NERV - Earnings call transcript Q3 2019 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Third Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today's prepared remarks. This call is being webcast live on the Investors section of Minerva's website at ir.minervaneurosciences.com.

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

to of call Communications Investor like Boni, to at now President Vice Relations would turn over the William Minerva. I and Corporate proceed. Please

William Boni

morning. our today, and quarter be company's found available with Investors press can X:XX financial section the of at Time results became Good third Eastern AM on A website. release XXXX the

on with morning, and this Our on XX-Q Form SEC www.sec.gov. quarterly at was be the the found report website also filed electronically SEC's can

Dr. Financial the Remy Executive and on today Chief call President. and Race, Minerva are Business Russell, Executive me Chief Luthringer, Joining Officer; Executive from Chairman Vice Officer Officer; Geoff Mr. Rick President, Mr. Chief and

prepared our for we call the Q&A. Following will remarks, open

filed indicated. materially those due for filings actual forward-looking quarter from detailed fully a our the XX-Q the based caption are the on about Factors with I under Before plans, materially may would forward-looking constitute XXXX with statements Reform results prospects to statements are including SEC ended that the expectations, like forward-looking caution that we that to of more include XXXX. actual from and variety factors November results and Litigation Securities report these SEC, today's X, under purposes Act Harbor differ Form begin, provisions may on and the statements of to statements uncertainties current Safe cause Company's expectations We risks our of the Private the for September you quarterly future on remind Risk XXXX. These that differ are to in discussion subject will XX, that our

circumstances today's company these speak November obligation call update law. except disclaims date, or to Monday, that the of XXXX, Any forward-looking X, occur after statements call, made this by as statements events today's any only required to reflect any and forward-looking as on of

like Luthringer. Remy now call the to would I turn over to

Remy Luthringer

for everyone. joining us Bill, you, Thanks and good morning Thank today.

programs. I year, the of made end in we the have XXXX near would this during progress clinical-stage review like we As our to of each

read trials and First, results in completed four top-line disorder, MDD major we and from insomnia. have seltorexant out with depressive

enrollment Phase in MDD, expect results fourth MIN-XXX have in quarter and Xb in trial XXXX. of the we top-line have Second, concluded to we with

have in III with temporary the we and our our enrollment of in advanced following we Finally, recruitment patient discussed Phase we product trial roluperidone the resumed October. pivotal lead have patient pacing delay

Beginning with enrollment with trial Phase III levels. have roluperidone returned expected rates to

Scale, considered number in pause the of the maintain quality of stated of but for expanding study jeopardize last integrity over randomized, compensate to the patients track impact remain we not double-blind, enrollment The assessing we at complete the and placebo-controlled the enrollment, suffering elected Syndrome of trial group, change to Negative As milligrams trial trial chose This to of parallel of safety in symptoms recent double-blind to milligrams schizophrenia. XX-week score negative patients the XX-week over efficacy other from Marder's designed roluperidone XX symptoms of and monotherapy NSFS, is PANSS is in the from evaluate as baseline period. symptoms primary and negative to month, on slower that speed. XXX the Positive a using recruitment sites we endpoint XX year-end. In of in we this approximately discussed we negative and factor treatment October,

XX period receive milligram XX active to during of the placebo drug patients which extension double-blind receive are or either randomized milligram weeks continued the those patients a enter during phase on drug, XX-week if the enter on elect original active to while dose, they XX After to into extension open-label period.

treatments CGI-S. Global need This of unmet addressing negative in no for scale PSP Severity Performance Social Impression approved. Clinical and medical schizophrenia Personal symptoms a which a includes endpoints is secondary trial Key and significant are

of quality screening the all is patient entry Our patients pre-defined selection meet maintain to and criteria. study's enrolled the that ensure overriding strictly objective to

activities to drug specifically application a preparation program remain filing new for on of the the roluperidone related Other track.

Catalent, For pilot example, schizophrenia. into manufacturing under packaging. we approach in to during which negative the the supply to an with a generate select in profile We that commercial-scale potential new to agreement product from will this quarter, we transition past and the entered remain and commercial confident treating trial therapeutic we symptoms of exciting

with trial treatment major to a based Moving enrollment completed adult patients MIN-XXX benefit, with pharmacological may Xb we this clinical moderate molecule XXX without disease at that a We Phase features testing. of levels of in and least the the psychotic of profile earlier from particularly with of patients with characteristics depressive MIN-XXX, in have disorder, anxiety. believe total shown diagnosed on

Rating design The by screening Depression the two-week treatment and this Montgomery-Asberg six-week doses milligram MADRS from phase over post-study trial objective The a the mood, evaluate the a of a period. treatment with measured follow-up and period. double-blind to X score study X.X efficacy in in two milligram depressed MIN-XXX, baseline compared six-week as placebo includes primary of symptoms phase, total of Scale, change of is reducing

include using the in the Anxiety of objectives HAM-A. symptoms first assessment Hamilton anxiety Scale Secondary of change baseline from

Global Second of Global CGI-I and treatment. over is safety illness six a change Clinical using and of in of Impression Improvement of Scale severity Clinical third Severity Impression CGI-S, the weeks Scale,

cognition, in sexual to action these of assess to and improvement. function, plan mood onset sleep, addition we In measurements, also

expect trial have We top-line in quarter to results of the this XXXX. fourth from

MIN-XXX. under known results these XXXX, seltorexant top-line Pharmaceutica we trial product disorder. insomnia seltorexant, and was and Xb Our in Three one trials completed last MDD, one with in trials clinical-stage announced Janssen of Xb X During Phase and Phase were from also co-development as is with

would As completion summarize results of like conclusions to trials. cumulative a following in key recently, this published details I these

symptoms. improvement the insomnia. in or First, mood and mood and seltorexant SNRIs, the in patients its therapy in add-on mood shows as to shows improvement meaningful and consistent and sleep as seltorexant presentations, stronger effect with monotherapy, In SSRIs

and both subjects, from elderly both and to compared seltorexant and safety from mood. orexin-X maintenance milligram XX the robust statistics, believe of of We consistent on most treatments and an the dose this improves and doses is antagonism, seltorexant discriminated sleep mechanism data sleep profile. tolerability other of In The profile with in shows the effect a zolpidem. induction the new placebo. action, be MDD, for defined current and over receptor both safety encouraging cannot seltorexant benefit that insomnia selective shows of study Among

pathways development during the defines moved a product we next that in currently described the clinical forward testing. from The We discussing roluperidone, year, our Janssen. have seltorexant the approved regulatory look for trials, significantly and candidates, have that We're products differentiated steps focus in program indications. exciting the with in a activities of next MIN-XXX currently steps we into believe target this forward highly to which I

our Geoff to I would turn to like financials. call the now over for

Geoff Race

Thank we a XXXX. discussion A release may more results you. earlier be our today. the XX, on issued detailed operating morning, this Remy. our for results in press September with report ended SEC our filed summarizing of the XX-Q quarterly found quarter Earlier third Form

cash the to and and and cash million XXXX. were months for sufficient Cash, securities today, and from same We commitments believe were million marketable the mid-XXXX. XX, for XX, for least cash cash restricted the cash, periods XXXX September will nine as to development company's ended equivalents, $X.X respectively securities XXXX September into three of that restricted meet million and be months $XX.X approximately XX cash existing Research $XX.X marketable its and equivalents, $X.X the in at compared next and expenses $XX million million.

The G&A during compared and $X.X the General million and administrative expenses nine-month salary to compensation primarily in and increase to ended million same costs. to $XX.X professional nine XXXX. activities, for XXXX million support were higher included months respectively the million and the $XX.X non-cash also due $X.X three the then for the expenses September pre-commercial in XX, period periods expenses increase fees was three-month stock-based and and period,

months net and $XX $XX The three respectively $X.XX for per $XX.X or company per and $X.XX compared million a million respectively nine share reported the September period to XXXX or ended and for the same $XX of and XXXX. million in loss $X.XX million $X.XX XX, respectively respectively share, and

back the operator to for to questions. turn like any I'd Now the call

Operator

[Operator from from Instructions] question first And comes Amin Biren Jefferies. our

Your line open. is now

Unidentified Analyst

if the is prepared for number your correct the be sites that Hi, will you counter Jean good expanding in me of but mistaken, to stated morning. This you Yes. [ph] I'm remarks Remy, Phase Biren. and sites, III. these delays Could which follow-up they of questions? perhaps on quality the recruitment on you coming the roluperidone and from? elaborate are this have countries some decision, I And

Remy Luthringer

Hello, I good English my exactly -- No, not opposite. the we maybe think it's enough. is

the contemplating that a variability reasons not I'm so sites late is clearly, saying and are, would sites. was process of you as I recruitment we be obviously to of add this not wise. obvious in for But adding always what for additional do fan to know, So

enough. good not added was English definitely my if have sites. I again, we any not sorry definitely So But mean,

Unidentified Analyst

recently shown? you in studies just And published what of the some it perhaps as studies had this results you've have that that you. morning, thank you also and and showed data drug-drug looks the for minimal completed some roluperidone, recently analyzed Okay, Could interaction. preliminary elaborate interaction on XX-Q your though those specifically

Remy Luthringer

I the last already Sure. but we time, think And addressed I this mean.

of Phase II the had XDX two mean, So XXX, have is XXX. PXXX of perform discussed what FDA we what to with the I we interaction obviously we interaction an meeting, was biggest done, the and with agreement have at this end studies cytochrome the and

and XAX studies. that aspect effect two mean be But the of I we minimal. the molecule the obviously it marginal. these are of can mean IA and show is the on mean, I and exposure in the is So, because add-on metabolite given interactions the very MIN-XXX on for because reason mean the drug these that's is I really good also the MIN-XXX And XDX indeed. really and have levels with I the they active part results why, is completed drug extremely monotherapy. a different

Unidentified Analyst

color is pain. you just regarding as you. action looks patent it also perhaps you you've on neuropathic Could this MIN-XXX, indication Got to pain. an it, new some to in plan application mechanism of thank a And of provide related And pursue? filed XXX the though

Remy Luthringer

I Yes, in results I predictive what this area, all you of the -- will mean, see as know models. so so are pre-clinical results I extremely think again, pre-clinical this the But in models mean clinic. you

exciting the why that's we filed mean results really I the reason have there and we So really, it.

example, on was like know an clinics. came also for you we to pain Duloxetine [ph] having to I in have effect detention as research how models some -- this and mean this So idea

results deeply this has I And we better understanding. can a much molecule think see really So our to wanted into as available. what you going currently

so action, come difficult concerning to we still the a to now working it on obviously final are is this. conclusion, mechanism And of

rich combining pathways. MIN-XXX pharmacology know, an As serotonergic you is extremely dopaminergic and pathways

up come pathway pain that with a this control based of model, guess is an incredible on clearly in pharmacology, But pharmacology pharmacology but implicated think mostly You results the this or possible, rich can always of on serotonergic this to effect conclusion pain. date firm -- complex which to has I is this

Unidentified Analyst

Great. file from the for And of you've some MIN-XXX maybe quick results it one intend Parkinson's. me, you When to looks one also in do just had more a model primate for IND XXX? like

Remy Luthringer

really I I is of you have with really domain solved endogenous a mean order the started a secretion package. So, with and to methods have MIN-XXX. to bit and mean, Neuregulin little very are pre-clinical discriminate and a we here sophisticated you struggles as Neuregulin-XbX working because really we of as -- are extra-cellular in this bio-analytical had know, need method between we We now

full problem this solved go with now the have pre-clinical now and we can package. We speed

an are filing the really think we year. course next ready for track IND on So to be of during I

Unidentified Analyst

you very Thank Okay. much.

Operator

Thank you.

Joel Our next is from question Beatty Citi. from

is line open. Your now

Unidentified Analyst

you calling Janssen? remind Two for time-lines John Joel. steps seltoretant is morning. are any next us in for Can from decision me towards this and around Hi, what developmental the this

Remy Luthringer

from So, or colleagues my script with the I best up plan as to my are I with that working really in we Janssen forward. come mean, really, mentioned moving in presentation is our

really are advancing very We well.

definitely for debates a is many think that, insomnia. a obviously that I the have, great this of the We as so I due molecule gives because is I to drug it in past mean, lot opportunities already explained, fact

as on a obviously patients. is which And which is more it mean, I you really this also I of on think important is I pronounced, which are it and doing is mood. hyperarousal effects the insomnia have something mentioned, some drug translating complains if in is effects in mood something insomnia, on

will plans the step FDA next very going Phase also be And soon that we generic the we so advise this with II of very to have the in based end an and obviously finalize to Europe. Now, on for seeking which meeting is will we happening move shortly, able and be feedback, are forward.

of bit you have So this with and we possibility complete us block feedback we all finalize update have stay and our a to the we again, little will when plan.

Unidentified Analyst

to then you the XX Great. of able will for a or to ahead data as brief you for file be do roluperidone, need And anticipate safety wait will filing them? follow-up prior months to

Remy Luthringer

This is obviously a great question.

the the on definitely primary is XX weeks, phases. endpoint So double-blind

phase be interact to to rolling NDA we mean moment So worry, have the I the the safety with base. particularly And not really the is clearly, start I think can this file. where know, XX were it months be I really a XX this given with And added when months XX think FDA can months the in to be as data really, XXX you the because blind gives we will think have or start can really we we results talks to patients safety about we do I data

Unidentified Analyst

Thank Remy. Great. you much, so

Operator

Thank you.

Butler question is Jason from next JMP Securities. from Our

is line open. now Your

Unidentified Analyst

for for with a thanks Roy Phase end is [ph] FDA? I Hi, II the that just the Jason. of on has follow-up question. This the taking been for scheduled in seltorexant, had

Remy Luthringer

for the we a date. been are submission So done have and waiting

Unidentified Analyst

FDA then your can to you Phase any trial the they plans recommended the the share? on for the roluperidone the conduct on as did great. And that of changes any discuss that Did III. us have breach can on data and you well Okay, or you other comments Thanks. the remind with

Remy Luthringer

we we really the mean, Phase of had analyzed been full as I you like II deeply analyzed data and Xb we registrational FDA a a which Phase our definitely. meeting, agreement No, know, pivotal have end or the had when with study.

So with is this I it a have late-stage because into smooth base going development. protocol was since it when discussion how has on submitted protocols we Phase exchanging mean, FDA the obviously clearly, very a and III nothing FDA. the to changed is regular you're We

in We CMC. have obviously exchanged terms We had concerning of CMC. also meeting

Phase lot terms design, nothing a endpoints, have of of exchanges, we protocol has the meeting. in II the but -- had we primary So study changed since of end study

Unidentified Analyst

you. Thank Great.

Operator

you. Thank

Our next from question is Chardan. Jessica from Schmerler

line Your now open. is

Jessica Schmerler

Hi, taking for thanks question. my

one quick from me. one Just

that decision terms any about that with the is there mid-XXXX, announced? that runway any the may or the outcome assumptions change through In cash decision possibility of making Janssen after of is is

Geoff Race

million out the has to we'll drop the period in Jessica rate cash for burn about extension but prepare steps around our Yes, roluperidone and a those so run we and expect couple as the we necessary. quarter, years cash been next over get the XXX, as we clarity last the we predictions, to year, that $XX adjustments over with next plans direction of and as obviously make on significantly

Jessica Schmerler

Thanks much. Great. so

Operator

you. Thank

Minter from is question next Myles Our William from Blair.

open. is now line Your

Myles Minter

of Thanks guys. EU wondering programs. questions. proportion taking to the in patients Hi for just the about roluperidone I'm the US

in program, patients portion for to versus database follow-up particularly I've read would EU for that of seeing Sorry you phase proportion the out got label US care enrollment that arm? in rate to that portion the safety about the any and hop on that of but FDA the be about is dropout this, how the from extension does of in open the that. comparable update of double-blind trial? that after also Thanks. on a potential Are

Remy Luthringer

a in in a so. we question mean mean this think, great really have with the the done as I way Obviously, very and I already Yes, explained past. this FDA. I is I interactive

from and of our been to coming So see from order extremely the I divisions FDA clearly, open-minded are overall of advisors with I the complete the Europe again, efforts US, carefully here possible clear, [indiscernible] endpoint this discussed US. was had I that, patients. complete I so agreed mean the mandatory, this But the some the close patients and like before. are to the would what will what been crystal and this objective the as come best and from we think advisors And we what to as patients mean, discussed this efforts the mean be that we very really so has a XXX is our and best is FDA from this heavily or is that study in clearly primary was the and do XX% study combining , the will not

is, I we only clear guess can negative it of to really mean as this objective same pick MADRS score scale, they if to you because the mean, see want box the the are I who score. the of going But here, the have who to also to basically. the terms only US So PANSS into is the according very in to improvement of patients direction

is XX% best So efforts. again

Myles Minter

Okay.

just difference the of the open-label expectations the efficacy So extension to and the trial require? patients the in to the As would in trial? how portion US of and is they the portion EU, no there many clarify, in safety

Remy Luthringer

of our what really patients US. safety monitoring you molecule of in can is, And I the you guidelines, obviously behaving tell see always overall putting pot as that you versus patients is when is can coming, don't here so placebo. just completely [indiscernible] we is are different blinded, in of of are we the today, think the how we what or you is any between terms it's doing, difference even this same efficacy. tell the scale this is the blind, going all recommended practice, planet from blinded important. are And I because the good And what whatever in checking you're I region are Europe

mean popping patients. there I patients up, nothing, -- European safety, the which but popping up and blinded this a US I again between between of it the terms In different is is all same. the which is is exactly obviously mean is

much it but failures that up you [ph] again, a clearly completely in between And indeed, in recruitment yes, is being advertisement. have good my any see a all mean in very is US, blinded, mean, more difference US point is we screen US as by screening, extremely really here based I carefully, really I it view, shows I impossible right thought in terms something the done patient. know And think which think very think thus often I I to European is and is of we we So I the the patients. it are picking which today, I because mean as is, important of mean

So it's we more screen working have of screen European in, and terms is noise But I bit cannot and really no our failures. as I failures, see efficacy, I there little filter patients normal the have patients. you more safety, I coming is when of have but explained that because difference you a mean, more mean well, in are think the that between terms in before, US in study, we that any

Myles Minter

the Okay, MIN-XXX, meaningful I data good, you Phase theoretical peer seeing patients and placebo, over that their that the is drug, if that single could for trial, space that difference stage? is III what that's there. companies you scale that scenario, the MADRS trials designation some the II point with helpful. later pivotal for we're approval that is a enough then on early I've potentially in that one in Phase in for as have powering using And And think US for on threshold just assumptions is trial, do it of clinically sort the are X.X heard apply breakthrough

Remy Luthringer

mean yes, Phase in really and powering, X So treatment mean, very mean, study, points hope I indeed, I can't you that a have milligram. mind placebo. we what go in and Xb two small mean, with the this using obviously seen I greater milligram trial, Xa mean so we X.X that, on we to great terms X.X are and whereas milligram X.X of study, out these are in a small this but we used Xa milligram, in I the see Phase in Phase questions. Keep based between I yes, delta, X.X

with hitting I mean good X.X, and where here, more. a pharmacology, good see pathways the it's we more already, we really hint than that effect So points molecule, or definitely X.X depending increasingly on hopefully strive really should mean, with think I by very and have exposure we a really I we our more see will

US the about study, Now second concerning your in enough recruited of number in we well interestingly patients, extremely US. point this

within options think I it's all a are So can the to options always yes, different order contemplate in good. We data extremely all different herein. pool contemplate

Myles Minter

for the very update, questions. comes to out. Janssen Thanks Okay. much when forward the Thanks. Look it

Operator

Thank you.

next from Douglas Our is question Tsao HC Wainwright. from

open. now is line Your

Douglas Tsao

morning. Thanks questions. good Hi, the for

in of maybe Just know you Remy, terms MIN-XXX. just

Just curious versus advancing potentially things out like by seeking and hope in yourself did we III interest if into Phase the that a as seltorexant? you with partner expect, play

Remy Luthringer

a Again Yes. great question.

mean think us these different you these I will said for and based a I so the results, the let But again, Douglas. us on land let think So wait let us it where options. little as see contemplate with we us give please, results, time correctly. we I see and results, results, the

Douglas Tsao

Okay, great.

And there both make options of those where sense? are so, meaning the would that most scenarios

Remy Luthringer

different [indiscernible]. When a if running you different you where here. have of you in roluperidone that symptoms, different have XX we I a as readout are indications. strong types like take molecules mean, positive negative know negative a ours company diseases, a We roluperidone, symptoms with if options, know, you're

very portfolio mean huge indications. a very, So becomes, of with lot a it obviously I

have to So options. different be open to you and listen the

readout today, data let have what As we and you of the next. I first of the will update on mean, us

Douglas Tsao

enrollment. breakdown two just Have has that then, between of change you And in been of of terms the roluperidone, regions terms seen largely Okay. same? Europe US in in between and the the any terms dropouts or

Remy Luthringer

Can hear did the you I not end. end? repeat the

Douglas Tsao

drop terms out any regions in of two roluperidone? difference the between -- for the dropout between Just rate

Remy Luthringer

no. answer short the No, is, answer the -- is

recruited. related at But any definitely I no again site, I to explained, US, is have once here, all. I the when mean, in fact think site-by-site, there think the depend really I screening selected patients to difference study, the and I mean, the are It mean in of not on as the I right have We difference. is seen you the are the the patients way

site, mean not mean the our perfect, each to to trying feeling or have sites with each to you you know a have follow back is the say through we're to So have [ph] to and really intervene be close. you something obviously here. to observations if you achieve I have that site, that go re-explain completely we're I to lot not to to what I

So clearly, European I I mean mean, of difference see long we between short, sites don't in the story [indiscernible]. US and sites a terms

Douglas Tsao

Okay, great. so Thank you much.

Operator

time, this back questions. I'm At would to you. no over remarks. I showing further Thank like Remy to call turn the closing for Luthringer,

Remy Luthringer

molecule. all questions these great you our Thank and those for in interested

So, we first exciting all the very on it months update is molecule. really out, a forward really, I and ahead weeks of true a that coming to successful you the have looking very of and after few result am results us,

I seltorexant, again and soon and So on really bye-bye. this very you, you. other Thank out molecules to two call. update mean looking for read forward we Thank you being

Operator

participation. presentation. your Thank again today's once for this concludes gentlemen, you and Ladies

may You one, disconnect. have Every now day. great a

Minerva Neurosciences (NERV) 4 Nov 192019 Q3 Earnings call transcript