CYTK - Earnings call transcript Q2 2024 | Cytokinetics, Incorporated

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Operator

Good afternoon, and welcome, ladies and gentlemen, to Cytokinetics' Second Quarter 2024 Conference Call. At this time, I would like to inform you that this call is being recorded. [Operator Instructions] I will now turn the call over to Diane Weiser, Cytokinetics' Senior Vice President of Corporate Affairs. Please go ahead.

Diane Weiser

Good afternoon, and thanks for joining us on the call today. Chief related Murray, Chief quarter interactions will Malik, and aficamten; EVP R&D, provide earlier program and Commercial Robert regarding recent updated Chief planned will and and milestones. Quality, and activities review for from Sung overview XXXX; FDA with Officer, will Chief expected EVP review and President our address Blum the regulatory of will and and our and guidance EMA our filings; Regulatory overview Financial will for updates the Officer, and development of stage SVP, Affairs commercial recent Callos, will Medical an Stuart quarter updates a Blum, readiness Executive trials financial provide begin Officer, finally, provide aficamten; an for update EVP of ongoing omecamtiv progress provide and Andrew Lee, corporate Robert and Chris Kupfer, CK-XXX clinical upcoming financial review SEQUOIA-HCM development with to developments; our pipeline; mecarbil, strategies SVP our Officer, second and Fady the of the

portions discussion, responses questions, future including statements the note to facts to of rather events that forward-looking our relate than performance statements. Please contain and historical that constitute following and

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

actual now contained obligation to after forward-looking our on to differ materially financial to the today. the that undertake regarding results these is XXXX this I no SEC call cause from results turn current statements statements Form SEC in over furnished to any will our Robert. Additional our X-K information filings, could filed quarter call. factors And concerning was in update forward-looking including We second that report those our

Robert I. Blum

on us you, call joining today. and for thanks Thank the Diane,

of significant aficamten launch advancement quarter as enabling of clinical significant and capital of as as myosin a our programs structure achievements was potential later-stage modulation cardiac marked progress continued of well the of development commercial our as second on balance pipeline. by strengthening sheet notable well across and our built execution foundation The the further

were Society Congress primary results late-breaking European Heart present we from Failure of the clinical May, SEQUOIA-HCM Lisbon. a Cardiology's session trial pleased at XXXX In in in the to

results As expectations. already Fady patients profile with will a elaborate, SEQUOIA-HCM efficacy to has our a safety inhibitor aficamten myosin and opportunity next-in-class potentially emerged expanding high these that category met points The of cardiac from as HCM. for

B participated During dialogue our ahead productive a continued Type to the FDA for mitigation to safety submission discuss strategies potential in our FDA with meeting of NDA. an planned and we aficamten. with We quarter, of risk monitoring related

an discussions of SVP how forward We on provide interactions are joined Regulatory as globally. went, us at update has today pleased planned. we're to Affairs regulatory these our moving Chris Quality, and and Murray,

in treating to the with the respect unmet GALACTIC-HF. regulators the we may over with conferred failure of the omecamtiv we With that on potentially results play from past omecamtiv need have What of We of population role occasions, was mecarbil, failure, and risk year, several on evaluated people increased unique we found analyses are and opportunity large with hospitalization. steps. address conducted at failure experts a numerous heart heart limited who patients potential and with altogether, mecarbil next omecamtiv heart while severe our growing for and compelling treatment a to options we spoke

clinical potentially and synergistic with of alongside a Furthermore, following to commercial advancing patients minimal believe omecamtiv for Phase standpoint deliver terms and treating adjacency to confirmatory launch of an sustainable should specialty the franchise mecarbil shareholders. investment omecamtiv to costs HCM CK-XXX, we high in trial high With aficamten. opportunity to can we on increased both a return cardiovascular a positively. build commercial for we value the see from III R&D maximize And by further physicians, of read unlock again, out and

out our to our proud we're shareholder in with that, also arising highlight research. anchored plus foundation of niche specialty for with Fady, with and from specialty over carving in more myosin cardiology still I'll adjacent our of program please. ongoing, development muscle extensive And to development our to lives patients call Overall, on improving indications label-expanding aficamten biology later-stage an programs clinical while with the the site multiple set trials turn come cardiology potential enhancing platform the pioneering We're value.

Fady Malik

late-breaking are In the including additional Thanks, trial. quarter, presentations of were Lisbon, primary also clinical results profile Medicine, we consistent which product SEQUOIA-HCM patients. become with primary Robert. enable the aficamten the in myosin in choice and second of and inhibitor that Journal New our among of results, pleased target The X the may the trial present X cardiac from to very England were analyses physicians published to simultaneously

aficamten least in less observed XX effect consistent X.XXX by improved X-point improvement Subsequent KCCQ significantly NYHA class exercise patients symptom the per VOX treatment were blockers. and a for capacity, milliliter was the burden patients kilo with secondary peak than increasing The and placebo in placebo. per compared minute P compared all improvements, including prespecified to of subgroups, treated of beta with at X.X had results each by functional receiving XX treatment aficamten all X This substantial X.XXXXXX. weeks showed in with across with that P-value including improving the of endpoints, patients XX% reductions a

with significant LVOT post-Valsalva benefit the baseline to of SEQUOIA-HCM, way by the substantial of aficamten or mercury in and of gradients XX% gradient. the on LVOT at the treatment that's Another In a characteristic evaluate reduction of its hypercontractility resulted effect millimeters of XX in post-Valsalva is treatment aficamten looking HCM. underlying

reduction with substantial we in in LVOT an with than and average. in consistent fraction, LVOT rapid Importantly, the this without a impact hypercontractility reduction in in LVEF gradient negative occurs paired left on on ventricular improvement HCM. less ejection Overall, a X% observed reductions of gradients was that

and [ The and the its of the aspirational ] initial published and reinforced results these American comprehensively the manuscript key aficamten. Journal into describes in paper and engineered safety SEQUOIA-HCM colleagues Coates Association were profile pharmaceutic to dosing from recent the that of tied observations. expanded and Heart results Carolyn detailed by SEQUOIA-HCM A Dr.

rapidly escalation gradients Specifically, that aficamten weeks within or these reduced of X interruption without either showed discontinuation LVOT for dose treatment analyses treatment need during initiation the the phase.

was target that very maintenance the essentially Additionally, once change a phase low generally dose linear to the pharmacokinetics treatment, and led were that variability LVEF regard. placebo with in during little in of the from indistinguishable attained,

the its pharmacodynamics LVEF LVEF of were -- for titration less and demonstrated. less convincingly down of Effectiveness of than XX% reversibility

ejection were goal to is treatment gradient heart reduce The events. Importantly, normalize associated in no failure to LVOT there HCM left ventricular the of also not fraction. but only

outlines an of than paper LVEFs XX% aficamten any these treated the from had XX%. with As at largest higher, in the individuals LVEF greater excursions baseline, XX% None patients LVEF with had baseline all visit. or below

these Plus Results objective care and have aficamten, reductions largest integrated totality treatment. product is from elaborate the X data analysis to of most participants be to biomarkers SEQUOIA-HCM the function presentations We European of The in X and presenting the be hypercontractility, LVEF and including of late London, Society will with FOREST-HCM the aficamten in the with presentations Cardiology presentations. upcoming severe safety on that, from consistent medications. standard will will we oral an to believe KCCQ, breakers profile. relating withdrawal how cardiac X presented. related our in the occurred achieving related importantly of structure, Alongside we'll of target Meeting

in program MAPLE-HCM trials aficamten. on ongoing clinical for report the Moving this on during to quarter. we're that pleased complete to to enrollment We're track

are to we longer enter fact, In new seeking no patients screening.

reminder, this obstructive monotherapy aficamten's of superiority a compared clinical potential to the As metoprolol's HCM. trials evaluating in monotherapy

positive, the relative first enable And read half positioned to beta therapy aficamten how blockers results first-line should out opportunity XXXX practice commercially. quarter launching and expect evidence label completing of of enhancement the this when we'll guidelines. represent to be potential we provide aficamten and to enrollment a could on as be We ahead if hope in

extended projections. has Failure Phase short FOREST-HCM, nHCM in year due Recently, continue ACACIA-HCM appeared substantially, European symptomatic completing aficamten data current in in Enrollment the functional patients in NYHA burden, a with to the open-label and XX on XXXX. substantial quarter. progressed of drug patients Aficamten ACACIA-HCM, with and Enrollment NT-proBNP. during were no This clinical is we published trial events. our with and the activate the brisk We trial. pivotal patients improvements treatment in of nHCM. forward look with patients non-obstructive to experiencing There continuing sites report this patients in weeks enroll with clinical with the data adverse from have enrollment Heart generally patient through well aficamten we of treatment with of in symptom clinical the class first extension discontinuations tolerated XX to is consistent HCM, Journal goal through with remains to III

that results suggest available. treatment forward from FOREST-HCM ACACIA-HCM results be HCM. in of safe both to aficamten building and These longer-term patients more from on can data seeing hopefully look findings we with and, And effective with these course, with the when

enrollment oHCM, clinical Our we trial to a in evaluating opened pediatric the quarter. population fourth patients with of second ongoing aficamten which symptomatic of is CEDAR-HCM,

the may CEDAR-HCM HCM aficamten, of a next-in-class opportunity further segment utility as extend provides potential elaborate to additional of population broader the an further an profile.

Caucasian and in meaningful tolerability Phase a impact lives. have gather on to aficamten a in expanding of quarter, for evidence participants we will pharmacokinetics, aficamten able may differentiated Finally, Japanese I during again, patient be aficamten believe the we be Japan, healthy and of started approval and potential the required positive where evaluating to safety that study

I'd front update the like for to provide on Murray aficamten. to invite Chris regulatory an

Christine Murray

quarter. to I'm share the call on Fady. during past progress updates our pleased to Thanks, join regulatory today's

NDA monitoring FDA, planned strategies risk our participated of the mitigation As related Robert NDA to submission. which submission of and meeting Type during during ahead safety aficamten, we B in support with in mentioned, quarter, for we our the discussed

a and meeting gain risk FDA's reminder, to cover discuss meeting submission. matter. topics more on the meetings completed the provided aficamten the they how our opportunity on safety including inform to this a results where recent FDA of X third and pre-NDA were second February, may manage perspective a properties first and and related earlier of important in to meeting into review pharmaceutic to to approaches elaborate SEQUOIA-HCM specific This the As insight

in for has have this pleased we very ahead and of the of to the progress FDA with FDA are continued We series submission of made the gain meetings, aficamten. engagement with NDA

our risk specific understand following topic review we that propose a mitigation distinct approach meeting, we be with aficamten mitigation NDA. will to ultimately a with the FDA recent Type risk B While to plan

instead a reducing FOREST-HCM the the agency trial open-label outcome frequency months above during X Type every every monitoring was protocol echo their if X maintenance systolic treatment that important conditions extension echo undergo now phase. The amendment treatment recent LVEF months there's for of XX% amendment is required other to agreed an to the oHCM with meeting B and may of of during Another patients that function. the allows maintenance of absence ongoing impair monitoring our

amendment safety overall the protocol and thus far. based development observed program The on in was tolerability the profile

been aficamten could date. interruptions treatment monitoring As now attributed aficamten. in clinicians to have real-world approach we've are approach no reported, reflects to who echo potential FOREST-HCM The the in how to manage FOREST-HCM patients taking there observed risk-based for implemented

potentially Agency. to and communicated, the to NDA submission we for complete to basis, during enabling July track FDA the quarter, rolling that opportunity of sooner. that us provide modules rolling to to prepare initiated which on we're NDA our their the on today has third in MAA this rolling am completed review first begin this submit the our happy also share to FDA previously part the to we to of continuing I FDA As a submission work, the in submit agreed Alongside are the Medicines quarter. European will submission

to which and quarter, the in During in submit national with participated to the plan content quarter this of Xing, submit the we and and the with Chinese year, with later meetings the for plans pre-submission in partner, during an coordinating the we in have we confirmed recent agencies aligned the In participated year. Drug meetings fourth this of parallel, EMA Evaluation support an our Center China our MAA are we pre-submission NDA in to Ji submission. EU on

to ensure Altogether, across Cytokinetics geographies major globally. big steps forward aficamten is for submissions taking

turn will I to Now over Andrew.

Andrew Callos

of HSSA In we our at to aficamten, our strategy patient treatment Chris. finalized to distribution inclusive campaign next second overall plan quarter, for month development design Thanks, we market support launch patient continue the pharmacy which program. and and the specialty experience

our trial several potential on result product trial the hand, also opportunity. the the SEQUOIA-HCM -- With to from results the better propositioning studies in we impact and of market the advanced positioning, of on market understand research value

share informed seeing I'm mitigation preference which encouraged our risk by the ultimately approach. and results will distinct recent label by be research, I'm from

the payers our began our of our Recently, we the continued expect and exchange team During information U.S. to continue and account payers. quarter, engagement to through pre-approval of results review burden the management economic also we payer date. with SEQUOIA-HCM obstructive PDUFA with key these interactions HCM,

team, development field-based the a in I'll have spending which also that you value we treatment [ define of of our size, diagnosis full We the And leadership sales initiated completed of we HCM approach support gated At to in proposition our dossier XXXX will our structure team taking payer both build leveraging of value a the U.S. represents ] overall teams, alignment and hire percentage shelf only disciplined overall sales we regulatory Europe, plan potential small house a and onboard as currently commercial plans to are planned work to expect that close claims. but field finalize to our remind for of in proximity We approval the infrastructure. for the same nearly to time, infrastructure. reimbursement. we and aficamten. and

XXXX. expect launch progress our We're focused activities with Europe to we European up commercial countries as strategy first distribution, positioning, would which planning their Germany follow. key continued year in to to to country also readiness commercial eager in into activities and aficamten related launch We through this continue the ramp and our to in branding, on reimbursement

is great on base remind plan is a focused to cardiology across you, Unlike limited to succeed. approach, special of our we build subset cardiology a concentrated cardiology where believe potential franchise, to continue a compete distribution there return unmet model, future as investment. the patient and patient well to interactions and prescriber cardiologists, specialty the will We're potential are a To a be on our by that led over building all pointing to the With support high Stuart. way opportunity to to address on services that, turn I'll high-touch large aficamten. need, for towards call broader

Stuart Kupfer

Thanks, Andrew. results that of were agency concluded for approval, conduct they FDA, of our alone of from omecamtiv In GALACTIC-HF trial were I'll while sufficient start additional with an mecarbil. the with not mecarbil. interactions the omecamtiv supportive clinical the

of was of we on top As doubled the large outcomes ejection you in outcomes fraction. risk significant GALACTIC-HF, heart which omecamtiv than of failure patients, recall, observed cardiovascular with in magnitude trial more the in of mecarbil prespecified the reduction care, higher-risk standard lower X,XXX of subgroup patients with

in recent failure increased NT-proBNP Heart further patients hospitalizations, blood with failure benefit risk lower and more heart even pressure. treatment higher those and

subgroup confident severe we're Given of that treatment standard in as an benefit with the over lower patients of fraction care ejection of patients, mecarbil very therapy potential add-on omecamtiv was in heart the failure. X,XXX to with

monitoring more both The and approximately to heart confirmatory enable simplified smaller adherent criteria. patients planned trial quarter GALACTIC-HF, that in preparing III pragmatic to to trial entry design run and and period year. elements the more enroll in us failure Phase be including this begin patients with than efficient a severe fourth less will will clinical X,XXX requirements, HFrEf enrich stringent of this include for We're safety

we're binds CK-XXX than now as cardiac because to development mechanism this in clinical Shifting a that series inhibitor inhibitor myosin of it pursued aficamten. XXXX the of but still We does detail lead the I'll inhibitor, myofibril and optimization cardiac And be ATPase. that of different additional into CK-XXX. We it not with remind the bind we domain action. Meeting. myosin at mechanism Biophysical our produced to some a of CK-XXX chain partial aficamten, like further described the you motor of to regulatory had action mechanism advancing own light for its myosin to distinct HFpEF. myosin a instead consider the of CK-XXX

generally X%. healthy single second I to the was at from we the showing XXX XX tolerated from Phase and quarter, the pharmacokinetics milligrams. data At participants CK-XXX announced in line During highest with relationship top study, to well that safe doses linear and life. PK/PD milligrams, be shorter half CK-XXX XXX less than compared a the placebo even shallower The appears than it LV for decrease in single was has fraction of aficamten, mean dose ejection to

cardiac present in the the may these because quarter. modulation the it of this year solidify with we're top And HFpEF. a preparing quarter to CK-XXX in and of We our the of our line supportive in meeting data leadership full to this with profile cardiology IIa program, findings specialty are believe plan fourth patients We're and in pleased myosin further franchise. at Phase a medical advancing trial start clinical

on update I want to provide an CK-XXX. Finally,

of During and assess I study, negative participants. Phase analysis which the pharmacokinetics its observed the Phase data safety, signal completed met second study. I primary There safety to quarter, and of single in or of CK-XXX in no multiple objective were healthy from the we doses tolerability effects the

However, in data the advance we identify a CK-XXX opportunity after recent strategic light sarcomere to omecamtiv for review other our mecarbil, mecarbil. portfolio a which is I our a And review not and activator. by priorities, Phase to compelling of relative did of committee, also omecamtiv decision

pass we've with a development further As of to And result, discontinue to that, decided I'll it Sung. CK-XXX.

Sung Lee

in common report in after to the We The sheet. execution pleased of and of quarter Starting finished the end We're discounts of by and the million of in commissions. was our approximately investments million at compared quarter proceeds quarter of public second XXXX. a $XXX.X of stock the underwriting resulted offering quarter-over-quarter net deducting increase the first primarily driven that Stuart. the results. with $XXX.X second quarter XXXX cash, with XXXX balance to cash financial $X.X second billion equivalents of Thanks,

$XXX $XX agreement in The clinical loan mecarbil, entered common clinical a obstructive and investment III private that million Phase $XX HCM in $XX trial million amount of In May upon addition, trial upfront of in Phase Royalty $XXX omecamtiv launch commercial delivered aficamten funding of in to million of support CK-XXX stock for of strategic signing. IIa in Pharma into placement. is term million confirmatory comprised shares potential we million a the for financing with $XXX HFpEF, million a

of in a revenue The Royalty $XXX and to to by of that opt remaining trial of an upon million fund option have of investment $XXX million to increase in the Pharma million term a their we should satisfaction for trial certain to $XXX conditions Pharma in Royalty is in draw up III an of interest in up to the loan CK-XXX. the choose a Phase clinical change comprised CK-XXX

We with believe the net overall cost aficamten, expand program financing, launch competitive support our and advance proceeds positions an commercial package attractive comes development the market equity capital. from financing And the to combined its us well pipeline. of and of the with

to in the in by for activities wind-down was were COURAGE-ALS, for first personnel million driven period $XX.X toward in the the which quarter $XX.X expenses. $XX.X investments driven were the of XXXX G&A XXXX XXXX. income on million XXXX. expenses quarter decrease XXXX second of and to The The million $XX.X in Total $X.X statement. period in $X.X readiness XXXX. the compared by revenues and compared ended of increase Moving million same timing commercial period million was expenses second same quarter the second the primarily in for activities quarter for same R&D of the primarily compared the to clinical were trial to million in XXXX. of

or basic same $XXX.X XXXX to loss XXXX. of for share of was Net $X.XX the million a diluted $XXX.X $X.XX per period second per diluted basic loss and in for the and share million or quarter net compared

like financial our Now to to for turn updated guidance I'd XXXX.

$XXX $XXX to $XXX now $XXX $XXX be to the between which to comprised to operating We million million. in to operating to expense range expect be is depreciation, million expected of previous and million the Noncash $XXX compared operating $XXX million. between to to expenses GAAP million range million is compensation of previous stock-based of included compared GAAP million expense, $XXX

the previous range be expected to million hand initiations primarily which omecamtiv non-GAAP the of $XXX million. that, previous expected over cash increase to expenses, excludes to operating million of to to to CK-XXX of compensation trial $XXX Net driven back operating million between is million to $XXX Non-GAAP $XXX GAAP million the compared million compared and Robert. million. $XXX being be $XXX expenses it depreciation, to and and of range of stock-based to between is utilization is $XXX the Phase III IIa $XXX it Phase by mecarbil. I'll trial The in With the

Robert I. Blum

Thank you, Sung.

specialty we're allow capital in conduct also us a us an advancing position label focused we in to pipeline, aficamten also summarized, category potential carry development launch of through including CK-XXX aficamten, that potential to structure later-stage As of will while clinical and the mecarbil of and expanding continue with believe commercial segments. our one trials biology and global area omecamtiv financial adjacent Sung advantaged all to cardiology fortified

strategies our end, that cardiology specialty build To intentions advance and to our reaffirmed commercial recently we our franchise.

may However, also as we business we've recognize an building quarter, during X-K This shareholder opportunities it the fully responsibilities or involve ways shareholders, M&A. in take stated understand to fiduciary may our all of value. We consider the will obligation the and our to we issued second form today outlined we to our in maximize alternatives. potential consider

building pipeline by to and way becoming aficamten. is maximize a we ourselves our shareholder enduring by But value today in can leader value anchored the plan category

to development Ciechanover, our We venture pipeline served firms. potential Corporate to financial Chief Executive led Corporate business Celgene Business of as Development held partner at also leading Officer. who and a Vice Steering external our previously CEO Biotherapeutics, that as new at with Atara joins to us President, capital Isaac augment and positions strengths Isaac were the end, we leveraging welcome and quarter, To during our envision member Committee, opportunities. R&D pleased he

and build Isaac as combinations. as we're wealth expertise other company's well may expanding new to spin-out out potentially we mapping M&A, geographies, business both and for as include continue and Cytokinetics. be him external grateful into side new buy divestitures R&D brings a will for business catalyzing potential which responsible objectives, knowledge potential which presence with of companies Isaac activities the side, and and sell

pleased proud heard, accomplishments relating approved, for I'm progress made quarter. And a its mitigation profile, submission especially past our if NDA as commercialization. for to potential of we for distinct the this and the we're with you've aficamten FDA risk with

to discussions we nature to to of emphasize Before any however, present do FDA, further depend our do with intend the we our questions, updates with FDA move on review. FDA not to that confidential not on due further want matters, to that answers we knowing these I and to details about meetings and proprietary plan provide remaining questions will

Now I'd milestones. like upcoming our to recap

European For additional we present Congress to the expect of results this later from aficamten, at SEQUOIA-HCM Society Cardiology month.

We submit this to an and Ji to QX year. an support China planned second in to expect EMA MAA of QX the to to in NMPA NDA XXXX submission Xing in FDA the NDA in the the to the coordinate half XXXX,

We enrollment MAPLE-HCM third this in expect to complete in quarter XXXX.

We enrollment objective XXXX. complete in XXXX enrollment expect to in to continue with ACACIA-HCM throughout

participants year, this CEDAR-HCM year. year study continue the to we aficamten in strategies and our the continue expect this in advancing I Phase go-to-market for Caucasian through aficamten of enrollment expect and to Japanese continue We to

mecarbil, confirmatory to trial quarter XXXX. a expect III start For the in omecamtiv clinical fourth we Phase

the study fourth XXXX IIa in trial start For CK-XXX, and data a quarter Phase at the Phase from present expect in this meeting medical primary clinical we quarter to XXXX. third I to a

through the activities this biology-focused And to can development for year muscle preclinical and clinical fast continue development development and to activator with call open initiate programs we additional later the skeletal remainder and to with ongoing expect research troponin directed up please. now And we operator, that, questions, ongoing preclinical of year. the research, muscle a

Operator

Salim comes the of of [Operator Instructions] from question line And our Mizuho. first Syed

Salim Syed

to a question guess joining. on the Isaac I had with -- on Isaac matter that want welcome congrats just related I company. And to progress. the

I -- I Just seems that give no is to the it of something or how us like there framework know here? across. business. came in X-K to like thinking it possible press the important was But that's your just sort release

was we mecarbil? gated expecting around thoughts in business development should cards? the be potentially aficamten maybe of doing in if to activities and that's So the more updated business omecamtiv Or cadence primarily just development Europe, the around this

Robert I. Blum

Yes.

fall or respect the on aficamten way development either activities doesn't in North business certainly, foresee Japan really those is our Europe America. believe on going to do to more to that of Isaac this the corporate development. and development take So track. would in what business are matters as Board change under in to about And aficamten, opposed And I The ongoing with where thinking bringing to I Isaac I already less speaks we're well lead.

As geographies commercial an ongoing increase we as want footprint our to in what we think and about might enterprise. R&D

imagine and with currently monetize And even more in potential opportunities so pioneer we potential combine how others. meaning as to position things that new about both leader a activities, to the and augment and both buy sell-side we're in we the to this side possibility think and doing muscle a think biology, following: space, we're a good

discussed we aggregator think asked companies? how think many about How we've do we technologies? have an investors and about do spinning As the out being past, in potentially of

expect I large. anything meaningfully wouldn't

And I to strategy year can this how believe hope be and that a working in For meaningfully think architect ongoing question. in the I a leadership. answers we're colleagues spending way, so but how for will Isaac do our about factors to large I R&D think this don't into less and we in more ties be I it implemented on thinking follow. space with that how leadership maintain ultimately instance, that your great capitalize that years

Salim Syed

did. it Yes,

Operator

Tewari from of Our next Jefferies. Akash line the question comes of

Akash Tewari

can't patients LVEF And for ultimately I FOREST. with that on which this all is amendment one into the echo this talk with about strongly the realize should a about read XX. an FOREST, now protocol we Robert, meeting allows FDA, predict be? you from your more. a pending follow-up Shouldn't but how sneak should require much in more X-month And data FDA a won't maybe, what I REMS at if there REMS of possibility

let's you specifically it spin-off about that say, pending say, ahead talk preferable talked company be about has portfolio? let's an to a Can of, HFpEF off. might you might I'm spin-off certain asset a thinking CK-XXX in overlap that some You and spinning is why there if, assets. why M&A, assets about

Robert I. Blum

I interpret my comments is our suggest own could way monetized clinical that cardiology we're But to expanding otherwise, we there's maximize value, franchise through as as spinning from be specialty that in value whether on you that's earlier benefit could as about wouldn't in or a specialty do of we're that thinking lot doing the asked, I what potential in other we programs ultimately shareholder other funding believe we're ways. preclinically. M&A. our do Yes. think any and as cardiology off And ways later-stage beyond

any needed it the patients frequent in in to FOREST lot position really FDA to FDA, recommendation the we time FOREST data I'm we're As to to a and that are not represents basis standpoint we real-world that and for a however, changes I'll by contributing having of a more from clinical our frequency on underscore, to much the question But how do, of a do elaborate evaluation -- relates believe a your meeting. aficamten, on FDA monitoring been echoes managed, again, for pertaining way like pleased in meaningful long amenable which to change data, occur. echo that monitoring we isn't these accumulated a having quite seemed foresees

do a don't between choose and as to you're may what So that profile. respect that's think change this That's make that unwilling far connecting potential of correlation with do go add Fady, as so a asking I that dots to matter? to to call. on is I'm FDA you direct But ultimately, encouraging. I'll there perhaps that more on the anything might to want risk mitigation

Fady Malik

and we've amendment the date. think for that consequent I reflective protocol of acceptance FDA's mean FOREST months echo every generated of data the to the of our X I

expect would be those I to So in review NDA. their data of also important our

Operator

Our [Operator Instructions] next of Hung from question Jeffrey line Morgan Stanley. comes of the

Unknown Analyst

This for Hung. Jeff on is Mike

more beta of at benefits remains generally, in more And this Looking prior but and coming lot likely on aware point, at are of HCM CMIs gradual. thinking the these patients blocker. just the still of uptake physicians are a

physician like what's And MAPLE? that and broad, CMIs you thinking like about to how So [indiscernible] uptake? that, frontline about that's that rapid results do the think is from needed

Robert I. Blum

to ask please. I'll respond to Fady that,

Fady Malik

good a question. that's Well,

evidence against executed not think we as to only looking straight function first-line just improvement affect regards MAPLE also improvement And it at does the reason but up beta differences the symptom hope with wall to thickness. to aficamten blockers, the and and for as designed the was how primarily use demonstrate I remodels, how of we in therapy. provide heart in

Some chronic seen characterized no beta things those inhibitors, myosin of really whether of blockers. cardiac the occur ever one's things dosing we've with with

improvement symptomatic not we in also hope some data disease of think but would and functional the a And modification. show we aggregate evidence will suggest only

I think, a eventually all should care contribute a So standard things, of blocker CMI. beta first to those changing the of from

Operator

of the with Roanna from Leerink. Ruiz Our comes question next line

Roanna Clarissa Ruiz

And they're there a to on tagging elaborate maybe leverage impact that you data bit reviewing if results It as provide to initial more. well? is that possible could or while any you happen filing? sounded the could about to could So the the aficamten's MAPLE's FDA like curious with discussion I mentioned was there labeling MAPLE, aficamten's some you that of help

Fady Malik

I'll take Roanna. that,

section that application available But that think them in be our in would in of approval. the and publication of the another been data mechanism of underway. physicians of my a we not data because we commercial think around did the I say and time the action. data potential point our so aficamten, reference was this application that necessarily of provide prior we've benefits colleagues to to are include already And the I hope of just would will for I the what and exciting aficamten's available they would show approval be

Roanna Clarissa Ruiz

physicians be Got reference as to would well, And able this right? it.

Fady Malik

will, they will. expect it I certainly if it published, as gets Well,

Operator

of comes line from Sachs. Goldman the question of Paul Choi next Our

Kyuwon Choi

Can me? you hear

Robert I. Blum

Yes.

Kyuwon Choi

ask your Robert in I thoughts of to or how recently to Fady, potential modality XXX and mecarbil there on HFrEf be and a just and thoughts your as road just planning failure planning just HFpEF your for target data next trials that and for the omecamtiv context of view positive and treatment might want the down GLP-X for of both here? and developments the on and sort heart algorithm stages

Robert I. Blum

that for question. Thanks Yes.

doing in patients from not complementary sitting and I believe be benefit think may other also we're therapies. therapies, in we light that important is opportunity who a provide rooted myosin same would to as those alongside in of work that the mechanistic for very what that it's can way modulation other an of one be but

turn I'll that, elaborate. For to Fady to

Fady Malik

obesity. patients of see of they treat really HFpEF many agonist. and not rather think to background in segment focused Obviously, you're to and patients and obese like whom a are that I not begin of the There therapies, Well, HFrEf GLP them. -- that to the HFpEF the a for expected HCM are uptake certain on population, have is GIP lots population that significant responsive they're

not So a just I that the moving of patient so think mostly refining there's a population sort target. it's

have do require on other -- You'd background we with entering background rather therapy, we their them therapy as before be to trial. stable just not the

that reached continue the probably be entertaining they trial, to or some until GLP-X be And beginning similarly, to patient and our to criteria. meet in still wasn't a eligibility wouldn't at had enrolled continue a eligible weight least stable

standard of certainly sort there's with will employ. that deal ways So think that, I to

Robert I. Blum

to while add high these and sometimes to innovations And HFrEf just these mortality remains where analysts how and some of one comment. opportunities see how patients therapies. residual and those we can't do many we exist standard alongside it's morbidity investors, care, modulation especially is still the HFPEF, think I of and lost and in believe unacceptably pleased are tolerate myosin of Maybe this in patients for on

patients also they forward we're not looking may to and and where omecamtiv So benefit places these modalities mechanisms. CK-XXX from and in evaluating other in

Operator

Truth Securities. of the line question Devarakonda, next from Our Kripa comes

Srikripa Devarakonda

may or a your on efficacy. survey KOLs, not wondering of market share That from patients seem wondering survey eligible about population indicate of the potential possibility? I aficamten is in case, for they're not switch the see based satisfied is was was XX%. this to concerned slides patient or you preference just CMI to mavacamten with but especially as safety be to base whether aficamten about about Your your

Robert I. Blum

strategy. compelling that? work for other analysts speak but elaborate. you out, do Andrew, that's it done to and have you to which Yes, core want as can not potential in But that pointed to as as relates now find And our maybe, you to regard Andrew switches, that we

Andrew Callos

certainly. Yes,

and guess of of available we when aficamten. majority the the of I approved, market One treatment things. the vast couple will educating and XX% be is a new not on Second, aficamten, patients, focus expect to over to physicians aficamten differentiation CMI be So on a if on patients, of we probably it were

probably research market. will the expand us that Our tells it

will and patients -- on will patients not for for We're other a CMI We're mavacamten product share. be switches. go more and want in they the that physician physicians make work stable dialogue are talk not more and to then it to that more the If a to to expand or So them, and about if switches. patient switch. going up going any patients

Operator

comes the Piper question of next from Yasmeen Our of Sandler. line Rahimi

Yasmeen Rahimi

mecarbil, omecamtiv on color For steps rate you gating or a limiting to study? could the little what additional steps provide kick the are bit left off

Robert I. Blum

ask ready in study, I'll Sure. him are been have Fady get many. to to working and start and some not And this to team those diligently speak detail. to the there very

Fady Malik

regulatory elaborate. and had generally interactions. protocol. agreed as essentially, We've trial, start the Stuart to we've But indicated I'll we've before, on the ask

trial. it's putting operational matter aspects the of up the So of a

plasma assay If again. up also you'll that concentration we a use remember, stand we also have to

this if operational. anything ask it's got at he's to add I'll So And mostly Stuart point, to that.

Stuart Kupfer

learned course, we position where a from of that a to add really in we've to were Just GALACTIC-HF. lot,

also that new We a higher population, study even optimizes more efficient trial. design a appropriate study on to that's essentially helps and trial the us the focusing run further have this more population, informs this even a target risk huge needs and for database

So the think position a good we're quarter. to in I in start fourth

Operator

of comes Our Charles Duncan line next the from question of Cantor.

Charles Duncan

agency. it it's meeting MAPLE soon. a quick absolutely that from progress going and looks with to good done question Congrats the be approval. Yes, Fady suggest enrollment. though like be on on had to that anticipate I recent the Comments post

NDA? be I upon it line guess to the anticipate I'm that rapid approval? could little on wondering initial a what review could Are if so or you requested of results And possible be the Or assuming bit review to color and a included you you for time is afi? provide MAPLE the

Robert I. Blum

what expect MAPLE I Fady think have timing, anticipate results But you to you of misheard aficamten. and to add? his to prior about might is want we Fady, might anything was there when that said in approval we else come point

Fady Malik

Yes.

the first in my remarks in said XXXX. it prepared I think half that of I expect we would

it first still that potential might ahead get You standard guess a review, But half or review land. have the we can kind whether in do the may of and math to where approval. when of we priority lies

expect necessarily the public not contribute so to I but would in be And those data domain, filing. the to

would there update the data, add, should and review I during NDA. safety a safety contribute be extent Now to an will of MAPLE blinded include will which but that's our the data

Operator

Mayank next B. Mamtani Our from question comes of the Securities. line Riley with

Unknown Analyst

should we your different? vastly expect actually etiology, William no an that. across on expect Mayank. to sarcomere patient? hear a is When how the obstructive Just non-CMI say, on for HCM or treatment modulator, This love thoughts same is hypercontractility these effects should -- to main be Or thinking if we about, the cardiac to

Fady Malik

really I whether Well, I think know non-CMI, one don't exists. a

speculate all how might being active think evaluated really on reduce reduce drugs the -- address in myosin of number the the function of HCM. hypercontractility myosin's how the can't they it current that the clinical cross-bridges sarcomere. I and to bind We in modulate and trials So might in in they contractility ways subsequently

the response other have may way they So differences in differences. relationship their exposure in or

HCM, the an HFpEF really opposed to -- But certainly, fraction gradient to maybe clear that that's mimic they not it. population a ejection And issue a and that in of a that that that inhibitors in obstructive effectiveness. some context believe failure. population. it's And Obviously, show SGLTX is will preserved heart explored other SGLTX -- mean HFpEF exist. more to nHCM as is promise or to in being I I them HCM. think I effective certainly to different clinical something on mechanism but the can't how leads we've be to doesn't seen for the is there me have speculate I profiles, in potential is maybe SGLTX closer in there guess the inhibitors approximation HCM, reducing really

Operator

question next Butler the of Our comes of line JMP. Citizens from Jason

Jason Butler

study. one another omecamtiv Just on the

is comparison about time you've data about in think potential generated, think positive should targeted enrollment lines? to already of lines? there we the enrollment population prior when Just any time here the the and how And we patient terms study

Robert I. Blum

Yes.

the and in I'll but this, need unmet being Stuart the ask a Fady by being the is speak drugs of to subset trials. other about rate talking especially So we're for to currently high but studied which clinical for which is event not and addressed market,

be So for that they meet be they investigators lots us we foresee have that already by of a this that criteria the outlining. we're patients are embraced which will telling that would study

that publication, were economic advanced Felker you important. you the failure I'll and remind heart be for which see morbidity, could there, And can patients GALACTIC Mike high the in subject author. the of high value the And especially was a there lead mortality

So that Fady and population want study? talk about Stuart, enrolling do you to a in

Fady Malik

ahead? Stuart, why don't you go

Stuart Kupfer

Robert. Thanks,

higher the under are unmet that treatment patients a those larger high-risk of observed targeting magnitude population a also benefit. we subgroup it's And out, pointed of Robert had As and GALACTIC-HF need. patients in we

trial. target GALACTIC-HF. already population smaller that we the X/X rate that's is size And the the the course, mentioned expect. event can of will run advantage, again We've of higher because that we the of about be So that a

lean more run hopefully And faster smaller, so trial. a we can

X I if a was analog. contemporary think as that's consider study little a of closure. years from And just trial you patient -- in and ran over a VICTORIA That trials, good such first trial to sort

I thinking that's we're kind proceed. of will so And the way how the study think about

Operator

Raymond James. And question of from of Sean McCutcheon next line our comes the

Sean McCutcheon

maybe and informed your XX-week Can the necessity your to higher you data an powering what's of about the -- impact context as assumptions how cohort the potentially will it's specifically speak the competitor, optimization, your of over Maybe doses, patients importance FOREST? you the speak advantage those and in Thinking interpretation results? getting to this prior in of ACACIA? dosing of KCCQ KCCQ how how has have for the to non-obstructive

Robert I. Blum

Right.

of incremental in that So was higher think plasma back targeting to underscored prepared a principle and associated the which we that level drug the by efficacy. be what incrementally to you concentration stepwise his and [indiscernible] Fady start dose lowest with firstly, manuscript following progression referring can SEQUOIA I'll and spoke remarks effective

on reason, in discontinuations seeing titrations are not to magnitude that get EF Only any lower dose gradient. especially pleased when for we which for you see titration on dose And doses. nor but on relating dose with doses, the seeing excursion dose-down down low -- larger to an effects occasional we're EF, that accompanied higher an we're associated to that's by

think SEQUOIA answered the that's that therapeutic So that underlying very we hypothesis question well.

speak As nHCM, and it relates maybe that, to to to Stuart translation to please. Fady ask I'll

Fady Malik

think And in hypercontractility I population. nHCM, hypothesis a state. nHCM so it's variable Well, of is the really quite improving the very on a the

need will need patients Some less. some will more, patients

concern or treatment order have So drug range, patients, in doses having a drug forth of so and you useful. not is potential stop to the off the also potentially back will, be use maximize a that it, very can can if of overdoing but easily to full titrated having quite in and we effect

as the as And in and from published the been that open-label FOREST that's we both REDWOOD. that I extension to data data referred the well published saw

a pretty on symptoms, remarkable biomarkers. KCCQ effect and So

into account size we REDWOOD ACACIA, we what we that thought Phase observed designing the X the be took study, would So in effect Cohort REDWOOD. of in -- II

range the because you study out, came that in that was will, Cohort placebo-controlled. if in helped that expected not that us, the SEQUOIA fact X solidify When placebo effect the REDWOOD in the was we

think powered took we it account, XXX And we into and with that so adequately all patients. about we

So now. for maybe I'll stop there

Operator

John line of Gionco our Co.. question the from & Needham next And of comes

Unknown Analyst

for guys We the the any for on you John on or may time from updated opportunity? trajectory And able how today. HCM you just regarding had improve whether mavacamten launch market to learnings be to the serge thoughts when their touch you wanted is This comes launch guys?

Robert I. Blum

Thank the question. you for

one they're mavacamten we an QX that a should is centers. a should We launch expect certain that demonstrating So from lingering drug of that questions lot firstly, think impressive meeting it's the exactly certain to the numbers. growth. in And we think patients a what that addressed quarter-to-quarter emphasize for the relating think of that the a sales we QX needs of

profile benefit aficamten be highlighted, from And will as a market. cardiac of prescribing. we should be the perhaps that benefit we more of more expanding myosin be who XX% for receiving believe of to XX% the hopefully inhibition and believe, that of to physicians come to that expected be we the aren't inhibitor, there's still, and With will cardiac do category next-in-class myosin patients receiving when Andrew over hopefully number said, over patients eligible still

profile hearing Andrew marketplace in need. hopefully market Perhaps to for I ask on what the on may he's our next-in-class deliver and how aficamten could comment

Andrew Callos

experts, launch we outside patients think be making a making and started excellence trajectory, engage point when view I I sure to it's HCM as of and broader So we sure and can support patient going of to of about affordability. utilization cardiologists, clearly, get support centers from think well service educate that as

on make all focused we're really those trajectory we're to sure So elements that what our launch is expecting.

to hearing we're certainly expand market, think arena. to it's and and community. from going second certainly the We CMI a what in engage the of utilization option in CMIs alternative continue welcome terms In we the of

Operator

line And Oppenheimer. Rohan of our from with the comes question next

Unknown Analyst

Leland This for Rohan is Gershell. on

might the that are learnings efficacy studies great any population? of HFpEF evaluated Just design it's XXX the Phase findings be on inform given II a CK-XXX, in aficamten and how might that to trial with for from disease respect there safety

Robert I. Blum

relates to question clear, I'm HFpEF informs... in Just as your so nHCM

Unknown Executive

XXX.

Robert I. Blum

is that HFpEF, in XXX right?

Unknown Analyst

Yes.

Robert I. Blum

or you to do take you Fady, Stuart, Okay. want that?

Fady Malik

want you and to ahead do go Stuart, Yes. answer?

Stuart Kupfer

on We've what is from we some that the function. of patients But lot. but with that aficamten a HCM. improve is only think terms a obstructive in learned more calibrating focus of not main the non-obstructive and HCM, HFpEF is answer lot in essentially diastolic the program, function cardiac would in HCM The diastolic clearly, we're non-obstructive relevant course, population short decrease contractility here the Well, targeting. that improving

in now let's in of sense, benefit we magnitude and ejection some confer potential would the fraction say, that the might the very a the non-obstructive we safety the with is function functional and that improvement. what decrease of that, symptomatic profile improved of, of is favorable diastolic evidence understanding what efficacy. of of observed some course, course, how corresponds along population with have have into goes And And in that translate, terms

certainly targeting into design optimizing the -- could the that we'll translate study populations, designing most. those So and we think observations benefit

Operator

no to and like I to for this further showing remarks. Blum, turn Robert would questions CEO, back at the And now conference President time. I'm closing

Robert I. Blum

to operator, today, you, on especially the earnings on light advancement thanks talking us with away to track things about an initiated important meetings as considered coming FDA this and everybody the it we're matters in pertains we've we're we've we've risk for joining that that especially in call QX review. of the of complete NDA given be we and had light that the mitigation inform call quarter Thank of from other and believe the been rolling of submission this will pleased some aficamten, to the of especially strategy that and

European to also it conclude go-to-market in to point to it Operator, this are Society aficamten at we can We're after advance strategies efficient With and a month also way shareholders of of those. the we'll good look the also we and structure updating putting relates capital Cardiology that, and the to presentations we later use company both as forward later-stage for fortified capital forward we with especially pipeline. omecamtiv speaking we and CK-XXX, please. that pleased look to relates to as and call, as the now you that our it

Operator

you call. participating. This concludes for today's Thank conference

disconnect. now may You

Cytokinetics (CYTK) 8 Aug 242024 Q2 Earnings call transcript