Mirati Therapeutics (MRTX) 8 Nov 222022 Q3 Earnings call transcript

Good afternoon, and welcome to the Mirati Therapeutics Third Quarter 2022 Earnings Call. My name is Jenny, and I will be the operator for today's call. All lines have been placed on mute to prevent any background noise. After the conclusion of the speakers prepared remarks, there will be a question-and-answer session. [Operator Instructions]

to Mirati. Asay, pleasure Corporate President my at Affairs is introduce Vice Ryan of It may the you Ryan, begin call.

Thank you, this afternoon's Jenny, and welcome everyone to call.

Chief Officer, of Stelzer, Officer. Research the David Development; and Dr. Baum, on Laurie today our and our President Executive Chief Chief Christensen, our Officer Scientific our Head me Financial Chuck Hickey, Officer; our and Joining Founder Chief Jamie Dr. Ben call Meek, are Commercial

Sandler. are Medical Alan We joined Officer recently by Chief appointed also our Dr.

I’d inform statements be are to certain future uncertainties we begin, materially may that we will Before actual and call make like differ statements. and from forward-looking. statements you subject many events during deal risks those this results forward-looking to in such Because with the

these review that XX-Q Exchange Securities discussion uncertainties, XX-K, Commission. and Form on full US our report filed our a quarterly on please and and with the For of reports annual are Form risks

XX, afternoon, we recent our financial the This results at corporate section for This ended released release available mirati.com. Investors on XXXX website updates. of the and press is September quarter

turn David you. With I'll that, over call the to

Ryan. you And us joining the today. Thanks for call on thank

as The our productive another quarter for team one advancing third important made progress strategic Mirati was initiatives. the

the As several catalyst over could months. a the result, what earned realising break next we of be transformative

be to in have to agency opportunity that for U.S. the our application with First, the with we a our very and adagrasib. non-small could constructive. PDUFA thorough interactions the for we adagrasib people made living prospect soon compelling lung XX excited by We is approval continues are and December cell believe, cancer receive

adagrasib quarter. is expect adagrasib approach setting. XXX non-small updates first milligrams daily which cell in share our direction combination full will dosing on more with line our twice Second and data this include most multi of and pembrolizumab, approach concurrent to the the prong line dose cancer at across lung we development This first advanced

of readout SAPPHIRE the end interim year. topline by the to the track on of study X Sitravatinib are we Third, Phase

and Fourth, we will file made program significant an IND progress advancing say inhibitor this in the his Jamie MRTXXXXX later more about XXXX KRAS plan to GXXD commentary. our quarter.

With commercial launch over call to on and that, readiness the to provide an organization. our update I’ll turn Ben

afternoon David you to now pleased good and we everyone. report I’m Thank launch-ready. that are

a assembled a commercialization can facing XXX% few have are We great customer successfully confident field why U.S. highly an our and – goals. organization explain commercialization we to I’ll effective trained. which commercial we force deliver are have take minutes that our fully teams on

and commercialization supporting experience our in affairs and team a and integrated medical by sales cancer has extensive multiple First, fully U.S. team lung platform. market supported digital specific launches includes of unique a access,

focus, Second, that with team unrelenting serve. our adagrasib people to has and we commercialization delivering and cancer HCPs living a oncologists, the singular

all payer team feedback a unique from positive adagrasib. Third, nearly with has profile the perspective, interacted a on top the of plans across our receiving of country,

generate We the expect launch. coverage to broad first of few months within

over increasing KRAS particularly teams XX% the market community of such continue work of both as opportunities where identification pivotal testing on patients enrolled. our Fourth, setting, GXXC-eligible development was in study our and to

distribution best-in-class. and in oncologists, also this patient have a program and program we We with designed believe is partnership community assistance

it treatment compelling in will drive coming These position strength ASCO, adagrasib and a a as to of rate from treatment to the their also of due We decisions. rates. low XX% including months activity, adagrasib's are we survival market and believe pooled Importantly, discontinuation analysis attributes a to median we profile. to XX.X presented response strong adagrasib's key overall at in prescribers include related clinical the utilize attributes demonstrated of

of estimated activity demonstrated active ASCO is patients. including approximately to central and untreated metastases, has those adagrasib at in XX% that with significant CNS presented with metastasis, which GXXC we patients nervous KRAS occur data the in Additionally, system

are also which mind people compelling physicians. is believe in clinical the non-lung types, We of in with multiple we seeing important tumor data

these important, the opportunities leadership term, with and second-line GXX we combined the organization beyond believe space In differentiating an within summary, future characteristics, long position that KRAS the including well us over experienced focused initial setting. for market commercialization

I'll you. David, to turn it back

Thanks, Ben.

Before pipeline, an to I'd update we announced the few discuss like a on leadership to provide our take moments today. we transition

forefront retire owes and debt and a him Chuck founded people Baum a and the gratitude to of has his Chuck nearly then to has a and more to impacted of biopharmaceutical pipeline And at adagrasib to is positively Chuck, life's generous as a for dedication living have industry position today without not vision. the thank for partner than pioneer. for We He has been would oncology. cancer. made at XX colleague work with Mirati Mirati X years years. We after the us Chuck's XX in innovative Dr. has leadership, target very be to broad CEO established and the a decision great next which service of years who all. led organization year approval and his Mirati. receive

important who development of Directors. that operate support President continue and quarter and Sandler, the will This R&D Head Chief a of quarter oversee second to our of continue he will leadership Alan from and transition quarter strategic we Officer. as Chuck Medical benefit the will to smooth to XXXX pleased member to will provide Chuck as has organization transition I'm as to several a joined Mirati of fourth in Chuck's Board the on-going Dr. guidance is of the milestones XXXX. into enable second the of

at with to Sandler development of Oncology Dr. including Lab Head opportunities oncology for pipeline explore drug including Global development bring the additional is XX Alan Zai Product our first-line to the made combination strategy. years Development and adagrasib, in and late-stage Genentech. at to qualified have oncology delighted the progress as experience, of and our we company extremely very We're continue

leader paired investigator oncologist, medical leader key with his as knowledge that employees clinical a leadership experience I complex Alan an programs, record has Alan's academic benefit shareholders. depth him his track industry patients, XX opinion successor and proven ideal career, R&D approximately including a managing to practicing and a fully and extensive of and an expect medical academic makes his Chuck. and knowledge, our experience as years during will

to his I'll to call initial thoughts. the over share Alan turn

you, targeted such David, thrilled and is I talented people same need. afternoon, everyone. on share and to good passion. Thank work and to an lives pivotal an clinical commitment relationship professional I'm by a I the a long, which exceptionally want the number relentless the personal deep start I a it's and could over have with Chuck to to in of and with alongside oncology, him that rapidly appreciate in joining Mirati. events, leadership catalysts improving prove to science significant and focus to months privilege absolute ascending that I through company Mirati saying in a we at be support Mirati a as time. It for such next Mirati. at several work be be honor encouragement I joined important navigate will with team his as

believe with my Metal drug believe my towards assume on impact to applying experience, the significant decades show make compelling promise. our Looking experience cancer. robust to familiar best-in-class ahead, of to Chief I'm advancing intimately From look people great I'm role Officer living I forward which of prior and clinical a pipeline with I potential with is programs, a it of Mirati. excited adagrasib the of

the update to clinical turn I'll our on you activities. Chuck, over call for an

Thank you, Alan.

by sincere last over Mirati Let XX to begin have my the who all expressing me with years. colleagues worked my gratitude dedicated me at

of from like future strategic forward Alan my be of to to member several transition. of and but perfect cancer to Mirati bring opportunity and and company's to for the a With success. optimistic second daily potentially quarters lead part organization's responsibilities about leadership support, the I'm The be helm, career. our influence future. just a to celebrate board the proud few will with will Directors the XXXX, Board people it's treatment the options as during on the on been would the at quarter my and work for highlight accomplishments a of my operational I needed I a complete I of our of best-in-class David extremely continue time finish, moving has

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adagrasib. gears begin With that, discussing switch and I'll with

and later in previously of GXXC with colorectal CRC where ESMO, from positive cancer KRYSTAL-X, adagrasib in evaluating as monotherapy metastatic with lines people begin treated results we Let's the a in cetuximab shared KRAS third or mutated or therapy. with combination

investigators KOLs, oncologists from data been have our overwhelmingly Feedback and CRC positive. on

we differentiated combination cetuximab in progression-free XX% primary of moving CRC forward. showed a will a profile response particularly expected, combination and and As The approach efficacy compelling survival rate with the be months. our and median of demonstrated X.X

expect the utilizing are the about results accelerated discussions pathway care our in current suggest FDA confidence data compared The adagrasib. we for improvement the and differentiation these that of and of And of this approval late-line part Notably, combination for viability soon. the substantial standard story finalize with potential with potential strengthened the of CRC. to

We cohort this patients late-line a plus be CRC NDA of KRYSTAL-X are II enrolling in seeking expect indication. approval the which supplementary cetuximab for to of of adagrasib in the filings Phase our actively we additional combination study, part

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CRC important data, is types, differentiating characteristic As for we the potential adagrasib believe from program. people an these we living see treat multiple this tumor to and our with has

Moving to lung cancer.

upcoming important catalysts. several have We

we and the date. as FDA We XX on-going have an active December with PDUFA our approach dialogue

our David with the constructive. agency As mentioned, be to interactions continue

to U.S., European Beyond we are advance marketing of authorization continuing their application. adagrasib's the review with the Agency Medicines discussions on

towards to the We expand goal of the Union. progress our to patients adagrasib to in availability European make continue

to updates approach. development share we cell non-small key cancer, expect across first-line multipronged our In lung

As a milligrams for full of setting. with in adagrasib the first-line confidence and the XXX the cell combination in adagrasib The twice pembrolizumab. us at our forward path dosing combination in initial reminder, we give first-line lung most shared cancer non-small dose concurrent is ASCO the at initial approach daily advanced data

this to with immuno-oncology conference mature ESMO study targeting we Phase evaluating December a is Our KRYSTAL-X data of combination larger in number are more well, and II patients. enrolling share

to number have tolerability expect cell we scientific enough follow-up data, and combination. of safety sufficient the With to understanding have our first-line plans on help patients feedback the a from the along the setting. These these data, better from FDA inform non-small a will of and cancer advisers with lung registrational in of

on strategy, update IO. We at and are will our finalizing we an next steps provide our first-line ESMO

I'll well worldwide. now study previously non-small discuss KRAS III with patients treated which cancer a in confirmatory Phase randomized KRYSTAL-XX, enrolling GXXC lung mutation, our cell is

Cohort adagrasib's therapy. population would, II consistent study, checkpoint same expect This a chemotherapy KRYSTAL-XX A, pre-treated having and patient KRYSTAL-XX received inhibitor our reminder, a of in Cohort be our heavily therefore, As performance XX% Phase to evaluated with the both with results. in patient we was registrational prior in patients is A population being conducted and

profile active, introduction Additionally, cancer, expectation the have believe shared objective with formulation, clinical tablet nervous adagrasib clinical tolerability. possible will see a overall and data GXXC people the of best-in-class date the on which the KRYSTAL-XX, and to response in rates, the untreated served poorly is improved metastases, to in penetration Based patient a with we've our may for inhibitor activity demonstrate large we differentiated we is population. and with it's CNS. CNS lung strongly that of central or Adagrasib survival first system, substantial

lung quarter. a We chemotherapy. a third-line benefit treatment and or interim outcome. sufficiently studied study in enrolled clinical SAPPHIRE with checkpoint a Phase following was called demonstrate Sitravatinib, non-small track study this results being powered to top SAPPHIRE. line survival study this positive who cell study well shift This prior is derived for designed cancer inhibitor to patients The is believe on with Let's the III non-squamous overall to second and registrational which

approximately this basis of disclose year. form top We the to approval lung XXXX. and patients a to the in being release Depending the has end the intend interim in at the the markets by medical third-line share a people the with regulatory with the U.S. and line number the filings the Sitravatinib positive, for in in results of be of a could the Europe or cancer treat large we by potential in outcome, both If data analysis non-squamous cell with on full middle meeting expect second of submitted XXXX. Europe. non-small U.S. press to XX,XXX

call that, to With update earlier-stage for development the over on I'll turn an pipeline. our Jamie

Chuck. Thanks,

begin a inhibitor targets potent the me which GXXD both KRAS that is briefly on MRTXXXXX, states Let KRAS selective inactive active by touching protein. and of the and

in have In the GXXD human exposure. We've historically cycles, with maintaining the concentrations confidence progress research, response the we duration to strategies and In our maximal emphasized formulation full enhance administration. of been we've of oral coverage significantly target of a drug in sufficient past, designed the the our human challenge. highlighted dose increase oral clinical target ability KRAS drug inhibition the to development importance absorption for achieve systemic which trials emphasizing increased made and observations, administration and maximum durable these has to

a the we the submit and We excited expect and that the remain XXXX compound potential As large with in to this population transformational for result, this cancers. which XXXX, the of mutated could we're have very oral end year. by formulation prioritizing of about patient underserved GXXD a IND

cancer As than approximately the times is mutated population. a larger reminder, GXXC population KRAS patient the GXXD patient X

are pancreatic colorectal people In addition, and cancer highly GXXD mutations in prevalent with cancer.

to tumors patients solid exposure based drug an We're harbor which XXXX on deletion. clinical therapeutically systemic on-going MTAP of experience, tumors. cooperative by represents achieve MRTXXXXX, early preclinically concentrations cancer up in an gene whose This clinical moving is with MTA encouraged deletion trial gene targets. expectations meaningful pharmacokinetics to our patients PRMTX Now on the to consistent XX% that I/II Phase our our and enrolling inhibitor. shows with are defined

our designation report the were to XXXX and strength to granted reflects that for medical potential We're Fast we preclinical XXXX which pleased needs. the the also of quarter, Track in for third unmet address data

data in clinical ahead, Looking clinical concept. initial and XXXX for share generated we a to data this sufficient selected demonstrate we've expect proof to dose of program after

inhibitor addition, MRTXXXXX, SOSX we've Phase was strategies is application investigational of initiated drug to We pursuing our and for by XXXX trial. to another enhance our new recently a value activity range In I believe that has accepted FDA, clinical the potential the to of of KRAS-targeting be the used and broad in adagrasib the combination by and a indications. strategy example maximize adagrasib of

including the as potential mutations, SOSX of non-small of We non-GXXC cancer also value malignancies recognize inhibition independent family mutations. as lung KRAS other RAS well cell EGFR-mutated harboring

recently be our two strategy. Also, of important clinical continue to have which adagrasib we part collaborations, an announced

mTOR Preclinical advanced KRAS and tumors nab-sirolimus mutated collaboration First, Bioscience of supporting cancer combination Aadi we entered with of inhibitors mutation. the with into to with lung adagrasib clinical evaluate other the GXXC combination in people evidence and a solid KRAS cancers. and shown non-small compelling models a cell KRAS have harboring

the inhibition and may result combination achieving anticipate compared signaling We this resistance agent. directed in that will a selected durable outcomes single bypass more also pathway is KRAS-dependent pathways improved either KRAS-dependent in addressing to tumors. of and and deeper patient The that

pursuing with PD-LX adagrasib we entered one, the therapies molecule in Mirati's difficult-to-treat with supply people clinical a small their small adagrasib collaborations focus to to with Secondly, of clinical into demonstrate benefit Both on agreement evaluate inhibitor. Incyte combination combination living oral cancers.

will additional We future. illustrates Mirati's with and IND our updates significant forward to discovery making the the in near we're in efficiency the we're the third productivity of the portfolio. internal look last providing This Overall, XX engine. pleased months. across progress MRTXXXXX be

to off With that, will Laurie. it I hand

Jamie. Thank you,

begin we products that me in management by and from continue in utilize innovation financial ensure long-term drive a disciplined a to manner sustainable perspective, launched to capital invest Let pipeline, we our our saying to growth. effectively advance

I statement few through touch other financial income on walk Now our will and metrics. a key

recognized associated which with of payment pivotal was in Zai the milestone indication adagrasib of license Zai from our third we payment the XXXX of million sitravatanib of $X quarter the $XX.X $X territories. transfer the a a contingent $X.X was from pivotal first in Zai with adagrasib This as revenue in of part and for by the where clinical million was of study recognition third XXXX, $XX.X study on Lab compares of of milestone a that the the Lab-designated the second revenue million know-how quarter with Lab BeiGene-designated million to for million, BeiGene Revenue a associated driven agreement of start and territories. in clinical starting

million in $XXX.X other with for growing in compared in due expenses compensation of $XXX.X employee-related primarily for salaries development increase to head and share-based the million including increase third is period quarter the expense support an increase were to XXXX expenses, The to our count associated same an XXXX. Research and pipeline.

expenses launch, product expense, and costs million $XX.X facilities employee-related were administrative other increase share-based increase for to support and potential grow for General sales, costs our commercial of organization. salaries XXXX. due The an G&A in a preparation we compensation an expenses, in XXXX to and an in in including staff primarily IT is marketing and same as to period increase the the third and increase in the readiness million quarter compared in $XX.X

per for same basic loss share $X.XX period gain million for dissolution XXXX $X.X and recorded third Canadian share The was MethylGene, compared of loss the $XX.X basic the upon of Net included XXXX. third net loss which of in was a XXXX diluted the per quarter quarter subsidiary. or to million million and the $X.XX diluted $XXX.X or for of net Mirati's

investments, billion XXXX. and a $X.X cash, gives approximately with us short-term cash cash runway We into ended the in third which well quarter equivalents

under net our X.X about quarter, sold earlier Please results. which million third approximately our additional stock see quarter of details $XXX XXXX our proceeds facility, from afternoon common ATM the generated press release we million. shares this for During of financial third

you. it to hand over I'll back David,

Thank you, Laurie.

call I the questions, progress team for am let has our opening Before this quarter. how made by pleased me with the saying conclude considerable

our to diversified the U.S. continue launch We of pipeline potential for advance in prepare and the adagrasib clinical

of As for ability who the look adagrasib excited be we and people of And the of happen. to those stakeholders that close out prospect us that very are year well you capitalized, this we in we remain about which cancer creating can Mirati launch we're value enabled the approval helping the vigor. to to with granted stakeholders, we assure a We XXXX, with host that and to thanks coming further investigate clinical optimistic and gives the to opportunities. so will promising will weeks, do I remainder

benefited it XX the built has up. evolved the as last watching from we and Fortunately, GXXC analyzing market ground months from KRAS the in been

We strategy. and community with be accounts helped us what which engaged formulate launch we very will extensively have oncologists, a key effective believe, to

As our are very heard progress are initiatives, have today, and excited we pipeline solid you our future. we and making optimistic on key about

I'll I'm and quarter. a and your grateful thanking for we collective close of this such in lead and On dedicated the to individual behalf interest accomplished truly support organization. for Mirati, thank at by company. the efforts you Mirati their of team and proud us all

call we're Jenny, for to that, open ready With the questions.

question first Sachs. with Instructions] Thank from your you. Salveen [Operator Richter Goldman And comes

early led may PD-LX, term? afternoon. question. this with collaboration about here in partnership what data you for share longer and confidence could to your just on what the Good just with aspects their you to this of taking oral gives Incyte Thanks and regard fit And where thoughts my you the

will take Absolutely. But Jamie that.

Yes. Sure.

confident ESMO in with our frontline And be we'll talking mentioned, all, think IO. pembrolizumab we that in of about very at strategy setting. Chuck I combine the to as remain first

driven interested program us to that combination augmenting an have with approached of very development think but in a the opportunity them strategies. setting, Incyte essentially it's further Essentially inhibitor of easy with oral variety they us. They're with very was Incyte. their a And robust about trial by I clinical it discussion with collaboration, adagrasib And design. essentially, PD-LX -- in for the for

you. Thank

Tyler And go Cowen. we'll Buren with next to Van

many I'd your at like heartfelt tenure career. Chuck, Hey say just very guys a impressive during your to accomplishments on achieved the much. you've in Mirati thanks congratulations

made you'll You've missed. I've the you, in KRAS on and enjoyed truly your with targeted mark the be working space, broader and oncology

you. Thank

we the ESMO beat With is be to to impending What Grade bound IO. acceptable what X on the that, about you think I'd of data the a chemo rate just potential LFTs? trial? the limit believe do adagrasib-pembro combo efficacy at response think in KRYSTAL-X pembro would plus the like guys you pivotal And about as ask side, upper of do compelling

your Sure, take of -- words It's about Chuck. for I'll kind thanks first that. all, Tyler,

see let you'll me. know I trust as Just you again, he's not anywhere to him so going tomorrow, mentioned,

bounds in full details for Regarding in going K-X conversation IO. all at about that, everything to to and And have mentioned. and be weeks. let's you as get upper we see weigh expect strategy X those on, we'll We're what ESMO weeks, at the out with our as ESMO we'll so to X Chuck that and setting IO frontline

Fair enough. Thank you.

Gena move Wang question from next And to we'll with Barclays. our

I to forward Chuck, missed. with great We be past years. we welcome Has to the you. also board. that you on many add, been Alan, working -- working look Also, will look with in you wanted

regular And KRYSTAL-X. on patients were also June, you tablet? just that the of since be abstract the aiming What the this regarding from percentage be update taking abstract? will I have cohort all ESMO IO, for also late-break capsules. So update from one in or At will question patients last

answer will question we as that caps. we'll more know throw abstract talk We're you, Chuck ESMO IO tabs share tuned the over -- as I'll to with shooting but of I'll and of at of Gena, over weeks. it that. details, soon next into when and Sure. some stay the the that, jump couple late-breaker about about specifics to that's and for Chuck

Yes.

be vast the recently majority enrolled at exact were since we'll the don't the will -- will the on have that discussion ESMO patients it's the been dosed our And tablet. all I tablet. patients So Gena, of report IO on have last the percentage but for of you,

you. Thank great. Okay,

Evercore we go ISI. to Jonathan on, question moving from with Miller a And will

don't taking of well, launch about Thanks expect for still second-line from had be to the sense bunch actually on on line. I'd proportion data. ask that major of congrats we've the Why patients question adoption love on me my get and Chuck. to your what second-line questions a as know rate in testing I the KRYSTAL-X status? going second of And Is setting? a in the a second line KRAS limitation in their the you since launch

at Yes, this closely. very Jonathan, we've looked

continue the at We it with look closely, details to and Ben of you. will share some

Sure.

at as So you know, predominantly testing diagnosis. occurs

that rate today is So we of market. just so or over think the testing X/X

over room in of So grow they And these some patients point, second unfortunately, progress still there. to seeing your patients being identified. some those to line, we're as of transition, XX%

So issue we available second is continue expect identification as grow think both as patient over as and grow of almost to the market today line. on to a we that well in half linear rate the basis has that it to do room testing

mature. will be it to into -- will think market a continue I take while but with we we'll it fully again, to a and So launching think be grow, little momentum,

that setting? Thanks already how relatively very space? be about to reimbursement in in that the accomplish, is active you given easy much. And Do KRAS expect to

very well understand efficacy and We issues We pretty across profile we take months, all last significant particular, couple coverage. so profile engaging be we'll the XX months will a get understand of coverage. quickly our the of see and to the don't country, our of they top broad spent and X that adoption, but very on in to with payers expect front. broad have rate it there The do

very Thanks much.

go we'll And to Michael Schmidt Guggenheim. next with

Yes, my question. Hi commercial another guys, thanks taking for maybe question.

launch should switch next December, from so relative we the about more trajectory industry there clinically With considering the perhaps in about approaching thinking experience, the year, perhaps think Thanks here opportunity other newly to adagrasib patients much. Amgen data Is inhibitors? patients? diagnosed KRAS an the the Are drug? PDUFA of of addressing profile to potential we how differentiated

Ben add couple things. and start of a will I'll

launch months of LUMAKRAS. XX we're the forget, not Let's after

patients second commercial the to LUMAKRAS, program the of access market. drug. do the on launch first of are have to to early available you are to that We a Being moved for an patients market, you, were quickly that immediately bolus

So first that us. available helps the certainly population not will that to mover be patient

second the available at patients be that launch not of available were us. would third-line to Some

Rapid reimbursement that's approval, to the in so will in months. early reimbursement a of going happen, we few mentioned, expect take the as Ben months first -- but

trajectory market. will LUMAKRAS. be But the over time, a see time, than the will we be as over second But launch slightly does with certainly adagrasib of one little to we a different leadership So launch time. see clearly asset different bit over the uptake and see market

Yes. I'll just a that, from great switching deal expect add in no, wouldn't we existing. to of see

second-line So patients be which where playing really is to sourcing we're in that we'll from. new population, patient

the benefits realized patients So this as over David we with see of being to more but linear incremental the over by that approach mentioned, don't expect time time. and bolus the significant physicians first-to-market assets have,

go Morgan And we'll with Stanley. Mike Ulz to next

get numbers patient wondering a data sufficient couple Hey on of for ESMO weeks guys expecting at and you that us here. give just I thanks also if follow-up IO you on of follow-up Maybe we maybe having safety. taking we're the of the here and maybe But could sort idea a a good question. K-X a efficacy know the should data months the to level mentioned expect. read or in Thanks. rough

will longer at what weeks what We're going of be shared be we it be it data. shared will patients and certainly therapy will share share have definitely early now, more -- there. from we'll at to in Mike, ASCO. than we we're than It all details the durations ASCO is to four going

and it forget not And PFS will patient of that, details population. in we're the tolerability but at weeks. over really have But In case, looking all those OS efficacy. response safety rates. the combination be to more four and this Let's and it's at in look time, look at we'll this

Thanks.

go And next we'll with Bank to Jason Gerberry of America.

an that sort Hey adverse just you mitigating guys the of what was just need potentially use there that's for. commentary Incyte questions. Or press don't PD-X is on may release, and -- of to see as my unmet curious Incyte My maybe solve thanks going chose the agree just immune-related events. some taking curious about for with. question of to language sort oral you I'm

And KRAS then looking KRAS and patients. the new you X% the study It PD-X followed Phase sequentially also, TPS greater just by than a monotherapy like started II at seems rationale.

been curious anything World seen study with to what that Thanks. driven just extent Amgen data may the Lung. have was So that at by

This Sure. is again. Jamie

a press way and But Incyte mitigate you consistent is on releases especially of way the to first I oral language around molecule, that the and an that this this question their is to half-life shorter is regarding immune-related So think believe Incyte a any really commentary potential release, that if around don't throughout, they've and flexibility look I of would used the press They all and really this molecule. say the your positioning think positioning kind adagrasib I at Incyte's way. applies AEs. in just

So I think that's the first answer.

on checkpoint think second other -- administration question sequential inhibitors. immune pembrolizumab, KRAS with or I the of think I inhibitors regarding

KRAS is, the immune of and and this forward. in some to do the moving there's clear Our concurrent mechanism-based with a advantage, cells administration. believe focus ability with and forward co-administer We microenvironment a drug to concurrent checkpoints immune believe remains essentially interaction affect strategy do mind, that our path ability between there's a its that a affects in that our the administration. remains We clear

times ESMO of year. IO good the of this call, on picture As mentioned get you'll at that couple a a

next Raycroft question to with Jefferies. And from we'll go Maury our

question. Hi, thanks for my taking

where guess, activity? light discussions the draft in you about approval on talked any And had to label you does a you do the have XX. specifics Can provide potential You CNS on with include And with you're overview place? more I have it December before get at particularly, tech meeting? FDA? specifics adagrasib a

Sure. them, the constructive agency. conversations details having -- What say interactions we out soon we we more The about with confident appropriate is I They're it's would have recent as the come the we're approvability. and will as but remain optimistic productive. are the details very conversations the of NDA. the into think get We to approvability or don't in of of disclose the remain the

And label in comment is the that? Got you have as label? on the do far anything CNS it. there data goes, the you Can as --

going interaction time. to FDA specifics Yes, the the into this we're of not get to

move a with will Eric question to Joseph we from And JPMorgan. on

evening. LUMAKRAS the differentiation XXX III data feedback underperformed efficacy your good launch given of if Phase for ESMO, whether, view to of the kind sort your of update Thanks. in Phase you've the I'm on opportunity II at wondering I guess, just with wondering curious for with where the of any whether are read-throughs Thanks taking sort LUMAKRAS CodeBreaK there represents I'm the Hi, KRYSTAL-XX questions. that from of evolving to whether any had and study. adagrasib. profile physicians know an Also performance.

Yes.

our CodeBreaK population think out I the in to IO that was what Cohort looked just population chemotherapy that response from look for you patients and the KRYSTAL-XX importantly, XXX, had if A during So identical. PFS similar And call, CodeBreaK the look that there out just seen if to very you point patient pointed patient the were at K-XX, we that XXX. those at plus rate and

do what is predictive XXX we would the happen that of actually from just XXX in was population that So data was the different. think patient

don't checkpoint to between trial. coming for population studying any there So both patients those our on therapy to we're since were patient be in our we studies chemotherapy administered and all difference inhibitor expect, our in case, before IO

more us the GXXC as for physician a the the fit adagrasib really where that of the with reaction data response CNS overall more rolled mentioned, profile feedback. to regarding been was then do activity, as the out in would we survival shared median at ASCO, cancer have shared of Ben It's we've colorectal And the with has actually began they data very landscape, physicians inhibitor. competitive rates, had data data quarter good we've And encouraging, adagrasib, totality shared, at that that at when of need the a the this physicians, armamentarium data KRAS ASCO. seen ESMO, been as the third that

a of with customers, positive the lot spent us. have time and All for very been feedback of us has

to physicians treat be anxious So have product are to their to patients. able another

to the opportunity excited we're that So to about upcoming present physicians.

Ben go we'll And next with Stifel. Burnett to

the you I question wanted ask to a just NDA thank on-going much. review. Hi very on

patient as -- being did the of you reviewed adagrasib, change change have the what to formulation many that's tablet, level tablet the NDA? capsule the patients from or how part data of disclosed of submitted Regarding FDA you to you this with that

Ben, But regarding is the formulation the tablet approved. say have the that's is formulation. tablet disclosed we've can not that information I expect what and the NDA in formulation we to

Andrew will Securities. with SVB And to we move Berens on

the Chuck commercial for guess another for thanks the questions, I congrats reaching the Hi, LUMAKRAS. on to milestone. my and

that I the on And you than degree anticipated. on color that. in Wondering had could to and mentioned you give do some just then a have you prepared learned more if what think launch, I after the too, which on most a follow-up was us been going has think plan you differently. question, many lot LUMAKRAS You comments what sluggish

Sure, first Andrew. will question. that Ben take

intentionally the Sure. an I'll micro customers the that see. just our we've -- organization very markets start we with built and around the --

representatives. across coming that's sales and So access, medical our

we've differentiated hired a So best-in-class a we that team. really think team and

differentiated believe from a a as the then we study of over been and do our actually in spent for lot patients it there pertains And specifically, really were of that the Secondly, dynamics, time. XX% we've mind really Keep while product. we've enrolled the a out community. account got to

spent office occurs So and and the in lot we've is of doesn't, in centers for a who flow marker responsible and understanding health it patient community electronic genetic role. if or the system the really time where that the the in

time that that really there think is that we can a lot spent with we've operational try challenges So some we effect. and of help

the we're mind. in our the to in field and bringing keep And even promotion noise and GXXC doubling XXX-person kind team, more the really of over top with of that KRAS space mind

additional hopefully, continue So we that market efforts, with grow in we opportunity think over a see And agent is those market. time. that, to the competitive really aggressive that we'll think really

And on BID then XXX-milligram question cohort. on-going just second-line the a Okay.

you at enrollment. be wonder that's along Phase IV a going in to far Just commitment confirmation think just still wondering that how And is I this point.

So are enrollment with regarding the specific trial. enrollment, we haven't that disclosed we with where

commitments, this prepared as conversation think well. post-approval to I we're don't have time at that Regarding

those I think we'll any approval, post-marketing assuming details. requirements, upon share

with And we Citigroup. Nochomovitz to next Yigal will go

great. the and then KRYSTAL-XX question an a much unrelated question. Thank taking very for PRMTX. on had just you Hi, follow-up I on

that it's to you. earlier saw approval enrolling Chuck want well confirmatory on was at specifically that you Phase today, FDA submitted indicated worldwide. the think say another KRYSTAL-XX, of when enrollment ideally And see the Therapeutics what they percent I'm I well So could Thank you to in your consider the the for the the ADC company, Wondering guys said time reason if KRYSTAL-XX is you for you filing. ask is accelerated and pathways enrolled -- NDA I sure underway said that III at time fully the adagrasib. the

that underway our underway NDA is take pretty bar I say a in where I'll to met prior is have submitted. It well The being KRYSTAL-XX substantially What Yes, our can accepted. was clear one. of we the NDA question. our And was That's aware is FDA enrolled. was enrollment. when very KRYSTAL-XX trial,

as for for that approvability not adagrasib, KRYSTAL-XX. issue we So see an do

Amgen Jamie, it's PRMTX the perspective can differently as you potentially And so to from then how this how XXX, probably develop AMG Thank a to the inhibitor, one strategy? from you're -- XXXX, you. it. Amgen's with well Okay. different as biochemical's on for drug Got the the drug, comment is versus Jamie. respect planning

structure as disclosed my Sure. through their knowledge. the it's little of a Yes, they read have not Amgen bit to chemical molecule, to hard to

literature with We say non-MTAP-deleted with selectivity we includes degree have XXXX, very for the are I cells. regard patent otherwise. the following just That cells. to normal and MTAP-deleted of comfortable tumor been cells would versus

that very pharmacokinetics peak ratio would we be selectivity. we normal PRMTX trough when sparing we regard XX-fold-plus And a out ratio, it's have to to likely with the we in So cells. model of clinical and believe that

one I the first-generation are to that of as neutropenia other And reason. MTA know, binding that anticipate myelosuppression, issues discriminate are the that thrombocytopenia, encounter and do a PRMTX don't and for issues mechanism-based key and there inhibitors we toxicities, that you not encountered. for for those PRMTX of think, lot anemia

where the you a and suffice deletion should MTAP-deleted genomic testing available. would number and cancers where is pancreatic cancer, if we noted response a finally, the we for of are non-small in is includes say path a to Amgen, the I common there That be cancer key fast-to-market up. strategy just the believe indications might where hold lung smaller lot of rate versus cell development Then drug interested that

leverage do activity, Our see preclinical to would be or can is of suggestive that program. during cytoreductive tumor development mechanism data that response this our certainly a you where we like action

Tuerkcan we Securities. go And next will to with Silvan JMP

my taking comments for made I kind have much question of a Amgen. very you thank Yes by regarding question.

roughly the they and So the second-line X,XXX been LUMAKRAS has far, lung non-small there's X,XXX cell patients, cancer estimate prescribed to in available.

I the in So good. eye, penetration my view fairly

you. the in, already patients, you fairly So patients? penetration how versus tip that, patients kind the lung a doctors would new high adagrasib these cell of that's telling or could come second-line cancer going you, say, Thank given in now that the influence non-small in forward hand new LUMAKRAS in pick to

has Ben Sure. that question.

Sure.

think to correct I just here. definitions on -- it's important get

line new XX,XXX patients. entire who market, the XX,XXX When to you second patients line. are X,XXX are at to second look plus there So that's

Amgen that's to So XX,XXX into market that XX,XXX. launched the the with

likely get will X,XXX that patients they time, really it's only over to KRAS once the Now the with treated, treated as inhibitor. and market closer get

while pool, -- and X,XXX X,XXX. launched into pulled larger that X,XXX really a the So majority being they that opportunity market. the again, forward that much in whole will larger have of comes But the moving was from that that from be

go will to We BMO. with next Evan Seigerman

is for for Thanks guys, [Indiscernible] Hi this my Evan. question. on taking

setting? just the or on community potential market seeing setting. versus the we segmentation. in the community hearing in means thinking for were had you you're physicians How And opportunity the mentioned in academic wondering a on what adagrasib focus the this call and from are about market what you So

both. focused on going to We're setting. actually academic Sure. We're a community,

are that's setting. leaders you in patients plus it's of majority lot important in the centers, It's have where are community the are of of community In where that, lot second-line conducted. opinion the the a key the setting, are. the have academic a the In So lung cancer, patients of more cell you a lot setting. non-small that trials the clinical community

Cohort on trial, at Ben as A were time, we trial of the his comments, community the in setting. from in XX% registration this So patients focused our are the both mentioned

and the have clinical are. experience, clinical community as trials that's well already physicians, patients So community other the it's number a where good because that we of the them on-going have within setting

academic we've Ben are. that So make, not too. approach, the It's will. community setting if has a the got surround-sound patients comment the setting heavy just also reliance where because a on you that's it's to

Yes.

in well. that that see community, And to pancreatic in I differentiated thing the think we pan is I'd add mentioned and continue CRC the tumor across presented Chuck think about that we and we to now as data the data, tumor in only treating there. as we're types also efficacy

in is we that as So forward, so think across as robust moving well part a really both monotherapy tumors. story the our of differentiation combination

in setting, They're centers the they point tumor are. not as community because good economic all types. the A treat specialized physicians as

will we to Olson Jay Oppenheimer. And with go next

SHPX thoughts expect expectations Chuck. when see might your that from to could to and And have I'll the any study. my we if well of SHPX add impact question. inhibitor congrats the share taking how adagrasib for And for about I plus may data on thanks wishes one that Hi, I could. follow-up, and and LUMAKRAS you Curious combination plus

Novartis. that program. Sure. an Novartis next the when sharing say -- sometime It's available be That on-going it to look the data David here. way a with SHPX I with would is leading year. And is we'll we've it'd got underway. forward with becomes trial yes, study sometime

said instead of Sanofi. I Sorry, Novartis

also and Okay. non-small that chemotherapy cell Great. a cancer be you guess, lung could registrational approach? potential for can plus or I on adagrasib the in comment whether first-line not

approach weeks about We'll get four We'll our strategy. so we to talk about the ESMO to multipronged the when holistic IO from setting, that talked now. month at frontline frontline next

Swapnil with And Sandler. Piper Malekar we'll go next to

Hey thank you for taking my question.

and is data pembro and the frontline the with in approach that is of to Although past, class that given combination see was tox a effect adagrasib to if KRAS alluded the pembro of associated you've is has differentiated. adagrasib just not the in there LUMAKRAS wondering importance specific that of setting, inhibition generated and any that the been like

will that. Jamie take

Yes, this is Jamie.

believe more effect. be and few there First about of not with historical are this this that inhibitors you and not at is are class tyrosine with that combinable. combinations is some there a And all, that a the to I immune-checkpoint combination, One believe effect. is we'll a think clear it's are moving if look in inhibitors, say we the talking we're forward kinase reasons I'd agents Again, that very future. class readily do

sunitidib, pazopanib, are and sitravatinib class, own and drugs combinable. readily other Same Our others drugs cabozatinib like unfortunately in crizotinib, not.

class it's see to particular that TKIs So I when think hard observation. a are the you effect that say

lot we're adagrasib of means. to intrinsic I its to note probably like through That means the class. And That is competitors. adagrasib low think point binding KI number issues. properties a some about off-target the best reactivity physiochemical two point to is differentiated in affinities and noncovalent KN drugs a to means of we one thing of ratio likely could act the adagrasib and is kind has avoid of

in The exposure I noticed terms variation peak-to-trough large pharmacokinetics, ratio of a second the physiochemical we in see exposure. property, don't to Cmax Cmin think,

disproportional the We interval. way are that, another think likely that see avoid levels example, of hepatotoxicity. we dose don't be over any, do and high it's for that's tissue So we drug might able to

class So effect. think a this yes, bottom don't line, is I

of the as to development historical think are ada. well several I drugs of there reasons believe based as both on properties physiochemical

Thank you Jamie.

for time one Jenny. question, have We more

Riley And with go Patel B. to Securities. we'll Kalpit

confirm first, to the communication questions to Yes requiring approval is recent that based Maybe FDA be Can with on the not date? that agency the was PDUFA you of before Thanks potentially you granting just taking any question. by that on hey the fully afternoon. clear for the asked. one good enroll KRYSTAL-X previous

Yes.

you let our trial. First, say, mean me KRYSTAL-XX, I confirmatory is which think

that. can So confirm we yes,

Okay.

speak think for I think that's us. I just speak I the -- situation can't situation. that I today company. a could for different

a setting, up? still certain shaping are full maybe Okay. there trial Or path subpopulations table? STKXX Maybe talk think you And the Phase is that in how was III about co-mutation approval some the towards accelerated Fair leaning on then plan in frontline instead? particularly the potentially a patients. previously, I enough. Is that complete

that to forward look opportunity part approach IO -- in see of at where four the conversation for setting, investigating all because tremendous weeks we multipronged that's really our it's adagrasib. to We a potential having certainly ESMO in frontline

at get into Geneva IO. us those hopefully, all in conversation. join you we'll So can for ESMO that details And

appreciate everybody. So with in look coming forward thanks updates we to for joining interest the here Mirati, additional us in We weeks. this afternoon, and sharing your really you

call. concludes this you for so And Thank your participation. today's

disconnect. now may You