NERV - Earnings call transcript Q3 2017 | Minerva Neurosciences, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to the Minerva Neurosciences Third Quarter 2017 Conference Call. At this time, all participants are in listen-only mod. 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 a.m. 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 on Remy Officer; today call Chief the Chief Race, Minerva are Business President me Executive Luthringer, Joining and Executive from and Vice Officer Officer. Geoff Mr. President, Chief and

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

or that except update actual any Dr. Remy forward-looking Before the as the from Company of Securities quarterly statements Litigation factors will with on call differ that to speak that occur XX-Q provisions expectations more and filed after due for this to to Form by the caption uncertainties are and ended begin, that any those risks prospects of forward-looking on turn over of these Private may reflect would I about as materially Risk call the you Commission XX, under November statements our and are a now law. forward-looking variety required Factors the expectations, remind today’s include may to to under today’s in for XXXX. our statements Any statements call XXXX filings report on subject results We Exchange safe X, including would plans like we constitute the with the discussion XXXX. that the obligation fully Monday, caution November These only materially statements XXXX, harbor Securities purposes differ Luthringer. like the our date, today’s made and on these forward-looking I are September Reform to results and detailed statements from Company’s current X, circumstances based of to Act actual quarter to events indicated. forward-looking SEC of disclaims cause that future

Dr. Remy Luthringer

Bill, you, I good of to trials to candidates complete progress initiation for that with as excited efficacy pleased you inform make also as today. known and joining am preparations continue and for us product we a and stage MIN-XXX. morning, Thanks advanced Thank good everyone. three MIN-XXX, MIN-XXX, we seltorexant clinical the

and by medical patients significant for All in of highlighted currently the need for available. needs, which treatment no products diagnosed with these unmet target schizophrenia, MIN-XXX symptoms unmet medical of negative treatment is

way, conducted the is this of MIN-XXX. to Our regulatory in review our believe with overall In that the Phase trials attention objective Xb earlier and support the commercialization, timely data high-level for primary and are our MIN-XXX. and rigorously will generated expertise with ensure particularly focus as beginning to trials, that a same we transition

with We’re forward end to X Phase year. the pivotal of the initiating MIN-XXX trial looking before our

as Review be Institutional placebo-controlled and design extension this its first note, Of as measured period. The three of label core score includes Xb Phase accurately include, the patients. as the our U.S. primary symptoms an by benefit in functional trial. randomized shows a for and open we related IRB tested The milligrams score will scale design placebo [ph] Phase has which symptoms, Phase extracted negative months study, two aXX-week, A Board, received months part The the the of Phase item to for of improvement XX-week Xb daily. scale in doses same submitted will protocol which trial. successful the final double-blind administered Marder larger pentagonal Xb will for the the followed into the more and once effect in have analysis trial p-values So, be XX is to score milligrams nine post-op Marder in the that outcome pentagonal be as negative trial trial period our in and from as IND unlike with we study PANSS is sizes merits correlates approval the trial, those to been used data the compared the by used and Xb using endpoint particular XX

clinical and enroll of U.S. U.S. We Europe patients XX% expect sites across to from the with XX at XXX approximately patients approximately coming the

MIN-XXX have X in a we data addition, its of inclusion to submission chemistry, an potential In the timely initiated NDA, controls, readout. for the ensure program pending Phase CMC, and manufacturing successful

the months, the and capabilities six that of for recruit to systematic have this last assessing a the so sites, detailed right approach we trial. clinical patients Over we taken

special gaining are We on ensure help quality placing the histories, screening. a to will patient disease believe which emphasis access patients we of

with significant months measured Specifically, symptoms scale symptoms. symptoms, patient or on inability the enrolling will as and PANSS in We who we XX symptomatically of score stable eligibility resulting this from represents moderate-to-severe stable population of the the negative criterion to well are function suffering symptom be believe everyday by and schizophrenia portion that for greater negative life. a several in overall negative positive patients, having

attention our double-blind the In focus XXXX, results on We first months this X will Phase execution from this phase in the team three half study. R&D line its key on of of expect XXXX. trial top

will Xb initially after interactions readout of recent key are we the several in data leaders, In the the publication scientific American which our in in extensive of publications additional Psychiatry. on with Xb addition, expecting future Phase will the our opinion we addressed Phase Journal from continue study. topics Furthermore, began that elaborate near

partnership and in market with development year. a seltorexant to We Janssen. product. a good known making our MIN-XXX and MIN-XXX potential next and progress second evaluating stage Janssen selective as in antagonist of is defining also also communicate are size This plan receptor clinical related NV, Pharmaceutica details we orexin-X under is

in We doses reconstitute approval European in Company’s with Phase significant a clinical design of Russia U.S., to trial a dose weeks, a effects trial post-treatment Phase phase. We responded the in XX, and quarter agreement and tolerability. and fourth this their Japan. its approximately for patients finding in dose this trial assess insomnia. antidepressant continue group was at randomized patient antidepressants as trials three pending Two and placebo to Phase adjunctive seltorexant and by placebo-controlled, existing its X the the of phases, Xb co-development response planned sites August and successful to include package first to The trial to double-blind Janssen in of effective amendment compared four up programs will than insomnia trial XXX are to of clinical will These both The Europe, help up MDD, are double-blind year. parallel and seltorexant assess studies enroll both relationship of of following a of MDD for in plan These Phase the The to Phase adaptive Xb three initiation the to phase screening the completion, additional the treatment more disorders, depressive major to seltorexant of patients therapy therapies. well quarter and Xb follow-up with lasting believe to enrolled second in XXXX, the safety on primary the Xb during patients of adult have XX past antidepressant three in these Commission. this license consists MDD. became not a two-week terms clinical a trial and An phase of objectives indications. six-week

recruitment Moving in on anxiety, thus anxiety. preparation to enable trial we both patients expect MIN-XXX, has of we our with effect to XXXX. for Phase initiate early the include Xa effects We’ll and symptomatology results started building depressive Phase also the in MDD symptoms who full to showed Xb clinical patient future. upon has that top-line preparation the trial, plan clinical Phase completed near In study the be clinical and results in from portion Xb of

Finally, neurodegenerative U.S. endeavor of beta stage potential this studies that of neuregulin-X a or the the ErbBX pathway us been to and MIN-XXX. pivotal patients has IND-enabling studies for with neurodevelopmental embraced beyond preclinical clinical linked this and on primary product recognize disease advance the development. of signaling of to the allow and Europe including way landscape Parkinson’s of stage regulatory our have extracellular the X of disorders, NRG-X recombinant with receptor. the conducting MIN-XXX the activating preclinical protein and will filings into trial toxicology with other families. we Dysregulation the treatment We to burden initial schizophrenia. we continuing the in compound summary, candidate, domain MIN-XXX Phase the In disease. with alter are The prepare to conduct is

unmet significant potential also that deliver from the have We suffering negative treatment and the schizophrenia posed patients symptoms to new recognize a beyond. for by we in need

successful as the Phase execution on results. during providing will the financial X well address trial, trials, updates I look forward our focused to other to our will years. highly the and of now with progress on pivotal our over coming turn Geoff, are who MIN-XXX We as

Geoff Race

Phase our in performance August Thank and issued revenue $XX may more from found release co-development was of XX, of which activities the the earlier September We accrued marketable operating $XX recognized with upon proportion you, recorded million, our using filed Remy. as The the Earlier approval as December A to seltorexant are the million as amendment the the $XXX.X million forgiven SEC, on September summarizing earned services of for of approximately method. XX, to third as results press of development compared today. with be as X collaborative of The in the discussion quarterly $XX.X deferred will the as to million equivalents our this Janssen. the of commencement XXXX, XXXX. the following of of upfront performed expensed date development detailed we completion were be XXXX. effective and European agreement morning, $XX.X previously and payment the XXXX cash of expenses, and agreement, XX, million revenue a cash and were received results payment on million Cash, XX-Q Form license report securities quarter $XX XXXX. Commission XX,

compensation million and September stock-based development in also of in to in in three the expenses and $XX.X Minerva Phase the the increase This X, XXXX. increase an higher of XXXX seltorexant were included stock increased clinical compensation ended We $X $X.X development quarter the non-cash million. on and expenses and expenses million public reflects primarily million XX, trials, R&D for program of XXXX common of offering respectively. in million, quarter closed MIN-XXX $X.X X non-cash July Research in months R&D approximately expense third XXXX resulted of proceeds compared program XXXX third the stock-based net $X.X the expenses that to expenses for under expenses.

$X.X ended million of were stock-based R&D clinical costs due months September trial. quarter nine million September the were XXXX General in MIN-XXX. September compared costs and and compensation of quarter offset under in trial were to completion X XX, primarily lower to the program included the an third Xa months increase R&D $X.X higher was for during and amounts primarily $XX.X Phase $X.X expenses in non-cash expenses reflects increase XXXX These XX, of expenses for non-cash personnel the increase the R&D expenses clinical This months XXXX, compared expenses respectively. fees and $X.X million, $XX.X compensation For of also MIN-XXX the professional by million for the program the XXXX. administrative XX, million, the higher third seltorexant expenses. XXXX the and $X.X XXXX. expense in non-cash development included Phase of expenses stock-based $X.X the in of million R&D expenses due increase Increased partially in nine the in XXXX. September three ended months million XXXX expense to compensation expenses and ended stock-based respectively. ended at included months XX, three September XX, ended million G&A increase This an nine XXXX to and in

XXXX. due XXXX. for the stock-based For September XX, the million September to and period $X.X in $X compensation compared included diluted ended nine G&A per months basic XX, during loss million share period million was Net and loss a loss the XX, a in expenses nine to or $XX.X loss same increase ended ended diluted $X.XX for third for of basic expenses to compared loss increase and professional $X.XX expenses of nine of $X.XX of months diluted loss XXXX million of $X.X million or and increase was $X.X XXXX. fees months and non-cash per was share net compensation million months or primarily nine expense million G&A a $X.X in the the of same as net and nine in the a loss of XXXX a to million, of quarter XXXX, respectively. first were in an XXXX. XXXX September share of of XXXX months diluted non-cash $XX.X first the for $X.XXbasic share per and loss stock-based a compared basic Net the for an or per This $XX.X

to the I’d over any the turn call Now, to for Operator? operator like questions.

Operator

Certainly. [Operator from Securities. JMP Our Jason first Instructions] question line of from the comes Butler

Your question, please?

Jason Butler

taking questions. Hi, my thanks for

Just a couple on seltorexant.

able Xb us design differences MDD trials? the on give between to color First, different Remy, Phase in any are two trial you the

Dr. Remy Luthringer

be which finding final mean, two doses focusing the the -- into the Phase So, will X. really doses is doses trials, I on or final one final pushed of trial

really a dose is trial. finding So, this

which the depressant of molecule While versus adding to to an differentiate to well really order between care. an is trial, care trial of standard standard really our trying compared exploratory MDD to second seltorexant position in is

Jason Butler

And helpful. from are not visibility Okay, insomnia have MDD trials do results trials, to then, all three or that we the XXXX you going in or seltorexant yet? get

Dr. Remy Luthringer

half really think these mean, the first I disclosed I past, of we will out in trials as No, read XXXX, have Jason. over the

So, how XXXX half is first you going, trials but the I clinical here. mean, never target of the are in know

Jason Butler

the the remind is then program? agreement lastly, costs And great. amended can Okay, per us just, the Janssen you the -- Geoff, for just for what for with contribution insomnia

Dr. Remy Luthringer

take this So, one? you can Geoff,

Geoff Race

certainly. Yes,

Jason. question, thanks the for So,

make no to seltorexant further to have contribution are Phase studies program completed. Xb the the until We

Jason Butler

a lot Okay, taking great. Thanks for helpful. That’s questions.

Geoff Race

Thank you.

Operator

you. Thank

of from next Our Joel Citi. the question line comes from Beatty

please? question, Your

Joel Beatty

the for Hi. Good morning and thanks taking questions.

X The trial. Phase first one is on MIN-XXX the

the between be doing new on to regards are X and compared coming consistency ensure sites with both Phase in to the level then you will patients? of a to patients sites, With assessing right to enrolling trial, the line that response also the the what

Dr. Remy Luthringer

important very So, Joel, question great and question.

As we’re I here that patients all study. the taking getting highlight the right precautions tried really to really the in into

right are the as enrolling the time to patients have you’re symptoms, we looking have that negative negative a to ensure present ensure patients study. into to end-point, over that So, because before you’re primary you symptoms the

Xb means, the the or it readout you is at be to ensure who that really means have a have work to the has what since of the and will to be of Phase X, in you study. of So, start have done done day, the of that access history PIs really which lot Phase it been and the patients the who to to access sites included end of the the

is I the this real factor. think key So,

in the of is with during get The PIs extensive the to of the but up study. study, order level or to consistent same them the bring beginning at to in readout a the not all second an good come order factor to expertise only the course ready and of training of readout

of symptoms the like and and overall but scale, homogeneity GI do check scales PSP also scoring we PIs PANSS all So, the also factor, the reinsure will as the of study we, will the terms the in of and occurring along way additional all our what we study. obviously scale. the will the I a same mean during blinded But, sites, during in all course the the negative completely

day. success of the are think I this key of the the end at two factors So,

Joel Beatty

if of through X related to will you in current Phase to is nine sense question fund position XXXX? able another sufficient And give your results the Great. finances. a to the of Are first be cash Minerva

Dr. Remy Luthringer

one? this take you can Geoff,

Geoff Race

financial But, for Thanks I what our with next study. normally cash the to give say we can with is $XXX runway beyond X the enough the to than will certainly have months. that the question, don’t million to other XX Phase extend say We guidance cash Yes. Joel. $XXX regard fund

Joel Beatty

file a program cariprazine one for And letter discuss how MIN-XXX a and approval is Great. in different FDA. to Phase compared little the from for to your to treatment taken you which had refuse potential path support bit then, last filed negative Could cariprazine? related schizophrenia could of question about the was QX a approval for Allergan X in received symptoms just and

Dr. Remy Luthringer

not Yes, order in negative specific you Joel. demonstrate a I negative But, symptoms. about symptoms schizophrenia, cariprazine. for think the that have to effect I approval Obviously, the will comment get in patients basically to you for with

other there have words not So, second side symptoms, negative currently drug is because in no currently approved available, in even the treatments the for they because effects. are approved market all they

two that confounding not really to in ensure have the are you these trial. aspects So,

versus a drug mind drug of So, a basically, should in symptoms in effects. with compare This devoted demonstrate that keeping is negative the case is effect side only on that way be the placebo have to you order to the specific MIN-XXX.

we symptoms sedation level the molecule symptoms were the during no maintenance and Xb course same As no other trial; Phase trial. talking able we the at to molecule, you have am we show about with the [ph] know, as the I with expected have of positive the of

hopefully are this if versus two the with to able symptoms. effect the will in come the So, in really this an having I same we Phase can readout you order file X do for in to Phase filing we all use have the here doses, mind, in can is that to a same placebo you a NDA for an effect X because comparison way think specific to on you study, the negative conclusion claim have and

Operator

comes LifeSci Capital. question line of from next from Sherman the Our David

Your question please.

David Sherman

to just if Phase Xb color be a program Phase your insomnia. for for I there going are Thanks you could taking the for you add give what guys. What to testing study was Hi, will more wondering on question. XXX? my bit it and X little

Dr. Remy Luthringer

for question. you thank the So,

us dose Phase the in provide finding. will is again what Xb So, insomnia

narrow X. Phase to into dose, down several which therapeutic push test doses should will we in the So, really order

a So, finding from suffering it’s without several psychotic insomnia patients with doses really dose disorders. in study

the the this is of study. So, purpose

Operator

you. line Amin from from Jefferies. [Operator next Thank Biren of comes Instructions] question Our the

please? question, Your

Biren Amin

Thanks trial. taking questions. view clinicians for How a my the would Yes. standpoint? clinical on from Marder PANSS Phase X Maybe the you do just think relevance

Dr. Remy Luthringer

case significant this, we score what KOLs -- an I are are nothing have or effect is for the patients I it looking But the negative think and Marder you to is their on I But, clinicians the really fact as understand life. mean so, and or daily what because available. get in to are this negative So, scores. obviously, to main cope think that is symptoms patients; outcome PANSS looking that for and authorities the for to are But functional bad addition think there approval. contributors the show enough is these extracted to from negative out treatment you important in from able scale, in a symptoms impairment not with really know coming effect probably as of cognitive to this is the I know, these as

looking window to the level. It how of the I a functional gives window. it scale; patient of And and such the as the difference, item a a JXX already, between advantage PANSS socially. a interact was which to score into item an which the the patients Phase called we a is ability So, on is opens study pentagonal this of is explained is scale improving which Xb there is have that the Marder used of is score the score Marder think, from kind the

discussed Marder So, mean and this with FDA. a the scale we reason proposed the this is have why I

Biren Amin

enrollment previous a to it. are switched And time think then, medications. of And over on washout MIN-XXX? to also allowing study. switch period med Got at prior they’ll the there their be in patients significant Is from I MIN-XXX the you’re between that psychotic antipsychotic

Dr. Remy Luthringer

a question. Again, great

the question as MIN-XXX few the to why been it’s simply, with is as is authorities. from mimic as or has a discussed switch market. in condition very this the previous clinical try days treatment And just. mean lengths a the very I because much And possible the So, to of be also short, in situation we once will as the the this drug

who patient is important symptoms, a indeed, confounding in MIN-XXX afterwards, washout after short want living, to which to so, So, need is which a have not are treatment very of the to negative we because avoid period. what his goes we responding here previous is also switch is doing, well yes factor. And you terms place back he normal factor; an of really to

day-to-day in in approach to is So, will it order the once drug happen the mimic is a really what very market.

Biren Amin

Marder’s of we’ve then, MDD. as control few Marder’s compare just the a to it. it’s the trial, evaluating this some endpoint, second seen the you trial endpoints Is by are do variability a in in type you exploratory of other the for the in question And parallel kind the Got last are companies on what seltorexant, And that averaging if like and use? seen score we’ve going [indiscernible] trial? sequential this design weeks

Dr. Remy Luthringer

This is are be hypothesis different -- sometimes this versus and design -- of and test is I keep you treatment the mean, to the conditions endpoint to comparison, which end best, if the simple of No. group want exploratory. it parallel will is versus

very sophisticated So, forward design, straight there. simply, nothing

Operator

this conclude program. the I’d question-and-answer you. And any for to session does like back of hand William Boni remarks. further program today’s to Thank the

William Boni

on care. a look Bye, great months bye. in Thank to dialogue Have and come. the day. us everybody for you our QX Take the forward to call. weeks And joining we ongoing

Operator

the Thank your you, conference. This today’s ladies and does in program. gentlemen participation for conclude

day. Good disconnect. now may You

Minerva Neurosciences (NERV) 6 Nov 172017 Q3 Earnings call transcript