Cytokinetics (CYTK) 21 Feb 192018 Q4 Earnings call transcript

Company Profile

Participants

Diane Weiser	Vice President, Corporate Communications and Investor Relations
Robert Blum	President and Chief Executive Officer
Fady Malik	Executive Vice President, Research and Development
Andy Wolff	Senior Vice President and Chief Medical Officer
Pete Roddy	Senior Vice President and Chief Accounting Officer
Ching Jaw	Senior Vice President and Chief Financial Officer
Joe Pantginis	H.C. Wainwright
Pete Stavropoulos	Cantor Fitzgerald
Ted Tenthoff	Piper Jaffray
Jeff Hung	Morgan Stanley
Chad Messer	Needham
Jason Butler	JMP Securities

Call transcript

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Operator

Good afternoon and welcome ladies and gentlemen to the Cytokinetics Fourth Quarter 2018 Conference Call. At this time, I would like to inform you that this call is being recorded and that all participants are in a listen-only mode. At the request of the company, we will open the call for question and answers after the presentation. I will now turn the call over to Diane Weiser, Cytokinetics’ Vice President of Corporate Communications and Investor Relations. Please go ahead.

Diane Weiser

thank joining and today. everyone afternoon, you us for Good our will focused for of as collaboration Roddy, with Officer, both as troponin under and of off about Robert Medical updates and of Officer our provide will guidance on with and of for AMG including will next development Chief President muscle development Phase Robert share our discuss of the advancing and Pete company financial XXXX Phase activator Accounting and our on under updates Executive muscle the our program, our myosin of the Fady the omecamtiv will Research both well thoughts EVP state our X comments Blum, wholly-owned Financial our mecarbil, development Officer well expected and which Chief reldesemtiv on provide introductory on our troponin strategies and additional as Jaw, Wolff, Ching inhibitor; X our cardiac Chief a myosin Amgen our concludes development kick CK-XXX, corporate of Development Malik, with the then current fast collaboration program, cardiac business; Astellas; a before SVP the Officer, the muscle our skeletal our activator generation cardiac as Chief are activator, the and will SVP quarter; we overview development with milestones. and our cardiac XXX, financial SVP skeletal Andy call forward-looking and facts that portions contain including relate future note performance our events statements. of constitute that responses statements discussion, historical following than and rather questions Please to the to

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

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

Robert Blum

productive execution Diane with everyone today. have for joining on us you, with and expansion INDs by submitted with GALACTIC-HF, for are the and our fourth whole and Amgen, throughout demonstrated XXX, thanks the we we Thank troponin continued year and consistent marked into of compounds throughout myosin AMG and cardiac again X was quarter of enrollment to which CK-XXX, clinical Cytokinetics The cardiovascular leading call we XXXX X trial the activator, cardiac of quarter achievements development advancing we programs progress positioned for omecamtiv XXXX. for pipeline industry our in collaboration XXXX compounds Amgen. our Together mecarbil. the as us well into the major with year altogether from new clinical wholly-owned biology XXXX of both research XXXX, during our muscle milestones in well extension past as in development, a next-in-class in was advanced development inhibitor in new in the advancing Phase outcomes

year, heart results risk launch XXXX, the to with optimistic. recent trial the because uncommonly and designed for track held the and the large failure slower most prevalence are approximately benefit monitoring on the on half sales. grow of of and expected unacceptably largest has now to increasing conducted. we U.S. remain alone made generate over believe potential enrollment from during which of of changes which meaningfully most around with to aging of ever a become GALACTIC currently To the patients in to improve only recommendations we year years failure GALACTIC, expected we amongst the for complete opportunity new biopharmaceutical failure than for from Despite medicine basis to the anticipated may mortality analysis over more relative initial in clinical care. and and standard data that product be interim of Moreover, in suffer is trajectory, outcomes X in omecamtiv Millions treatments heart is futility the heart X years the the We of in patients entry this demographics. meetings sector clear, billions over GALACTIC, trials mecarbil conduct no more for annual and In may the first and therefore on of conduct to the the within a half high is demonstrate is foundational the the heart to morbidity quarterly the failure past Novartis’ first track first clinical committee available to time. an Entresto are is

mecarbil such, upside of with omecamtiv heart for in mecarbil, on shareholders which given As Alongside and we clinical in unusual Cytokinetics conducted dysfunction. with activities opportunity our X Amgen for the stakeholders. patients affords company METEORIC, performance failure of and focus second last effects trial omecamtiv an the readiness the systolic other exercise quarter, Phase potential our on GALACTIC, deal will

this trial. morning, we the Just start that of announced

to test data that respiratory quarter forward the and On effects next patients for fast the XXXX, X our FORTITUDE-ALS, troponin mechanism in has ALS, that of In XXXX, ALS clinical neuromuscular from to with Phase enrollment adverse therapy in first demonstrating ruthless we of ambulatory these generated capacity completed we the we of Walk an surpassing a patients primary of We Distance aerobic for This endpoint without the developing from await our SMA. investigational Six efficacy the recently, with growing medicines trial endurance. announced FORTITUDE-ALS. are We in in we we of improvements X More decline and with muscle our Phase potential believe skeletal XXX our encouraging was results the patients and target expected SMA to prospects steps data business, next in feedback the and Six Astellas Distance, now we that function potential Walk with side that observed was with that patients SMA. results an reldesemtiv We of of confirming from Minute QX population believe leadership patients. improve look acceptable confounding tirasemtiv. progression is our of partner the FORTITUDE-ALS enthusiasm believe discussing slow to in reldesemtiv in time muscle shown exercise FDA as in with study longer Minute offer believe we underscores adult reldesemtiv activation. the live in directed of

CK-XXX. that an pioneered which QX we QX ago XXXX, learnings benefit best-in-class a We it other R&D we X the elaborated evaluation next-in-class Lastly, may details may as at and have years in represent gained in myosin unveiled believe and our programs. began inhibitor then several of cardiac this regarding we Phase area from opportunity in Day development we

recent XXXX the may innovations our and well in of we we Fady prospects to progress We accomplishments that and well have we remain will as over XXXX have describe sum, drug emerging about believe program they expand us more will optimistic afford. the that on stage sets about this In that properties differentiated development more development for CK-XXX corporate for say positioned may a candidates. discussed for intrinsic follow. opportunities class clinical our R&D the may time of momentarily footprint as

to our over call cardiovascular the to progress Fady programs. turn will I elaborate Now on within

Fady Malik

nearing our patients are And The the design. randomized risk planned at mentioned, and well. characteristics being Robert. over collaboration consistent events failure with being X,XXX patients, Enrollment for trial as to-date. mortality within of intended X,XXX high baseline these cardiovascular patients heart X to by is of trial as outcomes XX% progress cardiovascular GALACTIC-HF, Amgen Phase continues conducted clinical Robert its you, under Thank by

expect We GALACTIC-HF patients first to XXXX. complete of enrolling half in during

of accrued XXXX. Monitoring Additionally, planned Data we are Committee, number for events the in on of for half on futility first conduct DMC interim the to track or based analysis the a

The second ongoing during includes of an interim occur the and the will feedback. XXXX. we that recommend of regularly, which GALACTIC-HF GALACTIC-HF, been analysis including As meeting and data continued in recent assessment DMC from potential no the The encouraged DMC changes reviews again planned un-blinded a have trial has efficacy, the to conduct to has been in by quarter. reminder,

meetings leaves their investigators the conducted dedication and have second GALACTIC-HF in clinical to Phase continued clinical X quarter this including the Dallas San of investigational trial. study collaboration participated we and Also planned in activities meeting whose the Cytokinetics investigator enthusiasm and [indiscernible], During last as to be to medicine Rome, grateful energizing month, quarter, and as and during important contributions Each trial Diego. METEORIC-HF, world, novel mecarbil, with the recently for is omecamtiv us includes we coordinators, around initiating for readiness by fourth Amgen. Tokyo, conducted toward

As patients on will we trial mecarbil and the with reduced effect potential this for increase failure. just enrollment of Robert the mentioned omecamtiv exercise performance in opened to heart focus

study treatment CY CK-XXX hypertrophic wholly-owned of inhibitor, are of expansion the pipeline, which quarter, initiated in we the X myosin the of healthy to is during our Moving for Phase developing CK-XXX cardiac our the potential cardiac we cardiomyopathy. volunteers. XXXX

this reminder, study of a a ascending single randomized double-blind CK-XXX CK-XXX assess placebo-controlled As first and safety is to trial tolerability. clinical multiple dose multi-part and of

dose multiple We dose the study initiated in have ascending the are ascending well. study single this portion of doses now of escalating the and portion as

associated daily were wide CK-XXX dosing Preclinical data potential the and dose heart As a we a and cardiomyopathy optimized have predictable and flexible and The dose and suggesting titration dose fashion. physicians to curve best-in-class reduced with to response thickening potential preclinical dependent characterized, the shallow to and efficacy. reduce Further designed reversed hypercontractility hypertrophic of clinical pharmacodynamic that exposure window will showed steepening CK-XXX the for broad for once CK-XXX utility. with is of personalize said, properties we evaluated safety CK-XXX showed value. and pharmacokinetics in a that in

best-in-class to is for development As people and function the for in that from we goal map to to XXX restore X that therapy, HCM. our may deliver optimize suffer balance treatments potentially the this heart continue

one the for inform to approach profile the the hypertrophic have best-in-class received. is the We advisory and key two recently interest was cardiomyopathy our hypertrophic with product opportunity field great held with ongoing potential the target the program. therapy meet and patients presented one in well Europe cardiomyopathy board meetings, in to There of leaders had U.S. in in opinion we development and to

collaboration Moving cardiac the with call troponin XXX AMG Amgen being assess and Amgen. safety joint it Phase study in potential our discovered now novel, is research underway increase XXX, to function. cardiac the with by program small its is of conducted and oral, tolerability to we Cytokinetics under activator AMG to selective, is and X molecule

plans expect and development treatment to and program clinical are perspective the and elaborate believe expect progress. results during death. of productivity crucial as failure to pipeline a XX now, to to to million provide year from development am our drug serves in pleased muscle look to continued that cardiovascular growing I biology, worldwide, also function I to candidates We call I expertise over with on to area. three skeletal forward the hospitalizations and our heart and turn muscle updates reduce suffering XXXX. With We the in advanced people focus approaches on this novel our highlight longstanding reldesemtiv. a on And advantage cardiac Andy we symptoms, will

Andy Wolff

Fady. Thanks,

mentioned, program with for reldesemtiv FDA Six Robert announced primary we maintained an is feedback for have from acceptable the in Walk that patients who As registration efficacy recently endpoint SMA ambulatory Minute function. Distance potential

characterized hypertension, proceed therapies name with history SMA syndromes as are as Morquio and has endpoint of from Hunter as older to may well for we well several pulmonary diseases natural disease this pleased a treat its how that same such informing is to few the patients been confirmation with We here. as and approval in used Pompe

As the currently SMA-HI. several Index evaluating potential SMA Health global including scales, we or are secondary the endpoints, functional

individual the of SMA XXX in recall, Walk a study to the with daily post-op twice reldesemtiv decrease well treatment baseline and decreasing SMA-HI baseline the reflect the SMA-HI burden the SMA-HI of and total suggesting as Phase from the Minute the with in as correlated of changes the will analysis Distance during Minute X in that fatigue at increase statistically as significant by activity with disease you Six from patients X As Six Walk changes score domains, score reldesemtiv. correlation milligrams clinical nominally burden the by total as for SMA-HI assessed This X Distance SMA-HI. including measured disease participation of was X domains

fatigue that are considering with advisory secondary other are leaders. and also opinion on convening we both boards function We endpoints motor key and read

whether Phase may is now the next Phase in evaluated plasma study Cytokinetics to In X terms of X SMAs higher assess volunteers concentrations. steps, conducting than reldesemtiv study of were result of healthy doses in a patients designed higher with in

the development continue we study potential quarter. steps next Meanwhile, We reldesemtiv for Astellas. expect in SMA program data the from with to second this regarding discuss in

in international patients the quarter, ongoing our Baseline large FORTITUDE-ALS, and our That conducted ALS, are other similar to trials to muscle ALS, with including the to trials an FORTITUDE-ALS encouraging of completed in muscle trial who increase recently Turning time recent to reporting ALS trial therapies look patients that prior towards last trial. Completion large and muscle the We and ALS/MND the In we at and of that forward announced second in International directed demographics quarter. patients of this baseline considering dosing. BENEFIT-ALS during December enrolled more living clinical of we force, patient new characteristics enrollment fatigue. Phase the presentation in results informed in FORTITUDE-ALS the step fourth clinical of power from with on the first FORTITUDE-ALS. desperately medicine for those design Symposium reldesemtiv advancing of mark the of characteristics important potential in enrollment the people enrolled in need Glasgow, VITALITY-ALS. is X

FORTITUDE-ALS, In tirasemtiv in Association analyses contains VITALITY-ALS. these capacity Cytokinetics way Data predict past from the Phase continues lead the the clinical conference conducted Sciences home included quarter. press the clinic to data of in measured at for a with potential conducted presented Details analysis ALS, at of of slow in to related impact from from treatments the additional and survey and a and were new ALS. by addition, between to in and models part patients by in innovate disease ALS to data posters ALS, VITALITY-ALS by learning machine the new posters caregiver patient of progression during results trial using vital validation from funded on ALS correlation III results the and an from Origent of release analyses Cytokinetics the

to commitment learn here. insights with the and clinical elaborate much the trial to to as advance to execution. presented we won’t our and reflects support I data ongoing can ALS from community So as it say, Suffice our trial and design data

CK-XXX, fast conditions. our collaboration for are advancing under skeletal a treatment Finally, next-generation neuromuscular and with potential of the non-neuromuscular activator we Astellas, muscle troponin selective

We activation muscle muscle to research force, our on now, skeletal an to improve pursuing financials. continuing and are on program joint update turn muscle call And over Pete focused to power I fatigue. also provide the our will time to

Pete Roddy

will the will the Ching spending corporate of I release touch our cash, for We strategies. investments. Thank details our XXXX revenue are equivalents quarter in review cash, guidance actual with you, Andy. of and and More press development and then on our $XXX ended and results give million fourth a cash our in included itself.

for $XX in Our X following as from debt Phase includes and specified our availability in drawdown the million loan our cash data reldesemtiv of of agreement. SMA

from under accounting of and in cash with our Astellas revenue new and revenue primarily rules XXXX Our this QX recognized strategic non-cash came XXX, includes the year. alliance both ASC

million start-up increases for our announced be spending. reimbursed expected Amgen of FORTITUDE-ALS for the offset our XX% programs development for of million expenses decreases and programs, The including in to to muscle inhibitor research contractility cardiac spending and R&D by by attributable for for were These expenses reflect These to initial that $XX.X from the related to expenses on expenses, our other to skeletal fourth more of activities. and XXXX. for XX% reduced in primarily were myosin particular, muscle $XX.X than trials by our spending CK QX, quarter Moving in R&D primarily clinical XXXX tirasemtiv and appropriate program, reimbursed as we spending our reldesemtiv, XX% will our Astellas. changes reldesemtiv, to contractility About XXX. cardiac conduct recently METEORIC-HF,

G&A in quarter $XX.X expenses million million fourth QX, to XXXX XXXX. fell $X.X from Our

for XXXX Our strategies. take pre-commercial QX Ching development our for XXXX tirasemtiv. work from included spending will guidance for to provide support it here corporate and

Ching Jaw

And Thanks, will million. utilization with to revenue Operating our to that majority months is XXXX guidance the the AMG the Net are financial Phase XXX. entered XXXX reimbursed $XX Amgen $XX of and that fact we and XXXX anticipates of $XX fully given Pete. at than under the given range the the cash $XX million, approximately The expenses the paid respectively. our costs mecarbil FORTITUDE-ALS and XX collaborations end options we omecamtiv cash we over X of Today, for be of Astellas, utilization conduct associated million XXXX related be with for in company our development With million less range net guidance. million cash expenses $XXX announced cash off runway, And will will million XXXX of be of for for in $XXX cash million responsible XXXX. XXXX, METEORIC-HF to Amgen for will co-funding of million. with $XX XXXX. to of be in $XXX

manage strategy to our Our readout of cash from expected XXXX. remains results corporate through development the in GALACTIC-HF

As has that this we been advance capital to later our to collaboration to our CK-XXX, to program, which potential are year. a seeking expect Phase we historical including myosin raise practice, inhibitor additional cardiac relating through X

We are own. preserving an opportunity us other deal that Cytokinetics our research potential focus continuing towards on that to we could and economics, to a control and resource additional and development make afford our program key rights for under progress may partnership for

we may are the same deals leadership been include can which the muscle our things, financing. through raise in biology successful do to other project remain past have among in mechanisms other area. and in time, this monetizing optimistic evaluating same We the we that At capital,

will back I which Robert. several to with provide collaboration not to milestone And could XXXX now call turn opportunity extend our factored also cash are payments eligible to guidance We over into further and next receive runway. that, are the the over years,

Robert Blum

Ching. you, Thank

in inflection, half research outlook, of number already and compounds given of we’re a with financial the XXXX particularly well generated position, stages XXXX. proven the just this we engine and development, strong a having of anticipate are entered first we currently through year, our So, points advancing to vision execute that on various five about our energized poised productive

pipeline. Our make and the of our deepen, probability mature also strategic of our expand to and that the optimistic Company. direction successes remain regarding milestones initiative shift future designed We recognize and upcoming

shareholders. a to patients to provides valuable roadmap impactful investment incremental and strategic to process clear with the critically Our and annual most us and returns evaluate best warranting R&D the programs planning ensure direction benefit

we on strategy build We have ensure corporate to diversify to our and well agility novel investigational and maintained our as while advancing maybe to risk as execute focused to an continue uncommon staying needed as quickly into can contingencies optionality realign to medicines benefit patients. to planning,

Our has never been pioneering an and muscle translated of candidates, some pipeline function has to devastating our medicines expanded to investigational proud of work treat that modulate stronger and discovery we of weakness. the sarcomere novel in the diseases drug are outlook designed dysfunction of most into

for milestones expected our XXXX. recap I’ll Now,

For GALACTIC-HF first to of of half omecamtiv patients the of we occur to we first expect of mecarbil, XXXX, expect enrollment in interim the during for in analysis XXXX. first and futility complete GALACTIC-HF half the

also heart with patients failure throughout in XXXX. We METEORIC-HF to expect conduct

we expect the of from second data XXXX. half XXX For the subjects CK-XXX, of in Phase in X healthy study CK

of results For with program AMG joint continue will expect to for activities in And under research XXXX. our the throughout that Phase conducting research, discovery study we skeletal And next-generation muscle quarter we the XXX, the of XXXX. second throughout Astellas activators for expect directed Amgen continue X to we XXXX. expect the our preclinical FORTITUDE-ALS research from reldesemtiv,

contractility open the We operator we and growth please. of beyond other questions the call now our And research, research muscle activities to metabolism with also muscle. up towards the energetics including of muscle our expect to biology-focused the can continue that, of expansion

Operator

Pantginis H.C. the [Operator first from of Instructions] ahead. question go The Joe line Wainwright. Please of comes

open. is line Your

Robert Blum

Joe. Hi

Joe Pantginis

the Two how Hi of for don’t questions programs mind everyone. advanced Good taking afternoon. the on Thanks are. if you based question. advancement the

effect, with Curious, training first looking it’s impact on control potential the not closing do So, they effect? bounds, to for but the will? a any METEORIC, how this potential more the placebo to for on of when effect you you if the regard arm congrats rather something started. getting placebo effect, control or training like but statistical more, I less a in patients said, of placebo the Because are

Robert Blum

I’ll to question. firstly turn Fady. that Good

Fady Malik

think test lies employing, the really hi. in that Yes, is I the exercise which in answer cardiopulmonary Joe, testing. we’re

that which five greater trials, months effort they someone means muscles, cardiopulmonary that is exceeded included And into see to a about they anaerobic to it’s particular in thing So, capacity, are assess that be threshold, exercise by-products to or exercise. the extent. deliver more being carrying threshold you also is this to blood better that into getting related of not else these in there’s effort. anaerobic training of they to in and you apart, patients you’ve you in And accustomed you the the With shape, the assessments are dioxide peak reached that muscles two assessment get criteria heart requires their their nice to Training basically have their trial. putting can their a can not get because that, by people a in not putting this inclusion so to measure there’s carbon exercise is in performance to order it. and maximum their know oxygen getting exhaled begin the but effect, the that their trial, often bloodstream, of necessarily objectively testing, it’ll when better exercise you to that like only

reached the And of their end objective so, will, that relatively it provides have measure exercise patients if you performance. a

Pete Roddy

testing, the and And if just placebo, analysis a none effect, clinical there we’re than you than placebo works, you a see that let’s what the cardiopulmonary increase a drug that detectable from effective, exercise second result still drug and training the is second effect, of effect better trials true is while really variance. and If different is in the and as is of is, number exercise the testing, do the see in both with I treadmill having still the endpoint, them precise so treatment on tell on which technically do, say taken do can groups. also period you that of so, comes that’s is almost always but that’s out better for difference like And training analysis of you exercise third as and both I test and result better forth first, variance. treatment is it but that’s than just mean four the out you’ll a after

Robert Blum

that Does your question? answer

Joe Pantginis

No, if do it certainly guess drug. thank in does. from higher delineating has general, your And you second XXX, guess, helpful. around Thank level BD your, the a you this Very maybe more my with are then why concerned mind. types you. Fady I other comments, start I did Robert, program? don’t question you’re and your differentiated you why to But the did prepared very excited window how about shallow for in or on and comments can exciting about and with said well goals versus maybe, you some of you for the this safety And as have less therapeutic inhibitors? maybe prepared with front, more cardiac and drug potentially and like it’s then profile so you program, especially

Robert Blum

good a it’s So, question.

conceived So, therapeutic hypothesis years and Cytokinetics. originated to the here program at area of be this original ago many clear, we

to onto in window the a to given We’re this might matter, the a with expanded to area, not mechanistic also indications. in lead of ultimately thought that chemical how terms but both in respect certain open And elucidate way biology, how area experts only but of we’ve best also the pharmacology. this lot of in this

other think But in on lot profile of compounds we’ve I we a myosin we the of decisions is to respect the PKPD are sciences, the very HCMs, molecules done we’ve had plural, myosin contemplate also comprehensive in cardiac learned think underscore terms and best-in-class are properties to a how indications multiple activators how but to formulation for making of substitute not to of I potential. ultimately as there be the developing as there’s could good taking no with the way mecarbil would with learned think have very that we clinical cardiac not that to did informs CK-XXX for we’re the with parallel. of program, potentially what inhibitors going elaborate work well. ideal advancing biology approach known placebo-corrected students what that in order clinical to we careful that we intrinsic because its in for also understand initially in other in with have Phase terms what here regard omecamtiv that of trials best we’re informs best X frankly be the optimize I terms we’re in development profile And in compound could long effects, in

take So, I don’t here. lightly the opportunity

be how I some think it’s the deal it that great of properties CK-XXX might indicated Phase a in of that be we going of verifying sails thought a preclinical does forward, to the approach in CK-XXX we X have we outlined. we in validate don’t wind proceed. to think our our and could have anything evidence quite important with Day, Phase terms one, in I’ve Phase on and but be this X, that’s that. able Fady in R&D I you at I based the to of information X we fact did, in best It generating rapidly starts our from pharmacodynamics if expectation moving to data is add know, that then want year

Fady Malik

want to Joe? you there covered me anything think Is it add there comprehensive. I you pretty

Joe Pantginis

it covered like No, I of in you lot prepared a your comments. also

very added So, for the guys. detail, thank you much

Robert Blum

Sure. Thanks.

Operator

of Fitzgerald. ahead. Please Charles comes of Your next go Duncan line from question the Cantor

open. is Your line

Robert Blum

Charles. Hello,

Pete Stavropoulos

for you? hi, Pete Hello, this How on is this are is �� Charles.

Robert Blum

Hi, Pete.

Pete Stavropoulos

last all to like on X in you and I’d the expansion congratulate pipeline progress quarters? during the the XXXX

Robert Blum

you. Thank

Pete Stavropoulos

is METEORIC-HF. question my around So,

patients So, is the be is during baseline with capacity these would would change functional What of exercise oxygen have failure, for clinically assessing the cardiopulmonary parameter significant the and of an peak the kind in study. levels primary peak life the of oxygen from endpoint uptake on of and important on sort uptake the patients? an heart considered test quality impact

Fady Malik

Yes.

in answer of in peak oxygen clinical have of outcomes. what on I the looked to improvement is question at terms the based people think and that uptake correlation

trial changes to associated been per the are that. X.X We obviously shown be anywhere But milliliter in to have that a clinical improvement will to minute more directly running from per kilo past, a with speak outcomes outcomes. X in

And an so consistent that’s to the effects are you be assume meaningful exercise that in I patients. think tolerance meaningful improvement those clinically would with that can

Pete Stavropoulos

Alright, study, of oxygen you. sort screening predicted minimum you maximum, one require process more for enrollment during the question, for normal for enrollment? thank percent the value would the for peak of uptake And what

Fady Malik

Yes.

only of uptake the XX% trial require criteria for so sex, patients an enrollment weight their the age, So, predicted can and achieve at in peak entry the forth. oxygen

specifically enroll patients that we’re evidence exercise decreased, it not only their So, tolerance as of tell well. us has have objective but looking to

Pete Stavropoulos

you very Thank Okay. much.

Fady Malik

Thank you.

Operator

Your of the of Jaffray. from Tenthoff next comes Please go question ahead. Piper Ted line

Your line is open.

Robert Blum

afternoon, Good Ted.

Ted Tenthoff

you. thank front. lot on for update are going really echo really you? the Thanks congratulations the how and on a I the all guys, Hey cardiac muscle progress and front since Day, the Great, R&D

area. [ph]? win have if So the I expect should what experience what if for difficult may, here, can a you in all your appreciating from ALS perspective that is FORTITUDE, in what firstly, you With you expect nice a FORTITUDE, book would X be can, guys to put for us we

Robert Blum

many over of efficacy enrolled maybe a in And capacity So, albeit it clinical and design endpoint, with obviously the in primary that way using ways something I’ll candidate, assessors. learned in Keep the the the through around is upwards we’ve centers conducted vital we’ve of experience lot built start assessments slow tirasemtiv. evaluated to Andy. turn that now mind, with you, that in we’ve resembles FORTITUDE-ALS. patients drug endpoint same being X,XXX trials, that of and different same that in FORTITUDE-ALS and studies ALS We’ve then a already the

probability that into of the assessment about think So, a we based what learned of it that Andy the fidelity factors increases over and meeting the on design. constitute the the on trial clinically objectives talk we’ve previously. I’ll based what to would effect meaningful us But, turn to

Andy Wolff

recall, vital treatment dissimilar they again about a confounded slowing number vital placebo. in slowing basically taking you recall, was a people, what a in off you been VITALITY-ALS, was drug. in study So, but to we primary analysis the stayed everybody third vital as When for BENEFIT-ALS, at of patients in saw look which we not being in months. in decline had saw who something on you I the of also the capacity as if in saw substantially saw literally primary remained slow The measurements BENEFIT-ALS. endpoint on you but of drug, an of had capacity and of analysis statistically on that capacity are rate drug intent-to-treat by And contributed decline that we decline when a think as fast significant people highly

or the demonstrated than more tirasemtiv, tirasemtiv. we’ve can in better early of out fast So, I slowing if they much drop drop activator more tolerated than muscle we twice that progression of drop-outs seeing drug study vital adverse be of out think fewer events with demonstrate adverse well known We’ve they that disease throughout with we’re a patients they patients decline course and have and seen may we the intolerance. ALS, as and that with reflect did the a drug events often different for less drop-outs, randomly is skeletal to with take troponin reldesemtiv and associated capacity pattern

the a X.XX a can’t it’s think BENEFIT-ALS X analysis, We’ve as I from one additional speech, have X in we in we support. And p-value And capacity consequently, endpoint, primary that range better same somewhat in trial are in measures than some we the exploratory haven’t before, points, even were a with drug. to with there’s way and be many So, vital also points, promising, handwriting. that provide ALS trial obviously ALSFRS-R ALS usually which in do the even been which clinical is percentage patients maybe that that primary quantitative on in percentage measured actually and tolerated a also if less difference the declined saw less much and are would provide evaluations don’t see particularly an may any very win. but placebo

need on bigger an for endpoint, even I win, the seeing certainly be significant nominally those a for trends, significant we’re clear result and endpoints obviously the some make other primary results on – win. it of So, we it a but positive to think

Robert Blum

percentage – we absolute add percentage I’ll a experience placebo to annotations our capacity. to percentage decline on X X their points of patients expect points, just Yes. Based points approach slow that. couple that in likely vital will

pointing Andy that, those those patients as baseline of in very are that we the presented The drug receiving a investigational represent in characteristics news month is per patients enrolled the good other closely enrolled So, as the curves. significant or is December, X% out, we studies. that see resemble FORTITUDE-ALS in if declining for X% per to month separation could

that The reldesemtiv different add that’s our to nice some three would thing XX study comparing to well. right weeks And as therefore, that see these questions. So, confidence designed answer be ask response is, a of this over it doses increases the placebo. study is and we’ve to last I’ll dose-related

Ted Tenthoff

of I that. follow Yes, if just up very helpful. to on then And may kind

Let’s the of say here. sides both kind of coin

potential may, positive. Is negative. you. steps? Let’s hypertrophic to build What take kind out back would be yourselves the partner resources further help to a and say to of XXX or redeployed this those in it’s cardiomyopathy? say, something the goal is it Thank next let’s study I be would find And where comes really if maybe

Robert Blum

asking I think of was my question it’s to one and I pointing you’re good some comments. the very that by a

to to regulatory and want in respect important and think think – SMA, own it data programs we the I our have on our before – data the CK-XXX. investing pivot commitment were might might have more very unequivocally negative, other mentioned area of commitments you to ALS a prompt indications coming up we we’re like we us for see in in encouraging on neuromuscular favor reldesemtiv If determinations. clear to an path data reconsider make point while final with this and ALS we we any

learn into development year. in second I going lot next we’re in the about to the reldesemtiv the half few have months. a of think and our corporate thinking CK-XXX And factor So, that to

Ted Tenthoff

the coming very much. readout. lot you. you A Thank Great. data up, so Thank to I’m looking forward

Robert Blum

Thanks, Ted.

Operator

go question of Hung the line ahead. of next Stanley. Jeff from Your Morgan comes Please

Your open. line is

Robert Blum

Hello, Jeff.

Jeff Hung

for thanks the – hey, for – Thanks taking thanks questions.

futility remind successful, reported analysis? if the study as you the beyond planned? anything And us expect continue whether to then can GALACTIC, For be for will what

Robert Blum

about. and Fady. I’ll Yes, turn need it’s that we a be clear very something over it’s question to good to explicitly

Fady Malik

Yes, hi.

we access whether should of have or continue only assessment to stopping not, the for found trial unblinded compare be terms just treatment that we’ll to in tell DMC, will the obviously the able trial of in continue – and grounds making they dataset you For the us to they their have or placebo. But the trial.

But to decided We at other have will which event they they any with look probably to recommend unless base the that from recommendation – the to of of expect occurring go at there. time and the to able the for decision not regards the we stop information the that not be it speak in accumulated to the the then trial, would basis is would analysis to that a analysis the we trial. data in any in futility

Robert Blum

Yes.

what would we to data to be nobody data thought may have informed scenario, triggered report, such was well that’s scenario, study, have only appropriate we continue in access just study would not to because the DMC and expect So, only would the it that the very continue in should because be we futility. not we the any that clear, that should

Jeff Hung

And for next then for with analysis? futility omecamtiv guess, milestones the and/or I mecarbil, are what the great. expected triggers potential Okay, any

Robert Blum

payments? So, referring to milestone you’re

Jeff Hung

Yes.

Robert Blum

Yes.

under disclose. freely so, not payments. we’re where to we we’ve we those are Amgen’s to that’s collaboration have disclose this as in milestones get something closer It’s milestones, that would not not Unfortunately, we’re with that’s the position So, we trigger have could something that to do but thought approval to ability such something our instance. what able in Amgen, a that agreement

Jeff Hung

Alright, thanks.

Robert Blum

you. Thank

Operator

line ahead. comes Chad of Messer Needham. the Please of go question from next Your

Your is open. line

Robert Blum

Chad. Hello,

Chad Messer

for Hi. my taking Thanks Good question. afternoon.

you set For able other of might that this study to are volunteer at might help expect from XXX, limited be just these you the and some we out is some to data efficacy? pharmacokinetics second there what clear that or in hinting get healthy half, volunteers expectations for can solely can measures be it safety,

Robert Blum

Good question.

in in the expect from that. it and I’ll continuation parse we turn from into what can Phase So, expect what let’s volunteers X. to might then it address Phase we to Fady healthy over X

Fady Malik

Yes.

in Phase we’re not X, cardiac characterize plasma we’re its conducting and and blood determining effect sampling So, for echocardiograms function. also pharmacokinetics, but on only concentrations

So additionally safety mentioned and then tolerability. as – and you

outflow sensitive X to goal gradient. an normal fraction. Phase of generates to function modulates to flow hypertrophic dose don’t a is trials end to how many in the or the initial dose least drug, look X, drug cardiac outflow pressure leaving normally the the that an healthy which at outflow the Unlike and – outflow hypercontractile Phase intolerance and pharmacokinetics. that participants we have we’re of across and tract. be the meaning of be the that part in because is have of the So, would say fraction. transitioning cardiomyopathy here, and patients harmful we to blood gradient, gradient be obstruction importantly, more can tends pharmacodynamic the intolerance our We going not Phase should its an response Then signal the heart see participants. healthy to and have drug The – effect both ejection at describe – able effect reduce X, which obviously gradient ejection of to have to the to a than to But curve

So, there mean, nothing in That, gradient regard. measure X, the in – normal outflow so there’s person that is I a that’s to

Chad Messer

Yes, And right. then other prepared you that’s just briefly very, your very comments, question, helpful. one Entresto in talked Robert, about

terribly can I well. a of need failure, think in that, a terribly do heart which but so like isn’t drug lot not unmet your point innovative obviously was, better, innovative there’s

other Just if that, launch and to that lessons can from initial are that drug experience to any wondering, be be there learned omecamtiv? applied

Robert Blum

Sure.

utilization the but we be arena into this best fit market to in integration I authorization to it be innovative, heart there not in practice. Entresto actually are some conform what new are it omecamtiv how think that means There access didn’t new lessons a guideline doing think much possible the at and it facilitate the what systems has with what studies need. those with And really constructively uptake cost? the gleaned also to with that of but quite like think need one things clinical in conducts I true So for who some learned for those payers say case what only time. alongside care. there. and seen But models unmet the And the from commercialization. those with facilitate ultimately that think developed represent that ultimately we in in activities for at treated medicine care. are METEORIC, wasn’t conduct not of pharmacoeconomic other to for should ultimately, real it different of like medicine failure are there be cooperatively to care And budget addresses things matter. what from available the research of have are speak able the can with – an that as understanding the drug now what potential on subsequent and real omecamtiv be top to understand Entresto, I and that anticipation regulatory with because can be potential translate doing other are and impact mecarbil into we healthcare standard given firstly, first what heart patients might needs of and addressed need and best and standard also order be marketing part, failure large And patients hear become working omecamtiv that so geographic a should difficult in to world that mandated patients, we’re treatment, best heart should and additional that me the We things with that should order to clinicians, to will databases of millions there’s regard unmet The be of types that seeing to good is impact are to was innovative, be should It evidence had to authorities failure, it the you’re mining and of you candidate There best standard that the mecarbil. best of but as of one are world distribution. registration medicines of of, in trial think foundational Amgen also clinical be for will it’s conversation

immediately, that antibody the have Entresto done place So Novartis in reactions demonstrating the that certain value. have good and been since eroded as job impediments a put went think and up, I clinical pharmacoeconomic

Chad Messer

Thanks great. Alright, that. for

Robert Blum

you. Thank

Operator

Please Securities. line comes the The Butler ahead. JMP of go from last question of Jason

Your line is open.

Jason Butler

thanks Hi, –

Robert Blum

Hi, Jason.

Jason Butler

Hi, Robert. Thanks for taking the questions.

the reading from does covers this and AMG ECG failure heart the both know be information about volunteers. potentially CK-XXX. do omecamtiv later that stage one ECG to mechanisms useful disease predictive First think efficacy assessment trials? When both XXX we will here different other you speak healthy should What and and get or how drugs contractility, and in in of to that

Robert Blum

information, ECG, you but you meant of have point a I echocardiogram. Just said think might

Jason Butler

Sorry, yes, yes, sorry. echocardiogram,

Robert Blum

it turn over Fady. to I’ll okay. Yes,

Fady Malik

very it’s predictive. think We

failure, and acute at If you echocardiographic healthy you exposure And failure. response in study the terms of of another we with mecarbil we’ve in which generated for COSMIC, in then in have stable volunteers, relationship patients identical data of in are virtually those with most and patients heart what information, omecamtiv heart populations the heart failure patients they see chronic different trials. stable PK/PD in chronic with response look to that all is

data respond volunteer healthy useful the it is terms of in the understanding quite think how may I setting. So, in

Robert Blum

just of on clinical echocardiographic a would Phase X trial evidence and order also not mecarbil. inform learned in to limitations doing also data But learned omecamtiv we about with experience based what how might our how CK-XXX should We’ve design. the say we it’s echocardiographic informs developing absent advantages be about that to approach I Yes. learning well. as that’s inappropriately we misled we’ve with where select be CK-XXX think from in effects be with been could placebo in will the measures placebo-corrected certain we’ve omecamtiv to X, much subjective trials advancement I clinical mecarbil rigorous a what like way one in Phase Phase order and to could X conducted for dose

Jason Butler

just on program and about just test you your second you Can for Hammersmith then patient this about it test. at you’re in thinking you’re And population? on of SMA relevance of endpoints six-minute reldesemtiv, thinking the how speak prepared great. the the top this the to question secondary specifically talked Okay, comments point how walk about

Fady Malik

think these don’t I adults. children milestones. it’s does execute look It really infants relevant small and really developmental of to at older kids particularly very ability and the to

SMA want I regulatory with authorities more relevant. something had think Index. data some is walk global, if far more the test we a six-minute And encouraging Health

for patient in them developed and this So, sorts by by measures population outcome then these developing with experience endorsed getting someone reported lot FDA. a it’s of specifically of

need population – SMA just it’s don’t I designed of So, Hammersmith, I for really not this see do a to patients.

Robert Blum

based out approved endpoints affirmation that Immediately, with see this Six that, has the do secondary Walk the acceptable in an of Minute other think validated Andy include other we’re primary scales revealed could that that on global could we still that our even might the or components Hammersmith area. provide Hammersmith another there conversation endpoint. But believe FDA global a, as Walk and Distance SMA-HI on But has effect, in is may they Hammersmith. learning I an points that been is and Six efficacy drug b, Minute Distance of or be

in we’ll for able high more validated would order clinical be in considered what We’re be down suitable reliability use about retest that having would test, be about lots of to a trial have the say and conversations road. and have to to

Jason Butler

taking Thanks helpful. questions. for very That’s the Great.

Robert Blum

you. Thank

Operator

would to closing remarks. to like Robert call Blum the I over now turn for

Robert Blum

teleconference information we in for this very call to and information underscore that’s more interest there. is also enrollment the interim next to new forward our describe around you, while a participants such pointed about continued coming futility. path that a potential which forward us on obviously, in in lot And We about the and the we’ll have understand the GALACTIC of of CK-XXX, quarter Thank your as that have and today. reldesemtiv designed first support, concluding potential your today, all also heard much Cytokinetics, a lot thank you on operator, appreciate is I and there you

are times very busy in these So, Cytokinetics.

put look the to we this all our yesterday trial Phase thank clinical of morning the they’ve for very X work forward of personally study with of start new omecamtiv announced employees to a AMG I of make saw XXX, the all a You METEORIC. of start to the want hard forward these forward now in mean updating things happen the we the of can to year our conclude call. and we second that beyond. half and as may Company regard progress shareholders and roll the we operator, what with that you. With for Thank

Operator

conference This concludes today’s call.

You may disconnect. now

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