Mirati Therapeutics (MRTX) 9 May 232023 Q1 Earnings call transcript

Good afternoon, and welcome to the Mirati Therapeutics First Quarter 2023 Earnings Call. My name is Justin, and I will 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.

welcome this and call. Justin, you, everyone afternoon’s to Thank

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

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

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

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

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

Jamie call for to before you, today. some we initial us thank for the and line before you questions. joining Ryan, remarks Laurie and provide updates this provide I’ll all will then turning afternoon’s on On the Alan, call, Thank Ben, to closing I remarks call over provide open the

is XXXX the start. great a report I’ll the to launch to starting quarter, first from off with key on pleased highlights that the I’m performance. touch KRAZATI

cancer profile which driven see delighted by to KRAZATI, team. KRAZATI’s are differentiated lung our experienced the and was rapid of acceptance highly We commercial

oral inhibitor. highly a clinical selective patients enrolling and for study began in MRTXXXXX, also our KRASGXXD potent We

to a PRMTX SOSX inhibitor cooperative direction. move KRAS enabling MTA inhibitor our Our in positive and continued

this expect we result a positive milestone study be quarter, Phase In outcome SAPPHIRE for the a the Mirati. transformational to would top-line X of addition, communicate

partnerships as balance strengthening continue sharing a deployment vigilant and capital continue a capital ex-U.S. risk quarter, and of to data-driven source a and this our and further in to sheet. remained fiscally we of explore Furthermore, employ as approach to means

very of thousands the represents the and with future continue be people to The value of create hundreds in our and potential optimistic We substantial KRAZATI, to need process. full excited combined help innovative of pipeline an of about opportunity Mirati. in

the our I’ll now turn provide to who call Ben, over update launch. will an Ben? KRAZATI on

you, everyone. Thank and good David, afternoon,

the strong in with pleased the approval performance FDA very KRAZATI following We’re first of launch in mid-December. quarter

In Our of generated prelaunch launch, our off. KRAZATI preparations million are quarter clearly $X.X full revenue. paying of quarter, first net

strong that community the to Our setting. the academic approximately We broad patients, both highlighting settings. the both and of one-third academic community and new field access experienced prescribers achieved KRASGXXC in rapid force across and estimate long-focused KRAZATI adoption achieved share

which market of all XX% accounts, the first had As quarter, over target reached approximately of of of potential. XX% the we end the constitute

addition, KRAZATI already prescribed XX% is top in accounts. In being XX of the

second-line KRASGXXC quarter a pretreated modest majority were patients patients first naïve inhibitor in more KRASGXXC who transitioned included from have on the some class. late-line and another sales quarter, early our of some treatment The whom in heavily to The of patients. treatment are bolus the patients of

of Similar based Reimbursement, on perspective, unrestricted feedback our access clinical broad coverage KRAZATI. of with coverage achieved pleased payer progress the for team barriers access positive been are access has with and rapid has patients. minimal physician we the to value feedback,

to patients two oncologist than less drug well an to able Additionally, of weeks. significantly one ahead of in services analogs obtain have received closer our which week is with patient prescription, been

staff Feedback particularly positive. patients oncologists, with Comprehensive Medicare from in or included extremely also reimbursement office was and one within guidelines the Center aiding NCCN coverage and KRAZATI Network week has approval, patients. importantly, National of been decisions,

XX%. oncologists KRAZATI prescribe to intend familiar are those approximately for is with who Importantly,

in a use by and market. share significant that believe our increasing base, we depth growth of the ahead, addressable Looking second-line remains the prescribing of our setting market expanding opportunity grow increasing to

focusing that this and We on accelerating by attributes by differentiate will market KRAZATI accomplish development.

and Our well. key XX.X messages centered around rates survival median low overall months resonating are discontinuation treatment-related response XX% a rate, of

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

perspective, KRAZATI profile CNS this there significant the is was we only the patients opportunities to of NCCN market which guidelines expand with KRAZATI. highlighting second-line the inhibitor, KRASGXXC received recently From added differentiated market. cancer cell further for to the designation, mets, a KRASGXXC development non-small lung believe

and that of approximately the lung is in XX%. patients, to We both testing KRASGXXC community continues on increasing identification Our particularly rate setting. KRASGXXC cancer diagnosis the eligible focus that of testing estimate team now time

where Testing oncology providers. to better identify with rigs patients significant partnerships as is to are we’ve XX%, such and closer there mutations at mutation account targeted opportunities community market EGFR local ALK so opportunity established the for therapies to other a and level, grow a meaningful the KRASGXXC with

the grow expect robust in to We a GXXC XXXX. at market rate

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

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

lung this approach I’ll you, to of share second our Thank across in updates Hello, adagrasib, year. development starting the cancer, half multipronged by with where Ben. we everyone. first-line discussing key cell begin non-small expect

landmark X most response score. cell of in our update second advanced stratified look approach cancer the pembrolizumab TPS duration and of half Phase PFS first-line durability XXXX our compared in with a non-small such adagrasib analysis lung is the KRYSTAL-X include adagrasib first measures, combination study. in by of will and dosing Our as

laying patients for administrative meantime, begin will this us X the quickly of if and preparing are this enable enrollment by we to data are studies Phase groundwork, the In the year supportive.

pembrolizumab, doublet this of profile combination. on study combination Phase Given the we of pembrolizumab. with of plus the and study The initiated safety focus of of initial adagrasib carboplatin, tolerability the tolerability evaluating KRYSTAL-XX, is KEYNOTE-XXX this a X adagrasib the called combination in regimen pemetrexed and

in authorization potential our anticipate the cell Discussions on with approval non-small of enrolling on confirmatory well in cancer. Phase lung the now Medicines We adagrasib second-line I’ll study quarter, X are application. KRYSTAL-XX, third Agency European adagrasib’s is well. advancing their review touch marketing

We survival be regulatory which in approval. the data for of will full XXXX, share our expect filing progression-free basis to

accelerated have the a later In this several milestones, and important colorectal upcoming cancer, pathway profile, and dialogue combination are in on cetuximab with opportunity. FDA, in adagrasib pursuing registrational we combination third-line with represents Based compelling colorectal for a shown strategy differentiated has cancer. we or an approval our fast-to-market

supplemental of quarter the We in New Application are this submit track on fourth Drug the to year.

Breakthrough in evaluating Designation of adagrasib study well, Medicine New versus plus patients, the same to the granted Our Therapy recent KRYSTAL-XX England chemotherapy Phase last December cancer of colorectal X combination publication cetuximab registrational continues enroll in of year. following second-line Journal and especially

median overall is survival the of expect anticipate care colorectal standard XX survival with we progression-free data in that and interim to full median of results. by second-line, a with in this and analysis regulatory cetuximab is retrospective on progression-free than survival believe less in mutated cancer less plus in offer months, real-world standard setting. can We that to of achieve on Based these plans months than current enrollment and compared substantial potentially overall estimate five combination setting. adagrasib reporting the We the final KRASGXXC the and on submission in the for XXXX, of XXXX patients care KRYSTAL-XX second-line current we survival the year-end based improvement

ASCO at In the a and these in the addition, in pancreatic Based In meaningful that cell treatment guidelines this non-small non-small later solid in pathways of and gain with patients these compelling explore of for mutated added to metastases. the in pancreatic standard colorectal exist. expect compelling results, currently patient year. KRASGXXC approach cell in on cancer, study, on previously cancer mutation-positive continue we lung cancer demonstrated presented granted activity including our second-line accelerated set, addition inclusion subpopulations, this no we variety for data evaluating cancer X the data updated KRASGXXC This for of to care year. approval cancer clarity April was week adagrasib CNS tumors, was to which regulatory to Series KRASGXXC is clinically Virtual lung with patients. Phase options adagrasib last NCCN largest potential beyond tumors Plenary We’ll

in a top for briefly sitravatinib, survival is Phase I’ll on touch track SAPPHIRE overall this final for which studied registrational X a analysis study being Finally, line on called is quarter. SAPPHIRE.

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

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

states of Today, inhibitor, potentially both pipeline, clinical early our GXXD-mutant I’ll MRTXXXXX first-in-class MRTXXXXX, targets protein. our cover MRTXXXXX, Alan. you, GXXD with Thank and and progress including active the inactive on which MRTXXXXX. potent, selective and I’ll begin oral the development

and incidence of with several Europe. annual mutation of XXX,XXX KRASGXXD outcomes We on in associated KRASGXXD an and the standard therapy types The cancer. of that mutations estimate poor of is predominantly lines U.S. there care across therapy is with patients approximately

full target confidence attributes low XXXX MRTXXXXX. a development plasma the for in of long target plasma the with the in time interval have consistent duration Positive target long path are dose tumor includes residence attributes of maximal fraction, half-life. cells, threshold our subnanomolar free and for high plasma potency inhibition increased These successful and for a

underserved that MRTXXXXX MRTXXXXX transformative PK, the for designed X/X As safety, David the Overall, March. large we provide study, activity solid population. treatment has option to antitumor which the potential mutation. in tumors in initiated and with began study a the harbor KRASGXXD The enrolling of is Phase advanced patients evaluate patient mentioned, to and PD patients KRASGXXD a

XX% MRTXXXXX, lines and that enrolling human a patients and incidence an PRMTX on clinical cooperative our harboring Phase MTAP gene deletion. Europe. MTAP XXX,XXX approximately greater potentially the occurred X/X with best-in-class therapy We deletions all U.S. MTA is study estimate annual in inhibitor. gene moving to of across Now of patients there’s cancers. for MRTXXXXX in than in of tumors

difference differentiated bone systemic for with were non-selective normal unmet safely results deletions. tumor MTAP-deleted PRMTX MTA the ability only make This wide a which inhibitors, these the with mechanism-based present to and compared complete rapid outcomes which for development clearly The potential selectivity to high near medical binds selectively MTAP cells. in therapeutic with achieve toxicities. compared MRTXXXXX is modality therapeutic by treatment may The inhibition significant needs cells harboring in and a XXXX marrow tumors extensive path. limited uniquely target PRMTX complex, enable in provides with index patients to gene

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

tumors. study early well near All levels exceed based Our been to properties in XXXX MTAP-deleted current the in dose and and durable consistent Phase preclinical dose which to achieving escalation our predicted levels encouraging, experience now inhibition and modeling. on PK has are X exposures, clinical continues of plasma complete PRMTXand demonstrate

the We reported limiting we early dose non-selective and plasma clinical dose exposures, levels mechanism-based of therapeutic and present including the now toxicities we At limiting from clinical look potential year, observing in PRMTX toxicities consistently inhibitors. are any predicted half this not dose activity. observing, to data safety second signals forward sharing initial are including

Finally, pursuing KRASGXXD This [ph] and our first-in-class inhibitor a to Phase potential KRAS the our example range our to strategy has agent continues synergistic excellent of KRAS this the of portfolio SOSX EEGFR potential strategies MRTXXXXX, value indications. by inhibitors. for an X KRASGXXC, to Well, is and be of study broad our maximize enroll. targeting with

of study near adagrasib with in track clinical look our this on Phase significant XXXX the across we’ve year. combining the additional cohorts Overall, forward this and ongoing updates we’re escalation to pleased progress the to dose made portfolio providing future. in in and quarter We’re X/X half initiate second our

for financial With that, turn over to Laurie I’ll our update. the call

additional XX% million our will oncology by solely from was quarter of compares was financial of the $X.X through our and XX%. million first results. few on to afternoon Jamie. of therapies Thank which in first license for XXXX steady $X.X consisted and the XXXX of for and in million, which of key collaboration molecule $X.X this metrics. first I The of net and Please our about you, revenues. statement revenues. earlier press XXXX, gross license moving revenue range expected million in financial quarter begin by KRAZATI income and other $X.X forward Revenue other similar touching collaboration for see state This sales driven our quarter walking a the line of first release to with rate to details discount the small was quarter

this fluctuate However, from may quarter-to-quarter.

approval, were was and first product therefore the quarter first of the of for manufactured Cost substantial revenue XXXX. the during were portion A the quarter XXXX inventory sold to $X.X to first expenses XXXX $XXX.X development million prior FDA of to million period in expensed XXXX. to research the and were development of same Research $XXX for the compared prior and quarter for million.

reduction adagrasib. for the decrease clinical quarter as lower Phase the to costs clinical for These manufacturing was clinical completed a offset costs clinical MRTXXXXX salaries SAPPHIRE and in and development the we advancement in ongoing The driven were in primarily other our employee support the second earlier increase by programs such sitravatinib trial related enrollment development of X increases trials as our portfolio. in clinical and to in support partially expenses by decreases stage of XXXX, an

and headcount general XXXX. compensation million and costs for support $XX the the compared The and to $XX.X for same to related KRAZATI. increase to share was XXXX due in Selling, including were expenses first increase primarily salaries based and costs administrative of in period of marketing commercial sales quarter related million the an

the share, and approximately net first with XXXX of short million in $XXX.X was per compared same million diluted for the $X.XX the We and cash XXXX. $XXX basic cash, first quarter quarter $X.XX in for or term share, $XXX.X equivalents million period loss basic diluted loss ended investments. to and of or Net a per

is quarter, burn Drivers quarter approach the burn products as recognize net our include we quarter be the the and payment, Pfizer, growth. capital cash a bonus cash sustainable accrued of $XXX.X was burn year. the deployment quarter first our Net of invest We’ve data-driven to million discipline drive vendor innovation long-term with milestone in of a launch the in and payment critical to pipeline, effectively first to highest first payments the XXXX advance in timing associated expenses. and that cash will higher

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

within our a XXXX $XXX annualize of cash $XXX to range net million. We expect burn to million

Our current is cash runway into XXXX.

remarks. the back David to And closing for call with that, turn I’ll

Laurie. you, Thank

As you’ve around of the our and centers plus to heard, a in positive there that activity Much types, is billion best-in-class beyond. near Mirati is an monotherapy across the as the address KRASGXXC in multiple market and therapy opportunity confidence potential combinations. for tumor a inhibitor, abundance $X both term lines and as and opportunity belief and of our KRAZATI of

we We’re have also assembled. proud of commercial the the quality organization of

represented marketplace. any will It be future confidence that gives and us KRAZATI products well the in

broad In make earlier. closing, to continue also We our reiterate an pipeline will differentiated of meaningful important programs. targeted progress I oncology I advancing and point made

medical Our clinical succeed motivates your of pipeline for living people Mirati, you and thousands us On company. we behalf thank is and for deep in the and to of that cancer, as and interest the day. potential hundreds at to us with every support all address need unmet of continued of each

ready for are And call with open we the proceed. that, Justin, questions. to Please

[Operator from you. with Thank first And come Instructions] Guggenheim. will the Michael Schmidt

second Thanks that are in I other with or potential non-small Phase still considerations help questions. for in understand first Jamie as lung monotherapy where just next a that a on us will pursuits line how influence Hey of then cell table other outcomes question non-cancer question and any might data half point? had any for cancer. KRYSTAL-X the plans. my get to Is was one updated And we’ll taking so the powering year the it study, this data first are how the of inform here really combination simply the steps? at X your on you Is on, line potential guys, thanks there perhaps this on much.

the me, be I Michael. going to directed handling Alan’s but questions that related adagrasib Thanks, today. to know you Sure. question

for question. Thank Great. the you

and will to of frontline, XX%, patients. which, at available this the as The data half greater than data second and the which less of you data, to driven help also one in having that again approach data XX%. able know the divided the X% is XX%, will types data different the encompasses than than be us The less a looking into So year. be guide toward

guide all adagrasib year. less at doublet the information that adagrasib pembrolizumab is And well So, X%, provide which group KX, monotherapy that for on and that evaluating combination also with to in predominantly data that the than the that. we’re will and half have as we’ll looking a us is second of of updates monotherapy there in the

will all toward at help us this guide of So making informed an process time. decision that

And our come from Goldman question will Salveen with next Richter Sachs.

Hey, on thanks. This Matt Salveen. is for

Just a the KRAZATI on few launch.

the just finally quarter, still you linear you. Thank end expected share know do of LUMAKRAS? do the expecting what you sales? for of stronger trajectory then And likely and by what switches you than given First, driving kind is was are the the year a from think

We’ll questions. have Ben Sure. address those

Sure.

as third really in KRAZATI, mind any as of future. that saw in said we expect of and new a patients, mark could to remarks, constitutes the is new So one that’s which the, XX% see the we what a, on for about my only you at starting but time keep in patients prepared about patients

and So In about from we of excited to two most date some are the very common came seen there. moving well some we’re were had present. had was physicians as the where which where LUMAKRAS, switches, to growth the we to there physicians looking around patients, the GXXC again a reasons met reports regards that CNS other of inhibitor some switch as from hepatoxicity

getting we think And KRAS, And moving have we we leading is hold volume, play in linear time, then estimate believe we rate market identification better are confident be QX patient adoption. the, will adoption but the that a beginning that for will testing is type the forward. we that get yes, regards think increasing We that, directing or we ultimately a too, more particular guided this because as forward, in around we linear on to we’ll Again, as our to growth well not that to there. we’re at patients of at of XX% which still, move occur. increase as are of kind but do increasing the we still that still

Van question come from Tyler next Cowen. our will with And TD Buren

was us question preclinical in taking you based and the patients on encouraging what anticipated for treated MRTXXXXX, early being KRAZATI Thanks as bioavailability from congratulations pharmacokinetic guys. the Wanted KRASGXXD the Hey and the ask launch. all data on tell early the or can to the expected progress on or comments looking data? upon as if

Hi, take obviously. Tyler that have will will Jamie

Yes, been of far, the among enthusiasm open Tyler. there’s a investigators I so Sure, to lot think, trial.

have study’s tolerability patients the really available the and has of in and the activity at cover But far of in sense So interested a been context. our to experience and good. readily is provide PK update a quite well, enrolling our plan been likely so later time, clinical fulsome early it all XXXX to

plan currently. our that’s So

Okay. to Phase for half And up the a then? of reach that XXXX, dose plan is hopefully just update follow by for a the first on recommended X

to our would the at dose a then present some able to Yes, be Phase X it data the in be goal recommended related XXXX point dose, Phase timeframe. recommended and this have to year, X

will question from come next Gena our And Wang with Barclays.

two have I questions.

explored? also what XXX dose a the type new The of the just levels good to milligrams have patient, I with also how patient asthma enrolled sure make cancer window the first patient including when want my already GXXC. patient, just the all out kind and second treated, and confirm, of patient also wondering you to you due Brainlab Is therapeutic for the you wanted said And XX%, many a is experienced naive both GXXD quickest? optimal question one, regarding that’s

GXXD well take Jamie first the Gena will Ben and So then question.

met. question, those XX% patients the the the line CNS both approximately as as of Yes, of was for inclusive with well thanks So Gena. characterization late

the kind couple get sources. composite in maybe different again, of towards So but of XX% next it’s is of of all-encompassing those across better a we’ll months the for middle year, an those update more an a color the

early on days then, in trial. the Sure. And question, GXXD and it’s yes, the

dose in We escalation. are

dose making escalation be a at level, the do to a We or approaching study’s XXX PK XXXX daily basis of modest what exposure. but progress. the therapeutic good in, guided believe for done we’ve could we’re on haven’t below cohort milligrams currently predictions again, level and

to we continue a in soon open data XXXX the looks an It’s reasonably we like be updating as So we the data study. monitor study. timeframe. package, have likely the again, label would as And sized

question Jonathan come And our will with next from ISI. Miller Evercore

on confidence up a you that reasonable get update. much that at first GXXD follow that for point, my for at expected a ORR to I what’s that amount you give instance? of to formulation. an year very this on have the Thanks data meaningful taking would to to I’d has be able of from know, going evolved of half you IV. guys. expect like was question. you also And and that know sense Hi on estimates RPXD bit color oral get the just little Could give be next giving want I secondly this need PD, to you’re originally formulation? you how to we’ll

coming and, appreciate and it’s piecemeal very Jonathan, David going the Yes, there, all with The well, around data in just want second we’re know to pass a but not program about enthusiastic the let questions to we’re do is in everybody as I’ll to enthusiasm GXXD. on Jamie KRASGXXD. and

pass now. out data ready. come to with Jamie package it I’ll fulsome when it’s to going on We’re the

think a Phase to course, dose, X is sure it just but want I reach it build comment, And to to Yes. of our David’s we get we out make right. recommended goal

trial. dose and we clinical formulation So be exploring will in our schedule

the is, of think, that I So part the question. first

The second to related is part formulations.

in preclinical So been multiple developing we the have formulations setting.

formulation us We exposures we exposure will those lot a that confidence given of a administration. achieve have the ability via in the therapeutic has to believe oral and reach therapeutic identified

the exposure increased greater. tenfold up to or or have that by formulations identified have AUC we setting, preclinical the In oral

formulation. confidence and with evidence hit reach exceeding you to with have couple preclinical the oral exposure, when to in goal or with threshold that growth us we target bioavailability studies the the of that this given We particular at systemic And seen XX%. has concentration can regard really

like and we’ll exploring number throughout a including would has course, target regard oral to ensure dose administer believe be we full opportunity the this full maximizing important program the we here, with for to drug, continued cycle, for with is KRAS coverage its to interval, of be the ways which to life IV. continuing important and work the Of inhibitors. But we’ll manage maybe

to Stanley. with Morgan Ulz Mike on moving And

Thanks another Hey question. for the KRAZATI. Maybe just on one taking guys.

Just curious, since launch? increase you’ve or launch the in December, the steady Thanks. back in inflection KRASGXXC, the for is of of if testing noticed been sort rate since an

that. Ben will take

got we’re testing it’s keep to of are sure Ben. patient now available patients. and so a number we place or in diagnosis that. I’ll lot mind a a Sure, XX% to in well in some some not take right in spending even a The as because, local is records to in regards those and of that, That’s as continue the developed if those effort And those being time see that the physician, number frontline of low XXs. you’ve Unfortunately, make really in have tested. frontline oncology immediately where of improvement identification. physicians again, helping we’ve partnerships working we’re patients still to plans identify community that’s

to is So identification again, both to market and the well great patient really done really, a as a we from grow, think testing deal nascent it’s standpoint. front as a the on has market room

XX% marketplace earlier, that, Ben growth in the volume as with well. discussed in as And

significant marketplace. So this in upside still

Thanks. it. Got

And our next Stifel. come Ben question will with from Burnett

the across that had there results about in regulatory question variety mentioned? like do the guidelines Or the adagrasib actually seeing that a cancer earlier. about various for a recognize path for a of pancreatic a update addition I tumor-agnostic to path Looks treatment FDA? about you tumor KRAZATI of spoke you the to you’re Hi, study types. adagrasib you great. with Is basket see you. out Thank

Alan Ben. going that. to take is Sure,

Thanks for the question.

So be in we this important FDA, it’s with there. the are one that we’ll discussing communication and year one with and an that

different different, that can As they you’ve mentioned, are approaches two be taken. actually

having you a – We’re that. potentially potential plan, also that looking toward response of had indications discussions of cancer with and backup the mentioned, have pancreatic is two individual as and the Cholangiocarcinoma, individual we’ll There say, that approach, of rates. with higher some tumor-agnostic diseases

year, should the an give this be regulatory to you there. able path So on that later we on update forward

Okay. question program, great. ask if I PRMTX MRTXXXXX. follow-up the And on also That’s just a could

mentioned I I that where not escalation you’d I could point. give expect to just that activity you dose think are if believe where of was schema sense in work. just you’re preclinical relative you DLTs maybe us this seeing based wondering to you see at a on

Yes. said I’ll program Jamie what I’ll over a we GXXD with that second. in as to our put about well. caveat that

about excited XXXX. We’re

not data. going to release We’re piecemeal

later a is data I’ll to have update. pass will over update plan fulsome that, We it XXXX. The And for Jamie. with this year this have on to

Yes. Sure.

through And Again, make been investigators, several the we’ve nice rapidly and program. escalation able progress cohorts escalation think patients. dose enroll are we’ve these I the are and to I very now in able to the been cohorts. think, increasingly dose enthusiastic are for looking

not toxicities mentioned, And our escalate as continue at dose-limiting limited to to this time. have ability

and early a looking So questions key way tumor at activity now of our of there guide to signs about kind are of dose. pharmacodynamics clinical selection as

are now we what those a have said we and do point our having data, preclinical target the targets. taken will exposures at at looked cover that believe at be that would when that, dose And we therapeutic levels are

about say to look we’ll progress to talk later to them forward being this date, I’d year. So able and good

And we Jason of have America. from Bank a with Gerberry question

patients were quantify Jason. I the questions. shares of can of I in the guys. you is new And think on think one-third wondering you new Hey This said patient number the that one-third, Chi our I’m – of treated KRAZATI. if taking for share. Thanks had for KRAZATI

numbers on provide quantify you. numbers. I’m you to can well. would level of That hoping be some Your patient like part competitors if used helpful. Thank of sort as that new

to pass I’ll it Ben. on

a around consider accounts so this the that’s in window future. the volatile, think Yes. We that a see stage more that could some particularly in numbers because guide within data little robust the tended bit set. We at right launch the to we of patient physician

the then be and XX. in been field to team’s and and been written What key of to we about again, have been execution really of XX% access adopted accounts has able the top actually happy promote actually and, XX%

only we consider opening field So about data we the in measures very great up talking not future. happy additional execution, but are a very again, kind from And as today, with where strong well. of and sales access standpoint, can

with patient really we’re in momentum KRASGXXC And new Yes. the class already. the one-third pleased inhibitor the starts,

And with Raycroft moving to Maury Jefferies. on

pembro prescribed prior additional prior relation And to update. for on congrats if hepatotox the doing was Hi, share from treatment. from anti-PD-X real-world mets, timing the wondering that Thanks are question. they use, on the with being including just there? my taking LUMAKRAS perspective perspective can those patients for any you how in CNS between the on with I is patients KRAZATI, KRAZATI observations or switched how

Ben? Absolutely.

Yes.

So thanks question. the for

benefits KRAZATI we’ve close have it in tolerable prior first-line write and to seen, very displayed We heard not that we because our have profile anecdotally the a one to some combination a sequence the standpoint. as from of IO seen the hepatoxicity of therapy data, of is seen we’ve ability with

requiring washout from with actually, our the advantages is something period multiple So actually, a academic because standpoint. that’s as setting. we up we’ve study, times, And we we’re that not XXX has profile have think something come – a there actually that that reminder, particularly a in

little In of get been relation to sense a or hepatoxapy which have patients, early CNS too mets, it’s due to bit either that. strong to just the a switched

physicians with on the to considering for up in have really purposes early from but how publication following studies doing. standpoint future anecdotal and be who will clear very sense have a case that they’re this these We be

JMP a Securities. question from have we And with Tuerkcan Silvan

just triplet, chemo the you’re decision seeing a talk patient data so Thank If just populations bit scores doublet about with frontline? make the without the could here. very update Congrats the in the in you of here? that in can tell for And for regarding the cell lung anticipating taking year, Yes, non-small have my thank we thank bit you. second and I the having the the TPS how But question. could update half us that a cancer we much. options a how on understand are little frontline you you little pembro we you about, the

Alan?

the for question. Thanks

is well. predominantly some So greater which and debt of have forward, with the than less small XX% than waiting update KX, the the across the of we’ll will we all in greater XX% the recall, And cohorts, with which patients is for XX% course, have update in doublet, on that, the IO. as be data you at we’ll encouraging did than although moving

In that started the has is addition, adagrasib KXX, that to looks ongoing which activated essentially add have and to KEYNOTE-XXX study is doing now, what we’re a regimen. we has

that’s drug regimen. So four the

of is predominantly into the of be able as direction be a this an utilizing the totality safety what cohort review we’ll Upon approach. to and evaluation, also data in data that well KX of data second looking this of as the of and an forward year XX%. to than to We’re less then at and part that with year and the KXX as make the which half able latter which some to at emerged for opportunity the look decision best has move the informed

Joseph And we with JPMorgan. Eric from have a question

good question. Hi, taking Thanks the for evening.

So about I to first of of on in the the out net contributing Phase range be particular phase quarter? XX% types for inventory the I laid the guess, fluctuation X on – how histology I’m second launch should the bias tumor guess that’s if any we of breadth the also so escalation given gross just here if far could, build Thanks. quarter there’s addressable this the mechanism, then in and dose sequentially of thinking And thanks with to expectations tumor so or to any the concentration any the XX%. in trial? print. I And color wondering you far. XXXX,

take will Laurie second. will the part, Jamie then the first take

Yes.

out on we the million we modest in a $X.X for pharmacy just model, seen don’t of build. sales, specialty distributor don’t model, Based amount inventory. – we inventory of So large our see have expect inventory, our and

in discount move the the we rate, XX% expectations our to On that’s with as line kind through of XX%, year.

But oncology launch. is expect that hold to year. that kind we where other quarter-to-quarter, kind products, of the days range given be. will We see we especially in fluctuations of line and with It’s it oral expect for of to the early

broad of our Yes. the And a front, about first, the of think escalation. different enroll different Phase tumors your We’ve spectrum tumors. on question seen I X on XXXX types

types representative So deletions. of tumor I think have different a with lot we gene MTAP

is And thoracic that say cases, will the units I our other example, have or a number we GI for PI. in for oncologists, sites we good have of otherwise. involvement

our in based So data on in gene of different believe responses do preclinical the preclinical both we frequency tumor the in terms of deletion seeing types. well models as as MTAP

pancreatic like both like of these smaller ductal as where a develop monotherapy non-small the our monotherapy response cancer, rate, lung our using as well frequency and mutations, mesothelioma, response a and squamous possible as requisite cell, There may design if an we that’s to reasonable we both activity it’s that clinical driven the as strong as investigators. cell indications adenocarcinoma, and would primary accelerated of expect of be see as that adenocarcinoma the well trial settings drug this somewhat of endpoint, selection a certain

Citi. a take we’ll with Yigal And question from Nochomovitz

commercial being experience? the rate, seen you questions. there? the XX%? you comment Ben, clinical on you respect you’ve And to between just split think Hi in KRAZATI, conversion on regarding a made I of a discontinuation to you you. comment then the comparing uptake rate is the prescribe for with the academic the launch. thanks the the comment on versus then in that for taking and to prescribe third, few and how more the setting for XX what Could community the Could intent Thank

I’ll academic setting. your the been community obviously, with in leaders thought about split. the because it’s is you more academic actually encouraging quarter, to It’s a which XX-XX bit have the academic the in Sure. start first weighted

to that been the term. the great community mix so sales seen the to such focus and follow, adoption We So longer expect it’s do time, across that force over academia. big of strong a we’ve constitute XX% of XX% that’s efforts, our to expect closer to

we relation profile and stated are intent In physicians who in that to of prescribe, conducted part those first the it’s survey XX%. And to familiar written with that’s the their the relation have write to that in product in and around not those the intent a yes, for KRAZATI. quarter future, to may that may or

a every a intent have like. intent. rate very positive survey the conversion just there. again, of that of looks But I indicator what very strong standpoint So from don’t indicator that’s exact a

just third rate. of remind The on discontinuation – the question – oh, was part the yes,

not only unusual we’re performance very anything quarter We’re through. December, but mid- the that, early. surprises is Again, broadly comment of as see rates no obviously, than here. our in late first beginning seeing It’s product to very really late early launched We to come the refill December. to here more

So very comment standpoint. on from to not early that anything of that, seeing usual we’re that out but being

with a take Seigerman Markets. question Evan we’ll BMO from And Capital

about cell ask those Hi there is in markets on We with second-line markets? think are Evan. for when lung? teams cell anagrassib do synergies to third-line and [indiscernible] guys, relative non-small this you how to leverage any would wanted to for colorectal And the size sales the the Thanks. able you be non-small entering

Yes. Well, Ben take that. will

writing particularly really actually Colorectal vast possible breadth pancreas the are the of therapeutic it areas important majority which and the tumor very and with across shows across is are in prescribers where important really that’s of important. types, addition because us, to in the efficacy cancer Sure. indications for community KRAZATI that’s

X,XXX pancreas with indications in relation have to we and and of in there’s and we regards And to the think patients CLC about opportunity as addition, other numbers, In then beyond, there. couple thousand there’s well. the an from second-line a

and help in think are are supportive the have the it’s need, of So really but dire overall a not unmet profile we who ability these numbers of dire patients KRAZATI. to [ph] our really only

we cover synergy We to colorectal would those targets a add well. need they as that. got don’t from energized the And We’ve a infrastructure we’ve and off standpoint, field force, to experienced, built need. to super be able

on about there come So yes, to and opportunity that. the more excited

we Patel Kalpit from a And question with B. Riley Securities. have

Andy potential Thank Fleszar for the regarding you publications. Kalpit. is the question. This taking from for A on lines us couple for time

some First, of the we lung presented are how frontline and you cell clinical And expect December, to Cancer in be should non-small we data patients published? many from cancer centers unpublished outcomes Institute these Dana-Farber worth data when in expecting?

with preclinical the are second, any then when earlier? data formulation lines see that inhibitor a of bit publication showing there discussed a the oral surrounding And GXXD we time could you

Yes.

I think this from Sloan-Kettering, manuscript working outcomes the that to there. that clinical and MD on There’s well. Dana-Farber out Anderson follow has some been another frontline, regarding as of going is is from published the Memorial manuscript on is data

there color we So additional do anticipate being public out domain. in the

the like subset, a has a organization And experience, institutional reminder, additional often covers disclosing center, as just that been We’ve at Tempus academic a clinical on population there. and think with together, patients working when large given strong within in trials both the is been less the in [ph], enroll plan that and the put do than where overall, XX% which regimen institution. providers data unmet to on addition outcomes look with need In I that you we likely at KRASGXXC collaboration point. there some is the in medical

tying to Regarding be any I likely forward-looking data think clinical linked will publication the GXXD, data. strategy our preclinical with in

time the and be likely XXXX at XXXX XXXX think, being again, I the looking updates for in frame. we’ll So,

Oppenheimer. Jay with next question from our And Olson will come

taking talk Hey evolve? I I key progress. There presentations And guys, GXXC points to you. at data congrats a field have the about AACR few And And how differentiation inhibitors other if you Can KRASGXXC been across the emerging Thank all a conferences. the PRMTX, questions. for recent the on follow-up our of and thank on do landscape? could? had then expect you you on

think of the Sure. at that the Yes, I competitors. space closely we looking on course, are GXXC front, monitor and

where can points that are adagrasib believe that we leverage. think a do attributes some we number there are there I for positive of

One in is draw dose vast the avoid hard variation. kind for peak have BID and that those is places. And to the One high ability the of target to very schedule little full I the interval long the the X if half-life in we then peak majority, concentrations. to where hit of comes really not think

a hepatotoxicity to the also facilitating haptens response drug is The as we’ve that favorable it good and relates the another binding the [ph] fact down have fairly it when us of particular captives ability to and aspect do can able if second has the believe it immunogenic profile where help in that this immunogenic been I ratio, place off-target adagrasib affinity, immune-related peak dial is immune-related point attribute a think non-covalent flat has that run comes index. immune don’t the observed to AEs have we’re going that profile we an to due therapeutic concentrations off-target of to to been this index, therapeutic helps driver the I issue, reactivity associated may into comes especially when a a to hepatotoxicity KI has avoid toxicity cleaner with where

Ben presentation, adagrasib. we maybe to We that with this where and that penetrants, his that profile have a regard best-in-class we in another leverage can for had we do covered brain believe believe do is area

in immunotherapy monitor So number I advantages leverage and the to ability frontline think space, one we a of have continue that but setting. of those is gain we advantages, here. emerging, we with presence that the to do combine think, And and is the

overall is I’d other inhibitor survival say able approval is combined activity, of we’re our finally, agents then advantage nice very in across and rates a data, we response KRAZATI, Yes, our the the ahead have EGFR Jamie, marketplace, with folks, on various of tumor types, immuno-oncology, thank too. too. to we’ve I’d conferences, that, What also multiple build such you as CNS just years shown that. add much. we’ve been at present to or And

leader, feel that a market we’re way. KRASGXXC well as inhibitor we So, on our

for Therapeutics so MTA initial year? program? there about And you and any helpful. Thank then And you from the Great. Tango just the talk much. is later cooperative expect from what across the we That’s should this can data super PRMTX your read –

Yes.

few I a think there. things I’ll mention

to where we patient dose-escalating that pool. in and would So year, expand our different Phase can a study, dose Phase enroll where think perhaps levels, at this be in hope shortly Xb I expansion, the patients our set additional I we But expectations. to data two

dose escalation, four we’re piece. to We escalating patients three a of in are and with cohorts

would of provide towards have. the that we patients color number should So that

of PD, clinical second the any be present that goal signs PK, is think I activity. early would to point tolerability our here and

this relative cells that, we advantage don’t think that being that the to SDMA And of MTAP-deleted the One to to ratio we ICXX. for able at important is XX-fold And about XX-fold to tumor achieves our is cells need deletion. to that if think I to allow program does have harbor an us here that be what needed and issues. pharmacodynamic for PRMTX historically a neutropenia, preclinically tumor differentiation take and that is of feature to this have potential to do MRTXXXXX some avoid of see the there. tumor responses. ICXX will relative an other that’s thrombocytopeni MTAP-deleted that the associated cell, PRMTX-dependent level levels in And think we myelosuppression believe we’re off-target other believe achieve we been home inhibition able target a I programs out And with

update second year. to that the this be of half give able fulsome we’ll And in

question a take with we’ll Fadia Ami And Needham. from

afternoon. taking questions . good Thanks my Hi for

give be wholesome you X sounds were you could us some data wait the presenting? color they then dose, like will data to the MRTXXXXX, recommended size and Phase to achieve you on a It more set on set. First the present of

of expect would be cover Thank to if give then time? mind that we what should as benchmark on to size you as that able So some color by histologies some you get that we data? in as And well can the keep us be the that you.

I’ll begin on MRTXXXXX.

year. in trial the just we dose March Phase reminder, escalation a Just this started X of

with So it’s early the days program.

mentioned half in will fulsome Jamie the As XXXX. update by of first that present we

point It might So many a premature in at numbers will that days. be little Jamei? Anything time. bit else it talk about to early have how is

Yes.

color optimization a David, size agree. dose get opportunity to reasonable additional dose-escalating depends this to study. to ongoing and a takes provide a Phase set other X is levels many dose is of expansions, have how on Phase dose of really, how than the X that Phase recommended to in It’s to I hard think with say data it Xb I up a and the and much the lot

second a to what to alluded is question you think I expect.

in where really ductal the do the pancreatic had agent learning we’re there. where a as development response potentially tract Clearly, path a based we biliary with seeing our adagrasib earlier to we accelerated rate. think long drug are response space, durability rates the associated with single opportunities and I setting, able GXXC opportunity is arm mentioned in being in there in on and single So, develop know setting, monotherapy adenocarcinoma monotherapy a that

very likely and a And will we finally, to cetuximab note then looks cancer there the strategy mutation, that good colon apply also think clinically. XX% of KRASGXXD combination preclinically has do

do So should in supposed do the that those provides clear what to particular drug a really, settings. it’s I development path think

deck we in the is investigators patients as we’re here very opportunity We’ve for first-in-class, all a MRTXXXXX. enthusiastic patient So over as as Mirati an The and on Jamie hands can. U.S. for opportunity. XXX,XXX moving The got mentioned, it’s this. Europe. is, a This population is so about incident are fast significant the year

So we’re as as can. fast we moving

that over conclude the session. back does And I’ll for remarks. to question-and-answer the conference now closing any you turn additional or

afternoon. for updates additional certainly and Well, thank interest the you, everyone, year. appreciate we with joining you in throughout We this forward sharing Mirati, look us your to

your you. Thank does for That conclude excellent We participation. thank day. today’s do you Have an conference.