AXSM - Earnings call transcript Q2 2019 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen, and welcome to Axsome Therapeutics Second Quarter 2019 Financial Results Conference Call. Currently, all participants are in a listen-only mode. Later, there will be a question and answer session, 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

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

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

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

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

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

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

Officer achievements the Joining by Chief Executive clinical and Development and begin the will will with Herriot highlighting who Dr. the continue Tabuteau, who O'Gorman, Financial me who provide Nick milestones; the will updates our President call on Officer Dr. clinical of Clinical today are and financial Pizzie, recent update. Cedric Vice upcoming call Senior Medical Chief Affairs

over the I'd now like to to Herriot. call hand

Herriot Tabuteau

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

of product have milestones, significant achieved or best-in-class four accelerated CNS Over clinical candidates. months, Axsome first-in-class the the development clinical potentially regulatory which our and past

the as clinical clinical six key provide evaluated disorders. of as update if well are the lives I CNS developments in in milestones. indications, improve will millions upcoming have the seven being and medicines potential patients investigational with of trials quarter, to across living ongoing successfully developed, an different Our on

Let antagonist novel, oral investigational us receptor Axsome’s start NMDA activity. multimodal with with AXS-XX

in trial receipt double-blind, major meeting the late Following first launched AXS-XX and MDD the or study, with long-term for Phase successful the two and safety Therapy the July. which enrolled patient we patient new AXS-XX, disorder a depressive X a placebo-controlled is FDA, in treatment or which have in which in open the designation randomized, of breakthrough Phase June resistant TRD studies with MDD, GEMINI enrolled study therapy and MDD first and the X, depression label Breakthrough

Gemini To date, XX% the study enrolled. is approximately

in meeting, AXS-XX of the for of AXS-XX the either previously MDD. or treatment is on completed a the with positive of AXS-XX in STRIDE-X filing our support ASCEND trial Gemini the Therapy an and Breakthrough based As considered NDA reminder, from trial the to results of MDD results pivotal, sufficient TRD trial in the

on line second remain second report with trials both top XXXX, the of GEMINI track in We an in the results half filing to anticipated from NDA year. and the next STRIDE-X half of

The with Agitation of evaluated Advanced data top our Phase enrolled and trial in disease in Advance being is XXXX. AXS-XX trial. the now half also ongoing first XX% of X/X anticipated associated for under the is just treatment is Alzheimer's line

indication half oral, for our AXS-XX, trial to investigational with dual continues action of MOMENTUM of development novel, the of than randomized, X migraine. of target mechanisms line AXS-XX to Phase ahead track to medicine Turning of have acute XX% date, of on number we distinct in patients and under second the The report results the more XXXX. this To treatment enroll expectations. in of top been remain

required will related be to Based MOMENTUM the migraine. support treatment FDA of if X with NDA efficacy this acute trial held the we on ongoing the quarter, of the end In for meeting, trial AXS-XX Phase an for meeting the an positive of results to AXS-XX. the filing second only

MOMENTUM conducted both active FDA patients a with well enrolling protocol as a placebo special comparator. well response as to a only uses study history potent, acute is The assessment. to pursuant an established and prior is treatments being of inadequate

This bar, treat study successful, of we patient the the required database the potential therefore this second X in NDA recently safety open of year. We of high label, anticipate filing, which build long-term Phase in population. and half sets a profile if difficult to study a extension will next demonstrate AXS-XX to unique the AXS-XX for initiated safety

in in developed year. the of enrollment It norepinephrine this Phase product XX% of clinical of selective the narcolepsy AXS-XX, being track stage trial third symptoms narcolepsy. inhibitor we to the treatment for remain top potent being for placebo of highly treatment in of evaluated half date, and line target reuptake is Our To candidate is cancer oral, is the results this approximately controlled and report our trial. second X novel, on randomized, the

highly end. expected and transformative top to data the be next the following are the with before active months be trials have Axesome, year several from So potential line for to expected

AXS-XX narcolepsy. trial of Phase AXS-XX Phase trial of MOMENTUM our X acute the TRD, Our and of X migraine, in treatment ASX-XX of Phase Phase X of MDD, trial in our in treatment STRIDE-X X AXS-XX our the CONCERT of Gemini in trial

in cash two Favorable top of us clinical to extend beyond and In ongoing seven the of all fully us well the trials. efficacy would trials, which into fund from line clinical XXXX, these disclosed financing data readouts activities enabled recent is for fourth addition, runway outcomes file position our further XXXX. trials have NDAs all potentially, quarter to

to like GEMINI Cedric launched now some recently to trial. the over on to additional call details would provide hand I the

Cedric O'Gorman

the is and randomized, Herriot. or in trial Monoaminergic we controlled the you, Modulation GEMINI depression X late placebo in first MDD. In Thank in multi-center, with study. double-blind, GEMINI of Phase Glutamatergic patients patient AXS-XX enrolled June, a

total weeks. confirmed Other baseline. to endpoint safety patient assessments The Approximately measures. six change MADRS ASX-XX as XXX clinician MDD for is score scales, rated a either efficacy parameters, randomized from of primary placebo include, diagnosis well as patients with the reported with be moderate-to-severe other will the in outcome treatment or

design with the replicates the of and GEMINI. positive year. this control our use differences two size the largely GEMINI The readout second a GEMINI the We of ASCEND look forward placebo in this for trial to larger ASCEND of control half in major in of being inactive versus study trial the

With over that, I call to financial a would turn the Nick update. now like to for

Nick Pizzie

quarter quarter. the increase of everyone. This ATM with million equity conducted the $XX our at some from will of and Cedric second on provide $XX.X $XX.X key in approximately cash, and you, May an guidance. morning highlights via We up financial raise the ended Thank cash reflects quarter the I in facility. good million first million end of focus in

the and three the upfront our expenses initiation MOMENTUM safety safety in X the R&D X of study costs of was study G&A flat year-over-year expenses Phase AXS-XX associated enrollment study open-label higher Phase new million trend trial the reflecting with AXS-XX expected which the the in at second $XX AXS-XX $X.X and migraines trials, were X quarter clinical than MDD, were of significantly than AXS-XX. of GEMINI million. Phase Phase in of faster X of open-label

cash later operating our plan anticipated of conclude our to quarter our expected disclosed to trials, all will multiple based the current in position clinical and XXXX. current subsequent year. operations on fully trials decrease are fund into expenses believe We funds this be as fourth quarters R&D that sufficient

to We prior turn concludes Phase currently readout to any X will the call financial do to from lead efficacy Mark new the That anticipate quarter second Q&A not now equity XXXX financings back trials. discussion. the our I our review.

Mark Jacobson

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

Operator

SVB Goodman Marc Instructions] Certainly. Leerink. [Operator with

Your line is open.

Marc Goodman

morning. of this study. should of commercial all obviously faster marketing much about eight be And this you're you're talk of molecule in products one, your ago. Good probably indication? Can Thanks. then things, expecting right how Two were proof-of-concept second on the and remind thoughts we just than thinking you and Yes. now? of the about thought strategy us narcolepsy the about you what months Talk moving the you six, on

Herriot Tabuteau

crossover is looking the and With to is double-blind Thank a placebo narcolepsy study for questions. narcolepsy. this we're what symptoms you to Mark, compare reminder, randomized what to for regards those placebo of a regards with controlled key AXS-XX as that

and sleepiness. looking be those be So daytime cataplexy also will excessive would at we

be will indication. controlled randomized of trial in first this AXS-XX this the So

looking the ability increase we're of the Because design this those signal well-designed to results. should of crossover to study, study. relatively it So detect in but forward the think the that do we small,

proof-of-concept the thus narcolepsy the of terms flow In comes [ph] or non-clinical excess from in far, data. proof-of-concept

potently narcolepsy robusity open in AXS-XX improvement a trial in the in shown XX a translated to narcoleptic they reduction label. symptoms. and that orexin-deficient was positive results cataplexic sleepiness model as baseline well daytime episodes as in in episodes, show in from which patient was to pilot This a did patients and study reduce small of with was excessive mice narcolepsy a So

we've the regards With we to U.S. intend to always of partner our commercial products. said our plans, outside that

that make on to our and appropriate So front. updating the products fully sure we But the commercial commercialize we order we want And forward look U.S. still our that in on in expect we ourselves. is to do have the that to place you progress that, plan. to in leadership

Operator

Robinson Humphrey. with Lee SunTrust Joon

line is Your open.

Joon Lee

on GEMINI number to as Thank what studied you progress. do that you beyond in Hi, the is that, the of satisfy study. on of patient powering you. STRIDE What is the clarify TRD collected also years on also study? of top have you the is plan run on question long the submission question STRIDE thanks need the your Can for study. a the and how But And might study original so database. an NDA My years the silly question order it second to And NBA to The patient of order in all you based and the understanding And safety for is is minimum results that, the ADVANCE and requirement, you far? extension for need additional the congrats STRIDE the the based open-label that, [ph] how come ongoing collect many study. safety. study STRIDE? of

Herriot Tabuteau

a thank them so It all. don't please Okay, you we address us was remind all questions. for quite and those if list,

first that the question had study, X how relates do launched. safety open-label extension So we STRIDE and the which the to to with

is extension in are meant the study first long TRD as the we MDD. in enrolled in the in term of well quarter launch trial AXS-XX, trial July, did patients in we actually as safety exiting patient to So who open capture STRIDEX GEMINI that label study a

need reason in database well TRD. patients that do safety with NDA; with patients for to have a file both as is, order MDD, as the And we that to incorporates

been for terms XXX have treated to for months In patients are received FDA who've with guidance patient six the and is we've the been do year. the who've NDA needed, from for need one of We that XXX that the years AXS-XX filing. patients treated

will prior Now that ongoing Therapy to study year. and quickly to very of NDA the study, is And an what our started course what And gating is we filing factor not of in we safety meeting, us have half the next an did be place. Breakthrough that anticipation second that is a open-label and extension FDA of an finally driving in NDA. that study

And continue that capture know enrolled you in trial. in patients have patients order terms even in as study, who to in TRD, been of of STRIDE had the we target that the enrolling had Xtrial, number reached patients though we who did

extension And launch so, of STRIDE and the of the purpose the the is that also the in enrollment of open-label and extension safety purpose so trial. of

of the powering GEMINI study. the to regards With

is GEMINI the arm. treatment So treatment with results ASCEND it’s study the per what patients from was targeted about positive arm, per XX nice That builds GEMINI XXX patients has roughly is that trial. positive on and

only we're where is we're both have The been GEMINI about looked -- and at the seeing way of on for we we STRIDE anti-depressants that sizes, approved. which at average not the thinking effect looked that powering

been XX% these size. that GEMINI effect the So shown roughly X.X level to in as size of effect that well antidepressants we powered STRIDE be is active, have at to have that are range X.XX, the both and as to

Joon Lee

it line from about So the original expect just disclose when have or we the or complete study, data? STRIDE you the and in can unblind so, know expect for can open-label is factor that when tell to you can STRIDE, before factor bit can STRIDE, you the on it study top of is the we little limiting to the STRIDE question top a that if actually clarify you gating what us line study

Herriot Tabuteau

target the we're the the from reached target since actually half of working is results number before So we backwards that are we've we trial of second top end we the anticipate make this year. words, year of line the STRIDE enrollment, the meet thinking it the And year-end. other in fully and guidance is to way enrolled enrolled, X beyond we're about since in study that subjects, sure

add am – there that? so And to I Cedric else to is anything

Cedric O'Gorman

with resistant depression the No, is long-term into to other agree team taking ensure yes, data number of account consideration I appropriate one with treatment an that. that And our are safety just depression included in center. patients is

Joon Lee

data Well good you and thank the all you. of readouts. Great. so luck much, with Thank

Operator

with Selvaraju H.C. Wainwright. Ram

is open. line Your

Raghuram Selvaraju

standpoint. very Hi, that array of for able to currently my A though ongoing from taking much questions. all congrats very impressive an being clinical simultaneously thanks operational trials achieve on

can is to to clarity sense, of your release STRIDE have likely at data from juncture in of which the on And tell the delta do definitive between the sense have likely GEMINI. is thinking release a specifically one I us some furthermore, data what sequence you additional wanted releases on And and which you you you just and first? if be so results? get two of this Do those GEMINI the comment current of and of would? come to enrollment can status regarding a of timing

Herriot Tabuteau

launched With the trial. study you to in the currently are approximately June, was and question. XX% enrolled we enrollment late regards that in Thank for in Ram GEMINI,

So GEMINI. with that lot of the report track regards we will very results And for remain much STRIDE a year-end. in sequencing data depend and enrollment study that the for GEMINI, feel readouts will by to on on continued that, to

it's granularity that. hard give greater us than So to right now, -- we for

remain there quarter and the of the number clinical that, have year, trials I'm in to year-end. Now expect which --- months a having we in by five sorry said out we read

the is will GEMINI that STRIDE every are that report So, or sequentially so record everything be could and And of simultaneously. compressed. reality the they possibilities could

Raghuram Selvaraju

that for and Okay. on of label STRIDE assuming the also that GEMINI the AXS-XX Can hit. be comment obtained nature you both could

MDD. clarify just in you therapy. Thank additional a hypothetically what in I both So could maintenance position about you. if to and wanted AXS-XX a as necessary might would be label talk allow work specifically you also TRD to bit this that to obtain then And clinical little order

Herriot Tabuteau

major So of clarify be for the with the treatment to depressive would the to indication regards disorder. label,

in that the So indication from positive by TRD trial, for the STRIDE X and the treatment of enabled in would MDD. or reported the ASCEND and be for GEMINI results either MDD, the previously results positive trial trial

of and One be nuance package is though that would STRIDE the clinical be data the in indication would if trial the described a data STRIDE the that package even for inserts. of case, is part be in section positive would MDD, the STRIDE

received And with the to regards the controlled another that, would TRD, be in that in label study we've that a could addition study for But -- require regards importantly, study that a specifically from with that guidance TRD. also is FDA trial. to placebo

trial. study So this would STRIDE X easier an than be current to the conduct

clear to or we conduct these those to to be long prior a filing. term clinical studies for regards typically, indication, design. study are discontinuation and an with And marketing with not a be And not post those commitments, maintenance do term randomized maintenance long usually NDA the involve to which clinical long term or would required studies additional maintenance studies data, need

Raghuram Selvaraju

comment And commercialization with the and MDD effort Could a what versus of the populations? the Okay. to TRD and on these landscape the you like be recalcitrant privileged AXS-XX a between then, maybe in to of the in and bit standpoint. difference patients right currently if wanted AXS-XX nature are each indications. you're the about profile But just patient for thinking label patients treatment how could patient to TRD therefore sure a looks the regard MDD in about the make just imagine I'm have MDD lot I TRD, more one TRD were from that competitive drug in more you way. than a Because might eventually and this that thinking little

Herriot Tabuteau

are since well remember the will And, you very GEMINI promote to treatment. to to of with as forward and we XX% frontline fail of treated, as AXS-XX. treatment roughly that it's regards form the landscape, STRIDE, how these the but how we’re currently So much clinical that important both data patients from patients basis know that looking

patients And Monoaminergic treatment not -- currently. adequately percentage there in the So pathway. of one treated the currently reasons the for it's of that all lot failures out is the reasons antidepressant of a thought one MDD the believe we who for were targets large of that drugs most there fact for approved

with currently hits regards AXS-XX and novel novel so action what of represent a that the So we're is cause fact therefore it's as perspective, patients about excited mechanism XX% frontline those well have treatment as could from response MDA mechanism it for have action, adapt drugs who who were to patients it commercialization of patients an failed to that and treatment, the an would adequate a who induration. depression, to to of for resistant

clinical So TRD. including terms there's in there's in population patients and MDD clearly clinical broad entire overlap the need there with need, of

that's population. in So that are TRD that higher response, effective that is where if greater positive, where clinical bar is also treatment much that, in right assuming AXS-XX and even the demonstrate is need, in clinical of getting that terms is we there would that

of an mechanism And did show the AXS-XX of profile action, novel see apparently of based as trial what clinical response the one well and on happens action. ASCEND as comparator is regardless potent a efficacy current where since of active TRD, we rapid with versus onset we this

Raghuram Selvaraju

or like rapid Is previously the to onset regarding And frontline approved that been you AXS-XX an a baseline the the it drug could expect an label think tried if MDD it on because Great. points of of scenario made. action? of to as do with would that have is clarification SSRI, who be just you that just the of elevated just choice deployed you aspects it patients only in be failed and sort

Herriot Tabuteau

certainly to the, AXS-XX the Assuming assuming to could but thus maintained, that far not that turn clinical be that up assuming continue reason that who other know STRIDE also and significant that and to Resistant. no then there's AXA-XX to it would that, X I'll treatment, profile his show very that over our in of that to the obviously difficult a very Cedric be to show in and since are also think ability ASCEND thoughts, development we've in treat we trial would hence success been front. then treat, seen patients the name trial you trials, Cedric? it give that clinical the in the historically have used And the

Cedric O'Gorman

Yes better? trial, from the do think to suggested onset only existing so the is would And I as reasons there's ASCEND thing the for faster is real then would be profile AXS-XX or that know if comparable AXS-XX you is -- safe action the a question the the reason far that is better add I gave, you and to would compelling well and which suggest that data anti-depressants efficacy use safety becomes tolerated. is the of

So no is there if reason a in see that compelling a of use medication first yes, approved wouldn't one in AXS-XX I choice that MDD. think context, as to argument

Raghuram Selvaraju

you Great. very much. Thank

Operator

your Bert line is open. Hazlett with BTIG,

Robert Hazlett

significant for answers all here. Thank Yes. you the the

it. to answered this potentially of limiting step in Just maybe timing I a quick missed the program. you it, filing completion, for terms the given open-label rate that's extension that of question, Maybe

Herriot Tabuteau

treatment, one launched question. Thank the of We year put half guidance hence that safety us And recently. of for Bert then would year, the the you roughly studies the in assuming, open-label filing. second NDA next for extension

Robert Hazlett

had you effect terms the any active the in is placebo to GEMINI Obviously in of Couple manage of anything terrific. GEMINI design, placebo -- taking you and other centers in? comparator, conducted many study and are that are trial the success the material to but steps doing in study? effects with that in how you’ve being Okay, the manage study questions,

Herriot Tabuteau

of it will first. the I'll XX to centers. question, the So number in answer Cedric over who currently centers, those questions. I'll approximately for thank to turn you Cedric? With then second the regards we're answer

Cedric O'Gorman

been concern in response. particularly response Yes. definitely CNS vulnerable high and Placebo the Hi the is to a U.S. trials Bert. placebo have

placebo would placebo are that data response What However, we subjects know getting on suggest active response an the drug. do bias expectation the rise. a expectation is by is is driven

trial, was Now the in AXS-XX an the could agent bupropion. XXX% of getting active namely get chance ASCEND or they

separation, still GEMINI. comparator for an Because So GEMINI in active placebo a controlled, trials trial ASCEND chance to an of therefore, from the the than but managed there’s be we that a seen as getting set XXX%. for higher XX% bar bupropion. And is lower might was this agent the advantage versus separate active

the trial ASCEND GEMINI. GEMINI trial preceded positive for However, could expectation and theoretically the heighten also also buys

well-run to the extensive GEMINI our that all are larger trial. incorporate trials, is and enrolled ensure that the to a ASCEND course with has closely we significantly quality control replicate And But measures, the possible, trials do patients as as of appropriate and been are designed GEMINI trial.

So increase while ASCEND power enrolled XXX, will GEMINI XX a so detect to would this enroll further difference. patients,

to And of clinical date. so and trials far, the all with design we've been the pleased conduct

Robert Hazlett

Okay. Thank you.

Just ATM With the not committed to the least near-term one for financial more tapping at the regard the future. to in on foreseeable that you're side.

Herriot Tabuteau

answer turn to I’ll turn Yes. it to that, Nick now, over

Nick Pizzie

Bert. Yes. Sure. the Thanks Thanks. for question

But position ongoing did of We beyond given efficacy You our, strong in financial know you data trials. currently opportunistically. know overall facility the used it ATM which very the we our runway May. well our as use readouts provides

Phase As financings to trials. the our we equity anticipate currently readout on we stated not X based the do prior from plans future earlier, operating current

Robert Hazlett

Congrats Terrific. Okay. Thank you. progress. the on

Nick Pizzie

Thank you.

Operator

with Kaplan Ladenburg Matt Thalmann.

Your line is open.

MattKaplan

hope available a there the I little with in to morning, differentiated study? potentially terms dig of describe with and in migraine you other versus in a profile you the Can congrats bit terms that that more currently in good AXS-XX treatments migrane. guess MOMENTUM detail and bit show Phase design, I X what progress. program Hi, in AX-XX of the to are a little on to wanted

Herriot Tabuteau

Good morning, Matt and thank you question. for the

a know AXS-XX in forearm you MOMENTUM trial, study. is as So which reminder, is just enrolling a the

patients inadequate that either a that well with and -- with prior randomized would treatments to is with approved comparator, for treatment So to which is within potent acute study work AXS-XX, importantly rizatriptan, which known response a to historical be active which is and is placebo, the design migraine. very of who characterized

MoSEIC also of is components meloxicam AXS-XX. of the And which one

As a prior failed which this or study, design I questionnaire. inadequate of treatments with the using to only important is one history mentioned, the response, acute is have migrane that of optimization is element who patients and this measured mTOQ-X, patients, treatment migraines

So patients be are enrolled into only those allowed the trial. to

a So to a bar, high which that this treat. population because is sets is known difficult to be

there's acting other the fastest the that reason, comparator, is most The set which of triptan. in to fastest just why the we a study, using one high are active the potent be not is but rizatriptan and and placebo bar most comparator, known

So if would the we are for able what AXS-XX. show to MOMENTUM confirm be highlight a trial, to potentially and results positive differentiated it profile we believe in

is that So in development as on profile approved agents, well based that both as agents other are efficacy. as that are compared to agents

differentiation with been has of always point the So AXS-XX efficacy.

the If at down you most patient dissatisfaction efficacy. to reasons common for patient surveys, boil look all inadequate numerous or

current patients So that pain that well comes they migrate consistent not or sufficient their don't provide work fast or treatments don't pain pain work that work, enough do drugs relief enough. the They report meaning either relief drugs back. don't

It component of a uses the which action. the absorption, into regards to of we mechanism with MoSEIC of expect rapid at of of fast And dual pharmacokinetics least meloxicam AXS-XX, action. could onset would because AXS-XX translate

consistent least meloxicam, it relief So hours, half-life which which and MoSEIC relief. that XX greater incorporates to Thank to has more And contribute symptom you. pain help should of reduce recurrence. should at pain a

MattKaplan

Great. AXS-XX, how achieve required safety the for potential and for to filing? filing for then the NDA database Thanks. up that you follow of are going terms MOMENTUM And a what just the the NDA in on

Herriot Tabuteau

X safety in the of study filing. for launched Phase that AXS-XX, extension so of July enable AXS-XX. We open-label is NDA extension And safety an to reason open-label

are that patients who and So in that trial study MOMENTUM we capturing underway, are the exiting is study.

MattKaplan

's And Joon question. on good. Very one up I follow guess, just Okay. more

of understand breakthrough AXS-XX. the that outcome the So Therapy kind you fully designation, Breakthrough had of meeting and for

AXS-XX path there? describe In [ph] or and you terms necessary TRD? in of what paths so can those understand you Can to the the for the different and just potential potential is AXS-XX filing we that filing fully pathways for -- be just MDD

Herriot Tabuteau

system been path for of filing which So filing. MDD, the ASCEND using controlled deemed – trials adequate the incorporate MDD path one as are has enrolled the to required two for the be trial, for filing for MDD which pivotal

second this study, MDD. and the for Now is

The second a study from STRIDE the could in or come positive of trial the X trial. form GEMINI either the readout

are two there filing, for MDD. So there an to NDA pathways

for positive, would with to trial the assuming STRIDE And regards additional that with regards one TRD, is or we TRD. X need positive in

Importantly, trial use positive in trial a that TRD could that second second control. placebo

MattKaplan

Thanks.

Operator

turn this no back further I to would There are like Axsome Tabuteau over time. now questions at it to CEO, Herriot for remarks. closing

Herriot Tabuteau

to committed to joining with to difficult the look our and for pipeline, medicines us is the The treat forward CNS to the updating clinical on call. thank team developing of goal all year, the advancing Axsome We again new our you of Well for progress. on continued you rest disorders.

Operator

for Axsome call. thank financial participation. your you second This concludes quarter the XXXX We results conference Therapeutics

You may now disconnect.

Axsome Therapeutics (AXSM) 8 Aug 192019 Q2 Earnings call transcript