Earnings call transcript Q2 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to the Mirati Therapeutics Second Quarter 2023 Earnings Call. My name is Justin, and I will be the operator for today's call. All lines have been placed on mute to prevent any background noise. After the conclusion of the speakers' prepared remarks, there will be the question-and-answer session. [Operator Instructions]

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

Ryan Asay

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

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

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

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

are afternoon, ended quarter earnings This release for and we accompanying corporate section at June mirati.com. XX, presentation on results released quarter updates. This and recent of our press available the second website the Investors financial XXXX slide

securities. being afternoon a launch registration, of offering. not securities statements of shall by filing. presentation to a an with this buy we are to SEC the offer This to our or offer automatically the upon described constitute effective the us also an offered sell solicitation became pursuant public Additionally, The announced filed shelf that

preliminary offering. a and the the the prospectus accompanying our page or supplement website filed on prospectus with These be together at Investors the have the related website We SEC's prospectus accessed to can with SEC mirati.com. of final

David and Chuck our organization. for a address an the the to appointment search Interim leadership our CEO. the This departure during Baum, leads I'd transition CEO as within announced Dr. proceed, the period, Board transition we like permanent Before of afternoon we Meek while of important

it's President, and pleasure CEO introduce the Dr. Baum, Founder that, Chuck of With to my Interim Mirati.

Chuck Baum

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

start the Under updates. years, the provide will like before continued robust Alan, open acknowledging initial two he the we the closing guidance Laurie then I'll provide to people call to I afternoon's in made this cancer. key would remarks, David's the thanking over questions. turning to on remarks and some significant I Ben provide Jamie, call R&D played On in past company. advance a for have before line we leading and by David living lasting impact pipeline with our role to

David's KRAZATI, approval weighty the the a a During and this launched of commercial-stage have an both been the and appointed interim the we company's gratitude period, contributions. received for becoming return to and my this It role. FDA honor I I express company. to is company. responsibility CEO

President mission, will and novel best-in-class science deeply tirelessly robust advance of I CEO while our pipeline XX I to As and to and years, capabilities. am Mirati Founder, our the committed for pushing work boundaries of

As remains we navigate this transition, mission unchanged. our

of continue outcomes. relentless of will improvement and scientific and the excellence of We groundbreaking development patient pursuit therapies our

will Our the we remain everything innovation of commitment at do. to patients core and

and team of we wealth in the am confident experience our I the strength possess. of

drive capabilities focus on long-term needed the building of to Our business. growth is our sustainable

robust the discovery industry. of programs drug one organizations We have productive in and a pipeline most with the innovative

impact with Our areas on revolutionary on large meaningful can focus treatments cancer the have lives is the needs, where of unmet patients. and of

scores support updates, rapid of XX%. of Mirati. for share In very meaningful will which than non-small with and important believe the compelling provides Phase set, data greater several lung an cell for highlight will cancer advancement which patients we clear first-line combination in we into X this Today, Alan are development updated TPS

PRMTX the summarize inhibitors. molecule field is data in the MRTXXXXX, potential best-in-class our pipeline, Jamie initial MTA-cooperative emerging for earlier-stage clinical will our of In promising which

the KRAZATI, initial differentiated how continued In a growth. along commercial will of and have the launch second-line world-class with strong promise non-small cell profile organization, to the lung of describe Ben led cancer,

details certain announcement financial proposed of share recent will results. Laurie summary regarding second for along our Finally, our a quarter with public a offering

very excited am future optimistic about the Mirati. of and I very

well value impact for lives a positioned cancer. shareholders with significant people meaningful are create while We making to of the also living on

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

Alan Sandler

Thank X KRAS X patients data and GXXC Phase first-line evaluating pembrolizumab you, first-line of lung an this discussing everyone. lung combination slide cancer cut KRYSTAL-X, I'll non-small of year mutation. XX X with starting hello in as adagrasib study reflect Chuck, of My cohorts in Xa by and of with will updated adagrasib, cancer. a cell with with cell on commentary February begin non-small

slide December XXXX. X. updated in and follow-up doubled IO nearly to Patient prior median ESMO numbers our Moving since

On you were consistent the baseline see and across generally patient cuts data slide X, that will subgroups. characteristics

the now slide. adagrasib tolerated summary adverse well a been combination on pembrolizumab listed discuss Let's on safety covered the with X. safety Overall, slide of has combination the profile. the Most are treatment-related plus frequent events manageable

pembrolizumab. events led low adverse and these to manageable, of of or dose most acceptably reduction which either were dose of rates adagrasib low Importantly, interruption grade and

discontinuation lung Treatment-related patients in of patients. X% drugs pembrolizumab is either to regimens with just other discontinuation consistent This treatment or the non-small cancer both adverse of adagrasib and events led treatment in rate cell of in setting. XX%

what to elevation adagrasib of Liver events. consistent only enzyme discontinued the due Notably, liver to pembrolizumab clinically adverse of demonstrated move or at and presented with rates now low combination slide meaningful X.X% Combination ESMO was liver was with two Let's treatment-related IO. toxicity. patients low XX.

pembrolizumab than see comfortably results of care summarize outcomes adagrasib now TPS On are monotherapy, patients is which TPS XX% standard the the patients. and XX%. these of interim plus the I'll the greater efficacy the highly in greater XX, in than pembrolizumab outcomes of encouraging for with efficacy combination scores for slide

favorably the KEYNOTE-XX. KEYNOTE-XX response rate activity objective analysis was in XX% to scan, post-baseline rate XX% The was confirmed valuable comparing as even objective XX%. clinical the in defined at full at benchmark requiring least response set one in patients XX%, and Among again of the higher

not XX. tracking slide is has thus The lung survival yet Let's cancer progression-free care but reached, of above been advance standard well non-small cell first-line far. median to

but response above will cut. time also the for remains that yet of this not survival is immature the of data Slide analysis note I reached, well overall been has on XX, of as the benchmark. KEYNOTE-XX median tracking median Similarly, again duration

Let's It's a advance patients that scores summary, than the slide of relative TPS XX. study TPS to to In and adagrasib of accounting XX% patients KRYSTAL-X in the safety scores Phase and less support with closer XX% to than pembrolizumab the treatment efficacy into patients of X greater note XX% TPS patient greater population XX%. the lung with advancement of the than longer of XX%. cancer durations important strongly first-line regimen data plus with mutant to opportunity represent when for cell approximately non-small KRASGXXC revenue pivotal

to to approximately The are which we'll sites our move XXX study KRYSTAL-X Phase will conversion X compared underway, Phase we advance slide us X Now pembrolizumab summarizes monotherapy. plus study of design which expeditiously. for XX, adagrasib to the pembrolizumab help expect

We X progression-free expect with to the survival approximately We end Phase primary quarter requiring the finalize design. plan patients. XXX have the FDA third to study of point a in additional discussion

in this expect initiate year-end. Phase by study We patient X to enrollment

evaluating less less with than adagrasib of XX. clinical the our of clinical we cut clear TPS pembrolizumab patient TPS approach the KRYSTAL-X saw Upon in XX% plus in updated scores development discuss activity XX% now on summarized data than signals with population. patients I'll slide of

will that data these doublet not KEYNOTE-XXX existing these patients, carboplatin, of suggest to sufficient of which pemetrexed standard the However, be and care the approach displace is for regimen pembrolizumab.

Phase which on be and adagrasib less to pembrolizumab XX%. underway combination Phase for favorable, profile We will potentially X the KRYSTAL-XX to X Phase adagrasib anticipate combination continues is efficacy plus of scores data regimen. from TPS of enrollment However, XX% to expected plans safety to The add preliminary KRYSTAL-XX. plus the with patient and of TPS adagrasib population KEYNOTE-XXX initial optimal less patients study than registrational the regarding tolerability imminently a enable confirm with XXXX the us safety in than in chemoimmunotherapy X approach decision the based

in to potential cell cancers the slide combination cancer. shown plans will with briefly submit gears treat and to fourth non-small later adagrasib's and beyond Shifting the approval advancing of application track of accelerated for summarize year. on a in and are quarter profile we development this drug third-line differentiated lung new has I to for or XX, cancer, first-in-class cetuximab supplemental compelling difficult now adagrasib The colorectal

the X KRYSTAL-XX chemotherapy second-line plans these versus Our registrational Phase survival colorectal the on is of enrollment interim report overall in analysis survival same this study with progression-free cancer, complete submission final plus results. adagrasib we on based evaluating regulatory to XXXX for in combination expect to cetuximab year and and track of

pancreatic demonstrated adagrasib addition, solid in KRASGXXC-mutated cancer. clinically meaningful including treated other In previously tumors activity

to expect We populations approval pathways year. are our of end exploring gain by on patient we regulatory the approach in the and clarity these accelerated potential

we of that Finally, a I'm inhibitor. report Phase combination X/X MRTXXXXX, potential first-in-class adagrasib initiated plus SOSX the our cohort study pleased within evaluating to the

formal requirements firmly and will update the authorization its positive requested a believe a or differentiated CMA to benefit provide CHMP's reexamination related on but CMA fulfill not it adagrasib adagrasib's I conditional that profile opinion The based now a a that for does KRAZATI marketing certain recent CMA. has have an states in should CHMP risk CHMP that granted Europe. We be on of opinion. profile

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

Jamie Christensen

been and inhibitor. clinical results early this studies Phase from highlight our our I'll experience clinical study This an best-in-class cancer from milestone our data published Today, afternoon. I Alan. online PRMTX proof-of-concept early exciting has A including you, discovery for initial MRTXXXXX, Thank XXXX marks MTA-cooperative with promising by characterizing manuscript Mirati. case accepted potentially

normal in response therapeutic progenitor dose-limiting I mechanism and normal is of to toxicities Now cells, types. growth of Slide and PRMTX advance let's survival Non-selective PRMTX XXXX. incomplete to characteristics describing due and narrow the the including in bone start target first-generation marrow for tumor hematologic inhibit both indiscriminately will essential a resulted action PRMTX rates low generally single-digit cells unique a XX, by cells. of of coverage. inhibitors cell number This and index, where

a unique sparing MTAP cells, salvage deletions. harboring bone that lethality tumor cells that synthetic between designed in PRMTX a contrast, leverages MTAP-deleted cells In differentiated the marrow gene is normal target inhibitor MTA-cooperative and specifically exploits difference is pathway approach key a MRTXXXXX XXXX mesothelioma tumor toxicities. to while

methylthioadenosine XX-fold that Achilles tumor PRMTX is cells to rendering MTA of uniquely the This side partially state. cellular protein cells. the protein compared or protein to side of and of In MTAP of the metabolite in panel in illustrated the MTA. tumor In regulates on non-tumor cells of accumulation slide, tightly MTAP-MTAP levels This left right-hand active up an creates it the loss PRMTX higher MTAP-deleted results binds heel the MTA cells, inactive in the non-tumor MTAP-deleted slide, concentrations the illustrated the excess of MTA a present the in the of complex.

biomarker exhibits of greater a versus expected cells. XXXX does XXXX in in with for cell preclinical MTAP-deleted dimethylarginine. of symmetric studies, that deletion other relative activity index inhibit survival non-selective near In antitumor XX-fold or demonstrated not demonstrate bone normal selectivity at impact of tumor to a completely regression PRMTX-dependent complete SDMA called a therapeutic on maximum resulting and dose marrow variety SDMA or than inhibition cells inhibition XXXX tissues approaches. significant MTAP levels tumor the to an require target a gene broader harboring models MTAP-deleted in significantly

US annual Now XX. around than ductal across and incidents non-small adenocarcinoma including cancers estimated in Europe of let's the all is with an broad Slide a gene cancer patients. deleted of range XXXXXX in pancreatic MTAP to of lung greater move cell tumors and The XX%

curve indicates an major those MTAP gene patients have that of to the a MTAP poor composite with tumors deletion solid Additionally, deletion harboring on across an compared prognosis tumors. right without the Kaplan-Meier significantly a

a XXX XXXX mgs. Slide defined to for study. mg to QD levels Phase patients XX. escalated in including dose. clinical will clinical six on our data evaluable We increments potential currently XXX and reflect dose activity at a XX has daily or pretreated exceeding XX as XXX patients under commentary doses in I across dose recommended response, at safety our I XX, for now XX is for encouraging and My dose dose patients cut. II moving were Now mgs heavily patients once in or and administrative therapeutic XXX% the mgs evaluation Phase as maximum QD schedule been There will XX XXX describe experience from evaluable escalation June QD. a

than proportional exceeded fivefold. PK QD The exposure the dose increases exposure preliminary greater long with by exposure the the Average half-life therapeutic maximal a efficacious are the QD supporting within preclinical exposures target and results at roughly emerging and QD favorable range. administration XXX-milligram dose XXX-mg exceeded target in

we immunohistochemistry. have pairs, SDMA mgs a following dose all and three tumor addition, extinguished utilizing SDMA was at treatment In a biopsies evaluated three In levels XX day completely biopsy post-treatment in XXX baseline at QD. of patients

been responses tract for and achieved XX Responses at of six observed melanoma were levels peripheral clinical and Early out including nursing concept levels. proof dose response, confirmed partial tumors, cancer, with unconfirmed has tumor. of across cell malignant response including patients biliary one therapeutic the non-small five evaluable and mesothelioma, types tumor dose lung multiple

dose deepening observed patients responding we suggests cutoff shortly ongoing subsequently benefit. and in trial malignant expansion is sustained has data observed underway time, Importantly, several or the regression and in dose The was doses. The remains noted at peripheral unconfirmed clinical after tumor which I durable nursing response phase over tumor in escalation confirmed.

Our experience is early.

treatment-related most approximately XX%. vomiting has been events these different types X patients objective only adverse dose Grade X or to adverse levels fatigue. or events XXXX responses multiple observed events date encouraging. is The observed. or majority with frequently across Safety in and reported also five X adverse tolerated well out nausea, X. encouraging. of treatment-related The the XX no were However, of of were were across X treatment-related Grade observation been vast has Grade tumor

nonselective patients a nonselective also XXXX its the taken need new introduce profile, XXXX of favorable level dose of novel to differentiation options. patient a highlight PRMTX as significant of The of a been dose-limiting for Finally, selectivity date. MTAP-deleted together, the any of potential both approach cytopenias early and opportunity. therapeutic These SDMA opportunity in PRMTX clinical clear provide apparent inhibition and first-generation best-in-class dose-limited to meaningful population and data with from to also cancers significant support cytopenias first-in-class complete pharmaceutical with XX-fold inhibitors. When which of were properties and in treatment have evidence lack associated inhibitors tumors, not at safety activity, observed

Finally, I'll briefly summarize potential approach development our for XXXX.

a year. mesothelioma. interest beyond and to our and identify recommended Phase II this for First, II cell non-small dose cohorts cancer, cancer pancreatic is goal Phase The development include lung

emerging signals ongoing Phase for addition, additional study II prioritization. indications will our In cohort inform basket from and Phase I

about underserved provide on to potentially a significant transformative already program treatment update continues We and provided programs from population. interest KRAS a the with we half future very and KRAS look first our XXXX updates I'll option both are Overall, brief we've MRTXXXXX, other provide of and for the potential the strong to the The GXXD potent of portfolio. the I/II oral study providing progress to with patient today, significant As large patients excited remain XXXX. across has pleased investigators. GXXD and we've first-in-class our forward well Phase an on inhibitor. update selective in enroll the made

Now for with that the I'll Ben over turn update. to commercial our call

Ben Hickey

strong were of making quarter we results and good in and and to commercial more since full during positive delighted Jamie are the we very everyone. the you, reaching with very the performance we patients of Thank impact execution second The our need treatment. thrilled KRAZATI. afternoon, I'm strong share launch achieved are

and also expanding We gain share are market our of the continue the size market. to efforts

alike. robust Our $XX.X we was has profile product in $XX.X momentum product care differentiated sales launch in the gain $X.X clinical million third-party as and and KRAZATI revenue and we demand million sales providers for million of of generated resonated for efficacy continues figure in to net second use studies. KRAZATI, health with of The commercial KRAZATI quarter. this Included well witnessed patients

second-line treated academic across that patients, share highlighting KRAS We broad the settings. and inhibitor, GXXC and KRAZATI achieved rapid previously range within with among new-to-brand community both estimate adoption mid-XX% the a not

reached end the approximately second majority the the accounts constitute target of of potential. quarter, XX% which we vast had of market As of the

In of addition, already in been KRAZATI has XX% top prescribed the XXX accounts.

recently We later to therapy. line second patients, who a have XX% from our to patients line. are GXXC targeting with patients naive coming constitute KRAS are who the with the approximately remainder inhibitor, progressed These of new-to-brand

estimate From are coverage, barriers we have with achieved the access patients a our progress as payer and on access based with clinical has unrestricted rapid XX% value patients. been coverage medical are reimbursement, We perspective, KRAZATI. feedback and over pleased of positive minimal for and teams covered our broad access of

received, services patients analogs of only four closer average days positive. of well office patient importantly ahead in to significantly Feedback been staff and also oncologist's with an our an extremely obtain have Additionally, able is been prescription, weeks. drug has to two of oncologists, from which patients

intent to continue have to are XX% is oncologists KRAZATI, but those KRAZATI, approximately prescribe similarly to intend who prescribe Importantly, and of high. prescribe yet with for familiar knows experience is to using with

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

with Additionally, data favorably nervous in physicians. patients, showing received has been central activity by KRAZATI's system metastasis

The that in GXXC inhibitor recent CNS Clinical Journal previously of KRAZATI reflects that the only have is proven publication, untreated efficacy Oncology METs.

only CNS NCCN the In patients for addition KRAZATI the KRAS added METs. is GXXC guidelines inhibitor for with

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

increasing Our to particularly GXXC-eligible testing identification setting. on continues both team in and of the focus KRAS community patients,

mid-XX% patients the diagnosis, local medical estimate electronic in GXXC that further opportunity system. now in also range There and with a working of account is the increase at rates. these a time lung the are we record to GXXC to testing cancer KRAS KRAS level better We identify mutation, testing meaningful is at

and XXXX. grew we The KRAS on positioned basis well continue is at product in market-leading KRAZATI type linear over an throughout GXXC In of conclusion, a to expect US the unit volume become this KRAS XX% market. annual to growing GXXC growth

update. financial a for Laurie, to over call the turn now I'll

Laurie Stelzer

Ben. you, Thank

prefunded offering million to today stock. common shares investors As of stock Chuck certain choose, of sell our of to common purchase underwritten and $XXX we that proposed shares so mentioned, warrants launched public to a

The offering actual to expect conditions and other or offering of also to the up can of discounts as to is offering, grant a market underwriting million offering. to and option at or XX-day terms public the to maybe the price, offering the when the additional assurance purchase an be of to size as $XX.X less whether subject and We the to there no underwriters shares or completed commissions. the

million $XXX cash a XX, XXXX expect to was ending balance to our approximately $XXX We annualize burn of million. net now investments XXXX within June as and Our $XXX of million. cash range

to committed across are we burn impact ahead, highest XXXX by intend doesn't operational Looking ways we negatively reduce spend our our cash to rate organization efficiencies and increase the evaluating to value cutting drivers. that

I will through Please financial statement on our earlier a see details our this results. our walk income touch other and second from XXXX press now financial key additional release, afternoon for few metrics. quarter about

$X.X million clinical second of first $XX.X second $XX.X and driven million, Lab to revenue quarter Zai payment compares Revenue This China. for a by the of quarter of first of million from revenues. milestone XXXX sales of the $X.X trial due indication to in earned adagrasib for $X the of million for and was XXXX the for primarily which million pivotal collaboration license KRAZATI was

were A the discount to development in second second product quarter the million. XXXX. the range revenue research second XXXX approval, and within to the and to Cost expected of was gross-to-net during $X of expensed sold to The prior quarter substantial quarter continued portion be of FDA manufactured therefore, were of XX%. inventory our prior the to XX% for

as to and in Phase $XXX.X in in the Research development second quarter The second compensation. $XXX.X compared SAPPHIRE for primarily million same the was we share-based the trial clinical by for clinical driven in quarter million, of enrollment expenses costs XXXX. XXXX reduction decrease development period were in and XXXX, a X a completed sitravatinib, of decrease for the

MRTXXXXX partially an development increases as and earlier-stage increase expenses decreases our offset portfolio. and were the our in programs, These clinical in advancement salaries support of employee-related other by such to

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

diluted quarter results second $XXX.X $X.X to Net loss basic net per $X.XX period share million of basic of for million, was share-based in $XXX.X million, the including compared amortization or XXXX. per and share same include million. These $XX.X and diluted XXXX of compensation and non-cash for or loss a of expenses depreciation the $X.XX and

back closing remarks. With Chuck that, turn to the I'll call for

Chuck Baum

In commitment gratitude our extend Thanks, has want my lives also our shareholders our my to the scientific relentless continued I Laurie. been living to express for their conclusion, which appreciation dedicated their improving of of to I to support, for people pursuit with their to cancer. success. team to and want crucial excellence

you for of all us all mission. today and support us Mirati, at of for thank for behalf unwavering joining On our your

Mirati We against impact potential and the are very future excited about make in fight a to the significant cancer. the of

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

Operator

first from Michael Thank you. [Operator comes Schmidt our Instructions] question And with Guggenheim.

Michael Schmidt

Hey, in questions. guys. the my I welcome And at Thanks seat CEO now. guess, back taking for least Chuck, for

Chuck Baum

Thank you.

Michael Schmidt

I question lung the had update. on a cancer

TPS above the lot a if ORR sense I for of on study? makes there's accelerated was in the an frontrunner to wondering think planned you an with X point the the approval for opportunity end Phase XX% project patients us. So obviously

about And Thanks to It there a a that help any subset. the TPS would obviously data sounds patient than us from population? you shifting that towards XX% data terms KRYSTAL-XX so were KRYSTAL-X patient what like on X with in if And then decision be the want the triplet that question consistent see population. understand the learnings Was make much. study previously think should Phase October? of how you've in the we in seen that patient to strategy. study in you're Perhaps less follow-up combination

Alan Sandler

Yes. Alan that answer I'll Sandler. question. Hi. This is

bit -- bit. let's go so we'll by And

was of of Phase X yes pembro accelerated and pembrolizumab adagrasib. first the an study one potential the The with versus use approval

number a when And it more time that utilizing go It's but the progression-free patients is FDA certain and is to know about the one, time but study commitment bar increased possible. is a in we get you it will to a this something study started involved to using choosing accelerated more quick as a approval. that that allow high in as complexity we've believe As us X opportunities approach there's which at we're studies talk traditional -- for conducting fact manner. we also has a Phase survival considered, towards to a as

other signals The some had XX% think to aspect way. I along -- of you related clear than And population. KRYSTAL-X less provide the clinical There two yes, did were learning' questions combination the the adagrasib and and the data go sufficient with that of activity pembrolizumab combination in of to this setting, wouldn't with suggested triplet pembrolizumab. approach head-to-head be the but chemotherapy the doublet

subsequent We of prompted did to population, also which believe XX% early co-mutations addition however, X some which have the study may TPS informative our us analyses XX% the to of important. of in Phase be help be less population chemotherapy that in the for less a correlative will and evaluation than than

pembrolizumab. and further K-XX to we'll regarding -- plans we safety chemotherapy efficacy year by less adagrasib both the a next -- perhaps the evaluating to should K-XX after decision and will us first in half of able that adding address than XX% And population. from be in help plans, early have

Operator

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

Tyler Van Buren

the XX%. MRTXXXXX. guys. a around looking question This at looks responses the publication, Discovery are anticipating. exciting of in responses Hey were afternoon. for first like depth more I on is Thanks call, it think to Good glance My XX% update. people is the At than Cancer

at the And higher depth combination do longer you continue increase reduction tumor a ultimately lung or Did large in to as consistently doses to like and follow-up? agent indication monotherapy XXXX cancer? a view of a expect you with

Jamie Christensen

question. This that is I'll take Tyler. Thanks Yeah. Jamie.

something close is a we're -- attention And to. I think very to good very your it's question paying one.

I ongoing important bit been think over is a study it's something consider this for year. to for a

scans. have at doses some the number experience of a lower for We

look more But and only XXX if that, note a and those patients where scan. of to XXX- to higher most have doses, of the think we XXX-mg single may addition get And two are dose I have that, we levels as up kind or in we at the these scans. patients

responses we've six cycles four responses the that period beyond. to number deepen or of all, of then And even of of three have continued or those as time. two, a those diseases occurred during stable First secondly, seen,

really may that to suggests set not comes fully when data together be rate. response our it And that, mature

Could So again, that. keep please? we have repeat I it question. your And eye you on me, will second for forgotten a close

Alan Sandler

Combo.

Laurie Stelzer

combination…. is Final

Jamie Christensen

combination yeah. yeah, Oh,

Tyler Van Buren

Yeah. like lung combination cancer. Monotherapy

Jamie Christensen

Right.

if at our is So two it three in so we mesothelioma. I experience I think you responses look out far mean, have of

for one of out have indications We the of cell non-small two an N-of-X. we lung in cancer other have many

we're gathering that. So still

in Phase a initially will second cell should Our rules. with of indication. be with beyond and expansion approach And cancer six-month, mesothelioma to response XX%-plus non-small we monotherapy clear cohorts indications rules like lung setting. XX% cancer pancreatic X have approval or response Phase the line duration and rates stopping more believe And we of in X and that futility we accelerated is possible hit in designed clear if

Also combination to to work. prioritize further study the we're opportunity see responses our using in

well. a evaluate we're possible we hesitate really do although, accelerated is So believe that as combinations not to going to path there here,

Operator

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

Jay Olson

seen if expect had and from follow-up and results if maybe any on could. a February additional have then all Can question I Hey, a cutoff Thank this year? you on back question. updated progress us comment congrats we the Chuck. for you and KRYSTAL-X the in you the And on We should I may welcome understand data taking why was had more just KRYSTAL-X our results. qualitatively help updates recent

Alan Sandler

Sure. take is Alan. I'll Again that. this

So, of did. which us course with patients chosen the was follow-up February which approximately because was felt it additional and cutoff six would additional it months provide duration after we the August, of

analysis Additionally, later submission there this perhaps are and symposium plans year. to for consider additional data medical

update So that be data. another will the opportunity to

Jay Olson

how about then of many just lines on great. you many clinical how therapy for patients initial dose milligrams XXXX. duration have follow-up therapeutic cancer? And talk the prior efficacy lung observed the the in dose? you've can talk you. congrats non-small cell And Is range? Thank patients you Okay, for about of that also had the top failed? And XXX Can the

Jamie Christensen

Yes Sure. The of median prior for types And ranged prior could was different and of between sorry you study. over the three a of is lines. on lines patients wide six and therapy variety there repeat the-- two

Jay Olson

cancer. Lung

Jamie Christensen

The lung of cancer two. was one out

So, duration follow-up. there of experience an we're still building and

varies So, dose. I this think by

our that XXX. we're therapy. remain disease have is for Those on weeks. So, level or response active And first patients XX patients partial dose over those stable

initial Then weeks. more after. been Those XXX. over the progressive we about on of course then a dose have had and started we Those have have And XX US unless progressed nascent at a not XXX-mg they for level patients an bit also experience XXX disease. patients

protocol So as by dose. XXX was maximum administered the defined

We saw vomiting intolerable and two events fatigue. adverse X Grade of

So, pursuing going but be through level back period. be will we'll not the toxicity evaluation DLT that XXX or dose dose-limiting we to

make that, Phase will be we we it If dose. recommended potential that expanding as looking a at through X

dose this So, by bottom-line something have to let we'll and varies mature level is is median time. over follow-up

Operator

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

Gena Wang

One also with there least are at the give for to slide Also meantime. in the XX%. rate XX%. questions. XX%, us several you XX, footnote at response you XX%? XX Thank I update regarding have the back taking and the my a clarification have of the here and looking least Could February different in question forward working Chuck also welcome questions. XXXX I XX%, know denominator many you And XX% you the

Alan Sandler

that. Alan. you is walk to I'll this be happy Hi, through

of are patients responses That XX that the set. XX patients. full There let's were starting the number overall. is So, analysis recall

XX%. patients had activity XX%. Then evaluable So, overall. that a that the responses And that's patients your again rate XX represents response of XX with clinical

GXXC patients how with a patients included and we patient patient XX another then a the due patient to suffered ineligible fibrillation one stroke Now, and anemia. atrial who three being another were got who there

they received they set. full included since analysis FAS, the were therapy Although in the

GXXC in scan. patients The did mentioned five excluded If remove progressive for that's did patients that of a response you to receive And the two who disease. to that and scan XX% evaluation ineligible. patients three were of patients. treatment that I scan clinical a separate those had have of are patient received go have on the a XX activity valuable both patients, And and follow-up those of had out rate a not

ineligible actually that XX% that be you would if patient. included So, GXXC XX%

covered your I So believe, I question.

me if true. Let that's know

Gena Wang

Yes. XX%? response is There's another

Alan Sandler

XX%. be in one would response the be would denominator. It fewer One more

Operator

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

Unidentified Analyst

meaningful? updates. how is Hey KEYNOTE-XX points the And mature the more could this debate here There end OS? this. benchmark appropriate broadly? we greater around XX% see all comparison ongoing for including just you on more particular Congrats the fine data than on has Salveen. population? discuss you is then And for clinically direct thanks. to be for This Thank Matt you. TPS will been PFS In are could When confident

Alan Sandler

take Sure. Again this I'll those questions. two is Alan.

submit later So, a the coming PFS, the next mentioned. opportunity medical to to plans have will this the I had symposium as later we'll be And year year. in

And those all the to moving that very with follow-up. a scenarios may we patients progression-free censored. forward PFS some it maintained additional will are So that that we support internal confident with analysis continues there'll be survival We've will where quite again to turn run And seems see out to follow-up. them be it to be nicely how PFS this with we've able that are of done maintain. with that currently be various

part related second the question the to of benchmark. Now the

is pembrolizumab. XX, the as pembrolizumab there's the one of there subsets when And wealth literature so KRAS-mutant real-world data both benchmark well evidence data a at is single-agent you the of look of in patients. then And XX, number also

put In of at maybe at of the scenarios, of range comfortably the benchmark totality plan data better. we that the or there's So wide KEYNOTE-XX PFS that whole In are projected Phase that look real-world opportunity III the what of a and the is. to on together either at you the forward standard our standard and of do those it, be. to use KEYNOTE-XX, care of slightly ahead looking control. whether looking patients We evidence that way what all establish suggests our GXXC We'll that care for as of the study. as moving and taking

Operator

a Jonathan Miller question from with we And Evercore. have

Jonathan Miller

paper of LFTs guys. didn't year because paper we're for like noticed one discontinue. and on patient medical full Hi this to you mention on this And presenting table I question data? I I make planning you safety you, that give Are Chuck. -- taking is specifically all ask to the this Thanks for good going see I didn't and have early you from a at the instance PRMTX guess this caused meeting? a to

to just color trial housekeeping What I'm that a for to we'll overall the something requirements Can if that then and And or weren't give presentation trying full for design approval you beyond something -- So, on tolerability question. maybe at any EU a get sense that? this for responding they were a see met? a medical in meeting just year.

Jamie Christensen

one. disclosure planning are essentially line take until and year. additional you disclosure know, as disclosure right. a MRTXXXXX All part I to we've consider high-level actively this an not I'll think XXXX. top a guided And this We

to make to data would meeting, have as time an frame. we in forward. a However, the move look a present difference as at And we mature XXXX data medical as have continue opportunity to we at we soon but enough likely

and then need the the intervention. that been one and co-meds to dose require XXX of been most or at been don't number adverse adverse With events to and have three be. certainly generally levels have regard grade when to with safety, Again XX% well-controlled and we events. fatigue, are co-med drug events up they grade mgs diarrhea those But diarrhea. grade only or no generally nausea grade they common most that has this study, is nausea The of are say well-tolerated five low four very grades the two

you and I study. that think stayed ALT. seen three the I believe and interrupted grade seen, We've on essentially patient have patient with range ALT mentioned We one an in

encouraged of very overall the safety intensity. are we by profile dose overall So

or dose dose again, to dose In far. interruptions have few so reductions levels at XXX fact, up these we up very

Ben Hickey

I'll This CHMP take is the question. Ben.

reminder a had single-arm just And that a upon study. showed CHMP as benefit-risk. was positive So available CHMP, data approval a indicated actually the the that a is we conditional the filing -- marketing based

a existing there an the is that negative that fact opinion on could based be believe we However, conditionally approved inhibitor. KRAS

was a we extrapolation pivotal be from In results of could could addition, -- results, showed potentially the competitor, been which there. which have part underwhelming there believe

filed we reexamination. our standpoint are a -- have for From very we

the will months. four that results next of in We have the

well study of. And would the in to forward look we readout be the that that the our was and pivotal to XXXX. going K-XX enrolling of study we plans is of the launch that base off first our always study Additionally half pricing and

Operator

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

Jason Gerberry

question. Hey guys, for thanks taking my

Just wanted to ahead. follow-up

So with than to your like TPS design meeting X the greater Phase XX%. FDA you're it for finalize sounds

sort is going curious, as talking key there elements that what procedural, points? what PFS design the you buy-in point? comparator your or be largely are to guess I just So the I'm end need of, the or are this Is of such to

follow-up of KEYTRUDA then monotherapy if to market question uses the guess with my that relevance sounds commercial half go the uses comparator. And a like the I KEYTRUDA like It regimen you KEYNOTE-XXX half monotherapy. is probably

So of results are segment ultimately benchmarked that in going against patients? just wondering to KEYNOTE-XXX kind get Thanks. if your of

Alan Sandler

Great. the with This the the first meeting question the is Alan. I'll of half take FDA.

pembrolizumab on that the control an discussions where also appropriate of of combination with when be an and open So a would procedural I FDA. topic were were just stated some it's another standard arm. had there they early care dialogue think probably we There

have discussion confident discussions with on also But formalized well. have agreement pembrolizumab we key both meet with what that point do like is And as a PFS primary should very points. we'd the a arm with that end the again fruitful them as control and to them regarding we're

aspect. I'll commercial to have And the discuss is going Ben --

Ben Hickey

and Yes, the regimen by after from an XX% is patients. XX% sought highly the standpoint of -- care pembrolizumab commercial standpoint, of greater the the -- in attractive attractiveness over a population standpoint, monotherapy. a than From It use. standard current constitutes is chemo-free both physicians

approach an market. And attractive forward that it very bring a combination be will to market. the look IO long targeted actually tail and successful study with the hopefully the believe we the to So we of to

Operator

a And with Stifel. question we have from Burnett Ben

Ben Burnett

so question. much our Thanks taking Great.

adverse Just PD-X events profile I broad? one was in led a results. mentioned that on slide X little Congrats a guess, maybe is believe. you just the was low. you're give the I pretty to KRYSTAL-X wanted the in on could much if color -- events patients. I on liver-related trend to what that by dose looked there seeing slide just that to kind reductions I ask efficacy pretty reduction improved about But led described of that there any status, PD-LX adverse And wondering and or the on was high dose discontinuations

Alan Sandler

All right.

again. Alan, is this So

first. based expression. of last no So, first was PD-LX question -- levels There difference on

such -- GI no vomiting. or had there range few the particular that And interruptions, out. rates as that that events were as or ones a discounts associated were levels a far one discontinuation of one of with the TRAs out. a As There's stood other with number wide low no different perhaps it, there really diarrhea stood

Operator

have we from Ulz Stanley. with Morgan And question a Mike

Mike Ulz

Thanks study patients than follow-up greater Hey, taking just X frontline XX%. on for guys. the with lung in a TPS the question. Maybe Phase

XXX You're there. roughly patients proposing

Just estimates of number your that enroll curious how it on might to patients? based take long

Alan Sandler

that We'd the be result and to to the think Phase And being that half of enrollment and about expedited. We again. three will Alan to is quickly. This of will X like Yes. years. sites the as transfer activate able probably of the a two be in range yes, X Phase

Operator

Yigal from comes Nochomovitz Citigroup. question next our And with

Yigal Nochomovitz

Chuck. obviously you to great Thanks coming frontline wondering greater FDA therapies. back standard trial has the adapt the hits been few XX% to for to Yes, were and big a landscape the rapidly point? see talk just TIGIT want a the they PD-LX flexibility how with and cut taking frontline questions What on then trial trial, the hi. regard greater to role as end there's the the for saying CEO point that PFS believe competitive things. to change? than one Can I at of in Thank just market you're have the record With OS the you in see getting you. primary temporarily a you about for confidence least might Roche's care day data in for of if on type the IO And XX%. in the of

Alan Sandler

So, two questions.

mentioned the we'll about going as as of we're them we'll that the speaking of not say second-line a require we're confident that overall, bit second-line of will one that The talk study, OS, – course be point with comment will I've entity to seeing as therapy. whether I little it's because end earlier. accepted be known PFS Again, maintained recall be The or that PFS. a first FDA with PFS certainly quarter. the them was you talking will and primarily crossover something and in this about primary

crossover opportunity this the overall the study. survival. formal Although, frontline longer, subsequent live or between there's in for certainly difference the patients, they a can much lines detecting survival necessarily In since so therapy impact not opportunity of

discussion our on based that. be FDA will that the with So

at look well. course, study of the overall survival as in will We

once that to The impact have – second when with may other positive the does that started not full as – formal approval there's of essence midstream. been accelerated not to we've actually be as related to the impact agreed has we the in able go road agreed in of is and your a agent. that changed be occur have potential agents approval It down only a an TIGIT. with of that question a is has study positive approval happens We study. and part but the Basically should studies even such say principle not FDA impact believe our – only –

Operator

And question from Evan we'll BMO. take with a Seigerman

Evan Seigerman

for my on [indiscernible] taking the perspective. call. question much you my Hi, bigger-picture A so Thank from question. thank you

help maybe to You Can versus burn. prioritize take what's understand cash be would what more and little us maybe granular optimizing to a talked you you about you reduce like your this. the investments how important

Laurie Stelzer

more We're as so. We're into we do We'll for evaluate our XXXX. ways to be the our go with to to expense it's reducing hi, Yes, continue base Laurie. committed burn to capital. continuing looking efficient

do but the we we looking relates of that will not ensuring the across on organization programs organization. and a expenses to be with the so it value-driving have And as most focus parts

can't today. into more I but detail – So go

Chuck Baum

right. All

appreciate us forward for you. look everyone future. in and sharing Thank the with joining on Mirati, call today. thanks in interest updates So you the to We your additional

Operator

thank conclude conference. Well, for excellent Have today's That you does an day. thank participation. We do you. your

Mirati Therapeutics (MRTX) 8 Aug 232023 Q2 Earnings call transcript