Mirati Therapeutics (MRTX) 28 Feb 232022 Q4 Earnings call transcript

Good afternoon and welcome to the Mirati Therapeutics Fourth Quarter 2022 Earnings Call. My name is Cynthia and I'll be the operator for today's call. [Operator Instructions]

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

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

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

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

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

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

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

Thank you for today. on call the thank Ryan, and joining us you.

products. year advanced Mirati cell cancer. a product, advancing transformational cancer lung our and We significant for differentiated our force commercial made report mutated approval and for our progress non-small our was and launched first to I'm of KRAZATI GXXC highly experienced KRAS we or XXXX oncology metastatic received locally pleased first deployed targeted lung commercial field pipeline

from GXXC mid-December therapy and as dollar and opportunity belief types, as and that across potential. and in are KRAZATI multiple monotherapy commercial KRAZATI KRAS inhibitor clinicians, a it addressing its Our multi-billion we of our reception feedback market as encouraged the a initial payers in tumor both team initial weeks, combinations. lines well launch patients is The the reinforces still KRAZATI's launch while is in with early broader best-in-class

cancer as their clinical that an medical of differentiated develop of we unmet with products and need role pipeline potential endeavor the will broad care. thousands in our people for hundreds differentiated to living Additionally, has play to address important

and back for to and step cancers. near-term molecules drive clear on being mutated growth. best-in-class creating with capabilities a small treatment I at cancers, positioned on to success of well long-term we leader focused and the look Mirati products, achieve a our across is current it's As focus people, are KRAS

Our highly-productive treat KRAS enabling us a and develop range patients. engine innovation of has enabled therapies KRAS to broad to

have We in tremendous significant expect KRAS PRMTX to value a programs other KRASGXXD We this Moreover, on the progress. enabling combination Furthermore, our the we for horizon potentially believe our our inhibitor clinical dose first with inhibitor inhibitor our earlier-stage and in cancer SOSX showed MRTXXXXX, cooperative PD-X. MTA potential vast our patient quarter. to Sitravatinib first has transformational with shareholders. in including pipeline opportunity create our lung with

Alongside the launching programs, lung these commercial in built cancer. scalable on At we focused commercial development particularly team our a is of exclusively have organization, and present, US KRAZATI. synergistic

invest disciplined deploy Mirati Furthermore, our and capital. how remains in we

our and of investment the We corresponding continue clinical opportunity to drive to data decisions. on commercial analysis combination focus the

achievements combination Key beyond and back, second year GXXC a KRAZATI include Mirati. and non-small clinical KRAS Looking execution XXXX rates mutated promising was signs clinical in data line the response in in major remarkable intracranial efficacy. cell active with adagrasib early of US highlights approval tolerable safe for accelerated lung for differentiated class and demonstrating with in Best is untreated metastases, cancer. of PD-X CNS with adagrasib and patients plus

into clinical precision advancement of signaling MRTXXXXX, tumor. people for MTA first-in-class indication first-in-class program and PRMTX the cetuximab. potential of And MTAP-deleted KRASGXXD Broader investigational oral drug medicine potential KRAS cancer beyond our in trials. cooperative combination colorectal new An SOSX our and inhibitor, application with for our adagrasib third-line for MRTXXXXX, modify MRTXXXXX, an our selective

the is Looking on with ahead, which today's start. catalysts overview where a We'll a call. will of strong off we goals, launch, start important an detail several year ambitious XXXX KRAZATI and which is upcoming to

who to on experience. our with update provide turn you will now early commercial Ben, call an I'll the over Ben?

good and David afternoon, you, everyone. Thank

off I'm pleased launch to a start to strong report the KRAZATI. that of we're to

timeframe. the a giving As in our first forward earnings to mid-December right call. approved brief was KRAZATI reminder, will fourth to season. comments update that detailed on more limit a before Therefore, I holiday my look quarter quarter I

that very can positive goals. deliver been successfully Our our initial launch and confident commercial on we experience has we're

includes access supporting our reminder, cancer, fully-integrated a digital team experience market launches. team and commercialization This a of US affairs. marketing specific multiple sales, has in lung As and extensive medical

already has are industry-leading high patients. experience interactions an for focused had on target team with and and ensuring quality key extensive physicians The accounts

patients are an in initial analogs with XX five of approximately versus a December days. days being example, receiving For prescription of to treated treatment industry closer written

And and been our patient our unique received. programs well physician-centric distribution to patient have approach and access

of our where XX% pivotal leverage are study enrolled XX% patients the setting nearly GXXC community to our KRAS where in of experience We continue and over treated. was

with initial From progress restrictions is included with establishing we've are date. approval, broad access we progress. patients. Medicare made fast and coverage exceptionally an helps and in our significant to and in week coverage NCCN which strong was access no reimbursement of guidelines reimbursement with Overall, KRAZATI pleased particularly from coverage perspective, perspective, initial a within one

well. survival key are Our rate physicians in a of with lung centered our analysis months discontinuation cancer X Phase overall been patients and median XX% pooled XX.X non-small positive low and have on a as X messages cell and around demonstrated of rates Phase resonating response interactions treatment-related

patients importance of metastases. the data to known patients been who KRAZATI's physicians received the for system by has have Additionally, nervous in recognize activity CNS favorably with metastasis approximately XX% showing central

line The significantly non-small is second market cancer KRAS cell GXXC lung under-developed.

team As eligible such in a identification as and focus result, GXXC to community priorities both particularly on of KRAS our expansion setting. markets increasing patients, testing the continues

mutations while two-thirds EGFR rates diagnosis ALK approximately a We KRAS is for XX%. at rate time testing estimate and the with to closer GXXC testing of are

grow community oncology to with providers. opportunity significant patients opportunities we've the to a market with meaningful partnerships local where identify and KRAS level better is the account established a mutation at GXXC there So,

the important In differentiating become combined experienced organization summary, ultimately and market inhibitor. to believe an focused we characteristics of leading commercialization with KRAZATI the KRAS position clinical KRAZATI that GXXC

focus, progresses. KRAZATI forward Our a physicians patients from additional to commercialization the information look has who providing delivering singular I launch to and team could as benefit our it.

clinical Alan? I'll on now for turn activities. Alan update the call an over to our

Thanks Ben and everyone. hello

cell I'll key we updates adagrasib this In approach non-small lung non-small first-line multipronged to our cancer, cell starting year. share begin expect development by cancer. lung discussing with across

cell is the with our reminder, concurrent cancer adagrasib advanced initial combination of first-line adagrasib a dosing most and As non-small pembrolizumab. approach in lung

combination with with the points. this experience confidence Our key on path three provides us in forward based

combination is a relative improved the standard there durable of care. with to outcomes for rationale First, the existing first-line strong scientific

combination in pembrolizumab demonstrated adagrasib Second, a has safe with tolerable and profile.

the And still Overall, and compelling to third, cancer look will evaluating additional are this cell non-small patient the strategy are our from informed more follow-up efficacy data first-line we be advancement continue they studies. maturing, and data ongoing outcomes while clinical forward the year. of lung clinical with outcomes by later on to

PFS second duration six-month first year, look such an provide We expect which of in durability as to the landmark will at measures analysis. a half this and include of response update potential

than are a of evaluating study, X%. patients adagrasib KRYSTAL-X TPS also the we in as monotherapy Within less with score

XXXX, the the In combination an second half update that on provide monotherapy at also update we steps data of in the first-line and time. will KRYSTAL-X addition to next

profile evaluating of and the Part we which tolerability development an regimen has combination. also is of safety the been adagrasib adagrasib approach, tolerability of pembrolizumab. KEYNOTE-XXX by with KRYSTAL-XX pembrolizumab, evaluating combination first-line on combination and this our enabled of study with initiated The plus multipronged we part the Xb-X pemetrexed focus are as with in Phase initial study the carboplatin, seeing

the approval advance discussions Agency to the US, on adagrasibs and we in the their anticipate quarter. authorization beyond Finally, of third European are with potential Medicines marketing application review continuing

a at the most rate now combination demonstrated cancer which median last important in we in of our approach and moving months. a forward. X.X representative profile where and cetuximab In colorectal combination September year, upcoming with cancer I'll the survival is are to differentiated primary XX% in a of recent ESMO shown colorectal milestones. progression-free results, and compelling response Adagrasib have has move several of

for Notably, compared care a standard chemotherapy, very substantial have rates of which poor of the potential two and progression-free improvement survival of to regorafenib outcomes approximately these only response digit the current months. or suggest results low-single with

later with colorectal input forward cancer. on Based adagrasib or be recent rituximab pathway from the of we an plus accelerated FDA, the third-line in combination for will moving approval

NDA We in submit supplemental the expect the quarter. to fourth

patients KRYSTAL-XX enroll in plus well. study continues Phase second-line evaluating versus the combination III Our colorectal to chemotherapy adagrasib registrational of cetuximab cancer same

in survival based reporting results. expect interim of XXXX by We regulatory year-end KRYSTAL-XX for progression-free survival plans the and achieve anticipate on to analysis with overall enrollment full we with these final submission of

for tumors opportunities In include addition, these to development non-colorectal solid gastrointestinal KRAS present a mutation. We harboring adagrasib second the plan medical at cholangiocarcinoma, tumor GXXC pancreatic meeting malignancies in updated other data the types in quarter. adenocarcinoma, and important other

studied SAPPHIRE of I'll survival on registrational Phase called Sitravatinib, study second overall being this the which now in is analysis topline year. is a in a on briefly quarter for touch SAPPHIRE. X track final for

the to demonstrate clinically both meaningful remain sufficiently to study, we significant powered it While statistically ongoing believe we outcomes. and blinded was

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

Alan. you, Thank

highly MRTXXXXX KRASGXXD poor and I'll associated therapy types of inhibitor, in progress and with KRASGXXD mutant selective active the pipeline begin the states cover KRASGXXD is The standard inactive potentially oral both several which mutation and potent MRTXXXXX, MRTXXXXX, will I on Today, clinical on with our early our of outcomes protein. cancer. assets, MRTXXXXX. predominantly first-in-class targets

We a approximately with option colorectal, just that impactful believe these underserved the Europe. cell there be of and XXX,XXX lung estimate cancers, US We patients. that potential in mutations to is an treatment and MRTXXXXX KRASGXXD patients endometrial for within pancreatic, the non-small has prevalence

X/X evaluate KRASGXXD and PK-PD designed We of Activation clearance in harbor MRTXXXXX the is with trial in patients quarter. Phase an is the from mutation. tolerability MRTXXXXX on this first begin in tumors safety, FDA for solid clinical anti-tumor and sites The received underway of that and advanced study filed will to activity study patients the enrollment IND January. of

XX The and plasma attributes high subnanomolar than formulation tumor free utilize of in systemic drug study cells, increase fraction, plasma will absorption targeted enhance to Positive oral time the residence hours. half-life potency long MRTXXXXX long greater a of designed and includes exposure.

are has attributes plasma the the all the treatment full to KRASGXXD in for the path increased provide coverage large with the duration MRTXXXXX. low dosing option cycle. for our population. target These transformative of threshold patient for for maximal successful concentration development underserved has a target and a MRTXXXXX consistent confidence This potential

of XX% cooperative potentially MTAP This on MRTXXXXX patients PRMTX patients clinical in study X/X Phase MRTXXXXX, in all a than annually. harboring to gene and cancers. inhibitor. moving in deletion. human our Now deletion the Union greater XXX,XXX best-in-class occurs enrolling to approximately An for gene MTA is European US MTAP translates

While difference pancreatic the tumor sheath development and significant for preclinical particularly our in MRTXXXXX priorities will data tumors. This of the promising to lung cancer, tumor in in peripheral potential types, to enable mesothelioma cancer, wide demonstrated has and nerve has to a a development treatment make treat types. outcomes potential path. address may malignant a these tumors MRTXXXXX program difficult rapid initial include range these

gene Now cells. extensive with present education binds PRMTX results tumor only an to compared MTAP-deleted normal of in This MTAP cells our uniquely for as selectivity in MRTXXXXX deletion. reminder, a tumor complex complex. selectively MTA the cells harboring is This

a target with complete provides and The non-selective mechanism-based mentality to near therapeutic limited PRMTX achieve and wide which by inhibition were with generation differentiated inhibitors, compared systemic MRTXXXXX index marrow bone ability toxicities. first clearly safely therapeutic

than MTA the PRMTX other MRTXXXXX fold to XX selectivity selectivity the ratio highest relative potentially complex Finally, MTAP-deleted of for cells inhibitors. reported tumor is greater

on systemic study expectations Our without encouraging. with the generation limited inhibitors. projections meaningful the the utility XX Phase PK early achieve consistent our experience therapeutically clinical concentrations challenges in drug based PRMTX prior that to exposure associated and of are X preclinical has been

these the patients strength report reminder, to our the a XXXX. positive of focus also this half were for treatment safety potential add options. clinical a Fast granted agent data preclinical of and the activity. reflects who which and We have this of early impact Also of limited the as plan have be for MRTXXXXX, data share we to second clinical on Track designation in signs with to tolerability initial the update The will potential

of enhance for our Finally, study example data that our KRAS value and inhibitor. we potential range X an MRTXXXXX, Preclinical to has a a initiated demonstrated indications. of to first-in-class of adagrasib have and strategies Phase our MRTXXXXX maximize activity strategy SOSX the as portfolio, KRAS pursuing broad targeting the by the of

escalation Phase of X/X second this dose year. half in initiate to cohorts combining study presently ongoing expect MRTXXXXX We are and and the adagrasib clinical

and in KRAS of look pleased cancers, pathway research we've preclinical Overall, possibility made EGFR lung including allele-specific utility and forward In with our inhibitors the EGFR mutant inhibitors near the across addition, MRTXXXXX. providing the additional as compelling such updates augmentation cancers. progress mutated in to inhibitors KRAS mutated the of Other support future. RAS MRTXXXXX of and we portfolio significant

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

Thank our income statement by fourth full through other walking our for and financial release year financial earlier our press you, on Jamie. I additional metrics. begin Please few will this a results. see details and XXXX quarter about touching key from afternoon

quarter revenue of and fourth $X.X XXXX, was million $X.X solely $X.X of of and was Revenue for revenues. of $X.X revenues. of of compares collaboration to driven quarter million, collaboration the which license and for consisted fourth million KRAZATI XXXX licensing the by sales which million This

As the the was inventory holiday quarter, million fourth sales associated shortly $X.X in Of with channel. a season. reminder the of KRAZATI in before a mid-December, KRAZATI was the in approved majority

Research an a expenses adagrasib the XXXX. and associated salaries share-based of is NDA increase were by costs manufacturing portfolio. growing including headcount The driven in fourth following the program million and development reduction with period our million filing, headcount compared our $XXX.X quarter to growth for costs by decrease related our the $XXX.X for of XXXX in same offset partially the for support primarily to compensation in XXXX

quarter the expenses for prepared period to million including primarily head commercial were readiness commercial share-based in in of due of to The Selling, for same $XX.X compared XXXX. for general we salaries and count the million is fourth $XX.X increase an and launch increase related administrative the KRAZATI. costs XXXX costs and as compensation

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

burn with approximately in cash, ended equivalents runway cash Cash a fourth We operations $XXX.X us and was the from which year XXXX. cash quarter the investments, short-term $X.X for full XXXX. billion gives million of into

innovation drive that critical in disciplined our growth. to pipeline, recognize we invest deployment a and approach advance to as long-term launch data-driven capital is sustainable effectively We products

returns. create We have our focused benefit highest priority drive and have greatest opportunities, investments that to value our those patients, the shareholder on potential

burn annualize We cash similar expenses expect closely range and a will we continue to XXXX manage to our from XXXX. within as operations

include the the we'll of expectations offset partial spend burn cash from achieve XXXX Our to sales launch from KRAZATI.

a a and Finally, capital as we are actively and and exploring ex-US partnerships sharing, of enhancing of portfolio. accelerating source means as our risk

that, And with I'll back to over hand David. it

you, Thank Laurie.

work the know am of our me let complete. thus but our how team our the XXXX execute the accomplished as our has progress is facets the opening questions, key objectives on I work of across pleased conclude call far I'm in we by delivered considerable far we made for with mission, the proud team to Before business. this saying from on has

KRAZATI patient great had multi-billion with and We very pipeline positioned our market to a potential well start. populations and a amounting success creation. value addresses also clinical opportunities for combined is believe commercial our future organization Mirati dollar

We and to also data as multiple case for the have expect strengthen over we our only near-term KRAZATI adagrasib catalysts matures. time

in expected for also the Phase entering Sitravatinib survival has clinic with of next MRTXXXXX initial readout, half the the X initial data clinical and data year. MRTXXXXX We overall first

of have the progress activity, of or across stage programs a rest can expect company. it our the of the programs demonstrate one unmet valuation with pipeline meaningful In that If addition, on clinical just we patients we will impact strong of expect substantial needs. earlier innovative serve our thousands of of hundreds two

such, will you are about execution expect As Mirati, in our be us standout at and goals. support interest your future progress and another on continued XXXX the thank our of of excited all On year of we for and we company. behalf

And questions. ready are to that, with Cynthia, open for the call we

Tyler first Van your go And Company. at comes and from Cowen ahead. question Instructions] [Operator Please Buren

good the testing Wanted Thanks taking you about positive the for since question. it. to to Hi afternoon. early launch Glad ask mentioned guys, comments. hear

KRAS levels? panels GXXC GXXC more you the you or do or included elsewhere testing improve to focus testing? how tests to need is be get out your So, to Does

take Tyler, that will question. thanks. Ben

in Sure. all then hopefully think the inhibitor promotional with Tyler. It's a the ensure growing is is of over the that into lead coming KRAS we create that demand is think And will multiplex a couple to see things, rate that's and effort can we market uptick KRAZATI, to it commensurate to demand on the demand One quarter. the test. of the time, that an I of for additional seen with course one market. just quarter increasing testing the and by we've second And and

comes question from next Richter The go Goldman Sachs. ahead. Please Salveen at

any sales Could And expectations I end mentioned thinking Salveen. then on you your you Thank exploring the think just about ramp there? guys you. is commentary XXXX? partnerships. you discuss to you and Matt this share of volume on Could for you're call, things at the considering in

If year stop. for guidance not and regards in sales maybe will I explain, can We could providing not to defer to this Laurie. partnerships, I

the those start prudent to Yes, and it's potential. we explore and process think have to that begin conversations

that's the stages. very So, in early

next ahead. comes Please Barclays. from go Gena at The question Wang

is our on you Gena. this question. for Thank for Harshita afternoon, Good taking

with the on their label safety safety from adagrasib the you and tablet? color capsule of And it's you what launch the adagrasib Thank percent one First has early comment and on provide then what recent of one second can you. adagrasib you're to understand, hearing physicians given been to on the far have days, tolerability progressers? that you on but some on patients able thus with quickly, the launch. that regard We are on PD-X familiarity formulation

I'll pass It's Ben. Sure, I'll David. the take onto call first.

that we'll next conversation, of weeks couple and to the the of metrics end on we a only save for prior the year. earnings the so Regarding have on, the market

the update. to forward timeframe look in the we that launch So, May sharing

part of question, the Second Ben?

Similar in better responses around response, regards we that well at the juncture. really. source we'll We'll as be growth that and the have QX a get into the more sense physician as to some sharing of of call of

comes Please Miller Evercore go at next ahead. from ISI. The question Jonathan

Thanks question. the guys. Hi for taking

driven as versus giving on data combo think goals remind And of to have you forward, so you've from secondarily, for by maybe you're for about observed bar market right what's Do not you market duration we development what looking line the maybe there been PD-X share far, forward and those what on in. fronts obviously comps you PFS? discussion to Obviously, the indication balance going as PFS we what versus second lot As being a data? launch color testing? but a on second for then are, competitor growth in that update what's break try Can the people from of half, there's us XXXX?

Ben, first? do take you want the to

Again, first take be we do a metrics grow. we're to, sharing those goals nascent that has in both regards Yes, seeing bit We the critical. around I'll is is growth have and to think and internal the one. little market it the to think in share. or what way of still long information We it's market very do a around early that general

do we substantial moving that the So, be forward. part will of think a growth

well. take team share as there out have super and our our want looking market a But to we share by that we and are to also is competitiveness measure energized

of stage. in early the So, at that to future, but just more come too this

for. are take on going be there to what looking the the we hi. question I'll with update Yes, second

less all XX. XXX is comer is evidence may the the well that in the the that now perhaps evolving mutants GXXC comer. all So, initially emerging bar perform with or There

seen at in to order is way have to I in evolves seeing we trials. the coming shows first-line what that a going be would to we and studies a confidence this look as so we've in significant Phase this anticipate we what moving X peer-reviewed improvement forward journals information think it initiate up, over historically

comes from Schmidt Please question next The ahead. go Guggenheim. Michael at

for strategy scope recently. did Could thanks It have guys, Hi one the in us question. your meeting more bit like you this accomplished in I feedback let on should had filing colorectal my FDA think also you on the adagrasib cancer. for a taking sounds Thanks. you and just about later mentioned? a to submission be there year, as that the how have what before we the you of received needs and

Michael, I'll start.

going we that the by data we ahead, approval we to for based We seen will said that go the with this ESMO that on the year. last year. file very at a presented accelerated end was had conversation you've As of good agency

accelerated laid that for the understanding pathway, we the what approval got out. So, are requirements all

we so it throughout Now, just the on. to put together need and execute dossier year on the

to robustness You that of at also Breakthrough saw we the colorectal plus in designation Therapy line we in data have was the I rituximab. last received third also cancer that which the that setting to of adagrasib end year, think combined speaks

you'll anything there? say Alan,

No, about I be stand to enthusiastic think you we summarized it working quite well. and that get We to the hard going opportunity.

just will cancer. just We with the beginning that's colorectal say

for second-line a as and KRYSTAL-XX mentioned, enrolling Alan well we'll XXXX. well also underway that and that trial so have We data that KRYSTAL-XX colorectal cancer trial's have as

The next go comes Stifel. Burnett with from ahead. Benjamin question Please

This defining brain think cancer more pembro Thank the cancer active that patients drug and to And mets? adagrasib a Neil can important you Carnahan you as in combo patients? evaluating lung any that, you. do an second-line is follow-up Yes, then expect update lung afternoon. of how are to profile CNS for Ben. with we data on frontline When in good

Hi, part Neil. of first take I'll the that.

penetration. about continues be part us. as for well really you where is our picture know efficacy response including CNS picture the overall of as to of So survival rates CNS overall the But overarching is as differentiator important

in out show shown for have which to will the update distant to too future, won't are continues is initially and results be to an promising be We that KRAZATI. been a not expecting publication data

for pass the I'll Alan part to may of be And second the question.

want brain plan CNS think studies the KX when looking the initially of at metastases. forward Phase with that you patients treated question mets. combination in And possible was X studies, so and I second at includes these moving frontline the believe the you in part looking to previously with Yes. group have best of I the stable

they because confidence we take that and working more adagrasib we, in second course, we the will, and frontline would the data efficacy begin well. If of have a them, at setting with look line broaden setting, more in patient to every we'd as population as and get have anticipate that that

The next go comes JPMorgan. Joseph question Eric from Please of ahead.

this Noah Eric. Thanks taking question. our is for Hi, on for

is there MTAP a PRMTX Regarding also, is for MTA And and meaningful deletions biomarkers used a for between XXXX, sensitive MTAP further versus to Xa tumors? MTAP there biology with distinction that be enrich can deleted targeting and cancers? patients

For insight. I yet would that do we not category, have say

profiling with have are like associated data molecular the pXX status we've that the study MTAP-deleted biology and continue some tumors splicing PRMTX We and including where to we otherwise. of preclinical done biomechanism things RNA

We in will patients. study to those continue

The at that inefficient arginine we level can second us believe, a advances. dose biomarker plan target XX% will as of on looking look possible. give tumors. class be insight doing of There dimethyl biomarkers, to symmetrical for patient we inhibition in that as target-driven the And the much program at we'll of be at, as we towards take want achieve and the we those interval a level that here, as are

you And some reported think, there Agios. know, on PRMTX versus I as there out MATXA you been data MATXA. touched previously has Finally, by

Now, is [Servier] that molecule. developing

their as on publicly well. program they have think commented I

really is to where you the biomarker. tumors here is suppress have MTAP-deleted really present, difference that PRMTX think dependency in that believe key the we I target

as sub the is degree known Again, drive do this believe a I activity this. in anti-tumor SDMA population to full is to way this more that this to precise tumor and

probably cellular a It's index less when therapeutic Just that different plus you MATXA, than a way methyltransferase. XX of you effect precise with that for levels note methylation affecting PRMTX.

XXXX. that looking no PRMTX to believe are But could inhibitors, at with with these for MATXA combine the conclusion really clear inhibitors most we're doing the but again, through target way possibility MTAP-deleted is what here. We tumors precise you that tumors,

Bank Gerberry America. Jason The of next ahead. question at go comes Please from

about X Hi the I just in program you're your guys, thanks to for overall setting. taking questions. - so, Phase thinking frontline KRAS clarify wanted as for my a

a the sub in segments So on in some expressing in bit like monotherapy wait half. forward more perhaps that other more the it the move see pending second could little sounds XX% quickly and of that and durability PD-LX data

Just is end. the outside of to -LX any maybe pivotal a into X frontline moving decision it XX% the late your PD XXXX pertains Phase decisions sub on as in

And just then data is their PRMTX data with TANGO to going on in first X here, have some half Phase agent.

the you differentiate of as so, just differentiation where sort selectivity, think resides there, the molecules Thanks. that's how the XX expectations, And just comparatively in data on based the preclinical key your out your idea you fold about view of approaches.

question. I'll first for the line Great. thanks question start the with and

I think, first points of a couple important the about line.

one, one You're the almost right that there greater than to XX XX%. less than and are in essence three different the subsets,

has KX the efficacy this that preliminary is safety that is the setting taking and particular showing - in doublet be also which KX data shown the concept and have second at of we numbers another that and response patients in will a look some We that information year move so half to provide durability increased have regarding best an giving us a of forward more refined will rate, in the Phase - to X how allow the us of space. also we idea

we on amendment you and bit less work XX%, KX the from With be an to an areas. anxious perspective faster because speed modified less talked than Phase be were that a a go study to able The excited respect to we to in about, we're that X administrative really both with than which XX%.

KX the moving the but forward the From to we and with are administratively the from updated protocol looking are of greater in forward both second XX%, creating half year. on mentioned I than as requires scratch, it data areas in

cohort. have data-driven So, those on based all particular any able a we'll be and-or decision to of

XX%, on is is maximize inhibition index. you hands at here and anti-tumor operative believe of the we target XX% of preclinically, full what the the the to and tissue the in here, level for goal the inhibition our think Again inhibition want we the biomarker really second-generation molecules tumor target Yes, to plus for I what maximize activity. level want almost maximize touched question. we PRMTX be therapeutic dose And the again to in

area MTAP be one is cells tumor where harbor to this the believe XX that bone issues point This don't toxicity for we as as that's well we the going very this based an important tolerability with advantage generation to gene in published the inhibitors is where normal marrow spare to other cells fold relative other selectivity mechanism competitors time. the have deletion first over we at and some think associated MTAP-deleted

escalate note this just studies molecule pleased tolerability behaved generally, we reproducibility XXXX we solubility, a formulation, and with in hopefully the has levels Phase that the we'll to well very expanding. we where dose clinical studies to Probably up PK and and are study tolerability in start respect But to very the our respect towards clinical to been see what in far, so with PK pleased X for at continue are inching so far. we with

Ulz Stanley. go comes question from next ahead. Michael at Morgan The Please

afternoon the for quick just one thanks KRAZATI. question. a Maybe guys, taking and good Hi on

inventory December stocking? XQ, think we we in driven stocking, inventory additional should were Thanks. sales by anticipate about mentioned You as just curious

Yes.

first demand driving quarter you a we As the fourth We'll you always more launch, a as beginning were but the into to the not channel majority see as out to quarter, in were. sales product with December really so start the sales of come that. get on the in see and all it put of the in stocking,

comes The go Citigroup. question Yigal Please ahead. Nochomovitz from at next

design mentions Pembrolizumab Phase Combination. is XX LX than had a on Cancer you and And correct Adagrasib if you in will of recent one the PD if Discovery for the I'm PD is on questions. greater first-line lung, was Frontline there's ada confirm do versus Promise pembro specifically, the you taking greater I not that pembro. reading on the I because just for Hi, piece, it's you. discuss editorial quick Mirati entitled X February wondering believe can X an I issue the yet. Phase thank specifically plus XX. strategy trial that February specific for as be that just Thank the than LX X design

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X thanks I the taking question KRYSTAL-XX. Hi, had that monotherapy confirmatory question. the about for Phase a

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third adagrasib expect of Europe. in We quarter approval

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ahead. comes Ami next from Please Fadia question Needham. go The at

first had versus question my follow-up by XX% on line TPS in for thanks greater September the pembro. question. taking part the Hi, than a I

sort And good that that going anything with dynamics - preliminary submission KRAZATI, follow-up on outside the are sort additional a quarter. Is first in of there you once indicated kind how You've you we ahead - pricing. And then particularly additional a of to in stock FDA. the with about discussion launch, the Thank of terms had do the the terms go first perhaps think of trial? you broader the some of needs Or and data, the you. in Are just factors FDA? with of then there? about that cadence have any you've the of be in coverage inventory confirmed there to any with quarter

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the is in the TPS than the in greater standard would pembrolizumab regarding frontline So because care pembro setting. setting, comparator patient the be XX% of that monotherapy

the So that would be comparator.

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share metrics mid-December. the QX of the just on. this and and going information sales approved walk were We at earnings will will specifics of we launch in KRAZATI, access very in and QX calls launch share Regarding how the so through and and of those the is

So, it's very early weeks at this point, but we're excited to share May. that information in

comes question ahead. Please Kalpit Riley Securities. B. next from The go Patel

for Andy This Thank on for Good afternoon, questions. Kalpit Patel. you taking is

Regarding try and then, color of toxicity initial combination? combination on when pembro doses limit with adagrasib And you exploratory plus some this can expect in NSCLC, adagrasib this starting chemo-plus triplet? your data to from should from give exploratory us we what of you are frontline

thanks. Yes,

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comes question go from Olson next with The Please ahead. Jay Oppenheimer.

you thank questions. the Hi, the and for thanks taking update for

talk the For you. which XXXX, any for launch for second Revolution last And for and quarter in expectations you data talk KRAZATI? then patients? and about GXXD indications the SAPPHIRE on you learned from KRAZATI, your included the can for just similar planning of focused doing lessons Sitra pre-launch given are you sitravatinib across the sitravatinib, some Thank readout the or preliminary read about Medicines night, you're can since

Yes.

regarding they're probably also of QXX here different to think say types patients what GXXD point mutations, and the than spectrums setting, continue comment to including to of and that explore paying to preclinical Rev in And advancing the inhibit Med, imminently. Med time those attention inhibitors, other GXXC be but we are I we'll KRAS mutation different we about not this doing, excited continue XXXX mutations. on Rev at we including in

on this be that front. So, and when pursue we to continuing will update appropriate can

the question. Sitravatinib on And

see for take of are tracking year this SAPPHIRE of be regards adagrasib as learnings QX work, in will to study key the analysis we'll the launching reminder, will the events pre-launch And a final the any here. think, I expected. as As from

a degree that and to able expertise very the leverage as lung launch we have high be existing high experienced to team be as of at but team and able we'll existing believe a a cancer rate. Sitravatinib, infrastructure We to well

from that the very building lot hopefully and think the in is market So, the to of we a have a no product in to we well of file positive move promote team to study quickly. then need and that the back pretty for mechanism place ultimately on recognized

remarks. will are Meek, further any There to the Mr. you no I closing time, conference questions at or for turn this back additional

for we Mirati in and to everyone Thank your joining this look updates We us with sharing forward and you you. additional interest thank afternoon. you, Cynthia, appreciate