AXSM - Earnings call transcript Q1 2018 | Axsome Therapeutics, Inc.

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Operator

Welcome to Axsome Therapeutics First Quarter 2018 Financial Results Conference Call. [Operator Instructions]. 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

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

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

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

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

a Chief clinical Herriot provide President Joining first Affairs. Officer me update Tabuteau of Medical on upcoming and milestones. Tabuteau, Dr. pipeline Executive Development Dr. Cedric a of the Dr. are Senior and Clinical today and O’Gorman, Vice call review will

Dr. will results. our financial a and Following that clinical scientific review and update Dr. Tabuteau then provide will O’Gorman

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

Herriot Tabuteau

first all Axsome for end CNS milestones patients committed we Axsome this you, treatment joining have Marc. achieved first at further quarter development and To the will a to developing it I results and XXXX clinical details. that conference will call. so opinion presented research we several to pipeline disorders. morning for living review. for Therapeutics and our with Cedric is pipeline key brief quarter who conference expanded turn a with key update thank scientific I also leaders. you new Good day In over everyone Thank will provide then provide recently we options and year held a further which

unblinded is glutamatergic, start Phase in currently refer pre-specified the is resistant which in trial analysis with on anti-inflammatory Stride-X performed analysis trial. of a well-tolerated. AXS-XX assess AXS-XX the target indicated our Based interim on which Committee to subjects. of approximately of number depression first and anticipate to first trial a or subjects indicators. outcome trial cessation. on of smoking of research Top trial being line futility Last Last announced in first most or month and half Duke enrolment agitation treatment collaboration Phase Phase XXXX. evaluated trial incorporates XX% we the We to the interim between the second results and a we we announced half trials IDMC analysis candidate. which the the that Axsome. the action. next a medicine under of are will product of us The the analysis an AXS-XX target is interim Alzheimer's CNS approximately second interim a independent safe an Let which a in of of of this appeared patient final in trial this X trial that quarter IDMC the interim a oral recommended AXS-XX medicine XX% cessation in and month in monoaminergic University be we Data advanced in the also efficacy. refer anticipate the disease, in the being AXS-XX number oral dextromethorphan. consists Stride-X the is the SPX AXS-XX of Monitoring trial. results trial, is as treatment combines With in AXS-XX, clinical IDMC product the with also continue the we trial conducted analysis Stride-X positive separate of investigational CNS now the candidate and we our novel and smoking associated Enrolment three as first the that X-X ongoing generation in conducted is AXS-XX X for of this announced The year. anticipated and second Complementing this [indiscernible] year. investigational novel AXS-XX is next in Advance-X analysis for mechanisms AXS-XX a Advance-X

which The half-life. gears technology. of candidate a entity acute switching Meloxicam result our plasma in while for the is product Now which absorption long consists MoSEIC Meloxicam rapid of treatment is AXS-XX, Axsome's by Meloxicam candidate enabled MoSEIC migraine AXS-XX a the product MoSEIC of novel is a molecular migraine. for technology new maintaining [indiscernible],

making which first second in planned treatment second for will to I now XXXX. final X half anticipate AXS-XX trial we review in some we the of a the Stride-X analysis efficacy of XXXX timeframe. trial preparations are resistant and of Phase half clinical anticipated in the results by in anticipate With our starting of half the oppression XXXX We AXS-XX are XXXX interim an actively milestones. of with our in upcoming migraine

efficacy agitation analysis With analysis disease in the an we and of the interim Alzheimer's utility Advance-X anticipate an [indiscernible] in of interim half second XXXX. and AXS-XX for XXXX

acute starting is the achieve milestones. team working and anticipate these upcoming clinical of Axsome we excited The trial XXXX. hard in migraine X in to AXS-XX treatment a For Phase

ongoing details a more over our call regarding turn for the Cedric Now programs I for clinical review. will to

Cedric O’Gorman

and now the treatment ongoing have to-date scientific is XX% some and the trial with in of starting been discuss over enrollment the this Thank of randomized. just you, resistant number I of recent AXS-XX our subjects Herriot. trial of will updates Stride-X clinical in depression, target

year. a recommended and and an limited Stride-X offer the The approach indicated month results continuation be a A major patients. based smoking glutamatergic, Approximately with is smoking last a for of AXS-XX bupropion serious monoxide million previously day, is having analysis condition. quit. be the Unfortunately results for the in that trial interim want This IDMC, treatment pathways smoking low. outcome the in More efficacy. unique that salivary The profile treatment, to encouraging. was the the report to options are patients smoking trial stress, testing. change in continue. announced trial failed smoke look There mentioned and abstinence available Smoking its rates IDMC Duke of measured in clinical enrolled be the the in that trial tolerated. We Stride-X the for the a primary more interim XX of resistant in from forward disorder that interested and Herriot study the quitting of of intensity, economic we month to a success per was anticipated in AXS-XX breath are using cessation. IDMC's Americans of the first day Stride-X number to appeared results X:X intensity to with X of seven include carbon to largest AXS-XX analysis overall anti-inflammatory test, these on futility XX% U.S. death study $XXX the a XX Phase interim for to Phase will than Topline cause cotinine recommendation also adherence cessation this subjects symptoms, performed measure be first blind randomized abstinence depressive weeks. half under will X using and XXXX. may total and information anxiety or of smoked therapeutic number XX% preventable safe interim assess safety patient the therapies. analysis by in treatment the AXS-XX are second study four of analysis The a collaboration mechanisms measured expected targeting and the outcome trial smokers cost approximately of withdrawal conducted AXS-XX receive controlled Other second billion the on of of University. based depression. Last are in and an approximately safety are randomized favorable conducted target a than As a well cigarettes reviewed ratio year. of monoaminergic being second IDMC results in the measures significant proportion double available findings for the either are to The more smoking an is active on multiple they this

basis and for therapeutics. the of of data X These and of XXth pharmacokinetic quarter in for delivered we the data depression three scientific Society ongoing Turning reviewed Alzheimer's for American the the Phase experimental presentations, poster with X-X associated to AXS-XX which and mechanistic scientific trial one in functional agitation ongoing the disease. clinical first form Phase Meeting resistant in Annual at rationale, AXS-XX presentations, two the treatment presentations trial oral the

Duke of all We Marc AXS-XX day Dr. they to key Herriot of Dr. Health and Dr. forward Fava further with Jewish I potential opinion financial recently University of drive Finally to nicotine University. Hospital, Massachusetts as Maurizio R&D to updates first San our to for Dr. research leaders associated the throughout the featured turn XXXX. to over Davis providing look these and Stahl on depression, General needs programs now the presentations dependence James year. with quarter and Day of unmet California, of would to disease to provide by we held Agronin of Alzheimer's first update a the like Axsome's the clinical development focused The back call of continuing conditions. forward and Stephen Miami address in agitation Diego and of progress

Herriot Tabuteau

March compared our sufficient our the for and position and comparable XXXX. you, the ended first in of at the $X.X and the Cedric. December the operating XXXX. same of XXXX General XXXX million period cash during that million at to quarter quarter with sheet. third XX, million million Research approximately in as be period period XXXX million for for $X as XX, XXXX. had expenses anticipated XXXX. million in our to administrative will Overall into were with the Thank XX, million million $X.X with quarter cash comparable quarter $X.X XXXX. $X.X anticipate and were requirements Starting XX, $XX XXXX million in development the cash balance expenses current $XX.X March fund in We $X.X $X.X March operating expenses decreased We ended compared for

trial it including depression. resistant treatment trial analysis Both next several milestones results Importantly believe Advance-X X cessation turn will the and Phase the take Q&A the final analyses the trial through Phase AXS-XX X interim the Alzheimer's in discussion. lead major with now clinical planned disease to I'll and to in Mark next the of the of of for results in call Stride-X from interim of results trial agitation associated we us the back potentially AXS-XX the the smoking with migraine.

Mark Jacobson

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

Operator

[Operator Instructions].

the Ladenburg Matt of Our Kaplan first from line comes from question Thalmann.

Your open. line is

Matt Kaplan

little your portfolio? want and and us I and on compliments, AXS-XX help in how AXS-XX AXS-XX AXS-XX a to focus of how about that bit think terms

Herriot Tabuteau

view that forward Stride-X are are two the candidates excited trial agitation are product Alzheimer's trials smoking about We're complimentary as the those in that AXS-XX and announced and in stage disease ongoing also looking treatment progress is trial these and about do and we and resistant think as what So late XX the continuing the oppression of Phase-X trial Advance-X so X Phase and you receiving in recently know components the if two cessation. product [indiscernible]. our XX, candidate are to you very trials

what similar excited XX announce It are with little is X are So increases plasma with results forward, different. Phase does very contain and saw we aggressively positive we concentrations in about moving bit XX AXS-XX as [indiscernible] now and a XX. did we

between that the So to are that gives [indiscernible] us in the conditions that plan coupled confidence other AXS-XX with to beneficial indications. in which there certain observation differences CNS develop be may

for candidates and AXS-XX indications months. are AXS-XX those based two action the of these and you upon updating forward to are exploring complimentary, potential coming we multiple of there look of both mechanism product and in numerous So the

Matt Kaplan

the that for and on migraine a understand bit market? help you that in it's terms in of focusing AXS-XX, more, just the then us And little potential market pipeline AXS-XX can

Herriot Tabuteau

approximately we be that on to excited about has the really for we you the efficacies believe to thank are and the U.S. that Matt, an most is AXS-XX product XX% estimated very reason that the either have of one so who and them are about that's it 'XX, migraine of patients that what market or currently in [ph]. stark have dissatisfied marketed are that the in is migraine is the now for the and XX XX% highly is and market development important? acute Americans currently migraine, why small the onset There million market large. report in about The the so of is most reason now potential migraine we for facts that targeting current them their reasons dissatisfied primary that's one are that therapies they of dissatisfaction with it include migraines

times. time of other in and there work complain drugs So and have relief is also that other sense the to work not for enough, these the dissatisfaction at work for pain in makes the words indication. other We consistently some reason lack acute fast that of high other do drugs patients pain an words don’t don't sustained and a has enough with rate and do and recurrence extreme they

landscape, patient So perspective current from high a dissatisfaction. a under-served very that's and large of the

the why with IV of to MoSEIC a which is So hours Meloxicam. doesn’t results pharmacokinetics we're standard T-max as with do a Meloxicam Meloxicam like about We excited with MoSEIC five of it AXS-XX it observe Meloxicam. rapid reason compared absorption cooperate about in

bodes So and of well absorption in action. terms of a rapid that onset

platform reduction recurrence of bode and terms in were that we able long maintain have with In symptom [ph] Meloxicam well Meloxicam long a does a to for should which half-life half-life recurrence. MoSEIC

combine we [indiscernible] the a of MoSEIC known medication. you potent Meloxicam in that efficacy should with result very and believe Now

should reasons AXS-XX address that address if for the those into migraine you think dissatisfaction patient current with major would then and we pharmacoeconomic treatments translate overall benefits. those So

Matt Kaplan

starting first year.? you terms during this seeing -- is last up Stride-X then question to it of trial, at to the or up enrolment starting picking the point in And of been in AXS-XX has there how pick are this part progressing is

Herriot Tabuteau

recent will Cedric trends I'll you details. enrolment turn with turn over Well are I'll but will who a with to acceleration perspective we a give pleased provide some enrolment the generally it on over just but who Cedric in you

Cedric O’Gorman

pleased site of the of steps taken open very approximately been sites this patients to sites. trial we've far. We've and with we by quality in accelerating trial end the so we today the almost very robust has and believe doubled of are number increase We so continuing and XX recently good We meant. have sites a XXXX enrolment per number had the

and the enrollment So we're pleased right with now. the uptake continued

Operator

of next question Hazlett Bert line Our from BTIG. comes from the

Your line is open.

Bert Hazlett

again progress well. guys Nice as

a the we study in that So the could will and of of the you I that secondary that once in as focused criteria on and stick study? inclusion follow-on's elucidate Stride-X, may study endpoints XX along well considering what this any then may with describe might you describe some further and of you you're with the of XX. have couple could be other

Herriot Tabuteau

of trial at. give general endpoints that and of sense some in So might who looking I'll a give for the Cedric turn secondary over to be sense will we a the you criteria then terms you inclusion of I'll the

result then and to they having -- historical before would treatment then and being treatment failed an entry would two were trial then regards that’s is treatments two so treatment the either very open treatment failures criteria foremost patient or before patients them so I two one with prior treatments so criterion plus historically least in the to two fashion is having that resistance inclusion important resistant this is key the come failing resistant. first before label key in at the one depression, So so prior failed trial [indiscernible] in a as in and randomized treatments patients definition the or treated with that’s qualify that in is be think a of

standard pretty important definition exclusion would there think the to for inclusion with say standards criteria. the inclusion but risk I one one do have and I similar example if standard inclusion which as is criteria treatment and really risk of the other excluded So other standard resistant. to And inclusion so exclusion suicide has and criteria key of that's then criteria with are other example patients are such certain other anti-depressants most and inclusion they factors trials for

Cedric O’Gorman

look This is approaches when are of outcomes there study population look patient at you quite consider. in terms a at you Also standard a Cedric. like few this to

perspective the the you and primary have how but mattress, the are patients is you that know the So clinicians as Montgomery the doing. you the how outcome scale in patient change and for also they depression doing is addition also have to rating of in perspective

important of of like this improvement you global the so there's look sort also novel very from think also ways and be granular each can randomization mildly we to Hamilton will symptom of rate, improving. the are the given mechanism which also who can at it clinical significantly which you symptomatology drug look those improving, we time moderately at in how would treatments number look weeks of and important So are the over in to [indiscernible] of improving, a to the very period these then scales impression as you the six when look which response very improvement be and or that is at time view is primary course interested of of stakeholders improvement a which existing of can of at well, week endpoint to percentage patients the the what at compared of six of look terms but course different of

can then look use deeper patients these to of the So dive more across the the of scales and analysis percentage into item and worlds at always two differentiation. you points

Bert Hazlett

fast December patients a projecting primary talking and the positive know got with completion any resonating regulatory XXX chance, Stride-X is estimated on have this, are the there primary about date. need? you've there agencies again chance a for but single study this they secondary given any If bit you in the forward it's is and track that's clinicaltrials.com a unmet If XX, with assuming -- indication you are

Herriot Tabuteau

So the general a adequate pivotal study trials. the think the Stride-X we way and two do is that conducting FDA is well it controlled and require believe that trial, are Stride-X trial does the about in we we that

that precedent and from depending with adequate just on are the FDA data we and two that that company's conduct that course to about product possible the need approved get of have for would with course regulations know trials. having However our our clinical regulations been FDA you plans that suggest does to approach mean been plans be and it there I also with a clearly clinical one clear stricter and so the for the said not you've data well-controlled is an for know to is mentioned the that we candidates trial file one as perspective always only but want however That the you business. running what we're trial in what not here of way FDA

speaks designation depression patient treatments a break the oppression, indication heightened that given for here filing with geared do possibly reminder are serious other and encouragement, so perspective. has concern trial fast we their I therapy around towards is you Now with then the that the for condition one you fact to to know designation in potential regulatory FDA need treatment point think the other a the in is threatening have and for to regards resistant a recognized oppression with a point note as from from the as and to treatment in need a the have from that this clinical life one AXS-XX tracked perspective resistance treatment that resistant

will in as as and are we front plans which obviously things things the of data. move we keep So and those be towards center mind we terms strategic those all product our develop in

Bert Hazlett

second. Then for again XXX(b)X might XX molecule molecules a give with you that X X a are just X look intriguing gears just and Thank more just with program pursuing to with any of shifting just experience and considering really but that Phase Phase provide AXS-XX Could can you're the you given frame parameters like. pathway Phase us for just you. the color you combination some the what parameters

Herriot Tabuteau

know actively do acute new we'll So two come to the this endpoints, generally following which also at which X for FDA recently are so hours we getting AXS-XX with development core the generally relief speaking FDA study pain the two primary most from such and very those. endpoint, starting is we regards for hours guidelines year anticipate trial for two so is bothersome you a hours standard two end there will points in to for be But does with ready out points a treatments the with end migraine of end now relief guidance primary did pain be a at Phase standard but have free require pain not only relief points symptom. the

apart and other any in those so require pain there those then FDA X.X points a end So select for multiplicity and most facts from P the other a does hitting points each patient does is of symptom end end not kind numerous the points. words of bothersome where value of for enough are interestingly adjustment the two are

us be imagine which in be product pathway definitely pathway reference of magnitude is can certainly ingredients will we given allow to the AXS-XX terms of the we patient we in you findings looking that which address regulatory we of to and regards will to action hope the action AXS-XX. pharmacokinetic onset that so a think that pursuing maintained the since will component efficacy XXX(b)X at key and the to will be on unique with of FDA's profile As dissatisfaction with of the regulatory hope a active we

Bert Hazlett

you do expect yet? nailed have that down to do you Just larger one this one, quick how other study be,

Herriot Tabuteau

provide trial, get and intend that on actually details X up running. fuller the a We Phase we to once

to the baked any give in stay have in are terms you obviously guidance. So make but plans sure we that the of do we'd idea those like before of fully mind certainly an tuned we our size study

Operator

Instructions]. [Operator

line H.C. Ram Our Selvaraju next of the question Wainwright. from from comes

open. is line Your

Unidentified Analyst

Julian for Selvaraju. Ram is This on

statistical First one also analysis for that case penalty there no is is terms will Stride-X was that Advance-X the off in for the my of this for be understanding correct? futility the upcoming

Herriot Tabuteau

The upcoming physical the agitation. Stride-X is interim for that also answer the disease trial was interim the analysis in futility analysis Alzheimer's there for for expectation is yes, for penalty no for and the Advance-X

Unidentified Analyst

great. Okay,

safety are necessary or any specific studies narrowed PK stage have additional AXS-XX also indicators and any determined? and Regarding that be is you down still studies explore late to to

Herriot Tabuteau

continue The to needed any stage early unique isomer. to not the with indications always for nature, pre-clinical stage studies given or have thus especially are late the the elucidate absolutely as PK studies additional be any to do determined additional course as AXS-XX explore we to necessary or with features unique that and regards far with we single that well seen studies still are the of molecule studies that we that are further but there believe

Unidentified Analyst

recent So ketamine data in was resistant my treatment we context for of last should question just thinking depression. about on the AXS-XX I be how curious

Herriot Tabuteau

So and at you of compare if are them, look dextromethorphan do similarities. of the ketamine several mechanism action there

So both of onset and of signal the ketamine. NMDA they with and action, action the seen and agonist one mechanism of those are agonist are both fact ketamine anti-depressant onset receptor receptor are dextromethorphan fast action credited with two

similarity the pharmacology point inhibit a both other point in of two terms of is there they So the the and that molecules is there norepinephrine of and serotonin between reuptake. similarity

the in around index with which given therapeutic administration diversion. there but now agent intravenous been and is abuse terms of obviously ketamine example ketamine intranasally still for Now and of is issues concerns course are an

those glutamatergic and we're AXS-XX be with action obviously are we action are there the forward efficacy mechanisms looking ketamine profile. between mechanisms of So of to encouraged promising elucidate shares and results product action happy of proved trial and and of similarities the of Stride-X to that the the some mechanisms to have the

Operator

That I the you. remarks. concludes Q&A to over concluding will session. for back Tabuteau Thank Axsome CEO, call turn the Herriot

Herriot Tabuteau

the Thank you. you today. Thank for all joining call

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

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

Operator

you. conclude and call. that gentlemen Ladies Thank does conference today's

all great disconnect have may and You everyone a day.

Axsome Therapeutics (AXSM) 8 May 182018 Q1 Earnings call transcript