AXSM - Earnings call transcript Q3 2018 | Axsome Therapeutics, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to Axsome Therapeutics Third Quarter 2018 Financial Results Conference Call. Currently, all participants are in a listen-only mode. [Operator Instructions] 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. Please go ahead.

Mark Jacobson

operator. you, Thank thank conference and quarter for us joining results. Good to you discuss today’s call third Axsome on morning all Therapeutics financial XXXX A and September XX, details crossed the www.axsome.com. update results a short the on XXXX press time our a company’s at ago for ended the available financial and quarter third wire release providing is of corporate website

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

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

results. our review provide Medical progress of detail further on today milestones, Dr. and Affairs. O’Gorman, Nick will financial Chief and Pizzie, me Development Nick are our provide Cedric Tabuteau Herriot Cedric of pipeline will Officer; and Executive upcoming President first of Vice Financial studies review on Dr. quarter Dr. update will Joining a the third Tabuteau, call the a Chief Senior Officer; and Clinical clinical then

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

Herriot Tabuteau

for and pipeline CNS thank our clinical cash us broadened you several our extended creation. announcement been everyone The for past non-core of Good have runway Mark. and our you, We months today. period product a joining ongoing product all candidate, CNS morning Thank Axsome. new for value advanced productive highly trials, upcoming candidates with clinical in position enhanced our the catalysts front a of

our held we We of opinion diseases two and to leader have our understanding of to the continued to conferences highlight them. the and further a at targeting R&D potential addressing technology key product medical the events of number important are candidates

portfolio and growing AXS-XXX. AXS-XX, now includes AXS-XX Our CNS AXS-XX,

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I complex potential let of potential clinical announced it portfolio. and over of month, and non-core me developed which back non-CNS indications and our Cedric pain patents. Phase Primary Before for and of and new assets knee enhance value development and rheumatoid These value being product house, osteoarthritis, of are related product candidates The to product intellectual turn Two the Care osteoarthritis developed pain manage, being XXX a Axsome assets these of shareholders. symptoms Osteoporosis, Axsome for facilitates three in are related Axsome’s care of activities we pain five unit source further to provides a of chronic property Pain Axsome’s unit low programs, and the the the neridronate include and the develop These a few different about words business to by portfolio. new to over our by stage creation them. non-CNS in assets AXS-XX provide we pain regarding this structure signs call say ongoing is detail communication Last business candidates candidates X candidates covered syndrome. assets, Axsome arthritis. a regional and one AXS-XX business clear the including of are directly product primary

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Cedric O’Gorman

which trial I in our AXS-XX our top Stride-X first Herriot. quarter is final updates. in expect some the Stride-X you, safe and now the Monitoring of the or conducted now IDMC XXXX. IDMC. Thank In Enrollment and in will AXS-XX and treatment clinical recommended passed The depression for we tolerated. April by line was Data Committee that was Independent successful that recent of an futility ongoing discuss analysis resistant well interim of indicated trial XXXX scientific and results continue

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Neuropsychopharmacology of and last on number Pain oral candidate in at September. like drive November, our European portfolio Meeting the forward of further Barcelona, our all the call, since programs as providing and Psychiatry Turning the have now call I in CNS in continuing a product earnings our the to Spain World Study updates of poster to International the look the City to over they conference now Mexico in scientific in progress. of Association delivered forward to Summit Annual We of for October, September, focusing clinical College in Congress of and turn to Meeting Herriot. we presentations to back presentations, would the

Herriot Tabuteau

review Officer, current over Thank position. the financial Pizzie, turn would call Financial you, Chief Cedric. company’s to our who’ll now Nick I like the to

Nick Pizzie

you, Thank now financial morning, quarter results. and cover third XXXX everyone. Herriot, will I our good

the at me a investors. shares accredited per net of Last month purchase X,XXX,XXX Let completed a million. Axsome existing $X institutional start update. with $X.X registered approximately other stock price from offering were The with share its direct financing of proceeds a common of offering and

which pro balance X, $XX.X On as million October balance direct cash was As the cash our as million. of our September XX, closed basis June from XX, compared registered was $XX.X include offering of proceeds XXXX, to a forma XXXX. the million $XX on to

per along ADVANCE-X, increase related AXS-XX, of clinical comparable ramp-up million comparable the company incurred loss primarily Turning reduction $X million XXXX the and $X.X loss quarter trials due period of which compared the costs as ended expenses, XXXX. to the $X.X primarily and million public share associated cash the of that operating external to into position of increase by and development XXXX. to $X.X million was compared expense for of statement believe for of as of compared for third cost amortization for XXXX, to security quarter and and $X.XX offset comparable cash partially and with be period associated or studies $X.X the $X.X STRIDE-X, to million The as of $X.X In XXXX million. with million increased a $X.XX our the fees Research administrative a was We in net were XXXX our in in well loan current quarter was the operating ASCEND and due for were in fund XXXX Interest to of or as The $X.X quarter agreement operations. in expenses third discount debt the anticipated million our previously $X.X and million million costs. a the AXS-XX. $X.X of as third of XXXX. initiated with in intellectual expenses first was operating increase share XXXX requirements by expenses legal our per $X.X General an conclusion, Overall, higher the an increase will with to personal XXXX, XXXX, an as in to for $X.X net company sufficient period quarter with property increase SVB. the of million third quarter third our million. million which was of $X.X for

will of discussion. third the line Importantly, the major financial Phase analysis I and Phase the turn quarter trial in review. call top of next narcolepsy, line final our for the from both major trial disorder, depressive of including financial from results take the several of smoking to Alzheimer’s X now back concludes depression Stride-X our trail the from resources in trial in X cessation line AXS-XX we trial clinical to and current results the for ADVANCE-X the results line results milestones our results Q&A the believe That top associated the with resistant from interim ASCEND AXS-XX treatment top agitation X through Phase lead AXS-XX disease, of will for top migraine. us XXXX Mark that Phase treatment trial X

Mark Jacobson

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

Operator

first Instructions] from Thank you. of BTIG. Hazlett [Operator question Our comes Bert

open. is line Your

Bert Hazlett

an I data depressive comments in migraine. Thank the we would questions trial of single you. to only that of I some Thank and resistant be and for around additional the excited I readouts. couple said background depression kind one. forward going quick could could AXS-XX a them looking are in It’s will how heard Herriot is with the repeat large opening two AXS-XX, question you some that, readout is you study remarks hear to together that’s [indiscernible] migraine am going you so the that regard or months describe the the you just you. you for noise readout that I love have trial a in to to might And I off, question jump think need clarity there from is Two to around – got there disorder MDD the coming is then the to ask read-through end, MDD year treatment any readout and to

Herriot Tabuteau

the Bert morning, questions. for Good thank and you

TRD, to we around to first MDD looking MDD regards question to trial. results for the really read-through are with forward the the and So potential

excited include action We mechanism action. mechanism are depression. in of of does as the which action the is reminder a it novel And about glutamatergic AXS-XX of of mechanism a

will at certainly So any to this a the effect have be look clinical depression in we in the have that potential of first AXS-XX study.

for failed if populations whereby treatments, are the which there TRD different is MDD much study line trial, a I two good the you somewhat and positive is both they that TRD treat. results for because that be prior to frontline get thing not So the is a which in of expect harder Having definitely must the arms like for clearly MDD trial, that, between patient the The to would in trial. in this a trial, is – point difference we the patient population would trial. that I front terms trials this remind said case the is come the study, is TRD is a the two have And better. that the it patients other are out to sign would

is in We are work active an is disorder. major using bupropion, control to depression which known which

the while TRD on trial control are For using the group. the we hand other same

using showing are to a control, are patience as bupropion bupropion that we failed we prior randomized. being While

the there between competitive but of these the a that’s are design answer, So differences trials. two

I studies. about between at So be the helps the to two think potential I read-through that what hope you that least might

it’s So –

Bert Hazlett

That’s question? And Thank then migraine you. helpful. the

Herriot Tabuteau

the file comment just an trial do potential that’s to had made, With migraine from we’ve acute with the of the the asked based Sure. FDA, communications regards the as for the And believe study, as also one the about fact NDA migraine. that the Phase you of question treatment that had that also X with four that well worth we study. it a size they’re written migraine. upon guidance, to that, FDA’s the to for I new hits products preliminary in developing And communications,

the to X preparations be making precision AXS-XX greater size migraine and we’re will providing study we in the with launch trial very clarity, in the around near the greater Now Phase of future.

Operator

of Your next Matt Ladenburg. question Kaplan from comes

Your line is open.

Matt Kaplan

ask looking guys, that now the could relatively to the of going case or for the analysis Hi, – to have morning, on you’re going in the of powering to bit to remind in and the X the during little you us of the progress first forward about that us you’re these with STRIDE-X now all remind I you Can congrats near-term if near-term you assumptions respect and good wanted read-outs. a that study go, quarter. study? – given powering Phase to quarter final the

Cedric O’Gorman

is This Cedric. Thanks, Matt.

of different by four at mechanism been of excited as includes with study, mechanisms, [indiscernible] robust ongoing the And including the MoA. as well design. action trial very we’ve the conduct STRIDE-X and the progress which AXS-XX, its novel We’re pleased antidepressant clinical

So is control the open-label the as bupropion a that also we’ve we’ve bupropion an only and arm. lead-in, incorporated reminder, arm ensured in

has as are sensitivity ensuring that So a enrolled truly of that that are the result STRIDE-X but the that, variability into patients assay we’re treatment-resistant, and has the reduced increased.

STRIDE-X, power we’re target that of this as with detect signal efficacy subjects. that analysis, rate in the lower-than-expected power the statistical – seen the we’re preserving – the now believe So, new required lower observed lower well as with we’ve number to elimination interim we of an that study given the this with in drop-out retaining

Herriot Tabuteau

drug. robust analysis in by to design. the a rate that, power that retain – thus demonstrate with preserving of study words, believe Right. shown And initial was I should power to efficacy a reminder, there as has interim powering lower-than-expected Cedric forgoing in with And the we we be detect observed drugs our And sufficient an Matt, also trial XX% by as is demonstrated add in with Cedric, as what significantly to a the trial, efficacy the mentioned, antidepressant be currently of efficacy the which drop-out other approved believe trial level a satisfaction have been which be determine to the size the drug, our effect population. at far, what to to we’ll the depressed with as may conduct well if

Matt Kaplan

other you gone good. terms Okay, the disease also for you’ve are then already analysis you’re with the, Could what I near-term smoking expectation help for of MDD And should quarter. fourth be timeline in of Alzheimer’s and there. us – the guess, understand terms the there quarter, the in looking the the read-outs? agitation outcomes very first over and guess, I that? futility in What after potential associated the in cessation What

Cedric O’Gorman

I’ll Well, the cessation. question on take Matt smoking

a since including So quarter. a potential measured abstinence of data study that expect there the smoked, a And test. quitting smoking top-line well And into we the they’re and intensity running test specifically, this the there looking with is AXS-XX of incorporated Duke collaboration primary the in – versus for salivary as bupropion is study at in this patients is that’s is ways, to cigarettes is well. as and and first population also number smoking, endpoint an reduce number then as cotinine this who are interested in also behavior

smoking AXS-XX’s So approval and from to of dextromethorphan it bupropion. ability for reminder, us as a a treatment just data has dextromethorphan reduction bupropion the understanding give subjects an demonstrated you And as smoking smoking. already of intensity as abstain behavior incorporates pre-clinical to And well behavior, will AXS-XX as showing both enable animal, reduce has know and the in in cessation. nicotine-seeking nicotine-dependent an

to quarter that read-out the So synergistic forward mechanisms hopeful we’re the look as in maybe at – look first we of these XXXX.

Herriot Tabuteau

Herriot. is this Matt, And

committee, monitoring actual futility a upon which conducted the remain parameters, to So conducted agitation analysis, interim company it be will independent which the This looking will trial, with obviously data. will because be by for at this committee. interim independent an blinded regards expectations disease won’t futility. Alzheimer’s be for conducted the the data efficacy is data be the will an based analysis It analysis, will by monitoring the be to around

be what be could two futility. outcome for we’re outcomes, one and recommended based the other study that to outcome the So, potential are be is the potential upon to that looking could for is study that continue recommended stopped analysis,

Matt Kaplan

it. Got

taking for thanks again, progress. the Well, and questions, all the on Okay. congrats

Herriot Tabuteau

Thank you.

Cedric O’Gorman

Thanks.

Operator

comes H.C. Your Instructions] question Ram Wainwright. Selvaraju of next [Operator from line the from

is line open. Your

Julian Harrison

good on taking This for is for my Thanks Ram. morning. Julian Hi, questions.

data, major an positive talk a positioned with would internal depressive this assuming to commercial likely be pricing along able AXS-XX indication likelihood that the about disorders are First, from for you to standpoint launch? be how

Herriot Tabuteau

Thank to the now thoughts certainly, they given it’s the – could we you, but in it in for indication right leave those for the indication potential on have around the the have we that, We’ll appropriate but internally, have to think guidance, make AXS-XX. determine we this given potential, be, Julian but point premature question. not analysts – to of thoughts pricing past guidance what at public. And an terms an commercial

Julian Harrison

sure. Got it. Okay,

on, grounds should how as on about we thinking Moving compares to mechanistic AXS-XX [indiscernible]? be it

Herriot Tabuteau

with a of So regards inhibitor. AXS-XX for reminder, it to selective and as that action reuptake mechanism is norepinephrine a potent AXS-XX, highly is the

that So [indiscernible]. of of action is of mechanism different from a action mechanism

various of genetic of well-validated of agents model upon So strong narcolepsy looking agent which we’re excited been levels orexin-deficient in in action with canine AXS-XX, about a inhibition. lot the norepinephrine model also animals, reuptake based but of norepinephrine at various mechanism with only of not the data work the a reboxetine active narcolepsy, is genetic has that in done

symptoms think excessive well we address sleepiness. would for strong data pre-clinical the are of that, preliminary and mechanistically two clinical AXS-XX So, to indicate of as are daytime key the data Those very cataplexy that narcolepsy. as potential some also the

the for to out regards as the with pretty certain profile to other agents one compared there, scheduling. that further the that is are about feel product DEA we So lack of the thing of potential

So DEA-scheduled to that why regards to the as currently AXS-XX features potential DEA-scheduled. trial. we that’s conducting product all agents With the don’t are expect clinical are other compared to approved the we be of

of in fourth first quarter this so we X half are XXXX. data to Phase then forward So very year, shortly. And of looking our are in trial launching forward we readout looking the to the from that

Julian Harrison

my front updates for still have else And curious been there licensing Thanks the that. in any am to near-term? if recently Okay, open question, the you and last I great. are just Grünenthal anything on

Herriot Tabuteau

updates. on major So updates front, the regards Grünenthal no are with really to the there

an which reminder, for specifically XXX Axsome over our bisphosphonate intravenous portfolio care intellectual has which assets now patents have patents. developed And is as large we XX patents primary consists these of of property indications. over of XXX a patents neridronate. Just been those a very which has number cover and a Neridronate compound cover pain in

And regional Grünenthal. regional One large in conducted trials regional is by syndrome. two complex neridronate being of is complex in complex our syndrome. pain are it X syndrome. Those which in pain now And pain the cover use of Phase patents

patents Specifically, syndrome. pain specifically cover we XX complex regional have that

that post would reviews Grünenthal that indicate has the believe have filed patents grant patents that so value. on CRPS, covering Now, they those

Julian Harrison

it. guess open got my question, are then licensing last the in you else And near-term? Okay, for to I anything

Herriot Tabuteau

further our disorders. we difficult always treat mission is CNS to So treat to looking are which to drugs develop to

we will the most advancing of our a AXS-XX, assets. on reminder bring are include right So additional recently And as really open leave now AXS-XX we core AXS-XX. and portfolio. door those to course then focused always in But

right a we what to full is on for clinical focus now So would those to advancing do programs. trials and we have like plate

Julian Harrison

Thanks very much.

Operator

this to further back over call questions no are There at the presenters. the I time. will turn

Herriot Tabuteau

Well, all great. joining Thank you today us on call. the for

to disabling safe make difference patients can and committed disorders. from are effective prevalent suffering finding We and for treatment that a CNS significant

may We the our months the far as we Thank our on look pleased we focus you with again the continued progress forward objectives. operator busy now you are anticipate informing in the and and you with disconnect will be year progress of XXXX in achieving so our ahead. to We exciting reminder call. and

Operator

today’s That you. concludes Thank conference call.

You may disconnect. now

Axsome Therapeutics (AXSM) 9 Nov 182018 Q3 Earnings call transcript