,

a symptoms narcolepsy, associated reminder, that and those there treat of five to product are only the currently products to approved are treat one cataplexy narcolepsy. is of As only with approved

and some sodium many know but including it that is is – oxybate, limitations the scheduled. patients, have fact which for which as product does So is you that effective is

results neridronic of impact currently syndrome. be and we the and relates assessing XX two as disclosures acid trials see mentioned, a treatment is in complex to It for AXS-XX looking portfolio excessive of the a to by specifically of than received X of pain the the complex neridronic the pain which neridronic more IP cataplexy. being Phase to of the developed therapy acid, have lately on is breakthrough potential patents, for large from syndrome. regional public with regards on has compound, complex So, CONCERT getting regional which treatment is the acid neridronic forward cover also reminder, third-party the based issued FDA. pain With it cover syndrome. use patents which a treatment its We acid do bisphosphonate to And we will regional also been have trial for new designation and daytime Cedric we’re as also measuring And really sleepiness. as

to grow. portfolio So does that patent continue

complex was to clearly this potential product is question trials and also in third the in asset our an regional your which terms pain the acid the to programs, that we of with treatment so of regards and the runway. And cash And in regards syndrome. or strong our included with are term the covered guidance for opportunities of in believe neridronic do of given monetization, position patent

that is of runway over guidance And comment Nick, reminder, what as in to XXXX. who on turn it cash quarter will fourth our I’ll is guidance. So for the included into a

Nick Pizzie

so are our Yes, funded Herriot. announced we’ve – studies announced everything that our already current all cash Thanks, resources. Sure. basically fully with

and STRIDE-X with include in expected also XXXX. narcolepsy, the ADVANCE-X along up for the of and, trial, AXS-XX and to QX So be half which cessation that is obviously, that’s does migraine, smoking wrapped the first

Ram Selvaraju

complementary of whether of may potentially you very be or you to dexmedetomidine quick of if space you your efforts position agitation you. various agitation Thank much. ongoing the was wondering that in one view comment of aware particularly see you own context related Thanks competitors? then the efforts agitation. Great. the within Alzheimer’s it as as on if to in up, follow manifestations And treatment could guys And I

Herriot Tabuteau

very disease and some nothing companies So, these is to especially you currently we’re patient distressing products other of treat approved population. always there’s Alzheimer’s treat affects to happy try Since CNS to large agitation. see disorders disease a agitation. It as develop Alzheimer’s it to know

are the need applaud of other as agents. clinical really others the be So, the of do. fact we clinical And that results course, it we the with trials remains the see seen, what to

we’re our trial that about that profile what excited think because know a running do strong really in approach proof-of-concept. exactly think Alzheimer’s the is they’re we’ll soon we and We’re agitation. quality clinical enough We disease

Ram Selvaraju

Great. Thanks very the progress. much, on and all congratulations

Operator

will There back are for to Axsome’s concluding the over questions. remarks. turn CEO call no any more I

Herriot Tabuteau

in the with in successfully living progress our that patients these developed, candidates products We pleased disorders. are lives we’ve in CNS have positive the If changes thus made XXXX. are very far XXXX and the with potential to of meaningful make

forward advancing remainder starting look in ongoing this We our to you the trials second again multiple from over quarter. are And year. for data clinical the read-outs of top-line committed portfolio investigational we medicines differentiated our CNS of call. joining to our Thank

Operator

your call. We conference you participation. like for to today’s concludes would thank This

now may disconnect. You

Axsome Therapeutics (AXSM) 14 Mar 192018 Q4 Earnings call transcript