CYTK - Earnings call transcript Q4 2017 | Cytokinetics, Incorporated

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Operator

Good afternoon and welcome, ladies and gentlemen, to the Cytokinetics' Fourth Quarter 2017 Conference Call. [Operator Instructions] I will now turn the call over to Diane Weiser, Cytokinetics' Vice President of Corporate Communications and Investor Relations. Please go ahead.

Diane Weiser

Good afternoon, everyone and thanks for joining us today. Robert Blum, our President and Chief Executive Officer will kick off the call with a few introductory comments about the current state of our business. EVP phase and omecamtiv X our updates will mecarbil. Malik, the on development Fady of Development Research provide Then program for share ongoing key lessons Andy Officer that may analysis and SVP to learned CK-XXXXXXX results some be or applicable then the of and Wolff, further of insight VITALITY-ALS Chief from be following development our will Medical CK-XXX. CK-XXX also the phase trial of FORTITUDE-ALS an X ALS. on in update provide with Andy will patients clinical trials research. in updates and provide will clinical for expanding the Fady development on CK-XXX the other speak pipeline then program emerging our to out of Peter for Accounting before Ching runway well to extend open financial Jaw, with a Robert milestone SVP our XXXX Officer Roddy, and and as overview strategies company concludes and outlook SVP our our as Financial XXXX Chief questions. and Officer will expected before corporate additional guidance call cash our quarter, our perspective will Chief for on the we share provide financial the portions of that relate to note harbor the that Litigation including historical rather the and performance purposes statements to events facts Act of Private statements of than responses of for discussion Please Reform safe constitutes contain future XXXX. forward-looking questions the provisions following and Securities our for statements regulatory Examples collaborations our potential strategic financial approvals trials with clinical candidates. relating of initiatives, of product Amgen may eventual forward-looking guidance statements include the and our our our to and goals, and Astellas,

projected differ those materially in may results from forward-looking actual these Our statements.

undertake to update statements our call. most now in turn concerning SEC including in forward-looking X-Ks. I contained actual over this to Robert. We statements our call information results differ materially Additional that these after no from any those could the factors And, our to cause filings will forward-looking obligation recent is

Robert Blum

disappointing the VITALITY-ALS. We Cytokinetics the call Thanks, for Diane XXXX us bright a for thanks everyone begin despite last today. outlook year results with again on joining to and from

commercialization of the today suspended had of outcome having tirasemtiv, are regulatory VITALITY-ALS the development filings rapidly we have been position potential to company tirasemtiv. to progress that prepared positive the of we While and in not

many diversified biology as However, and we muscle create trial, pipeline and to pharmacology on scientific portfolio offer of the maximize quickly agile of is to built investigational our the the to novel which to business and data, from shareholder the opportunity advance single pivot business most. of to of and patients pivot a first was refocus like mechanism enables to in medicines and it clinical to resources an and clinical Cytokinetics day a these instead times allocate our matters have diversified in where maintain R&D strategies forward push progress program to return. or stated our benefit monetize when response in but candidates. a architected us not drug best they outcome times We model to company the

previously financially. As we have operationally, current for prepared the strategically, outlined, we scenario and

strong balance future. Now omecamtiv both and are CK-XXX underway programs with our a Amgen mecarbil trials, together under of the a we productive will collaboration of in first sheet, class a Amgen expected we and On for with our clinical on which collaboration on foundation report building with Astellas. this our milestones call, activators, late-stage all growing collaborations with next in novel compounds solid generation pipeline including two Astellas, pipeline muscle a combination and provide under

start generic using reldesemtiv as use international World the that Regarding the name we we States CK-XXX on will Council. Adopted recently from the Organization and gained of this approval name Names Therefore, reldesemtiv nonproprietary CK-XXX, for for call. Health United

at our in be continue our multipronged we about financial be emerging to strategy There to outlook promises continue optimistic well Cytokinetics. We as to as will and also elaborate point in while inform program execute omecamtiv we to development may is compounds our research. XXXX to clinical and a exciting we important research to programs. execute of unlock phase advance from R&D development we as potential as also the an much from research compounds beginning potential X and as on for clinical elucidate XXXX mecarbil program reldesemtiv newer the further of the emerging potential year phase X

me over turn mecarbil. Now let can to the Fady, on he so you omecamtiv call update

Fady Malik

all outcomes a Thanks and sites having the XXX proceeding significantly approvals Robert. the conducted with GALACTIC-HF, secured regulatory XX well our cardiovascular Amgen by being of collaboration achieved trial activation phase enrolling X clinical over that patients. is currently trial in for under countries are

track design. enrolling that the intended with is the have risk note that trial profile and consistent to pleased patients are trial on We the

omecamtiv protocol trial and of continued specifics second in with clinical conducted assessment, performance distinguish the this could planned is from medicines mecarbil interactions, other failure. omecamtiv with X for at After and failure, and by also in goal trial development, for omecamtiv which complete consideration patients on of design feasibility, results regulatory heart Cytokinetics report phase to same used the the collaboration GALACTIC-HF. potential was feasibility treatment exercise the be as activities trial the related the We to that focus other Amgen. mecarbil decided to increase of to to heart mecarbil readiness of The time we've

as of consider the patients related with in of clinical mecarbil omecamtiv progress to is previously failure. the Amgen enlargement with objective for stated heart the research, to example, additional we shared potential heart reverse to Our for

to the program as learned progress evidence to call VITALITY-ALS of Our and first mechanism to as on you cardiac discuss differentiated FORTITUDE-ALS. the objective and activator turn product class elucidate the Andy profile. myosin of supports for update lessons a clinical now in to well from the the in overall meaningfully novelty And translate that the perspectives have is over clinical I'll

Andy Wolff

results program apply to to back from our VITALITY-ALS November, so Fady, may we've reviewed continuing like ongoing I'd reldesemtiv. Thank on today, analyses development for our that in reflect

from observed one despite the Interestingly, unfortunately we prolonging rate titration in week phase the with in As treated SVC percentage in patients our who that BENEFIT-ALS, of three to the slow the and than upon dose prematurely decline tolerability treatment steps tirasemtiv by we two in label was you improve open weeks, VITALITY-ALS, challenges the or of VITALITY-ALS, nearly to lead double-blind still in know extending among actions discontinued patients vital the on placebo capacity observed percentage with times higher controlled saw XX placebo. observed XX.X by clinical declined trial smallest a recent to average Less than expected SVC placebo. database. in from weeks trials what VITALITY-ALS, and decline during those those has weeks and slower trials, on XX.X XX XX than points over the baseline weeks in in be was BENEFIT-ALS major percentage on including been to patients Based the ALS. SVC to previous in power the we and expected In approximately points. contributing decrease

in XXXX. in considered for VITALITY-ALS. those enrolled to the with in characteristics plan typical the X mortality of and the apparent recent most were fact despite patients These in weeks observations addition, at baseline trial Whatever recent of carefully with trial studies clinical trial in of may a large phase power need using disease XX this it, progression change that as inclusion In in [indiscernible], occurred less what was than the half VITALITY-ALS rate ALS. ALS from in be similar to despite reldesemtiv X we potential was Phase will observed underlie patients criteria these

we which to there contributed conducted in of analysis. because months in of several in reduce primary focused many randomize we In at of December an conducted continued the included earlier. in on XX Importantly, unlike belief the remained Despite the VITALITY-ALS whether the data all as or to was terminated to effect FCC this, results was essentially that to tirasemtiv of patients end clear the presented often our an in missing order in at the the BENEFIT-ALS, have analysis, observed intent analysis MND tirasemtiv on we an to our amount the as point primary which placebo This results not a measurement the drug. keeping having study supports efficacy treatments despite trial to treat analyses versus on-treatment VITALITY-ALS, biological double patients ALS primary well benefit development analysis, inability reldesemtiv. they weeks reaffirm who additional that contributed from a blind analyses primary demonstrate

early tirasemtiv these for we seen Because we experience for tirasemtiv to regarding us continue decision the status our over the in of of access effects muscle with make to of patients for label phase VIGOR-ALS, advocates, with on regarding of access the phase patients the challenges and to aware in will inform XXX off design development, experts X analysis skeletal analyses also drug-drug tirasemtiv expert trial to tirasemtiv patients. ALS week, our ongoing chemical first were patient access next surely pre-approval generation an and of eliminate target extension troponin X in interactions is tirasemtiv advise want comment panel trial improve are Our and next scaffold distinct other to current with convened and clinical from clinical reldesemtiv trial inform And in There potential plan I We this tolerability quarter. open clinicians, continued completed earlier to a activator to fast VITALITY-ALS potency. statistical to a how designed a provide treatment its will best our conducting VITALITY-ALS. ALS. for FORTITUDE-ALS, plan to in this the trial. reldesemtiv a ethicists, continuing we who

X phase these in we have studies volunteers. elaborate, will recently published healthy in intended Fady As demonstrated improvements

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XX measures home. over handwriting have screened sites activated, FORTITUDE-ALS, in have SVC have addition, we To enrolled. date, and been In patients and functional been and nearly speech measurement XX of of are XXX novel at included

of on year. the way the we half in So in results XXXX first of are completing second well half with to the enrollment expected our

review the In remain activation essentially from ALS, regarding issues During their optimistic tirasemtiv. conduct to the this they view trial of most end that a and in Those trials FORTITUDE-ALS and the forward FORTITUDE-ALS clinical of reldesemtiv tolerability of don't investigators, better therapeutic reldesemtiv and visit our the of patients sites the potential are fast belief of reldesemtiv appreciate year. We VITALITY-ALS. context are continue and of the to have in result the troponin muscle tirasemtiv. look for grateful before FORTITUDE-ALS. FORTITUDE-ALS ALS our investigators important with to one members in reporting results of investigators significantly observed them quarter, team as will We remind engage are compared our benefit in that results enrolling all general, to completing enrolling in skeletal application the and the efforts between to differences the senior share potential them foresee first the of our VITALITY-ALS, any critical with participating conducting,

Now back research. I’ll turn developments Fady updates to on well the call over in provide reldesemtiv as as additional to

Fady Malik

VITALITY-ALS fourth muscle function weakness Andy. a in conditions role. Thanks busy to we're impaired both a the in advancing bringing diseases reldesemtiv quarter four trials close, in non-neuromuscular with which of the mid-stage In and meaningful clinical or neuromuscular and play parallel

these conducting Astellas the neuromuscular As pulmonary atrophy, addition to you non-neuromuscular obstructive know, spinal the frailty. clinical ALS, disease, trials in while muscular conducting chronic is includes and is trials. in trials Cytokinetics

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We from in trials clinical results SMA patients expect X to phase first. the report with

year XXXX. you March a which nearly know worked now enroll going diligently CY-XXXX reasons. opened It's to for second for we've of several in cohort been the slow As

ongoing in participating many Sites approximately their before. rosters, to either not First, at and clinical too through therapy continues enough the of The in functional are on are trial of their patients led are said clinic now connected with other XXXX these nusinersen approval to we the being more this they since eligible dependent while clinic a obtain in or and many pool part availability patients most new an in to due exhausted to to not on seek sit screen treatment of as process potential of XX% their practice. having many patients older based patients on them they it. novel go patients not rate interested identifying outside basis, functional have failure

at CY-XXXX In appears plus the enrolling clinically in short, consultation the variability on which analysis analysis based in conclude side, to patients represent power measures. have On that accepted for with take less meaningful Therefore, placebo change to inform to of that several of QX. our to we this in we've cohort from endpoints than our generally versus X, partners of after a sites XX% of efficacy differences the differences. the statistical efficacy conducted baseline plan of elected have in are recently our blinded Astellas, sufficient enrollment

will community to kin research. critical and given there's the community greater is understanding patients we the landscape and the and forward the score is what factor We instance. during it's reldesemtiv recently patient a consortium time of within SMA clinically better activities technical an see SMA in to participate look inform SMA urgency function beginning a using analysis data point then with community. That evolving the Hammersmith and of if to once proceed is we've clinical forward which in seen Cure A leading on And We of data evolution in a believe conclude by care QX. the we in the definition to sharing interesting of patients to therapeutic final SMA dosing. clinical scale SMA such trial we're The for from evaluate to our understand attention with expeditiously effect ALS. patients an to moving the of potential endpoint the beyond

patients the small motorized immensely a independent to could increase strength be that in stamina wheelchair could SMA. with control thumb of example, of a meaningful lead For more to and movement a living these

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were reldesemtiv. observed with tolerability issues the in X observed with not tirasemtiv phase Additionally,

of translating hope trials, or four stamina force, to our of results we to As and diseases look muscle see impairment. and muscle power these to four or results we weakness mid-stage in conditions clinical improvements

the programs. announced collaborative at productive the our we've and diligent year, we especially independent and of as been Finally, research in start

the our XXth a that compounds we cardiac have Cytokinetics and skeletal anniversary, development from dozen focus on research, celebrate contractility. emerged muscle we As primary nearly mark

development recently As leadership in with compounds we our pioneering flourish. independently, are proud under to one and three announced collaborations we each and another new and Amgen biology continue Astellas, muscle our innovation that

Firstly, we're generation under activator advancing next another collaboration Astellas. with muscle skeletal a

approach other flexible next for be a indications for be is Our the in and indications. may franchise portfolio more generation whereas compound to develop reldesemtiv may which certain strategy developed appropriate

on skeletal extended was troponin other discovery fast Our novel and muscle collaboration activator activators. focus muscle research skeletal XXXX mechanisms will both through recently and

Additionally collaboration generation our muscle advancing with cardiac activator in next we're also under Amgen.

more We study. first as expect its to approaches about this phase in X have class say to it compound

will directed call from advancing Additionally, elaborate to a independent provide research. Pete later over to plan this both we biology updates, compounds we are our these to R&D. now the And financial. cardiac of compound a those our sarcomere muscle an at year on update to I exciting With company turn new

Peter Roddy

revenue guidance cash, Ching on related included More the several financial development, XXX to are Fady. cash our a included you equivalents, revenue strategic itself. Other and comments muscle next for Milestone will million XXXX earned make with and in details license the came press QX quarter spending alliance revenue, in activator our provide with the and in of QX in million alliance primarily I release strategic ended fourth with on our cash, under our in R&D and candidate. $X related development investments. strategies. research Thank Amgen After from We generation cardiac Astellas. nomination

Our omecamtiv continued increasing of mecarbil. million revenue future of X.X reduced all co-fund sales and XXXX in XX QX potential for was royalties as million GALACTIC-HF we on to by by

have three about of total co-funding quarterly million of completed XX X.X our a for payments million. We until $XX more have of commitment we million

reldesemtiv expense an with muscle Our to trials associated to XX% activities. seen programs decrease just muscle approximate development expenses XX% fourth contractility percentages for research quarter include programs in our These for an appropriate expenses totaled About tirasemtiv. our our in we've as cardiac of expenses expected both other skeletal over quarters X% and and attributable our reldesemtiv, increase prior what and were contractility clinical XX the with tirasemtiv R&D XXXX with million. R&D to which and

expenses through in from results thereafter. of quarter which truncated included were VITALITY-ALS G&A Our commercial investments the fourth effectively readiness availability

contingent possible potential planning colleagues positive Our great make commitments where to the results went to on of planning commercial lengths VITALITY-ALS.

Lastly, I'll stop gave XXXX sale QX to cash for XXXX expense strategies. needs future will XX.X and note guidance for our accounting of Ching million. in I'll noncash interest Royalty royalties there Pharma rise that the of to related and XXXX share

Ching Jaw

XXX this guidance given of we XXX by range net other guidance. anticipates be approximately excludes omecamtiv company cash that XX payments for Thanks Operating cash XX months receive won't million. revenue we million, will our our the current financial of expenses in represents range announced The today With of the expect XXX mecarbil the XXX cash to offset the over be and will recognize in partially revenue Pete, cash to XXXX. cash of will revenue from utilization XX guidance it million. to million XXXX. be revenue XXXX contra X as runway program our XX for Cash redevelopment co-funding million in phase of but

of two we XXXX in takes cash XXXX, utilization XX% cash year items to utilization reducing to million XX% XXX will over of with net moved by associated year. activities approximately into Compared penalties. site results we of commercialization estimate be consideration. potential down and Our net the supply these contracts following to and contracts center clinical no headcount with Immediately wind VITALITY-ALS, commercial such as froze quickly of care API the

our clinical near reduce trials term in our are We clinical also partners. will the our significantly collaboration current part reimbursed by as costs of

XXXX this pipeline the we expected from to or most year, GALACTIC-HF XXXX. for catalyst data While readouts value our look reldesemtiv that are we recognized in multiple in forward results

manage XXX financing. milestone on to million without is current goal cash this diluted through our Our relying important

through which deals expect As for sarcomere raise advance directed opportunities practice, phase later will has cardiac program to to collaboration and this been partner look our non-dilutive we X year. we to potential capital our

receive to period. payments eligible this milestone collaborators over time are existing also from our We

the and we are approach summary, As Robert financials to and that pleased end risk a position we while always over we and pipeline. a expanded I take Blum. to strategic mitigated to call strong back begin with will cash our With hope advance now to will turn our XXXX

Robert Blum

Thank you, Ching.

and our We we So on as so conviction and we expand three of is do development a impaired that clinical to advance as pipeline as vision engine four moving company day applications drug track and muscle with extend well remain one. drive conditions research powerful execute continues of function, against mid accomplish muscle on enrollment three for mechanistic and operations, and research contractility remain and energetics note forward compounds include It results perseverance as novel about moving addition this the we XXth beyond XXXX year our strategy driven, from that trials innovation with off to to gratifying purpose especially had with and diseases same authentically potential I'm into reldesemtiv growth, values of ingenuity, by our potential platforms are evidenced we metabolism. additional optimistic as centric Along way, exploring is GALACTIC-HF. begin clinical XXXX of to and our stage as also muscle continued the associated for while new candidates to as muscle expected I patient weakness the and start the year. well we will productive

let expected recap Now XXXX. milestones me for our

to omecamtiv expect in heart patients of we year. mecarbil, chronic failure one enrollment GALACTIC-HF approximately For in with complete

mecarbil exercise We also phase for finalize X is with evaluate expect patients trial to omecamtiv in the increase heart failure. performance which potential its of plans to intended second to

in of a XXXX. from in results expect we with reldesemtiv, Phase reldesemtiv X QX, trial clinical patients For SMA

reldesemtiv results with trial from XXXX. a in ALS half in of Phase expect We patients the second of clinical X

second with clinical results half reldesemtiv in clinical Phase from we a of half in We adults trial X results Xb from the of trial Phase XXXX in with also mobility the second expect expect reldesemtiv COPD in patients XXXX. limited and also of a of

IND-enabling in X one Phase into which development with For to one of may with advance studies XXXX, our proceed year. this pre-clinical one we expect research, to two Amgen, compounds, Astellas,

skeletal studies research discovery an initiation with please. to questions generation the our to directed XXXX can through now compound activators. open muscle And joint expect X program the we under We of with to that, directed up in advance to also XXXX. call sarcomere we in of Phase research enable expect Operator, IND-enabling Astellas continue next unpartnered to cardiac activities

Operator

first Our is Instructions] [Operator from the Fitzgerald. Cantor Mara from line question of Goldstein

Mara Goldstein

you bit maybe trial exercise at? that color give on just you delta spoke design of what terms us be based the you more am could I the that study broad you'll performance looking that use about the in on to and hoping are a little the parameters what's

Robert Blum

Sure.

you're to the it clear to Just I’ll be question. turn mecarbil. your referring Fady of X Phase second omecamtiv trial to answer to Yeah.

Fady Malik

I the detail in this year of certainly to with think assessing a as I'm in still lot you going down, exact I to know, to as we're there it’s that details prepared -- performance. early those regards think little and several we to how heart endpoint ways give specifics We’ll designing more exercise the be you but later study. are in failure, of lock describe types

but specific trial certainly we’re of being it'll assessing the measures treatment techniques than is of such of the be be incorporating secondary what size comfort patient But more towards as did much its endpoint. ended we leaning for range are in patients one of more in exploratory also of as than hundreds cosmic will limited also galactic, potentially will galactic. activity, duration means activity interested it modern smaller monitoring for open We other and say [indiscernible] as the

the Sorry, the a speak I think to specific it's little of I details can't but be into more early protocol. still

Mara Goldstein

maintain there and out to a points and able primary Okay. fashion results around so looking how sort And correct, again, second reldesemtiv, was when a is that put data being switching could on ask, in look if read the of trial there the we power, blinded into so if of, amongst at to a just you should those results discussion that that endpoint, gears about the and then you when report those you out? you for so SMA think will, distributed power you those no that's end I hierarchy

Robert Blum

exploratory hierarchy Yeah. multiplicity the and haven't an basically points we of for adjusted no endpoints. There are study, either. treated equally, All end being is

be endpoint describe of same the is will evaluate be them values we evaluated as same level it each the on endpoint on them -- at look independently. will the basically sitting p on all that nominal. and each So platform We

Operator

is of And JMP Jason question next from our Butler the line from Securities.

Jason Butler

reldesemtiv compared are would you Just I program any in vitality, there through ALS. there one on broadly Can it how learnings and that guess, with have with it what a the arm you the control from Phase little X compared flow expected historical bit about and reldesemtiv on, you the studies to learned and program? how what if talk

Robert Blum

Yeah. by I’ll to been admit to learnings into you somewhat of to because of things the and done that about conducted things we still characteristics patients maybe will decline trials, are this has process We've as that that vitality this placebo treated Andy I the that digging Andy well. including some we glean the unsatisfying the been slower other may things in doing from recently share to mentioned, some similar, experience. expected fact we've ALS crystallize be turn to despite somewhat trying in compared the we still baseline your look of some very and but thoughts the still and part, are we that learned, surprised than

Andy Wolff

also time or a calculated and first XX then titration the disease down of of progression we the that total trial. rate pre-study endpoint at cetera, but being on still looked you mainly, different symptoms they we've score were being lot looked and target mean baseline treated, was at what at terms ALS they looked FRS, discontinued, in their they after the we've our they it can how I whether is does of know characteristics, were at treated et patients where you were level, whether assume the things, Well, XX of the of a at into weeks, primary come

much has at really population faster You to into what to your can and trial us mention slowly trials. we only, middle progressors, shown that progress really tell none and about ones. score, the populations seems that progressors it have capacity we the come you although much around divide of in total would haven't your XX in that points slides bio mentioned XX and that slower then pointed informed your X. would weeks can only this have earlier more thought I have why down smaller look the lower in came We down you we seen you we've which FRS decline mortality, ALS to it

clear So there's it. explains that nothing

Robert Blum

is we is things appear by can question study or to that that and conduct. driven with study I think still do. issues the site by intend this are immediately be VITALITY-ALS say to issues site we we tolerability we with as you but doesn't The variability other that into confounded to know it have site nor might things digging still other what you tirasemtiv, some

us remember with entered we by company Origent beyond and collaboration Association company into developing a from progression may this ALS a the little learning and You called we've provided characteristics of which into grant looked that Sciences patient rate maybe of received enable as machine at rate by is to that, deeper previously funding characteristics tools things is obvious a like progression. and that dig Data a disease baseline otherwise disease that the

inform we're hopeful lessons may other that So some this learnings. and

adequately way we FORTITUDE-ALS on we bottom didn't we've effect learn this frankly thought based today, nothing the reldesemtiv might than despite saw in that event is a see the order the altering we what be placebo FORTITUDE-ALS. we powered decline, at and that trial should able slower we that or I line learn that we're of in think believe that design know with time consider expect we therefore however or think affect the don't fact the expected and that to conduct prompts we there's to to us learned size conduct that

Operator

next Chad Messer [Operator from line Instructions] Our the is Needham. from question of

Chad Messer

we a exploratory, it’s you do sort marketplace of have maturity itself. a larger that of have in and the of something it’s going faster perhaps worth guys care of will enrolled getting the study, doing or assuming just another know pivotal on ways sort I SMA, think study, mind take interesting In you have but study in do and

Robert Blum

one a spending on It's of Yeah. that lot we've very and time here. question been good a

you're so study. Phase X has that to and what can around I are this of think and assumed. Phase therefore, certain than the already initially patients. to screen clinical of that its think for into conduct kind conducting planning in quite X what with it's XX% go reldesemtiv of be therefore with arising we to in has the rate as what a process that are But a the enrolled the that XX% variability appears a its than of to this lot So the we in that the than a we a the will what assumptions CYXXXX be case encouraged variability be is a on in point, enrollment that stands But to made with nor SMA bit study and in that to we're adolescents studies firstly, endpoint not study. less fact adults by the with would to your small not not would research. expectations practical most it's data There's failure be mind intended. study which been we over we rate larger that And regard history keep seeing It's point SMA, variability fact refer the intended XX what we very own of we conducted SMAs, appears from it less of one studies be and pleased

at turn alter able clinically what order to you in the want if and criteria see out, from to add? ways if we might could you exclusion else to there's tease I'll of the to Fady So think inclusion we're I signal maybe other looking be meaningful to And the noise left anything a in way we geographies registratable. and anything apart also be and

Fady Malik

middle including so just be to in the making this online came treated will nusinersen patients conduct change would pretty this we next mean obviously, and I nusinersen and study. study the think disruptive I of been of Yeah. have that the study

most treatment plateau. and some steady I of would and you on we age likely that that patients in they hard to X, people said, nusinersen reach a be to As did Phase this nusinersen on it's know are range state. be we when to the wanted expect When initiating reach sort more get of

and this we out the to that modify can of in also emerging based results on the the that get of entry entry critically see we increase criteria patients them, we in the context that will trial. maybe results that at we We can so look trial the of the

as definitely issue be So, Phase focused a X something you on program. key about point and to think we'll we

Robert Blum

landscape, not what for with evolving, why think we're but The another as design reason soon new the appropriately with only as potential would engage also potential should therefore we investigational the SMA of potentially Phase and our into therapy should may know complement is the and consideration them. It's as as excited of its SMA what be I ultimately Phase study those X advent around nusinersen, therapies. be to new these a QX how you think positioning rapidly truly take all and see and any, continues I conduct that a we directed results prove our medicines belief complement reldesemtiv can in And community focus where not design and therapies other medicines but well, them, is have might gene trial. best exclude reldesemtiv and to that's stratify X to around to a of

Chad Messer

I'm see a quality hope to a you, wrestle with pivotal. data problem, to the high of have you the excited enrolling and very problem quarter next Like

Operator

is line from from Piper of Jaffray. And our next question Duncan the Charles

Charles Duncan

means. I'm seen data and timing I FORTITUDE, One perhaps he mentioned believe color on what of wondering reldesemtiv, because had provide better noise, wondering then of if I couple a I'm is that and Andy questions. additional just the is of he’s XXX some if significant with this or and tolerability could

Robert Blum

year. before end the be data of the So should the available

just terminations we disease They've more to there adverse they've frankly as with for did associated did blended tended in say can’t the in not I we but have see few at look know gone noisy then think early that, place the of you're in having number BENEFIT-ALS of and a the and that be I data we the ALS. events. nearly progression we're and also been,

we’ve mentioned So, this tirasemtiv. we've and in the relative our that they Tuesday on how another trial tolerability also the both with gone one of to the Wednesday investigators, night to was visit tolerability is and and day essentially talked of I one on about every

Charles Duncan

analysis this know you VITALITY about that wondering, and those on of told a VIGOR reviewed anticipate decided you and roughly there, any to I’m question ask kind appreciate those you me to little patient some but tirasemtiv, that have XXX first bit additional then stories an and appear information on pointed data be so persist would a if to more to, you presented Let and in also of And population interested to form? of on patients have a that be cohort. that all, interesting peer when

Andy Wolff

the we done Well, eventually the in publicly we anything haven't patients about I will. that haven't long. believe in treatment VIGOR-ALS. They said aggregate

So, any carefully. paper clearly for submitted available but I results conclusions about them, meaningful to be shortly. we’ll think published. The them design continue think will VITALITY-ALS I just the and It’s follow was

Robert Blum

expect to I pertaining you'll this from I the be that, data in see in to a Yeah. expect is already slides presented manuscript. year. analysis, that beyond primary which published VITALITY-ALS

there's medical study, also era. conduct presented. research This and also meetings, the as later X this in to certainly modern lot regarding where could be year learn ALS Phase that possibly scientific clinical Secondary VITALITY-ALS of the a there manuscripts large such a is and are Congresses in

to with more we to those inform to to So provide happened community. reldesemtiv information things with the make understand ALS to may we not available, help do that us intend importantly data only that what also but and tirasemtiv,

points XXX Andy VIGOR-ALS. out, still tirasemtiv and over remaining as is on VIGOR-ALS patients there Regarding

those of may placebo VIGOR-ALS. for of with that been treatment one only of patients not have been too blind got, on controlled tirasemtiv Some randomized also have upwards tirasemtiv but XX-weeks double year in

patients of were interesting experts earlier and the this and patients two on thing as very meeting them this convene one others. out got week we the be offered to was their with and to do there experience it are are that to quite Andy who years insistent tirasemtiv they those you've remain able we pointed investigators So with to as some and that by right would clearly opportunity want of

that So still about and say we'll in best that more to make later have we're how happen deciding this quarter. to

Charles Duncan

call but within it I those data and call Robert, won't patients? are any, efficacy, activity you're you it, as collecting VIGOR tracking

Robert Blum

any data progression we've se capacity gotten in mean, and ALS vial measuring per FRS. Haven’t primarily activity also VIGOR. looking by against the at I their really been

Andy Wolff

of in that the efficacy collecting alongside some safety VIGOR-ALS information. are of we So VITALITY-ALS, we're also endpoints in measuring same measuring

Charles Duncan

of noise. Back or great combination enable to alluded agents color a define that? look it's if in be but eventually looking you if seems say have doing so wondering with used with should and kind when primarily to then for terms of appreciate versus then you think And tough like seeking reldesemtiv, like I at SMA signal it to final you what and I'm studies finally, any to a nusinersen. in you question, future what to clinical your further all consider on study, are patience other study, And it's this combination be me good but seems drug a you're with these it's will approved it beyond in in I this, as

Robert Blum

that second the of first. part take would I

that enabling. up be community now other SMA if the and think will studying potential -- the in combination the or protein at Phase CK-XXX now, the this really drug drugs. enhancing therapies This with I effects muscle which you clearly pipeline. of increasing SMA I in aimed are X the or of end mean, and others speak nusinersen then drug that the of we’ll speaks or would, lead SMA levels therapy is that therapies gene in is they enhancing of

moving looking them developed, are probably and directions, in as value p PRO seeing of the in that’s that points points, of end similar the the important end at question, expect do see regard your looking across and and to much what that the had which them do With some it'll also to them magnitude that be be endpoints was certainly combination been will might have used be to they with as a second so I most investigate cohort. we'll the the to end and as ultimately first introduced new point way eventually in we And sort think well. an exploratory us compelling, makes

and of we'll a perceive I from how then they're that give think are well things as will those of there. all patients how us doing sense as functioning they go

Operator

back this you. I'm to further showing phone. the have Presenters, it questions turn And we I time, over at no

Robert Blum

we thank with forward hopefully that, you realize muscle we the participants continued updates course your who potential for promise novel believe We XXXX to of candidates. joined now to and you Thank interest drug great to Thank your XXXX. providing all biology on mechanism Operator, look call can you the you and for the funded our in further please. the offers directed conclude teleconference through support Cytokinetics. our and today. well we’re us

Operator

does today's this you call. conference Ladies and thank for participation. your greatly gentlemen, We conclude

disconnect. now may You

Cytokinetics (CYTK) 15 Feb 182017 Q4 Earnings call transcript