AXSM - Earnings call transcript Q2 2020 | Axsome Therapeutics, Inc.

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Operator

Good morning. 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.

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

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

Mark Jacobson

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

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

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

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

Cedric will of developments provide Financial Commercial and Affairs. recent Tabuteau, Pizzie, today Development President on Executive the Herriot review and Officer; Officer; O'Gorman, the Officer; first Marek, Herriot of Vice Chief call then Medical Clinical me Dave milestones. overview Joining Senior upcoming and Chief an company Chief and Dr. Dr. Nick are

Nick Herriot, financial results. review will our Following

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

Herriot Tabuteau

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

and pipeline, AXS-XX regulatory major and including then important a update, will Starting we our achievements the we Over development with upcoming several towards in in pipeline and months, the highlight migraine designations. past candidates disorder our Therapy quarter product advance our respectively. provide Breakthrough broad I Across achieved several the NDA two AXS-XX and clinical submissions addition continued to review this in depression, AXS-XX NDA press milestones for quarter. FDA new AXS-XX will milestones. including MDD. morning, pre-NDA meeting in solely that the or track progress the fourth release, major to with in release for To results clinical a of of in focused the we separate AXS-XX our treatment have completed We a MDD the on we disorder, FDA end, in generation remain data. regular program, depression successful our quarterly press submit on depressive the financial issued in to depressive the

quarter sub-studies of populations: addition, the filing. COMET-SI with from of to of suicidal results Efficacy we've with and year the Phase MDD trial, the to depressive antidepressant COMET-AU defined the have one X fourth conducting the resistant further the continue the efficacy open-label will patients disorder as anti-depressant; MDD, studies trial open-label planned evaluate and the in We're are study treatment who symptoms, TRD; expected AXS-XX. standard patients depressive anti-depressant this who in In major or we will in COMET the trial inform also in treatment three in unresponsive profile pertinent these despite ideation. AXS-XX of efficacy the clinically support COMET of AXS-XX which X MDD, safety trial in completed COMET-TRD NDA call Phase patient three in safety trial which enrollment

in Results will given population lieu time for trial. mechanism approach starting these fourth more trial conducted TRD, of the AXS-XX useful with placebo-controlled a being and in will study this quickly X additional the MERIT as are We be generate half MDD prescribers action trials quarter information this patients, which AXS-XX trial trials We patient The Phase randomized resistant early with to the withdrawal commercialization. believe MDD types data treatment patients MERIT helpful TRD. in spectrum in the information broad are new COMET-TRD of of Overall, the by as MERIT generate new initiated we on This a and from planned across clinically that especially will XXXX. of previously expected first double-blind, in X AXS-XX. also XXXX. the of of call Phase

as our the demonstrated FDA Moving our compared Breakthrough designation supported from disease disease treatment the with In designation the AXS-XX. agitation. Alzheimer’s in received for positive which a agitation This Therapy is onto placebo. disease from Alzheimer's we trial Alzheimer’s patients ADVANCE-X program in agitation by to reduction of in results in pivotal AXS-XX June, substantial

Phase filing. migraine with AXS-XX the initiate important fourth second in safety trial treatment track completed the in X migraine, remain call for extension now we on track program we the on the this our to trial support the migraine end, are of fourth a study in this quarter. NDA have to enrollment we NDA planned in of AXS-XX in Switching We acute to for Phase X year. AXS-XX, which indication quarter of of the the submit to that To MOVEMENT open-label AXS-XX

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

by Phase rapid with week, Breakthrough substantial designation of program narcolepsy supported compared was to AXS-XX sleepiness X positive results Moving as for from cataplexy for patients treatment the FDA and the narcolepsy. next placebo. received with excessive in the we which cataplexy, study, to The Last improvements designation demonstrated Therapy in daytime AXS-XX our CONCERT AXS-XX. with and

of on XXXX. are narcolepsy quarter of AXS-XX fourth Phase of in treatment the to track We initiate trials X the in

COMET-AU We unresponsive trial COMET-SI would MDD, fourth actuate and in from FDA to over agitation; conditions to products and we the in approach now With all X disease Alzheimer's patients significant submit to Alzheimer’s difficult-to-treat results cataplexy, AXS-XX the of of potential and care. MDD in expect disease depressive now late-stage trial trial depression, in quarter. with who trials upcoming in and promises our a NDAs our with commitment highlight major These with for to financial leading regards AXS-XX in turn exemplify narcolepsy, the in efficacy our time. fourth clinical suicidal potentially Phase We life second and designators our pipeline the COMET-TRD innovative launch AXS-XX the and treatment for resistant major call trial treatment to X to changing AXS-XX year CNS to in busy agitation, antidepressant developing like of provide advances on Breakthrough three And a for medicines to the the CNS MDD; to be rest our industry AXS-XX designations: in narcolepsy. both patient in Our in been milestones, quarter. I all our fourth the disorder in anticipate to the quarter. AXS-XX migraine, in granted development AXS-XX ideation, of has provide will AXS-XX Phase track Nick, in update. remain Therapy the in

Nick Pizzie

decrease continue morning, million while discipline. the and our with to maintaining approximately commercial as you, in the And to quarter, a cash at ended first net in clinical million accelerate of approximately end Herriot. second We preparedness a the roughly good We strong sound million. fiscal remain $XXX cash, Thank everyone. $XXX programs we compared quarter financial of position in $X.X

R&D for which were period. were the During in non-cash of increase quarter along of XXXX, primarily and June comparable expenses were yielding expenses due stock XXXX. driven XXXX $X.X increase the the for in million XX, issued decreased million. XX, the with of quarter in $XX.X majority million for commercial $X.X XXXX gross in related period prior comparable function. an shares, was $XX.X compensation versus the by build-out for million G&A quarter, the we million of approximately period ended ended was the expense, comparable clinical ongoing of $XX trials, to the the June our a completion a million The $X.X XXX,XXX proceeds

position our least second back our quarter two turn current cash Q&A the XXXX at plan forward, to our concludes will is review. financial call operations That to we the for our years. based lead fund operating to on believe anticipated now sufficient Looking Mark current I discussion.

Mark Jacobson

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

Operator

[Operator Securities. Instructions] Lee Our with Joon first question comes Truist from

Your open. line is

Joon Lee

generating Are A have the the or is results about incorporated comments up. question that And hypothesis I possible it can into Thank you. submission? a purely NDA these follow be on studies.

Herriot Tabuteau

trial also long-term then which submission. safety patient in trial the Thanks, be the be populations, expect will of COMET measuring the included sub-studies data filing. COMET question. is we’d Joon, in incorporated It efficacy for to And those study. our different into the are FDA the NDA The

Joon Lee

how mechanics have after enrolled or And X these one of studies to And Will in up three selecting going the follow of will that. enroll study regarding sub-studies Phase sub-studies. from you COMET -- COMET I into into long-term to patient X enrolling Phase more the long-term Phase studies? you you. patients you be one sub additional in the X into Thank be the enroll are already safety those the safety study these

Herriot Tabuteau

the disclose, the is COMET enrolled as enrolled enough will patients. we to There subjects subjects be be in XXX total, in of study about number

that in subjects sub-study. enough are surely there So,

are analysis.... those what patients these and sub-studies groups also being defined respectively, on be prospectively collected separate efficacy will data So in and patient those is fiscal

Joon Lee

very study you're MERIT which you taking study. a have lower withdrawal Great. X regarding it's to approved And design? your anti-depressant this withdrawal -- of then randomized randomized Are that effect? placebo study, is interesting Phase approach, a on aware Are aware tends you which

Herriot Tabuteau

you studies if was esketamine that look worked Yes. the data design. randomized The the of study so withdrawal -- one a at package,

Operator

question Mark next SVB Leerink. Our Goodman from comes with

open. is line Your

Roanna Ruiz

the for for is plan Roanna line I is package? Mark. on sub-studies building you COMET this from these some that taking or guidance own your have coming robust come was of more question. sort that did pre-NDA the the data FDA out meeting curious, Hi, that of of out from trial, Thanks your

Herriot Tabuteau

we want really to as is of I'll your to as part answer the from that there Cedric clinicians, to this a make study question, of just to come is given drug wide of So first yes, that. possible and that sure guidance. patients. speak new new the wanting mechanism in us information did FDA of spectrum But action available let to much And the not

Cedric O'Gorman

add question. only been I have would treatment it terrific short-term treated by that the clinical depressive patient COMET, ideation. are you’ll rich in with the MDD and patients depression, of population, really for short-term have resistant the depressive our a at population Thanks enrolled patient safety given important The populations as major suicidal was that and disorder of that And study we the opportunity thing major is studies hundreds look our a rich to recall, depression both disorder specifically treatment-resistant long-term then such study.

sort very in a profile sort said, was outcomes. look of further elegant of of And really order their antidepressant clinical and important way patients Herriot So at to characterize look guide these utility the way and as efficacy at AXS-XX. to

Roanna Ruiz

And then of TRD question in between differences treatment MDD. we you on a something terms bit maybe that could one little that -- do explain physicians about recognize, and Is the and will quick how easily unresponsive that paradigm? what think clinically,

Cedric O'Gorman

Yes.

well-recognized populations. they are clinical So

And resistant MDD, to or patient also antidepressant. continue to treatment despite to then more have symptomatology, despite recognized patients who -- symptoms, or unresponsive you're for two So who continue with like have that a for is widely antidepressants. as depressive the failed who population, treatment patients depression respond depressive population about one have talking

definitions very the that's way. groups, why So and we well-recognized approach and prescribers, in distinct to physicians that

Operator

Charles Our Cantor comes line Fitzgerald. the next from question of Duncan with

Your line open. is

Pete Stavropoulos

for Pete is One all initiation progress MOVEMENT can regarding studies. tell Stavropoulos anything us is, of the Charles. you persistence This Congratulations question is the for there trial AXS-XX? the me the Hi. of and patients about new on on quick on

Herriot Tabuteau

more you better-than-expected. great the we've think And that when with we'll of regards MOVEMENT to study, retention, had we I patient So, provide details. trial, obviously, results give the

Operator

line Matt Ladenburg of next comes question Kaplan Our Thalmann. from with

Your open. line is

Matt Kaplan

in ask you a in in if terms to -- terms X of wanted little Phase provide a your bit the are what thoughts of program more I narcolepsy. little thoughts -- color could current

You later studies to starting expect year? guess trials. this Do two I mentioned you start simultaneously two

Herriot Tabuteau

That the Well. question. Thank the is Matt, you, plan. for

should in in accelerate So, close parallel launch our the to or And like studies that as possible, right possible. that X by two needed. that to in program. Phase to would Phase commercialization. parallel as now, much planning X be do as anticipate launching do we're timing we'd them as And parallel We to

Matt Kaplan

-- the and you then studies back the MDD? if MERIT approved expect four results AXS-XX the do for the be in to from sub-studies label, study, potentially And those efficacy sub-studies, included results going is to the COMET the

Herriot Tabuteau

be clear, studies specific conducted to that So, not labeling. these support to being studies are are

However, data our data is, to doing will we're the we're what MDD, in generated And the these for indication in very that's package. what's FDA that about studies is filing the be included being NDA [accomplish] and is too important is broad MDD. the which

Operator

question Our from Myles William comes next line Minter Blair. the of with

line open. Your is

Myles Minter

that firstly overall on just but would Thanks. study? to treatment just, be improvement wrong XX% of randomization Just of I'm be? time on the period your treatment assuming MERIT wondering would And correct trial portion that’s the withdrawal MERIT if me there. what what of from in again, definition I'm part that response the baseline

Herriot Tabuteau

off So add. thanks else he'd like has Cedric see anything question. and lead Myles if I'll to for that the

order to the in MERIT to in study, specific have a but have patients they remission. be to in have be not reduction, so randomized So

these patients So, are who remit.

And And regards defined which then as. a with definition, would and sustained. is what relapse very to a be so that is stringent

not yet disclosed would it return be a So we but symptom. have that,

Myles Minter

follow And a package, on -- look that's then just up the is to parallel approval esketamine starting like in [indiscernible]. mentioned you a maybe lot the this

somewhere the elderly? running safety saw the track I in going a benign of So, as that to of pretty it the whether because just be profile down study future a patient asked sort safety in in that concern of just additional to you and those elderly pop ADVANCE-X curious you're we And population. trials announced wondering overcome already Cheers. today? patients why an seen elderly whether up you've you've trial disease that in haven't study Alzheimer's

Herriot Tabuteau

of of elderly. AXS-XX a the of sense ADVANCE benefits us provide profile in it Alzheimer’s the trial clear the one is demonstrating that certainly, disease the in So, addition in agitation of to did very safety efficacy

future first patient population So, that's really MDD. And the not certainly indications. the elderly, thinking the in to while helpful us that current additional do in about may we at include potential future studies in look

Myles Minter

Okay. And then follow on from me.

MERIT, the to completely trials. the that’s are of MERIT, patients Just none not Yes? are two these COMET, treated you're withdrawal enrolling newly define of with those come in these of into patients and out use terms population from those period to MERIT, like yes, of remission patient randomized have then in COMET trying separate you’re be

Herriot Tabuteau

trials. So, certainly you TRD. some we But they in have as who And we COMET are can study, the not much a two imagine, completely to look patients separate de of as lot recruitment efforts the are novo, as leverage have of would possible. whom

to patients of study. reasons from included. TRD. be very we patients TRD would our launched COMET-TRD a clinical who with efficient that's the who way may And definitely the COMET current So, those why one program get have It's have

allows us rapid And fashion. so us efforts. there and in and a a already it very reduces to gives recruitment population It randomized patient control data generate efficient that's

Operator

Ram line the with from comes Selvaraju question final Our H.C. Wainwright.

is open. Your line

Ram Selvaraju

some comment there clinical possibility you esreboxetine, of look you might the could wondering study a of have your studies at could FDA scope if different haven't on be context kind the if development fibromyalgia, set with been to regarding on already was within what be of a evaluated quickly of been comment on might a you paradigm to might of recapitulate scenarios the yet done? clinical that ask if endpoints I if Very Or completely development that having that? or

Herriot Tabuteau

the for Ram thanks So question.

results trials. do to have from regards you two and you we pointed as with as know out, controlled So AXS-XX, positive

trial. Phase one of is trial, a them of is them One X Phase a X

and much, simple to all, like the with go But what steps to what meet are if fibromyalgia. with endpoints clinical we'd the at is. through next is them, we is, that were with the what believe don't so data for conducted, up And changed down the FDA actually do plan have studies the and sit come the

we to with and met a have FDA. with pronouncements, we've with think as studies these we So soon in you as provide confirmation, all And do and we do the given we the speculate, before that. two gotten great we're position, make we any will to meet written want FDA, We before the positive details.

Ram Selvaraju

included firm necessary COMET-SI study label? work the of And in implications on might would that's if depression to the utilization the then case have drug trial, on efficient of specifically? positive, in if support the And you development comment potentially be suicidal COMET-SI any suicidal whether that's or what evidence specifically would direct for up And additional that the this can AXS-XX the on potentially the depression? be specific indication if see specific trial, could in we

Herriot Tabuteau

for Ram thanks So question. the

So and is reason the that of AXS-XX the why generating of onset action. seen trial we have is hypothesis it's COMET-SI is rapid one of the important its features

separation specifically significant from week placebo one seen also two. as and we’ve as So early week at

As a GEMINI reminder, our those endpoints in secondary were trial. key

And so, with that you be patients suicidal expect ideation that those would relevant. may features for

or the specific to So, the very will studies we patient we'll that provide commercialize But think not future clinicians we of do that product. the merited. results COMET-SI trial and see as are the results information clinical important whether in await for population

Ram Selvaraju

quick And then very just one clarification.

not release consideration into that effectively TRD. basis from of that whether the in supporting on correct? indeed TRD taken So indication. a for MERIT was filing Can for the evidence supporting elaborate just would be my be additional or understanding the the COMET-TRD through it going study AXS-XX expressly And press not and would terms is the that you COMET-AU in in correct

Herriot Tabuteau

the launch in our product. certainly -- these we to from for information be as as will that filing. useful trials be and relevant provide NDA are -- And as studies these patients studies think we data clinically included the will physicians, So, well these

that encompasses MDD these which we includes broadly, indication for of a filing is all but population, not which subset, more is to be MDD obviously the that, subsets. all for the clear, abroad Just particular subsets. And are the indication patient for of specifically

Operator

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

Herriot Tabuteau

time Axsome life to year our for of call you you as pipeline Thank This progress. updating on forward the exciting today. for Well. medicines. busy a to rest advance look conference our all potentially is an We changing attending and we our of

Operator

call. conference today's your participation. thank concludes you This for We

now disconnect. may You

Axsome Therapeutics (AXSM) 10 Aug 202020 Q2 Earnings call transcript