MRTX - Earnings call transcript Q3 2021

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Mirati Therapeutics Third Quarter 2021 earnings call. My name is Keith (ph) and I'll be your operator for today's call. All lines have been placed on mute to prevent any background noise. After the conclusion of the speaker's prepared remarks, there will be a question-and-answer session. Instructions]. [Operator pleasure Mirati. Asay, my Corporate President introduce at Affairs to is Vice Ryan of It you begin (ph), Ryan may the call.

Ryan Asay

events Chief David Thank to you, and Christensen, Mirati Head are Dr. and President, call Accounting statements and Vickie materially will forward-looking Mirati's Please this results this are future everyone Dr. include deal 's Meek, Jamie statements. afternoon's Chief call. of Baum, note actual Keith, With me Officer. Founder Mirati's, statements. and many conference Reed Mirati's from to Executive the forward-looking Because Officer, welcome with Chief Development, Officer, uncertainties, Chuck the Research risks and today Scientific subject that those and in differ may

uncertainties, September results corporate ended financial Form XX-Q Securities report our For website and press a you. we I'll please of With the section filed This full the at the This review afternoon XX-K on Form turn is our released our discussion on mirati.com. recent quarterly that over reports are that, updates. for Exchange Commission. available U.S. with and to call annual Investors and of and David, risks on quarter XXth, these the XXXX release

David Meek

on months Thank a your our and update On at near to most of few has results. since two Mirati's our It our about provide you, for differentiated biotech Mirati Vickie to CEO. clinical remarks in Mirati comment introductory afternoon, confirmed exciting science well programs, long-term with will one I and plans innovative novel update summarize financial and hope operational focus we thank a is will questions. therapies some an on joining These and this development the leading preclinical busy potential taking our my programs, on been of and this have to into a conviction weeks rewarding relentless you on bring There an oncology I biopharma. announcement portfolios company before Ryan. translating Good everyone, to in us. provide way is call, creating to are Chuck as afternoon's before share first my Jamie and company. asking patients. tangible that the our then

progress continue and our to best-in-class. rapidly We believe make for and expected as advancing U.S. stage profile our clinical portfolio Adagrasib. Adagrasib commercial we of clinical significant capabilities launch on the pre-clinical expanding 's prepare We is

drug review recently cancer. to the lung the the announced of designation addition we as previously treated first June, part real-time in In pilot oncology FDA process breakthrough we or submitted program, RTOR, cell data package therapy non-small to Adagrasib new the for submission applications

this We are NDA on track end the year. the submission before to finalize of

U.S. lung are well that for transformational this preparation and its to recognize look launch to phase a been cancer. cancer, docetaxel evaluating treated development non-small X cell in first-line aggressively randomized X in cancer. line trial X second year. we patients specifics forward sharing To registration-enabling cell A proof-of-concept for with we trials phase cell has and including non-small lung potentially Our therapy a Adagrasib plan, broad cancer full colorectal advanced lung phase KRAS-GXXC Adagrasib in our mutated in potential, and about underway launch planning next trial confirmatory for previously non-small

pancreatic with additional enabled capabilities drug and Adagrasib programs, Beyond cancer And multiple of preliminary portfolio the patients. of even growth tumor programs, regions us we including our assess our of and capabilities capabilities, novel such settings development the and strength innovative markets, with To date, us we the across and to These have employees combined for this provides help as execute potentially in Adagrasib cancer, over With and I'll key our on own believe all grateful and When strength, our in novel very combinations. enabled while them non-small targeted partnering success. Sitravatinib lung our cancer and to have team. their to The pleased I also our with like long-term more team are thank it cell would solid we're continuing colorectal that, to oncology and results in reported fuel selectively sustainability. for for Chuck turn passionate I'm of accomplishing. mindset research dedicated (ph). to potential acknowledge and internal China.

Charles Baum

Adagrasib X our late-stage Sitravatinib. David I (ph). Thanks, programs and registration will address enabling

the mutation cancer results dose a KRAS-GXXC an The rate review. disease prior We a Adagrasib that significant milligrams results Last from cell cohort lung independent BID, harboring with rate best-in-class showed XXX following top-line positive KRAS based for on demonstrated mutation. progress KRYSTAL-X tumors populations response advanced month results study of Adagrasib in solid therapy. systemic central multiple GXXC we XX% seen harboring announced registration control make continue non-small the of and clinical and a objective top-line patients with of to across have patient our XX% of at

data Importantly, received United regimen, cell a full almost care with chemotherapy present advance inhibitor which in commercial our We reported and States. XX.X% in that congress patients tolerability cancer. to all for in profile at was trial reported platinum-based U.S. patients the following of a the with medical consistent is treatment this checkpoint launch. non-small with We Adagrasib previously and in set the lung anticipated both in a results the XXXX of of advanced plan safety Adagrasib standard

the monotherapy received duration data X.X top-line reached. median results, Adagrasib XX had response the Phase in II cohort XX was study -of progression-free a least - survival one months XX.X the at to follow-up from survival in XXX addition at patients in prior These In months, updated of patients and we XX of who I, median milligram BID therapy. with months. treated a overall had of reported KRYSTAL-X also the patients a not median systemic responders, Phase yet The median of XD

enrolling non-small previously treated is cell KRYSTAL-XX lung trial, patients. confirmatory X Phase cancer Our

our part for year's of as cancer. is with U.S. important application mentioned have pilot new an the and remarks, (ph) lung non-small program patients drug Mirati the As This RTOR submission the complete expect David step end. to in his we cell and FDA initiated opening to by

have tumors Adagrasib other cell and in have we multi-pronged broad approach development express as first-line and non-small well monotherapy development that both solid for patients combination. colorectal lung with cancer cancer, and lung We cancer, KRAS-GXXC a plan aggressive cell as mutations. non-small In a in

in development in first-line We mutation. tumors unique express of are Adagrasib exploring cell cancer KRAS-GXXC patient non-small patients, as lung populations the monotherapy a whose two

KRAS-GXXC a potentially The first approach is trial. of co-mutation and XX, where we single-arm in whose tumors an have ongoing SDK patients registrational first-line have

months. TTS approach whose a scores have whom less STKXX tumors and of potentially X% scores standard approximately patients of X with care have of medium with less in prognosis STKXX study. than progression-free real-world less survival patients first-line is the X%, of the co-mutations, therapies than The is approximately poor single-arm XX% progression-free TPS median first-line response co-mutations with that data in published of registrational survival second with Patients monotherapy objective we rates a In than initiated or in suggests

Charles Baum

months. cell KRAS the these XX% population. of greater cancer non-small lung than X sub-groups represent X patient GXXC total first-line Collectively, patient

populations patient the pathways discussing each are the these potential of FDA. with registration We for

the the Of were TPS a Adagrasib enrolled, X all RECIST and tumor is for at rate could XXst to dose added therapy target cell milligram the X patients using partial later milligram achieving approaches indicate XXX% that Pembrolizumab. in approval with based to the dose BID. data leading manageable with Adagrasib of the key the a comparing the XX%. In no Adagrasib dose of the our with We was or response Adagrasib for XXX Adagrasib the response study monotherapy were according KRYSTAL-X these the prior trials. a milligram combination at are keynote results X cycle. over milligram the patients overall disease to the Xb Grade dose resection tumor adverse in tumor of Phase adverse cancer. for patients BID levels, the The trial complete additional exhibiting as These addition Grade who milligrams a milligram RECIST. the inhibitor chemotherapy of We One XXX as this lung with clinical experienced evaluation treatment which advancing combined and Of milligram the of non-small put KRYSTAL-X the were KRYSTAL-X dose overall cancer had combination that front-line with patients naive with full still Phase and both focus full the all We treatment XX% reaches dose with of target XX X as we confirmed dose no plasma and our non-small events profile XXX cell we and patients response XX.X% rate treatment-related the coverage combination Pembrolizumab. Collectively, evaluable of of To XXX ranging has of is combination Adagrasib evaluate full we to began have reported with in evaluated scan, patients clinical results on tolerability dose Adagrasib of frontline area note, preliminary patients the observed. in cohort X control response have Pembrolizumab combination XXX BID scores. allowed discontinuation KRYSTAL-X BID assessed clinical XXX the X platinum to Pembrolizumab was XXX regression approaches, combination from trials. the first-line level patients of dose perspective, combination setting of for go-forward X well events dose Xb and to evaluate the October in the in tolerability regression XX% Adagrasib. threshold checkpoint X across XXX After having KRYSTAL-X be response profile cutoff. at to concentration as in study Out and evaluable first -- BID in patient Pembrolizumab resulted Adagrasib of at across in before confirmed patients, of of enrolled an BID full Pembrolizumab lung of the XXX BID identified

mature, are data for follow-up months, X on months, of had with a as on cut yet off and the been to and XX X.X still treatment treatment medium remained X the the ongoing. not are X of patients of While data

X by of KRYSTAL-X Adagrasib Phase is with Phase trial, milligram we Adagrasib now the X in score combination a which study dose patients to planning XXXX. stratified initiate Now, are TPS and registration of Pembrolizumab enrolling are XXX at in BID

of Adagrasib with Adagrasib inhibitor. combination inhibitor we'll and strategies and be brain based to non-small activity inhibition combination the Phase of lung 's Boehringer forward extensive 's ongoing evaluate continuing Ingelheim eGFR, on ShipX addition an with Sanofi's X have first-line on Based clinical may clinical supporting SOSX with benefited and collaboration and metastasis. includes to including study non-exclusive non-clinical program the a about are setting. additional our combination look emerging focus investigational pursuing to Sanofi sharing combination recently with signed in patients other science. work, explore In clinical our cancer Pembrolizumab, the we additional that to next ShipX in year, approaches We have SOSX cell Adagrasib updates data We agreement

for monotherapy Oncology European XXXX pretreated the GXXC cohort and from results a that dose cetuximab of harboring patients with Society for Adagrasib combination control at Phase significant clinical a approval the to heavily the in The with FDA can During compelling colorectal monotherapy in mutation. results results pathway for or Congress, demonstrated KRYSTAL-X accelerated with BID milligrams of both and and with showed discuss shared activity combination XXX KRAS potential Medical a as study, Adagrasib disease cancer evaluating X-X plan in cetuximab. ESMO, late a these favorable to Adagrasib a patients cetuximab line We continue to tolerability the broad with determine alone enroll as cancer profile. in or colorectal or we

study Our with called of Adagrasib therapy is randomized colorectal with cetuximab Phase are X Adagrasib in as well-positioned KRYSTAL-X with X patients global enrolling plus cancer. patients registration Overall, second-line we colorectal cancer. enabling best-in-class a

highly mutated pancreatic colorectal preliminary study. X-X and results recently also which in shared are and KRAS non-small cancer warrant furthers encouraging cancer, cancer, lung GXXC efficacy positive Beyond cell we Phase

prior demonstrated experienced checkpoint combination cell Sitravatinib long-term study and are now inhibitor who cancer, at X an or results with with be types, a mutation combination pancreatic pathways the tumor non-squamous, on of and MRTX-XXX durable our The patients alive year's Phase of Nivolumab we will presented FDA. endometrial, cholangiocarcinoma, non-small XX% on We registration with that cancer update at we Sitravatinib. years solid evaluating tumor disease clinical with to KRAS-GXXC I'll benefit from potential this recently in X patients conference. including has ovarian, in survival, any and responses patients with lung provide exploring addition third other In other ESMO including a line second subsequent

Charles Baum

to Phase patients combination or following phase On documented Progression. with cell second X non-small -- reach who of turn Nivolumab to registration an in in survival SAPPHIRE the of that, needed third-line events is I progression programs. trigger our number have to to XXXX. pipeline inhibitor a preclinical in checkpoint study interim Jamie our the of over it with enabling second analysis will With treatment on lung half overall cancer track describe

Dr. James Christensen

Chuck (ph). Thanks,

We discovery have cancer on our targeted built for the also that and novel a of existing practice cancer that pipeline, opportunities capability patients. focused that and changing therapies at highly further offer productive development preclinical advancement is Mirati complement potential

present on based gene all are First, the of I'll This nearly to XX% deletions. cancers. lethality Program. principle MTAP These targeting synthetic founded was our deletions next-generation speak in of gene human via PRMTX program

MTAP at -- sparing the as deleted non-tumor abnormally best-in-class program. high-quality for the generation human Conference, methylthioadenosine MTAP candidate XXXX XXXX a the contrast to development pure known XXXX strong ENA, together leverages levels time MTA able targeting characteristic was the cells, presented inhibitors has metabolite and supporting co-operative target characteristics, to elevated cancer This properties first is a is also MRTXXX-XX possible which to of AACR-NCI-EORTC or opportunity. among while complex. MTX of the of In which predicted a exhibits known PRMTX selectively International strategy for first unique pharmaceutical target MTA, healthy cancers. As the PRMTX designed clinical as this -deleted PK Thus, selectively edge leading and MTA is is cells. inhibitors,

potency have profile versus MRTXXXXX, wild ability half-life. and at KRAS-GXXD. pre-clinical selective work of last and KRAS protein states, XXXX, ratio characteristics just human of along in the for KRAS-GXXC. we The We're inhibitor beyond therapies ENA of potent addition, highly insurance inhibition predicted I by conference, and developing inactive single-digit overview and GXXD mutations discovery GXXD accessibility development both KRAS which an At nanomolar bind directed the significant of selectivity XXXX-fold KRAS KRAS-GXXD. In ongoing includes a and to provided encouraged our - and targeted for High first-in-class month's

including also proof coverage principle as observation We assess development observed potential this variants. formulations, strategies, have the continue KRAS marker maximize month's to extent generated of and regression mutant proof-of-concept mutant are the inhibitors, which yield E&A pre-clinical various eventually for PK Last in could liposomal candidates spectrum-selective of non-clinical designed KRAS We a approach tumor tumor data view long-acting IV models. KRAS to including multiple duration encouraging targeting target and strategy of which data. included presentation targeting mutations. platform

development. compounds KRAS programs lead spectrum various optimization inhibitor selective with multiple evaluation under series and are platform-based the specific of in in stages preclinical Our lead stage

stage. SOSX's Finally, program as we continue in leverages and selection to is candidate utility this targeting KRAS progress our SOSX, a signaling modifier discovery program

lead progressing inhibitor it and IND pharmaceutical PK (ph). With Vickie human properties that, through will characteristics over currently strong predicted preclinical which and SOSX I each X unique development. have are to candidates, turn high-quality track We exhibit

Vickie S. Reed

activity, for basic in $XX.X of or an million General $X.X the Thank $XX.X XXXX headcount, growth discovery million afternoon other Research commercial from related with same in XXXX in and and a third compared short-term see equivalents, same our The release the for per the associated you, was other to financial and third a for with that, of diluted diluted investments, Jamie third it period to administrative basic period of our increase loss and of $XXX.X per With costs upfront from last increase Adagrasib, I'll which and as hand additional Net our details the to well XXXX. and business. were $XX.X primarily expenses $X.X Please quarter expense about (ph). salaries earlier to compared loss in increase readiness the to and and quarter with for includes million net of in share billion net is agreement development expense increased from $X.XX Lab. collaboration million compared XXXX increase for and an cash, an million XXXX. share and the $XX.X increase related due and growth $X.XX the for due the of recent in We fee increase the or third the Zai salaries proceeds was press license of expense ended for is $XX.X from preclinical activities, quarter approximately in employee-related dollars to in million this as quarter expense. our to quarter in third The an period same million early increase development results. research in expense development cash year. David. back

David Meek

Vickie. Thanks,

make We pipeline significant continue and to our operational across progress organizational capabilities.

and we with this the capabilities on development to broad are of built, focused robust addition This true maximizing internal plan. Adagrasib, particularly we best-in-class are In the we accelerating a where progress through partnerships. have is selective to our enhancing and agent potential

a We number of milestones ahead significant of have us.

of For from non-small X and with the second-line will present results the by patients our lung commercial detailed submission medical launch KRAS Adagrasib, Phase cohort XXXX. mutated registration at year-end, we and we plan and NDA a cancer, expected enabling beyond to cell complete congress U.S. GXXC ahead in

half to to Adagrasib year. plan first in of additional next CNS provide ability penetrate also into clinical the insights 's We the

combination X/X that after will CDK approval cell clinical Phase on In We potential tumors, in with as data for SOSX, XXXX, have non-small generated a next data clinical on patients our proof-of-concept including are also further trial pancreatic pathway future cetuximab, will and to combination ShipX, time we expect when agreement additional accelerated next will provide X targeting lung a Pembrolizumab as ShipX solid additional half data. first with guidance take we cancer. sufficient Based for year, eGFR, provide combination, combination of enrolled late of with other to steps clarity disclosures as generate or we sharing colorectal follow-up. Sanofi, in of well on KRYSTAL-X we the the cancer provide Adagrasib with recent on enough cancer the line of monotherapy or and study in have update with an in we Adagrasib

overall be which of be XXXX of to approval the the key basis survival for in the trial for full interim analysis could in second For Phase SAPPHIRE continues half regulatory the catalysts Sitravatinib, the Europe. X the U.S. from and submissions

programs, We management XXXX. launch development sustainable cancer our of For ensure to targeted we lung an are commercial perspective, From lethal MRTXXXXX, PRMTX in for track GXXD cell submit inhibitor program. ensure our lines plan an into synthetic non-small IND investing plan readiness, profile in MTA by capital we allocation other rapid our to as in as 's file And on robust, as are cycle colorectal Adagrasib therapy our optimal we to well aggressively KRAS MRTXXXXX, IND a and innovative for year-end move pipeline. broad -co-operative growth a life we earlier advancement of in a investing are to therapy cancer. U.S.

milestones that, the we're many forward take have are progress pleased operator, to incredibly With made and questions. important We look to with we ready we're approaching. the

Operator

from ahead. go [Operator our first we you. pool Instructions]. We'll Wang, moment questions. Gena take Barclays. hold for from Thank question Please We'll a while

Gena Wang

Thank you questions. the my taking for data. on Congrats

the go milligram BID cohorts, combo the data rationale the X. questions were XXX many milligram regarding seen X%. as a milligram regarding BID And the and BID, a about and have far as profile PD-X few you the you've milligram make for response in on to other well second TPS for the of and indication compared see both question PDX Did that I combo. enrolled I than monotherapy? KRYSTAL-X toxicity XX data BID How have what patient XXX XXX milligram from a the for So towards any XXX that as for a XXX feel mono you first-line with BID expansion confident the less to response so

David Meek

Okay.

start So combinations. the let's with

milligram we had XXX X treatment Pembrolizumab. and were terms patient then the number full dose numbers, to Phase at the KRYSTAL-X was naive milligram BID patients the were with majority those was BID this that BID the well. In we go And for XXX forward at we with both planning of That of And dose. as being the the K-X, started that dose. XB study that -- that initial if reason and dose milligram treated all we study, detailed, the the went with XXX

So agent, explore to and more events a had as that found more Pembrolizumab we dose BID, wanted full-dose we constellation similar events alternative was events. was combination But with that XXX XXX with issues milligram we milligram to than seen we what single tolerability that leading being adverse an had path. of BID in the

is the to that on Obviously, early, still adverse overall favorable so treatment-related drew due X didn't in with patients profile. we have So that so reported we patients today, any X it's patients. an have we just that in those events

the KX to trial, the milligram it, now amended modified enrolling are in and XXX patients. now BID We enroll trial that are continuing we

but arm up, have in so less second we'll less trial as that's X is, of in of than that there's Adagrasib do of has of than third TPS treated with TPS with the enroll forward the XXX primary milligrams seen And patients. the going the less And limited and than more focus. if reminder, we then worst data Because X% population, milligrams with -- one just with combination current But That obviously. the previously, we've Pembrolizumab poorly that in think than of a and the to and be less score with there's care. and design is described to population, patients XXX interest as XX was combination Those performing coming than data then which that's what populations standard we'll with the And the patient second, is it's care. than cohort, as lot X% the than more XXX a than have milligrams X% we currently, that patient KX and low the less the on others. less also, with X%, able Pembrolizumab. X -- STK as single-agent BID the a we which you've greater response is of more X% update then X% standard

we of to terms we overall our in area benefit care. strategy, felt that of had an to that So was that chance current standard relative see a

population So response overall identify with X%, relative the both exploring STK standard it to the the benefit and care. further both with XX worth to those and than was less current the tolerability, of but rates also clinical

Dr. James Christensen

on can bit. little And if I Chuck, just a build that

to that in for response England And towards there can you academic potentially in through in As response that rate reached X that recognized, data internally and population. can you Together, patients. at 's a I patient at increased if noted working TPS Journal Also just then is the appears figures think we but less see less you and there than it supplemental relates as that our that say to article, broken the trend you earlier we'll we Adagrasib on as yet, if TPS less by Sotorasib if dig XXX there PD-LX own continue note publicly to X sciences the TPS to than comments, about in certain be New may for XX% subsets. down rate when than mutations investigators an it's look we notable X score, signal this we're population. key or imagine, different with increased haven't correlative co-occurring explore look status. as be in TPS And presented STKXX determine hasn't the

opportunity. may perhaps two path there those be a a forward monotherapy with single-arm accelerated as that together, a suggest So

Ryan Asay

Thanks, Gena.

question. Let's next move on to the

Operator

from next We'll Evercore. question Umer Raffat with go ahead. take our Please

Umer Raffat

Hi, my taking for question. guys. Thanks

X I think broad may. today, themes I if here

for with First, on moved departure. on were thoughts just like today's a And background forum the given it'll lay management recent especially street on extensive both the public hear you on. to that departures, if some be how just folks could helpful us your interactions

Phase it combo much is on but for -- case combination in should is synergy with better Adagrasib, or bunch this PD-LX then agree at their thoughts with Secondly, increasingly share your in expectation level, highs. program's profile you clinical could of perhaps some much. that a Thank you And so your there's so the disagree Xs that? your reasonable PD-LX big not high we KEYTRUDA synergy next base year. street if where expect just pharmas and a or perhaps Would confidence relative finally, you in to lows reporting

David Meek

I'll first. go Sure.

of -- goals or the that on change not they were or financials. concerning where is programs of on me touch And result or advance all, that a we're And company. company's of made, the grateful were fundamentals the any Mirati helping And in our very First the let disagreement played to issues I with say, Joe Dan the with for or the management changes. roles and the to changes it today. what wasn't based would any impropriety

that of myself I These Chuck head role as So joining new say R&D. and on taking really overlaps wanted a to upfront. on are just based

affairs. visibility BD, the direct With legal organization corporate into these changes, I'll have parts more and as strategy finance, such important of

President R&D will report become And with approaching I'll commercialization. active over we CFO experience today, search about we rapidly traditional for grown, me as with ongoing. Mirati in direct line that CFO, there And finally, you an to commercial and functions of have we're a more a say the a all those directly. where he'll then and within have Chuck organization I'd his And need sight R&D. and discussed of more has Head activities is Now will, second if to with question R&D, into role day-to-day the turn think you when complex, is Chuck.

Charles Baum

Okay, great.

the X% That the the than the the survival. rate and XX XXX greater the currently. XX% less that a I well, the that is have greater that know way (ph), different score as to Umer populations it less the PFS are and and think the XX. outcomes Then outcomes mentioned, right, X lowest, than than you X%, would with overall So, as response I phrase TPS than we shorter a to XX% and

durations, would So as I simpler so than less to conduits a better in a than over study XX%. that synergy trial rather of the less superiority shorter, the longer finish. be wouldn't than but the show it's X% trial shorter and the the XX% take much -- and X%, be than would the larger trials, say would And to that be greater smaller the X% then would the to

than So will practical the define in X% us, design greater accordingly. which X%, of the better, we the attention is then patients and performance what the is on approach less Phase also to in X, can in focus we best think place Phase terms than that to the the initial X our of we a for the combination but wanting

way our I think And just at that's some from comment of to to KRAS the maybe competition? then other best Jamie, the on perspective. you want it if look

Dr. James Christensen

Yeah. Sure.

question a Chuck, focused immune we PD-LX a From parts an can associated at patients indicated response was suggesting do comment. an last that biologic seeing -- response less on seeing perspective, in data you I Before that scientific of in or is immune was co-mutations a the that were And meant than maybe monotherapy low with inhibitor response associated tumors, to this other a really for that And that, build just reawaken clarification to given Same refers scores. a presentation year. PD-LX recall this TPS pharma that mutations what if particularly therapy Adagrasib overall. story that as immune-related with poorly response, that or immune poorly immune presentation And a on last or tumors some what like that responsive from tumors checkpoint may PD essentially more your responsive on inhibitors suppressed ELCC KRAS of to response were meeting the with given but data illustrated therapy. having signature are X%. to or molecular and also harboring large in that STKXX we are companies. that those an going tumor with Is scores microenvironment I'm of having these to checkpoint that ask here? inhibitor the was

Umer Raffat

but with you well, next clinical or you differentiation do breadth feel comfortable readouts for Basically includes do guys of molecules the as those profile year, competition the which reasonably you expect for Yeah. have? all the efficacy on any

Dr. James Christensen

Yeah. Sure.

from from out very little first, competition companies, it of really domain others. with exception of Novartis programs any, to there preclinical we relates are Novartis, Lilly, aware maybe on public and And So as the the data pharmaceutical Roche, there's other data. some

upstream. -- reactivation otherwise, we of With will of program be keep here work emerging we on you, directed there targets from as our the at are to as at I some ENA to some to of on they're at think on benefit spectrum a multiple programs I drive well that the that let our continue mutations, to And MRTXXXXX, emerges, KRAS as as subject may So KRAS data this whatever for and what active continue inhibition. our the a which at to or And pulse is partially KRAS remind regard overall. maybe are own that KRAS least is referring less advantages state. data presentation those feedback may programs about the things of be science to and will

activity both and forward inhibitors. those these of Adagrasib appraisal that combination for compelled we just interested in types the classes pursuing are of programs say is as monotherapy But of So a and a or both by and continued that are of believe there in we'll opportunities. we path

Ryan Asay

question. [inaudible XX:XX:XX] you. Thank next

Operator

question We'll take Richter with our from go Goldman Sachs. Please next Salveen ahead.

Salveen Richter

more with needed in work us in third-line just alignment you With yet here the quickly. how you've path the and reached could and love afternoon. to used Good launch and the here really FDA think in into positive prepared milligram initial pembro, launch thoughts dose could finally, see or for combo give then then BID? you the And forward. And fitting Adagrasib optimization with pretty yourselves Thanks would CRC on 's just comfortable the -- if is monotherapy the you there update question. regard on Amgen XXX whether taking your approved given the and an be landscape in and you to do my with are

Charles Baum

we are that be -- responses, good a patient to dose partial tumor The tolerated. don't well did thus with resection, a but Yeah, milligram partial just start is have with say classified XXX combination? far to looks Why that who encouraging. the and results Yes. reduction surgical pembro as be couldn't BID response we the then

forward, there a path II. is believe further Phase we in that but doing we're investigation So

trial So at II Phase the dose. III. looking we establish Phase And will that the a that is KRYSTAL-X investigate in trial to that parameters where we're Phase II be the and activity would the

that of think Phase but trials we ultimately exactly in And come. the to of the used from So right the the track, KRYSTAL-X of design data to yet, will terms decide and we final set on in we're the next X then don't be the CRC. have answer

discussing So agency. options we -- that the we're to believe X here we're both going with there's

that quite single continue we XX% single-agent agents, So the is area more encouraging. have a potential of we cetuximab the with encouraging in less with both to the anything data, as than this CRC, results certainly have unique share wouldn't response agency a approaches, as and rate is The else -mutated with saw, seen agent. patients. here also follow of KRAS higher in and activity any to bit we we've little mature you very cetuximab So a thing actually. than single expect is results, It's XX% over would as a discussion you But that those

So the almost single in the essence, agent. is like combination of equivalent a

And path bring combination line data then approval care in study. course want so that because second confirmatory chemotherapy. setting result study we with mentioned, full a combination of we the would our is make and And standard cetuximab and versus to unique it's forward serve approval as sure accelerated of already as attractive of both could of we the And that started either kind - we for single-agent strategy. and

then in good go to the forward launch very discussions, the think regulatory well particular we're I on expect So our in agencies, with ongoing for position cancer FDA. colorectal in we question. And and

Dr. James Christensen

on one share. the I more had thing

in to population I targeted note a precedents patient important think in historical just it's also late-line colon cancer.

the Some has biomarker inhibitors approval PD-LX active of in MSI historical cancer. of you an may are precedent where accelerated -high, colon as recall that

we really a monotherapy, range then That's we're I were cetuximab would a receive the overall essentially XX% recognize Nivolumab rate in forward. that that range. would combination, path at And rate with as with response on approval in focus path. the say precedent. of certainly historical So didn't well response XX%

Ryan Asay

you Thank Jamie Great. and Chuck.

of As next approval the year. stated, And relative to the filed an commercial and RTO launch, breakthrough expect end the pilot be NDA program, by the designation with we mid-year therapy year. or the by will

team. mode and already are our So planning we launch aggressively with in

We medical the folks have across set highly already hiring capable the management a access, marketing, sales on of team. well. affairs, market begun And of we've as

aggressively this. I as So for planning we're mentioned,

the in answering Our Mirati team team from for medical affairs that for been join place has year want deployed affairs on physicians, the folks team across It's talked capable a not highly pipeline educating based just a today. about the medical questions our to the we already board. but physicians. Adagrasib, Many

we team that experience. folks lung have experience, cancer significant launch experience, So with are our oncology joining significant significant

all community most across asset we are a board. we're a we data we're hearing tumor why types, look excited best-in-class With of So about Adagrasib, the what And have the at We have Adagrasib. we have with physician when excited? on best-in-class team from we the asset.

also cancer. just non-small cell that We're So launch. for therapy layer we're about we're launch not lung behind thinking investing investing in the second-line And launch, preparation asset. of the for beyond best-in-class heavily but the lines

David Meek

lung aggressively as well, other the the colorectal investing multiple tumor over that types. at pathways patient significant But cancer and in for pancreatic we're cancer population the cancer time non-small same over first-line cell

any team out and the there. for -- will the that's be ready when approval So ready we're launch up against competition to

Ryan Asay

Thanks.

the question. next Let's move onto

Operator

limit question next gentlemen, please Rama Please with take Thank We'll queuing. you. constraints, And reminder, JP ahead. ladies you our question as Morgan. due ask Anupam single yourself and perr a from time that go to we to X

Anupam Rama

so question. could cancer Hey, for that X, to I'll steps think limit how mine further on Maybe that you think pancreatic said GXXC on opening the guys. which about the in much we I the you is next study. indication, should what Thanks it? Adagrasib, the warrants are on for taking comments for expand

Charles Baum

Yes.

to think So patients, of talk those results, XX% enroll, to then to Continue we mentioned. about response as agency And quite to we go to we the is need late enroll continue are very We nature which the patients more are cancer. specifically now. encouraged a line pancreatic and by back that we rate given good.

other solid to We mutations. continuing types also, enroll as that GXXC tumor I mentioned, are have

where done there of solid need types, same Is mutations. different approach across tumor that broader had across And so tumor KRAS-GXXC an to what is different sort was you're we tumors approvals do track, option to a familiar have to what the that similar were mutations. also as with types discuss

cell, patient So we're yet, answer together, are smaller you pursuing worth patients. than have though an add we colorectal when of further exploring don't to both. aggressively. are substantial but all number and them a it's that think actually We those Even non-small populations they

Dr. James Christensen

we One If inhibition, study some of signal in overall to being just of learn with positive future in recognize read-through seeing programs the XX% to detail reason really our have Thanks. that adenocarcinoma is path and we more there's add as an interesting GXXC cancer GXXD mutations. to pancreatic KRAS ductal well. can addition nice pancreatic is Maybe to -- well. that to about XX% as

Ryan Asay

next the to question. on move Let's

Operator

We'll take ahead. Cowen., Werber our go Yaron Please from next with question

Gabe Daoud

Hi, this safety data. tolerability just Thanks for the the the for Yaron. is with to Gabe for was with drill taking a of I and pembro possible specific little data. hoping our on some question down findings congrats on and Adagrasib if

cohort XXX secondly, response patients better historical of compared BID most relevant unselected first, that dose understand the with grade to you with And at they? BID first-line So the if relevant combo potential Thank what led could that also And XXX you and share any you. dose drugs. can X Adagrasib the where what the then populations evaluate KEYTRUDA. rates seen between were you the lower common if milligram the toxicities events adverse quickly the you mutant look the to milligram as KRAS most to the try at toxicities share we just two the overlapping treated for just how

Charles Baum

Right.

events. as dose, milligram overall BID really highest kind up. of the that you In of anything agent XXX single dose the came the the was know, In wasn't same in that of of adverse there terms our new picture,

common well. events events So diarrhea. vomiting, of There's nausea, some the were the most like with there some as GI related Pembrolizumab adverse overlap

in investigated picture the think effects And we the that's the at XXX that combination less I why was of overall that well so tolerated. milligram. And meant

As treatment-related were events said, XXX described single-agent previously of than Other were Grade we Adagrasib. events. the to similar types X of what not discontinuations X Grade any no the and there that, for or milligram dose we've

we up. come to has new Obviously, nothing X patients. We're process. need So There's early continue the study. in to

we Phase milligram on nd a we better as enrolling are differences and XXX a next the provide a full to data said, get study will forward between what the compare to we the dose X exactly decide X the now, triggering update get Phase that handle later a steps next year. on those have doses when are patients and XXX So we closer into as to I two

Ryan Asay

Gabe. Thanks,

Let's go to next the question.

Operator

Guggenheim. with ahead. go Please Schmidt Michael from question next our take We'll

Michael Schmidt

hurdle, patients mentioned, some data PD-LX all lung was if negatives had as preliminary XX% cell if as cancer accelerated in non-small published the just commerce? was opposed different regarding KRAS Hey, and the guys. you plans may you reasonable Thanks a some context already FDA wondering subsets is of just that?...? that questions. for cancer. cell lung for ORR, indicates interactions taking first-line in I potentially my if that to approval perform that up in for potential the your better And non-small

Charles Baum

But I There's population. information think that, on would there'll but of selective we from in than range, thinking subset, STKXX that bar -- the the for -- sources highly better limited here, I data in and subset characterize less the data X%, studies as KRAS KRAS XX% that's our the more available patients. forward maybe less go real-world to even be think and than lower is that lowest which TPS be other that

first-line of approval, discussing process the our continue in we of as discussions approach we So approval submission cancer. of in to cell that and are lung Adagrasib the current the non-small

is the forward and we -- answer we is those soon. those a and discussions should we through think are information further there need have we that define but But to that now what more an So path hurdle don't is. yet, discussions coming have ongoing

Michael Schmidt

Great. Thanks.

Dr. James Christensen

unmet add mutation. discussions agency, KRAS freely either TPS need to of X score I the acknowledge with -mutated think STKXX an less than they patients the that have a for or just

that analysis subset in the indicate mentioned TPS KEYNOTE-XXX defined poor response subset. did As particular earlier,

may XX% You the are STK X to Dana-Farber, KRAS and as around as of on second-line be Sloan-Kettering, rates with months. out to coming work probably are well first-line and MD Anderson, aware wallowing patients response in also with co-occurring of in patients X Memorial where really just both XX closer mutations insidiously PFS

the based on that see details we based and the to a the really in the with depends and by the encouraged is think mentioned, I devil agency, but like. what if In in first-line Chuck we're looks As viable the on would have discussions with second-line setting, is define the on is we our agency the experience, we enhanced what what do we the threshold see path. believe activity there data end,

Michael Schmidt

Makes Thanks much. sense. so

Ryan Asay

the question. next have We'll

Operator

We'll go from take Nochomovitz with Please next question Yigal our ahead. Citi.

Yigal Nochomovitz

questions. the taking for thanks Hi,

initiate deleted to on indications? and lethality a your which think cancers Can you're Just sense the had to are types when program planning for one give as a clinical just tumor the program you you compelling most us program. MTAP do synthetic

Dr. James Christensen

Yeah. Sure.

IND this filing year. We will an be

within start first enrolling plans is the are it working to We patient. the within quarter out fully for X, the but Phase range first

pre-clinical X, first may a where our That and enhanced see squamous adenocarcinoma, monotherapy includes the may that Phase on expect ductal is subset particularly spots With data tumors, nursery we your where of it tumors tumors. of subset includes carcinoma, adeno disease data. biology Phase mesothelioma, tumor and maybe X activity. and peripheral see and So in on preclinical the pancreatic question a suggests quarter goal These lung Xb, the based lung we cell of Phase types, compelling rates to where also to are regard small to response XXXX. study

we have our opportunity deletion, solid study that other type be there, in will Any cancer, head tumor those MTAP also a focus the bladder but to to is approaching us it of basket. gene So collectively initial input goal certainly has otherwise X focus, and deletions the learn. Phase start neck to with deletions carcinoma, an but component XX%. That study around Ultomiris and cell squamous our MTAP allows MTAP our

to set patients. first that adapt will any of accommodate study signals from design the emerging We

Ryan Asay

Great. Yigal. Thanks,

move question. Let's to next on the

Operator

We'll Raycroft take Jefferies. Maury ahead. go question our next with Please from

Maury Raycroft

Hi, thanks for taking my question.

on robust this getting and can success Just at wondering for monotherapy. update the if for enrollment this STKXX bar opportunity like what's you're look could in to for say with What you timing where population? Adagrasib a

Charles Baum

Yes.

that of and the in study So currently going well. enrolling it's arm

soon of the are agency, update to We that and have more with idea will need of of patients number provide enroll. the as we'll better patients what in we enrolled a discussions get an the terms

XX patients, to based think a to we target But maybe we have accelerated patients number. I something think XX on is validate XXX something that's previous approvals, the with them. in reasonable that that's

need the But we in response we're oftentimes that be to verify bit are we like which with we that have results, were in first-line, In the -- terms the of directly the obviously agency little and that XX%, to when the something where that can response think could ballpark be with is should XX% difference, already line in that's result. rate sure. obviously in the before the have define even later bar also agency to be that a acceptable but low, we better rates we we the XX%

Ryan Asay

Maury. Thanks,

Maury Raycroft

you. Thank it. Got

Ryan Asay

to move next Let's the on question.

Operator

Burnett Ben go Please Stifel. We'll ahead. take from next our question with

Ben Burnett

-- just level just you you Thank to do target interaction, any guess drug metabolism talked just Adagrasib. with plus on dose. of because to see that or guess engagement you this you you good coverage? drug you I Is Thank the the able regards how in engagement the pharmacodynamics any dose. you. basically of target able the with about, was of at good could or half-life maintain first-line to you're of how the change color Can good is I offer the talked and drug target just I maintain it that read talk XXXmg you just about pembro you're very that much. or if data wondering the about saw that And rate can lower

Dr. James Christensen

Sure.

answer that question parts. me X Let in

XXX X.X range per we be modeled of for data, schedules, that a we different our different the entire micrograms the non-clinical That all, At binding. for first protein over different models, should interval. approximately BID, level X.X was had at corrected concentration entire ml, the At dose doses, dose migs around plasma exceed So dose allows full the achieve of migs what target the we for nano XXX around per the interval. achieve or longer grams dose to XX,XXX of for half-life that dose mil us BID, dose micrograms above ml interval. per the

our above complete that interval and associated the confident or vast entire defined of dose with in concentration KRAS were pre-clinically target tumors. engagement near complete is the KRAS So that majority are of we mutated plasma for there

the the is, think of you can we're here to cusp on point second I filings. make as imagine,

different exposure quartiles studied loose way, median by particularly So analysis. at where we we've have below or or every otherwise. done we've the be lot exposure around predict And of would response And a done that clinical outcome response XXX the which but what would above quartile no quartiles migs in we look level. outcome essentially or a we we that or other lower in see dose, dose parameters when at associated rates with difference rates response And be lower those parameters. would clinical

the we should So active of at the are preponderance essentially that very that indicates evidence we very more XXX shape at course, study in believe dose, level. good a mgs be at BID warranted, dose of but

Ryan Asay

the on question. very Thanks next Move to much.

Operator

Jason of from Please, question Bank with go next our take We'll ahead. America. Gerberry

Jason Gerberry

the questions. come sort I back PDX guys. patients. Pembro evaluable combo, Hi, the And I broadly was X just the KRAS pembro to where KEYNOTE-XX, Can to this getting subgroup comment my here wanted Thanks for levels of that full frontline taking range of analysis patients. to across the what shows know I'm in -mutated different levels. XX% exploratory that really the at closer you is,

Stage X to wanted to data. got all patient And really perspective, on So were then sure numbers think just inclusion clarify to surgery, how we're wanted there Just just there were X realizing one to patients of dealing was advanced points. enrolled? small or evaluate that I here, those wanted with from make Thanks. ORR that patients metastatic this these the went so an

Charles Baum

What's the first question?

Jason Gerberry

Level of sorry, PDL I'm the window. --

Charles Baum

Oh, yes.

So rry.

which we With scores. select Xb the did dose, study, based not on type the we is TPS XXX milligram where patients investigated Phase or

were. do know we scores So not what TPS their

report didn't So on that's it. we why

X%. put when is and to For data have limited than we'll correlation the are what's study, is greater into as know, and they're available TPS less you that's we that patients the KRYSTAL-X than between is different upfront and limited response score X% groups X the or There still rate. typed know data. and And --

think to define And study, related responses the we're although patients I that further carefully. to parameters to these -- more all look other need advanced metastatic patients. the So And good, as said, enroll was we I were disease. the then of these stage more

a was in X the they the judgment the they investigator that on resectable. So judgment had the -- that And by reduction significant their about that it -- investigator that based They best it the the wasn't gotten patient. could tumor just a Stage particular and lobectomy was patient. decision of benefit

Jason Gerberry

Thank you.

Charles Baum

Still doing so still on and it's study well. on drugs,

Ryan Asay

take time. Thanks, off like point. and cut you. we Jason. it call Thank last out looks don't we're one we'll It of that just Why Okay. at

Operator

you. Thank

Please question from with go Andrew last is SVB Leerink. Our Burns ahead.

Andrew Burns

for squeezing guys. thanks in Hi, the question,

just said that boundary shrinkage. In Are therapy. responders? are then -- not press maintaining What And I X they said release, the were all think terms of reason responders, the on of of was you them you still of a XX% the them lower all response? the in considered all was

Charles Baum

and on -- in had ones the continue mentioned, I are that X resection, just who study they the study, response. continue plus the all Yes, on

So terms -- of And good. that's in looking then

Dr. James Christensen

XX:XX:XX] [inaudible

Charles Baum

trials. other is others, happened around yes. our RECIST they to -- continue patients responses reductions other the they who partial peers. after that well be just cannot whether response occasionally at criteria response initial who all have in had But to for There per therefore progression We seen and in But considered had what in patients other we've of the as all X RECIST. this of -- point. couple are tumor discussed, continued tumor as and cases of part it be this we call had a can

Andrew Burns

Is have any kept response? that up in Okay. might chance the going dose on there them

Charles Baum

question. your The missed have may I -- have may I dose?

Andrew Burns

in KEYTRUDA. and they shrinkage stay up and had XXX. these a to lost BID. then these Well, response. were were sounds response, would've a some been our would XXX like Yeah, they maybe that to go dose higher them of And XX% concomitant but possible it it

Charles Baum

certainly trials had of that That's to But to initial mean, numbers hard study re-escalate not to seen these on the we've small escalate and had to increase a or I XXX it's we in where some tumor XXX. reduction, though question -- this didn't. at stayed other point, protocol others we've answer. from -- an part patients some are

the So question. announced answer to that don't know ending the this We that's at point.

Andrew Burns

progress. the all on congrats and Thanks

Charles Baum

Thanks.

Dr. James Christensen

you. Thank

Operator

this the for and session. gentlemen, question-and-answer conference concludes this your Ladies your back time, At remarks. I'll to presenters turn or any additional closing

David Meek

joining me, this Jamie, and for Chuck, Well, Vickie afternoon. thanks

to and with and call Mirati design, deliver additional transform to dis loved look and discover, toward mission about updates many you their of patients. the thank and This our sharing therapies progress to can we speaking you of continue as deliver our 's cancer mission very much. of real for progress to toward we as to you our you therapies forward the design, future concludes the to today and Thank joining. tell, cover, excited with to As ones. continue we're lives We patients breakthrough

Operator

this and your appreciate Ladies conclude today's We participation. does gentlemen, conference.

may now disconnect. You

Mirati Therapeutics (MRTX) 9 Nov 212021 Q3 Earnings call transcript