AXSM - Earnings call transcript Q1 2019 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to 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.

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. ahead. go Please

Mark Jacobson

the Good wire us operator. Axsome.com. press thank all is upcoming our results you providing and on recent Thank achievements available short regulatory today's morning time conference joining and for financial company's on of crossed our at quarter call. for XXXX details clinical the you, milestones the and first a This website release and morning, ago

Executive Officer; will Medical Dr. Chief We Chief this Herriot President Vice prepared call Affairs; Pizzie, and Cedric by remarks Dr. of being with Nick Financial Development Senior Officer. O'Gorman, Tabuteau, Clinical and

will be line taken We are for will order the analysts. that they Questions the open in received. questions then from

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

I these such place and to statements any company now to the to not cautioned turn statements. like obligation Herriot. the over forward-looking call to are weight disclaims undue on update would You

Dr. Herriot Tabuteau

and everyone, for the today. on call morning, joining Good all thank you us Mark. you, Thank

XXXX very Axsome. have five productive The been of for first months

Breakthrough Therapy development major AXS-XX and X depressive received pivotal as well FDA. in the week, following with cessation. meeting have trial far MDD, the as We for positive expedited So Therapy disorder, in X of smoking AXS-XX status the a this efficacy MDD MDD, we Breakthrough reported trial of in designation our results Phase in Phase year, in and we AXS-XX AXS-XX or recent this FDA earlier announced of

of detail turning the quarter, Cedric, Therapy Nick, the trial it of migraines then X follow who launched before will of the a AXS-XX to quarter the as treatment Phase clinical would our trials, to also results. financial take to of Breakthrough first AXS-XX recent During review well X I the meeting as we of the trial a review MOMENTUM Phase moment acute and CONCERT light of in to status who our of with over narcolepsy. will like current in AXS-XX the up status in ongoing

previously trial, mechanisms potential second database development STRIDE-X second an the The filing required of Cedric. an TRD narcolepsy we acute the AXS-XX of both placebo-controlled the AXS-XX plan MDD, decades including in of Phase MDD, will AXS-XX with now As more a the at multimodal new sufficient in AXS-XX positive, to MDD if Enrollment of half depression it continue in call expected of trial in patients now will treatment-resistant migraine controlled second support important NDA trial of NDA accelerates treatment the with safety our this MDD of AXS-XX will treatment XXXX. action and X filing. results our in one the second in of results the along results the filing initiate in meaning to trial AXS-XX If the contribute file intend approval successfully condition. trial order have ASCEND X Phase which the X CONCERT year, now with the top-line clinical a the STRIDE-X several half the MDD AXS-XX in MOMENTUM trial results over to safety first X a debilitating an and in NDA resistant XXXX. the TRD, are trial the in approved extension of novel new quarter ongoing of anticipated the quarter, Axsome NDA, pivotal, considered anticipated of in targeting over from with of X to second of treatment we results initiate in number if Phase antidepressant efficacy in X with depression XXXX. readouts for of from trial of the Reflecting new the Phase application, for is STRIDE-X is expedited treatment build balance a or TRD in antagonist in completed of trial of of treatment for expected the of U.S. with in maturing with active to second drug in the AXS-XX XXXX. for I turn for issued the half Top-line activity. Therapy NMDA AXS-XX developed, placebo-controlled and patents, AXS-XX shortly trial this XX by we of reminder, the into efficacy covered a in than in year. the this Phase to year, We developed expected of is AXS-XX Phase Axsome's trial positive. half Breakthrough internally completed and X receptor may MDD. planned, a was novel, of Axsome the significantly coverage this Phase X which trial to placebo-controlled also on Alternatively, planned, pipeline, depression would in investigational the represent meeting, Based Phase with was extending MDD are in the of patients trial open-label, oral, STRIDE-X ASCEND XXXX

Dr. Cedric O'Gorman

would endpoint bupropion. significantly efficacy a important they AXS-XX of safety active for the the cessation The trial activity daily programs. X to Herriot. of analysis smoking The in Thank announced cessation preliminary we AXS-XX smoking on had showed additional University of to for month, double-blind, met AXS-XX pre-specified an of data on cessation. AXS-XX. provide and smoking smoking analysis treatment. I that AXS-XX The primary biologic and first the as X comparator are study provide trial Last because was the moment update compared spend the a evaluate the to findings randomized, pleased you, smoking Phase Phase completed ongoing top-line clinical Duke for cessation reduced with am its like our that active-controlled I to clinical AXS-XX treatment. of

near We the as development cessation forward evaluating in smoking the steps update of next and an look are AXS-XX in for the clinical an providing future. to aid

our the safety the to to treatment AXS-XX, depression. of program now Phase in efficacy the Turning resistant STRIDE-X double-blind, is ongoing AXS-XX a assess trial X, multi-center, and depression treatment with controlled trial active randomized, of

As enrollment order previously in safety in to NDA will the required mentioned, screening an and for filing. trial build the database STRIDE-X continue

of from double-blind, top-line quarter, efficacy results for this year. X STRIDE-X the we MDD randomized half and top-line the data AXS-XX expect trial the anticipate XXXX. of with launch We in a in this trial in patients second second to of Phase second plan placebo-controlled, half In

open-label quarter, this planned trial of for to MDD. Patients to initiate extension will positive, X also second Phase safety trial trial the trials mentioned, required in support trial, extension database STRIDE-X filing. safety MDD to ASCEND the safety an an support controlled previously build treatment placebo the an completed if enter ongoing safety and used NDA an the In build the we conjunction open-label may our NDA be to completing As required to with the planned placebo-controlled, database.

number Now associated double-blind days, with of with turning the study, are controlled the under this the subjects efficacy been trial Phase to associated just with AXS-XX safety patients in disease results randomized is target Alzheimer's multi-center, To a enrolling randomized, trial. XXXX. to Alzheimer's X-X AXS-XX, and agitation Top-line of in ADVANCE-X in of have first Axsome with evaluate agitation half anticipated XX% of disease. the

normally sets to or trial migraine. a which protocol of aspect week, trial enrolling response patients only treatments, pursuant of the important the associated trial to comparator, X, allodynia, acute migraine in top-line migraine being discuss will treat been acute to treatment the the acute MOMENTUM the of I randomized, with population second difficult of X half in the efficacy trial high patients patient than Earlier potent, versus SPA. conducted as history multi-center of days, rizatriptan of anticipated, has of is Phase treatment active a of the to from of AXS-XX. it a Allodynia enrolled of the and is the XXXX. double-blind, first AXS-XX is stimulus. is assess pain expected FDA this the non-painful worse a for majority safety MOMENTUM report as of An enrolling and AXS-XX MOMENTUM a Now we an XXXX announced bar the a With that guidance that prior faster use assessment, is outcomes. inadequate study efficacy trial previous results and in and in special to with controlled treatment demonstration are MOMENTUM of of MOMENTUM quarter the now Phase the

this of by encouraged benefit the which action treat AXS-XX scientific basis novel, AXS-XX, of pharmacokinetics population. mechanism distinct, however, provide a to are, difficult demonstrate the potential We the unique in of due and for to

X, remind you turn attacks of our narcolepsy. of potent symptoms is include the would assessments to narcolepsy, X This study the anticipated XX financial and update the highly multi-centered the novel, AXS-XX, for like other and inhibitor. results trial. The trial ongoing, now selective later to I call Lastly, to cataplexy in first a the CONCERT Efficacy provide Phase oral, quarter. frequency this over top-line reboxetine, Phase are I trial XXXX. of placebo-controlled, and like CONCERT Nick reuptake of a quarter of is to would measures crossover, will of study. is randomized, double-blind, norepinephrine

Nick Pizzie

I million increase is $XX.X XXXX equity sheet, XXXX, you, will with $XX in in the cash XXXX term Thank million everyone. XXst, financial morning, quarter completed we growth balance XXst, million. This financing and increase $XX.X as now December our new had with our capital and received March. into entered of Starting due of limit primarily to Cedric, FCB our in at-the-market from balance from proceeds of cover January, the results. good first an of March

March net million million, statement company a compared compared This be quarter or first planned Turning XXst, into ending safety of March increased the expense $X.XX period AXS-XX XXXX. quarter $X.X expenses legal to an operations, continued XXXX, increase of to quarter and to completed $X.X $X.X in that increase was We XXst, is guidance the XXst, incurred million quarter XXXX. XX, compared with current were personnel which million primarily non-clinical $X.X study. Research XXst, as as per The rapid due million well million, ending by March XXXX ended the sufficient our for an first first the candidate, cost to million, operating $X.X quarter of first quarter manufacturing costs. new external previously the a study, million STRIDE-X, X due expenses to cessation our to increase anticipate March in quarter in for smoking is cost open-label, for quarter anticipated XXXX period $X.X share, of of ending The position $X.X to expenses work. XXst, by share, million fees $X.XX for clinical and will our MDD the public Phase Interest fund costs, and or in as ending the progress to as for least for administrative the the XXXX, loss associated were million. $X.X General a ending company, million as a of March offset ADVANCE-X, $XX.X our as development and at first of XXXX, compared to per was for requirements the $X.X the the period trial trials cash of and million studies, net XXXX in progress XXXX. related along of initiation $XX.X the product with March the AXS-XX to our of Operating loss increase the the partially operating $X.X XXXX. higher with planned extension the of compared million. to AXS-XX, as as $X.X of the and cash MOMENTUM reduction XXXX includes our

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

Mark Jacobson

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

Operator

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

Marc Goodman

guys. Morning,

related I've there several the questions to that an ASCEND the are was it going it, than the the of these update latest how to and investors you. times physicians you opportunities? use to from commercialization the thoughts of fact efficacious normally rather question Can And gotten then to that on and and One this how you strategy you XXX you for used. just that's bupropion, this about Thank product respect think is with for is? dose is the give your on on us trial chose just view all how comment second dose higher can just the mg

Mark Jacobson

question. Thanks, Marc, for the

question, I'll first the question. commercialization for the over it and turn to take Cedric, then I'll So,

Dr. Cedric O'Gorman

that for Marc, up. the Hey, does thanks question, question come and

full the this sustained used a that's in in of fact And effective at GlaxoSmithKline, the for bupropion of the the was submission that and ASCEND within NDA originally range developed dose daily release, filing, dose for treatment shown and depressive XXX mg So, was of be dose also is had further, that SR, part doses that major the were lower. their to who drug, including disorder. approved

showing in look and you treating also been that the there's evidence effective back mg, mg, if XXX So, depression. upward literature, over XXX have

antidepressant seen as at clinically then, effect, results whether of and from you expected it So, reflects the with and yourself magnitude bupropion can a you you the actual meaningful does. see, look improvements ASCEND, ask

improvement, So, weeks, XX.X that point effect six that a an to after antidepressant expect would essentially, see see. does and you reflect you

Dr. Herriot Tabuteau

one Most placebo. that active against against study Cedric just is And the of the are if stress further the just I may comparator. to, points fact the was add alluded of too, that to trials matter an

trial. value we the what think commercialization, outside so, we placebo-corrected to past, to definitely a it our increase And said ourselves. to had is it we've NDAs Having U.S. these if to and about are the open would in eventually interesting launch. With intend madras we to stated file to the we of they of conducted the the been, In do for placebo-controlled product partner that, the that is might've partnerships that the plan definitely reduction assuming as intent, regards launch candidates U.S., in franchises

to lead of key have organization acting paths two for to side. to are product been imagine, the NDA candidates build that commercial fact you both on expedited, the can appears us, is Given and for focus as potentially our the the this a we area of

Marc Goodman

Thanks.

Operator

Your of your next Ram, is H.C. open. the line Ram question Wainwright. with comes Selvaraju from line

Ram Selvaraju

much Hi. questions. my Thanks very taking for

cash of additional Firstly, AXS-XX, that include clinical clarification, just point your a for not? or guidance, burn reboxetine, development does

Dr. Herriot Tabuteau

Herriot. is This Ram. Hey,

does extension. which assume MDD not cash Phase the with well are Our X includes trials current new the guidance trials, it ongoing, for It AXS-XX. as is also, the open-label as and studies placebo-controlled, so trial, includes the planned which AXS-XX, new

Nick Pizzie

study Phase And clarification the Ram, for it is reboxetine, stated, does sure as be clear, that the well include AXS-XX, as the that MDD, is include to so just for AXS-XX. that as X for made. Phase make for open-label planned Herriot study X safety just does it study to also

have So, guidance. included cash been in new they our

Ram Selvaraju

positive. What for the of compound? clarification, would is X study logical, step AXS-XX theoretical then And development point the a let that that us there Phase as next assume just be of

Dr. Herriot Tabuteau

positive. Phase AXS-XX, So, trial be initiate the launch X should intend for with and AXS-XX, fully we to Phase a study X

our that of readout intention so, study. to looking the that of forward in that And we're part the We plans. so stated is past,

Ram Selvaraju

and development see your candidates candidates marketing do intent market three commercialization the of of Axsome in pursue but pursuant the areas? synergies stated broader establishment in therapeutic then be and effort arrive within of within the how areas kinds multiple time and to of roughly obviously market independently, scope regarding framing what pipeline these and assuming to the commercialization And United the mass these neurology? the same you exploit, to the of comments, across infrastructure maybe States, Herriot, you even or the And two different commercialization targeting sales might therapeutic are that your on frame, current able of

Dr. Herriot Tabuteau

look One at are which targeting, broad neurology, they we look and the So, do two the our and you indications, psychiatry. is fall into if pipeline, you is one at buckets. other

agitation, look psychiatry, And so, AXS-XX, if you there. is have but indications. to disease disorder And and disease you at were there you for there. if at our overlap are overlap those symptoms by the treated look behavioral at Alzheimer's there the fall is indications, if treated for under then you example, the so would neurologists, look mood by is indications, psychiatrists, neurology Alzheimer's primarily then

look comorbidities that's those and that, neurology. a indications. of lot there's of So, AXS-XX, is lot also with of the if at acute comorbidity, neurology said that you a Having migraine treatment psychiatric both of

we those there in if psychiatry So, overlap at a pieces, you neurology, an do will, Venn and with regards that the building force, diagram. is sales in there mind look keeping to two

Ram Selvaraju

beyond Very point inadequate a on prior to the elaborate bit migraine therapy the you helpful. further being patients a And enrolled little study. for and MOMENTUM of just regarding sense that Can clarification whether then responses into only they been if or multiple failed already a Thank one maybe other you. patients through [indiscernible] [indiscernible] give these the failed they or [indiscernible] cycled migraine have therapeutics class. us of

Mark Jacobson

Cedric question. to I'll put that it So, to answer over

Dr. Cedric O'Gorman

Thanks, Ram.

hear can Ram? me you OK, So,

Ram Selvaraju

I Yup, can.

Dr. Cedric O'Gorman

efficacy acute the MOMENTUM So, mTOQ-X, a called patients we this trial, validated and in who assesses prior response the treatment. are use questionnaire enrolled to

which adequate activities, they've it's the from full mTOQ-X or and then the X had medication, been pain evaluate And MOMENTUM particular who trial. whether daily to to higher, point, class, basically, daily able hours two-hour been with freedom, whether to then whether inadequate had to result into generally, eligible treatment. disrupted in of it's be have lasted that different a patients whether they've their a XX dose as deemed of and a acute their are those of that's getting there scored essentially for are one efficacy migraine specific score any and prior actually not not it's treatment. plan And to but enrolled the patients So, responders have they're the activities your aspects one four inadequate response response, and be and response,

Ram Selvaraju

all and on clarification, very much the once again Great. that for Thanks congrats progress.

Dr. Cedric O'Gorman

you. Thank

Operator

Your next open. Maria, of is with Maria line question comes the from Skoboleva Fitzgerald. your Cantor line

Unidentified Analyst

actually Cantor. with Charles It's Hi.

First of other I morning, may taking team. for on with progress. I'm clinical or support a time and spotty missed Axsome the of of all, regard say, the Congrats is train year because our be NDA tox such preclinical an to prepared to on you studies there this AXS-XX, questions. Thanks. this Thanks next in but cell with service, studies, even will by, or terms as studies then have manufacturing, filing earlier?

Dr. Herriot Tabuteau

be which which Charles, filing, to toxicity take additional onerous so There reference Good clinical and is for such morning, a a of XXX(b)(X) studies more bridging done we are for studies, long thank are of of an positive. need we that the as definitely required, way. some conducted NDA, that regards would under With in and some this the normally time, studies, to can carcinogenicity which questions. is so the are studies, requirements you which terms NDA preclinical a the

that also is not that delay part not we for we shape in there, to of working and it and straightforward in that do but to factor. we not manufacturing. gating a on we've shape are regards and been would package manufacturing, good process an good we be by to being So, shape that is manufacturing able process, year. fulfill really should with so finalized in It terms one therefore, do whatsoever. of good a be The optimized, NDA anticipate we're in sort of be and next a while, anticipate any is And there

Unidentified Analyst

emphasized it's had would over regard like about as you is wondering pick to your if seems that you do AXS-XX, you with a had but [indiscernible]? a TRD, hard all what would I the mean, it or as you over question but indication perhaps to do larger better opportunity? It see favorite then challenge, is MDD to child, think think at again, And follow-up bigger incidence right you or as prevalence now, MDD I'm what

Dr. Herriot Tabuteau

people remember I that to MDD one So, thing about encompasses the talk think well as is as normally MDD as what TRD.

depression is patients failed depressive in resistant who major simply treatment two at but treatments. So, prior least disorder

they more difficult So, definitely are to treat.

indication, general MDD target it us So, population. with MDD the to allow broad does the

with we MDD over before about to say maybe TRD? to if all emphasized your have do Now, would we had again, I regards no. would question it

in clinical think tremendous. because great a running and efficacy of population need antagonist is with great we're sequence bar, the high of patient is I that we're But be population also, Phase NMDA that is is able activity. with the it a in think happy so are show receptor the which the to clearly very to we're that frontline which trial, study that we to We X much with more position given oral, ASCEND showing with benefits is that trial X in We multimodal greater. an a trials, in a potential AXS-XX, and where to very in the and AXS-XX. there TRD, difficult treat Phase ran study of order did the clinical MDD product, potential is be delineate

be So, allows think for product only to to in us that the essentially indication. the demonstrate efficacy broader of positive hardest that the we can and candidate MDD the it population, treat

Unidentified Analyst

on you seems which that years? last kind just do question just have migraine. a over color, further it And from evolving a finally, to therapy space-acute you for long-term [indiscernible]? anticipate in study running treatment paradigm if in And are rapidly AXS-XX, what the the is Thanks of AAN-XX, then back some of molecule for us like Herriot. with be coming I assuming wondering I'm with thoughts differentiation a share of you one the could and safety couple the

Dr. Herriot Tabuteau

AXS-XX. made on stated, that of regards for very about we MOMENTUM AXS-XX, of trial X we key and potentially fast of action. question product the progress AXS-XX, what as to the that further, to provide the to profile trial the the clinical year. features Phase the designed now So, MOMENTUM we with We're expect And and is differentiating will data we've view with have delineate now some thank you, this Charles, excited as but onset

We have the we more a unique results absorption AXS-XX, PK dual the that action the do of meloxicam also of candidate, mechanism with profile therapies. MoSEIC that in expect efficacy and should because product rapid consistent of of in migraine distinct and be strong current

Lastly, have our point in to formulation the that symptom does a long is and the reduce of meloxicam recurrence. half-life,

sustained In is that fact, at of freedom. we endpoints that looking one pain are the secondary is

enrolling to look things our say now, nice and the results trial out, clinical more a the aren't bit little for patients So, stringent front, thesis this study, difficult which that and ourselves that to if be like up bears we to difficult to all is to of designed in is see make forward to to we a trial, known very do we order treat. that with

[audio clearly should out] cuts of the AXS-XX able with comparator, delineate So, have trial patients used currently success, compares have MOMENTUM active have comparator, symptom known you be to the available inadequate also since AXS-XX, conducting the drugs. who we're do that we a especially and factors And so predictive is and also tautology worse outcomes also certain is therapy. current have we've a rizatriptan to rizatriptan, with also that essentially the differentiating response prior it who potent with if active migraine what of

Unidentified Analyst

if anticipate That's long-term And trial to having in patients over this helpful. reads regarding time? do out, terms to you what safety, of do exposure

Dr. Herriot Tabuteau

look expect long-term we will and definitely be out an certainly dosing that the to months discussions will of in six year. we with anticipate one be. repeat database period to that we need what and extended requirement would to exactly regards so With safety agency find over we safety, will And time, for at

Unidentified Analyst

added Thanks and with for the recent the the congrats on interaction agency. and BTD information,

Dr. Herriot Tabuteau

you. Thank

Operator

Matt, Ladenburg of comes Matt Your your is line Thalmann. line next the from open. Kaplan with question

Matt Kaplan

you. Thank And morning, guys. good

Mark Jacobson

Matt. morning, Good

Matt Kaplan

MDD recently you've Can that give Thanks, to I studies. design the new planned thanks. into X you thinking to AXS-XX and you're you extension parts some with of to in wanted in dig announced there terms timelines how achieve the the Phase the that out? and of open-label sense the respect of laid now a that us moving going you're and

Dr. Herriot Tabuteau

turn design new it over the extension X talk question. the trial, the planned of about study. to Cedric Phase to Matt, you, Thank for trial, and X the Phase I'll open-label the

Dr. Cedric O'Gorman

Matt. Thanks,

and So, had with STRIDE having to which database. experience requisite run fully a ongoing keep we're lot but is the and enrolled, ASCEND build going of successful study we've study, STRIDE now the enrolling to screening the safety

long So, generate a placebo-controlled it would in now be, relationships and we've have a to analysis expectation with feasibility top-line would established run how We've very running infrastructure and built our how be many trial, strong screening would and on sites. the numerous sites data. it take, enrolling what

additional rich based given the MDD of is antidepressant ASCEND be key specifically design AXS-XX regard really over the study, with placebo-controlled that can So, that we're well, long-term the excited year. our depression that placebo-controlled from with to bupropion, demonstrated this coming to numbers for treated effect to the build with point our will who around and has will patients months in lot And a trial design which the a very hoping study. be trial successful the And successful how else so everything database to of STRIDE-X good patients at coming MDD of have AXS-XX similar of and comprise placebo-controlled the things we so up news. with to XX patients well recipe anticipate open-label both for on of the have then previously. We one strategy, placebo-controlled what requisite planned TRD as was as extension, terms are six months ASCEND, then of that's keeping the piece same from approach

Matt Kaplan

when was you the helpful. given runway, to Ram's very of And company forward? or trials that he asking That's going kind on follow-up Thanks. do about about planned clinical and plan funding cash the question think then how a have, you

Dr. Herriot Tabuteau

question, for the thanks So, Matt.

financing about talk plans. Nick, turn me So, will who it let to about think we over how

Nick Pizzie

Thanks, Matt, Thanks, Herriot. the for question.

cash said is clinical current the opening 'XX, I anticipated us well trials. at first all remarks, readouts planned into current my least and which our quarter beyond of of our the As in takes of

So, of from our readouts pivotal potential and do the to of depression. an AXS-XX ATM, we use in opportunistic aside equity trials not offering anticipate prior

Matt Kaplan

very on again the That's and Thanks. congrats progress. helpful,

Nick Pizzie

Matt. Thanks,

Operator

final Bert, the with BTIG. your comes open. question of your line Gentlemen, Hazlett Bert line from is

Bert Hazlett

Thanks.

timing. regarding question quick a Just

In say having active the terms other X this is how long I Thank really IRB study and run order. just upcoming, is have tall timelines of correct. have things, it in -- control you. this, make seems about sure our the you're approval about study? Phase it a how like took AXS-XX do going in we to and MDD, wanna study, realistic the just that's it to wanna and thinking It it placebo-controlled for XXXX I to -- that data thinking think

Dr. Herriot Tabuteau

Bert, thank you for the question.

So, of maybe kind and your to you how think that about it numbers, assessment. we to us the tell in also own it would come help you help of terms for would to

study. the year. study in roughly was it the announced at at data, study end have and patients, trial major new a you and last approximately were That similar beginning four know, same as it reminder, to look conducted placebo-controlled trial X Phase complete year Cedric depressive at year, disorder that which be the the last So, that should XX we we year, comprised the a of conducted last to if you the at about ASCEND in We as able of launched time ASCEND design centers. and as stated, will this and

number an XX that now So, trial centers ongoing more study currently give a X of conducting you to will Phase trials, be STRIDE-X the a sense than in the that centers. increase and we're there with of you terms gives of in in sense

of to number the and year, So, reasonable report kind to and last any potentially the applying ASCEND of ability year think we rate end. give about data by enrollment sense really for rate centers the how a of trial generate the you that'll

Dr. Cedric O'Gorman

these one not two you're had study, a TRD do or in distinction the than important would to just the add thing subjects antidepressant I failure one patient the very more which population. their course, and study, enroll is getting straightforward of And need depressive that comparison treatments another a the could Bert, STRIDE-X if depressed for to have MDD placebo-controlled demonstrated you current well, quickly as into episodes, a made study so to

Bert Hazlett

the for Thank clarity. you

Operator

the session. question over Axsome's our for concluding turn to answer will concludes any remarks. call I This CEO back and

Dr. Herriot Tabuteau

for of Well, clinical progress, we top-line expect had and momentum forward to again joining morning. We Thank thank for our joining the our trial you all readouts keeping multiple balance and continue our initiations. We've updated look highly the to year. you through you to on productive data this this year, start call. call the including a

Operator

Thank conference. you today's your concludes for This participation.

You may now disconnect.

Axsome Therapeutics (AXSM) 10 May 192019 Q1 Earnings call transcript