AXSM - Earnings call transcript Q1 2020 | 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. Later, there will be a question-and-answer session and instructions will follow at that time. Accompanying slides are available for this presentation on the company website at axsome.com.

conference being today's reminder, a call recorded. is As

turn over Operating to would at now host, conference to like ahead. go Chief I your the Mark Therapeutics. Please Axsome Officer Jacobson,

Mark Jacobson

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

Our the corporate and wire available time and the providing a details first quarter on a for is at financial short results the release axsome.com. our of earnings of press update company's XXXX website crossed ago

making intended certain research present statements our source be possible statements. our intended During These and things, plans, to include today's will or our investment. the non-clinical additional use of call, conduct agents, may forward-looking of cash data, regarding, the statements we plans investigational and clinical trials, efficacy, utilization the other and among safety clinical and and future development anticipated future and report of plans, regulatory

on are that and assumptions contained statements information, and statements. are forward-looking in cause the actual that may risks based involve materially results to forward-looking expectations from These differ change those current and to subject uncertainties

These Exchange and quarterly including described other annual filings our and Commission, reports. our Securities the risks made with periodic are and in

made these company to forward-looking date today's are to reliance any You are update only cautioned obligation place the undue as disclaims statements, not on of which and such statements.

Dr. Commercial and Chief Nick Pizzie, Development Officer; Officer; Executive Chief Clinical Medical O'Gorman, on me Tabuteau, President Affairs. Dave are call the Marek, Officer; Herriot Joining and Senior of Chief Dr. today Financial Vice Cedric

of developments provide reviewing upcoming Herriot milestones. recent overview an including company first will the and

results. financial our review will Nick Herriot, Following

for will We questions. line the then open

to call the over Herriot. turn now shall I

Herriot Tabuteau

joining and thank first conference And business Axsome Therapeutics results XXXX you, Thank quarter Good Mark. everyone. you call. update financial all morning, for

accelerated past our the evolution CNS leading into we company. have a months, Over several

our populations. now industry. that CNS treatment have deep targeting believe significant advance patient one of limited and During stage that novel robust of medicines We CNS indications affect to no options the broad late and in difficult-to-treat differentiated the most portfolio we have continued this time, or we pipelines

pipeline we agitation, have now only stage disease controlled but trials depression, including from Alzheimer's narcolepsy late positive fibromyalgia. not indications, well also and CNS clinical broad, different Our migraine, is in generated announced results five efficacy or proven as

conditions these importance the prevalence, medicines unmet seriousness alone. affect investigational more underscore clinical patients million Overall, of conditions needs thus US our the in data and than by XX far. of these and The with represented them generated the high

have snapshot slide for On select The pipeline resulting a indications data from is controlled trials. clinical are which we opportunities positive significant. now of stage this efficacy our late in

For our substantial AXS-XX product improvement and announced in positive showing December, in NDA candidate, depressive disorder symptoms. results depressive rapid we in enabling major

pivotal And rapid condition. symptom similarly we our substantial last trial agitation, of announced from and week, ADVANCE-X disease demonstrated Alzheimer's which positive in this in improvement AXS-XX results

positive announced in also our superior results demonstrating have NDA enabling efficacy. migraine We with candidate, AXS-XX product

we And migraine. of month, our announced the positive INTERCEPT last results treatment of AXS-XX trial early in from

trial AXS-XX has and our cataplexy Our of candidate sleepiness, significant excessive the CONCERT improvement symptoms in for product demonstrated narcolepsy daytime narcolepsy. key in

Phase for candidate, a both profile differentiated demonstrated fibromyalgia, product AXS-XX positive has in results II our And a a III trial. and Phase and

lives on product the potential peak value. to significantly patients highlights just improve and portfolio have of generated total increase up $X our robust of generate clinical the This billion indications of to shareholder millions far. Overall, sales these candidates in thus based to potential the data

GEMINI quarter. in trials. remain the our track fourth major milestones, regards ASCEND to The depressive disorder for supported file With NDA our our by positive AXS-XX pivotal results is NDA upcoming in efficacy on from we to and

this further safety than extension in to trial. filing XXX patients been AXS-XX date, of III support study NDA to have Phase more And dosed A the is long-term, label, open ongoing.

for AXS-XX INTERCEPT NDA We The file also from trials. remain MOMENTUM is in results by in on the efficacy our fourth NDA and positive quarter. migraine our supported to track

extension label, study to patients III in date, this long-term, support have further open to Phase than of been A trial. is the AXS-XX dosed more XXX safety ongoing. NDA And filing

As the the AXS-XX, and team readiness in filing fourth launch NDAs focused execution. activities ensure for towards our quarter, we move AXS-XX to commercial of successful on is commercial for our

approved parallel, disabling late disease distressing momentum medicine. programs, the conditions we'd is in In other for highly development AXS-XX Alzheimer's look which our and a to in continue agitation, stage there including no

data. line Following these ADVANCE-X our to this we from possible FDA pivotal soon to indication, with the as top recent announcement intend results as of trial meet positive discuss in the

We we of the second year. study, expect half this of in design to inform these our which next the discussions anticipate initiating

the also anticipate building in second We year, our half strong positive results II III narcolepsy CONCERT on in with of trial. this trials the Phase AXS-XX initiating from Phase

innovation, patients. focusing CNS we industry-leading an as By early an will year energetic build the as on to make to culture to products the to our through next pipeline continue innovative readiness status company rest speed development that by commercial available starting patients of our to therapies challenges with and advancing quo

the would financial who over I turn Nick to call to update. like now a will provide

Nick Pizzie

morning, you, key will financial focus on Thank good some provide everyone. highlights guidance. quarter and I And in Herriot. the

programs is clinical our management. advance highly maintaining We rapidly consistent commercial the quarter a our while financial ended ability in with strong and preparations, fiscal that efficient position to

$XX.X $XX.X million. related the in quarter of the charge Net to million million associated agreement, million $X.X XX, million $XX.X agreement, of were March Pfizer quarter licensing the Pfizer which for with a licensing R&D ended The versus expenses were non-cash XXXX. R&D one-time upfront costs costs XXXX to related. comparable related expenses of $X.X the included the for the was period

AXS-XX due and for the MOMENTUM this more XXXX and most INTERCEPT, quarter activity The period, and the label trial increase AXS-XX the ADVANCE-X out open during safety to our STRIDE-X, close CONCERT, clinical versus significantly first studies, was to of recent costs trials, trials. including GEMINI and

safety closed of label and All studies, open aside from have been in process are trials, AXS-XX and now of out. being these concluded AXS-XX the the

quarter to mainly with costs, million the XX, comparable is from $X in function. were the million higher for build-out XXXX. stock the and personnel XXXX primarily change the expense, of period increase along compensation ended The for commercial March expenses G&A $X.X due

We that with We $XXX years. plan million quarter. ended the current of based with operating cash position two anticipated end our on believe in cash the sufficient compared least fund fourth at million $XXX.X operations our first quarter current our the for at is to

call first financial back quarter I hand That the XXXX Mark concludes discussion. to will our Q&A now lead to the review.

Mark Jacobson

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

Operator

Cantor Charles [Operator Instructions]. first with Duncan Fitzgerald. And question from comes your

Charles Duncan

weeks steps migraine. activities? thanks exposure them XX for wondered taking the March these limiting months. on questions. And NDAs rate for And and are Hey. of including checking or what and Is XX as XX would or Good there I I Congrats successes data, team. morning, you the XX NDA regard X Herriot in the clinical a characterize CMC with in the couple steps experimental and in the the had MDD for to any safety clinical are – filing. last new milestones? box questions

Herriot Tabuteau

Thank We patients would third safety treated and our for rate-limiting fourth file six you, is in patients be questions. need treated really, AXS-XX. our track trials. well do XXX product perspective, quarter a we put from time steps, This in months for Charles, XXX to the extension expect quarter. open studies one label those to The for for year candidate. on do as to have NDAs And as AXS-XX each the us for completed the

same manufacturing CMC been us activities, being clinical our regards is have at scale that which CMO manufactured for to supply batches good thing With using registration that there and commercial commercial we at for we're are the are now. also A production. trial

no scale up there's needs to be So, that done.

batches and I rate-limiting it, say and This there would regards any and manufacturing but is step of Now, tweaks always is experimentation, science there with is extensive simply for regulatory to no our to manufacturing purposes. no that experimentation. kind registration there's

Charles Duncan

you meeting two, schedule either before safety pre-NDA And, completed? Herriot, would activities, of or a CMC are those the

Herriot Tabuteau

standard. meetings also, recommended. Pre-NDA And are they're

for our yes, AXS-XX of process. and part both are pre-NDA meetings so, And AXS-XX the

Charles Duncan

Okay. one And just question. then, last

grow United opportunity But nicely very it, I'm challenges first the of States. seeing, market when you're You if, candidates of curious about that the indications think psychiatry, ex consider your substantial. with wondering call or out-licensing it's also what I thoughts regard are particularly Would thoughts And are in opportunity with what in kind the for COVID about two the I'm that to these may all, current but your outlined, impact market the there? with you US certainly of commercial strategies.

Herriot Tabuteau

reported of opportunities, been as for from well an have market to depression. effect increased as includes social risk documented of measures been that in depression key And, are place, distancing, sheltering has been pandemic the unfortunately, our and in incidence COVID-XX regards place, the factors fact, has With various which sources. on in the put

the So, unfortunately, in. environment a that we're is that current of reflection

outside opportunities Now, the with market think that of do US, they regards we are to significant.

that sales through whose we does outlined product US, we – of the this we worldwide and of correct could You're patients that and a to our Those for folks the Axsome number impact. just are give lives the sense just numbers maintain potentials rights did candidates.

of our to US. stated strategy, of our we part product is candidate our As the license outside that strategy corporate

strategy our part ongoing So, that activities. of is and that part is of our

Charles Duncan

increased forward the course on the over that to Okay. visibility Look year. probably of

for Congrats to appreciate on It's year eventful taking So, the my questions. progress. going an you be you.

Operator

SVB from And Leerink. your Marc next with comes Goodman question

Marc Goodman

commercializing about how migraine Hey, considering so just what and was the on the you're thoughts what oral are as compete advertising to able thinking far drug, have to DTC you're on the television good morning. be CGRPs them? with your played out I curious, doing

Herriot Tabuteau

the over for that Thanks, question, turn I'll to Marc, and Dave.

David Marek

that I the when differentiated us therapies the AXS-XX, we And has And Marc. that profile fare Hey. unmet helps our traditional in to Thanks uptake morning, marketplace well Good that still with have at additional is of speak been the I direct rizatriptan. to I terms to of that need there patients that triptans go morning. needs look searching have. head a we very with you is think data this I out think meet CGRPs beyond strong. the head think for to Well, that think for oral there joining

good I'm mentioned, about acute reacting completely surprised, need. not market feel new how we So, I therapies. the is the given unmet to as

make of we treatment in engaging journey. where those kind consumers. that with ways I a I advertising, with to TV of any options ways number think with of I table. take is they we off electronic qualified benefits of can think consumer of engage have when engage can can of we'll the data around And a direct-to-consumer we we're are Regarding is there the those are the sure point engage their more don't terms with in specific electronically. one and at one think you engagement we where But consumers, engage are that of that consumers. customers

won't goes. means we any would to would lean extent So, table look would we towards more use TV, electronic certainly reach we early, But as them. the engage off but where take we To options we'll consumers. the means this efficient to that most the that see

Marc Goodman

Thanks.

Operator

with your of And comes the next line Mr. SunTrust. question from Lee

Joon Lee

today Phase accommodative with of do to guys. or on ago? Nuplazid that, FDA you congrats I Alzheimer's Thanks And the you. disease Do years five for less that of question feel FDA taking along similar you my single what a plan path the on a seek so, market than do III? is questions. progress. And if you to meeting? for what agitation. did prepare need Hi, based accelerated on Thank the for And have to more Acadia to

Herriot Tabuteau

certainly is Thanks I unmet it for well indication think these this there public need, clinical need the agitation. contraindicated excited is Alzheimer's what is is as an We're for the disease treated. FDA the against as about are the the high true advised your in use approved. their be with that there in box alternatives And currently are need warnings And black this question underlies is that nothing population. or need against question, results Joon. because do The to which health And there. very patients out

meet need as Phase those II/III pivotal we trial strong. to results And do possible are our the to looking have quickly that with and FDA, with the we're is feel we what to discussions ADVANCE FDA. as So,

our Our that path. is base is we been the usual one And FDA additional assumption. always case that scenario, be would conducting trial. though, has That

pivotal has the Now, indications such pointing approved. approved instances in there past been is the as positive products where one which with pimavanserin FDA out, you're in nothing as trial have

certainly currently is is to And that we of we've It's just a want to there that's done. that it I hope what way not the However, to what that to run indication a given in pace accelerate we think most for plan best, know. the likely not approval the but the this way for And scenario. AXS-XX business. it's to

we're do we that we'll possible. meet the more as as looking and with FDA, expeditiously So, know once to

more years it In terms that. of is on FDA ago, or now than won't whether I not accommodating the comment was five

a We company. young are

same So, some appropriate more we answer be other probably as them don't have companies, to will that question. history the to it and ask

Joon Lee

Thank the clarification. one I you have more for just follow-up.

very to with the many You meet high for problem have programs. of a having class FDA

you. feedback listed three the share Just simultaneously? on standpoint have with meetings programs the the seven curious in the from FDA Are hear seven to your as get on half disclosure that plan when updates you multiple separate can of maybe Thank back have the to FDA you Or will a meetings actually we have to feedback. if is two just second discuss to meetings? going You you XXXX.

Herriot Tabuteau

don't listed meetings. seven know FDA So, Joon, we've I

FDA, Just that therapy AXS-XX interaction ongoing, treatment-resistant and do fast also a true. designation number are programs for depressive disease Alzheimer's in of do terms major which with And of designation depression for have we disorder agitation. is have and track in we the breakthrough

they important FDA. because more communications the those frequent allow designations So, are with

are of so, And interactions. there a certainly, lot

we development done the such that, investors. timing, past that change which – a lead then of when we a share we've terms do have in what is, in our about interactions talked And in is with to as material,

expeditiously one the playbook. follow Street. think or we is or other, So, with anything we that a plan is would to the communicate And significant that material certainly, the we same way

Joon Lee

Thank much. you very

Operator

your next Guggenheim comes And Partners. Yatin from with Suneja question

Yatin Suneja

taking Hey, my for guys. you morning. question. Good Thank

a couple. Just

on On the I if Then the a study review for ongoing comment you and the XX study or COVID? filing, priority do And of impact safety can have extension long-term is then, expect you follow-up. XX? any there because

Herriot Tabuteau

six-month disorder, because it major have For review. AXS-XX therapy depressive for breakthrough is designation, in we eligible

that a certainly the is filed, a of NDA breakthrough that. will features of seeking but, is is though, made, be we So, that certainly, That's the after decision typically designation. therapy one

do of the anticipating of enrolled AXS-XX, For impact, a patients COVID-XX terms safety largely impact in standard extension anticipate open we're currently, significant currently trials, And been ongoing those have not in the a number because of we label significant studies. review. on already

treated For each we currently of the patients of for label each year, for XX, XXX months is studies, and XXX XX XXX of or three for the open treated those goal north and XXX have in one studies. and to patients patients have

not the with to by of are most trials. less long-term visits visits. sites clinical trials, frequent aspects One their being Those of is trial which to the not patients impacted COVID, to go has safety or in extension do clinical able wanting for to

us. So, that benefits

clinical reason their to supply homes other the we in to choose alternatives their get typically patients to patients leave trial not And that why is in have should make sites to drug go place do And need drug homes. they sure to supply. to gets

Yatin Suneja

could a we longer, might is study that about going that relatively the to be help regard us with not to timeframe already the this lot you STRIDE-X preparation be then, understand a study should that the you be We TRD doing for that plan about in of but similar you a completion? And thinking understand just it. anticipation and starting the talk that soon. Got to study to initiate, took timeframe

Herriot Tabuteau

Street. experienced And our second some once that And crystallized we completing timeframe trial completing sort of internal once anticipate that TRD down more thoughts TRD they're that first be than We once from we'll with shorter of in the the study we'll share we the timeframe design know the study. projections. do exact we and nail more will the

Yatin Suneja

much. you Thank right. very All

Operator

your with question from Ram And the H.C. of line Wainwright. Selvaraju comes next

Ram Selvaraju

my very Hi. questions. Thanks for much taking

be Firstly, wanted reconfirm see to depression with Phase to AXS-XX placebo is could if just you controlled. study the confirmatory treatment-resistant that III going

Herriot Tabuteau

So, with it the through and Ram, possibility. that confirmed once is finalizing design certainly discussions we'll still you design but that we're we let that study, FDA, know. one finalize And the of

Ram Selvaraju

And have, or of like wanted about this currently the you smoking you thinking you're how on on all a be the on but sense get comment seems shots give that it at that cessation. prioritizing an Okay, can about you status things, might other of maybe time. us With thinking goal just great. AXS-XX update to

Herriot Tabuteau

the excited next A patient cessation largest our We're the cessation in the large steps smoking probably about and the meet group population, opportunity. we're in goal smoking FDA, the very the various targeting And to with product program. indications. candidates patient with that is our discuss various

So, that our is one this milestones year. of for

Ram Selvaraju

what from whether to esreboxetine approval the chance to need else I see, needed to from to as you've will would And great. talk was else agency they esreboxetine, in fibromyalgia gotten generate. clinical they additional sense you the you of gotten had you about be on just wondering expect for what potentially guys to Okay, countenance a data what if the to and then, them

Herriot Tabuteau

not Ram, year. goals yet of the met is AXS-XX. stated That discuss our FDA we this one have also for corporate to with

we looking will been forward which III that a Phase and do that already positive package, the to And has positive II expect generated. And data package a as So, reminder, that trial. happen. we're Phase data discussing includes

Ram Selvaraju

I the that's be landscape any would just competitive be wondering FT-XXX scheduled. nature to the and Obviously, how AXS-XX to lastly, your the that there, Okay. of you recent if give not But you the Thank thoughts going in scheduled. was you thoughts entrant. And is for see had on you. looks Phase it competitive helpful. narcolepsy FT-XXX particularly like going data AXS-XX, could us if as III be light of on then, program, on

Herriot Tabuteau

where need ingredient is as need medical our still has area options. understanding patients is Xyrem. of it FT-XXX, active unmet this So, an the treatment high new

have dramatically dosed beneficial are work other think differently that that that AXS-XX. it and differently, we So, would molecules do such as to be

regards like a positively AXS-XX, just but with it what that cataplexy, candidate excessive Now, also about cognitive of range symptoms, narcolepsy to positive that effect product affected we not had It a across sleepiness. is daytime function.

and And And be product It a dosing. current feature, think from approved addition the of another for we product be as welcomed cataplexy. currently not patients which scheduled, clinicians. well is would differentiation of tolerated. in broad that do expect range is to that very would reminder, daytime And, the is the improvement, we by be to which certainly, symptom point

Ram Selvaraju

And congrats again. Great, much. progress thank very all you on once the

Operator

line And Hazlett comes of question with your from next BTIG. Bert the

Robert Hazlett

thank you. Yes,

to more the the Is two in points. little regard that to us you the the with agitation, is, timetable clarifying disease MDD Not with that of or be benzos a important. in not even with chance with one And interactions that, Just the is designation? is more to with with a bit indication, Are meet need molecule, to given addition The Just the do with important AXS-XX the kind of then, to would state need, your antipsychotics when black opportunity? breakthrough for is that intend then, One could bit you regard specifically, and seems regard about Thank frame is to box? material atypical data. off-label be helpful. to there very Alzheimer's that but still, to little treatment? unmet a do opportunity, with What here. you. TRD treated important And FDA? unmet or they FDA

Herriot Tabuteau

around I'll Cedric FDA treatment interactions. let the the for then about and question. answer the landscape I'll Bert, talk questions Thanks,

Cedric O'Gorman

no highly increased a and death. accelerated absolutely for need. there's agitation decline, associated Alzheimer's there's with mortality, And earlier and with institutionalization highly moment, real prevalent cognitive and It's treatment associated the approved disease. disabling at Bert,

point prescribers and in which the resorting need their own prescriptions staff the it still use and are cause that resorting mortality, around you use homes the emphasizes stroke. of box drugs, cardiovascular have warning elderly. these problems tremendous with to people healthcare increased are to nursing But to association out despite physicians have antipsychotics as black anti-psychotic currently, So, and at off-labels morbidity,

treatment, which treatment an need any a been approved of need not for a achieved. first definitely yet all, there's So, has and for

Herriot Tabuteau

meet to always say this. a regards quickly are priority. There with agree but the we once that And we is, the a of seeking course, a a getting possible on agency. meeting, we'll meeting with FDA requesting interactions, FDA We timing of lag more to interact important have do are with data. as this these And to to the as is from

Robert Hazlett

you. thank Okay,

Operator

line And Matt Thalmann. of your next Kaplan question with Ladenburg comes from the

Matthew Kaplan

taking Hey. guys. for And questions. thanks Good morning, the

to design Just in you to or little would to you do, I sufficient? dig a plan of sense Phase for more could this that AXS-XX your current bit studies have narcolepsy. two you terms launch to do that III guess, later in year? III wanted And What's be Phase expect one the

Herriot Tabuteau

the finalized Matt. regards Thanks Phase not we've yet to narcolepsy for With III and design. the design, questions, the

However, II it our trial. incorporate will elements the Phase of a lot from successful

would difference terms the Phase endpoint, parallel the a crossover And in would and that group So, of a II we study anticipate be was be certainly. will that this one study.

then, we on And would planning Phase trials conducting simultaneously. them III conducting and are we two

Matthew Kaplan

that's Okay, helpful. very the Thanks for detail.

Operator

state And next you would please company And, your from sir, Myles comes question Minter. name? your

Myles Minter

got It's your both currently got proportion patients extension long-term safety the for Minter any whether must TRD The indications. that dosed wondering to Thanks be trial of talking got or single on in the enrolled safety patients you've as I'm you've would for questions. about those that the intend safety to Sorry, FDA versus William have both or just serve that with of XXX from have clarity of database Myles off. AXS-XX, more label open for taking the MDD Blair.

wouldn't of So, theoretically, have on trial. another the TRD you end one to next run the

Herriot Tabuteau

questions, thanks So, Myles. for

clearly one TRD improve So, label both extension never study by been FDA. and other or with patients of you way the the the does proportion, know, in MDD. And as open that that's terms stated exact safety

proportion about long-term as That compared who a talked been population. meaning is for TRD we've about that of those general it. general we're treatment to the MDD have year. number have trial, in we're it And patients to the the thinking TRD one patients way of that reflects thinking about the is way in what treated of Now, portion the with the

that was thinking. our So,

MDD for file And that study with the time certainly, to overall regards with we'll significantly more as that indication. then, trial, patients once the in TRD it probably database. a becomes our less have reminder, TRD, safety completed, that by for And relevant is we then do

Myles Minter

know helpful. design definitively to fail That's patients or But I the controlled yet antidepressants, you actually, patients? trial, more is then, be clarified. it use would the And bupropion on to prior in to if TRD two have proposed placebo are those and looking control theoretically

Herriot Tabuteau

of that in STRIDE-X we product clinical you certainly, practice we would makes – just That a typical that with bupropion. that, restrict we bupropion trial dosing any restrict trial, So, now, as reminder, use That the whereby testing. all ingredients sense. of active if the whereby AXS-XX the or patients you're And have make use. would were study would additional are is in do sense the a treated it

So, now right that's our preliminary thought.

make takes as we'll a that design However, that It carefully. final important into of design and provide want lot account the sure of the design finalizing we of know, the details. think studies. we those you more once are, detail. studies, And trial able to very And we you be have of finalizing to the we about

Myles Minter

Yes.

maybe into be prior the I bupropion restricting controlling looking prior trial. prior were the you but, about bupropion more history at at was in know and yeah, per these to will history the trial I would you of se, looking enrollment? coming patients, if at the use question So, the look monotherapy patient guess, use

Herriot Tabuteau

trial use the was as – prior to prior in to design but be, be to anticipate we it where failures. we by not antidepressant just was considered just – the bupropion be of now, would there not to was one or be for trial allowed that allowed mandated the Right that controlling did STRIDE-X

Myles Minter

Okay, any AXS-XX, cool. that how for on what and fibro, the deal of color me, terms of treatment extended you have got maybe reducing Is do Pfizer pivotal additional AXS-XX non-clinical for clinical you build the narcolepsy sort just trial? database there? – in a when final after And for one safety there this would to licensing then just would curious that database in

Herriot Tabuteau

have lengths database us, of from [indiscernible] various of who which time. with esreboxetine, patients for we licensed Pfizer helped It certainly the safety patient [indiscernible] exposed thousands and been

patient and, safety are numbers that And – look our those meet accelerate we looking database, fact, to guidelines. and database So, AXS-XX. or leverage in to filings we certainly to safety that for ICH would AXS-XX would streamline rich

Myles Minter

questions. the Congrats. Thanks for

Operator

final question Joseph come will and with the Thome Cowen our Company. from of line And

Joseph Thome

Thank taking my It's Cowen. Hi questions. Joe there. you for from

on how First, what enrollment as you criteria not you to ago, long data, the anything the in Alzheimer's in you this patients that following a through there you is would to study? of terms III go forward change too looking long Phase want presented be these or

in the my terms looking the Thank on be decision? regulatory then, closer agency AXS-XX, you question you. looking second endpoints one cataplexy And this are for looking at at at and study, of that And both when primary daytime sleepiness? will maybe is there

Herriot Tabuteau

the regards for just disease agitation III you With we Alzheimer's next for Thank got questions. the the our to last data Phase week. program,

to we mine of to continue to it want sure it we make next study. the inform that So, potential understand design to

and daytime program. lot excessive cataplexy of one daytime important, are are sleepiness one is, Cataplexy is other III to sleepiness. ones looking of there that – cataplexy the in with product both cataplexy. believe AXS-XX, are will we is only in that unmet highest for Phase products medical for excessive is available a our we all With exclusively be There currently symptoms at but regards narcolepsy believe we that the the And need.

will the And at looking So, be we'll both. cataplexy. on be focus

Joseph Thome

you. Great, thank

Operator

no at And Are time, there any audio this are questions. further there closing remarks?

Herriot Tabuteau

the Well, thank you on all call joining for today. us

updating We to we what industry. be CNS ongoing progress. advancing on robust the look pipeline in focused the late intensely are on believe most you We our forward stage to

Operator

this gentlemen, conference you and participation. Ladies Thank today's your for concludes call.

disconnect. You may now

Axsome Therapeutics (AXSM) 8 May 202020 Q1 Earnings call transcript