RVMD - Earnings call transcript Q4 2024 | Revolution Medicines, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Revolution Medicines Q4 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Ryan Asay. ahead. go Please

Ryan Asay

welcome, call. and our quarter fourth Thank everyone, earnings XXXX you, to

Joining Mark Medical of Chief are and call Wei Q&A of me today's on portion and Development; Dr. join Steve our Officer; Dr. us Jack Research the and Dr. our Chief and Goldsmith, will Anders, today's Officer. our Chief call. Financial Lin, Kelsey, President Officer, Executive Chairman our for

events such make may we will this are statements risks deal many during future those differ in results Because statements Certain the be and with forward-looking call and from actual to subject statements. forward-looking. uncertainties, materially

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

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

I'll turn Executive Officer. With Chief Dr. Revolution and the Goldsmith, to that, Chairman Mark? Medicines' call over Mark

Mark Goldsmith

progress as going afternoon, Anders as Ryan. a these will outline joining cover financial I'll and important financial Today, our pipeline with results you for Jack RAS(ON) of thank provide forward forward-looking progress priorities as XXXX Thanks, we us. highlights our of and expect for markers pioneering and what priorities. Good we inhibitor well pursue then summarize view.

This much in have delivery development treatment for and through we Our targeted discovery, for cancers that anchored RAS-addicted X and of XX-year innovative mission with the history of is discovery, at Medicines Revolution to delivery. medicines. patients pursued our pillars: is revolutionize one mission development

among in capabilities productive inhibitors our technology discovery the the RAS-addicted advances will platform cancers. in extensive we and have in to RAS stage proprietary with given have clinical industry, what's treating our enable RAS(ON) to innovative research bar for possible our original most First, biology in shown deep know-how expect and pipeline the critical assets patients us raising us a of continue be

have through program into late-stage advanced our our rate Second, multiple capabilities studies and progressed first-in-human development assets development. first lead

into settings We capabilities portfolio tumor of will continue registrational and therapy. we of and these studies our lines a across number additional as across strengthening move

preparing novel by strong commercialization our therapies a are regulatory daraxonrasib. to of we for in launch Third, support deliver patients subject building to capabilities successful approved to

patients commitment record reinforced and is strategic cancers, for map mission inhibitor of maximizing our track RAS(ON) Supporting our level road for the and by an to our living productivity successful is ambition RAS-addicted our ambitious portfolio can of execution. impact the with have

We have a been inhibitors, pioneers each space. a in and first a X GXXC clinical RAS(ON) selective inhibitor, Scientific clinical and promising has unique innovation selective profile. RevMed the in RAS(ON) with inhibitor stage the RAS(ON) GXXD RAS within inhibitor, resulted RAS(ON)-multi-selective

international we of which of centered introduced generic that or the shared mechanism for for on class compounds, RAS(ON) Last alludes the these is compounds. onrasib the month, novel names X to new nonproprietary each this action of phrase

zoldonrasib and multi-selective inhibitor our selective GXXC inhibitor. RMC-XXXX, innovative covalent RMC-XXXX, or RAS(ON) inhibitor, our RMC-XXXX, selective groundbreaking distinguished or elironrasib Daraxonrasib our covalent GXXD

zoldonrasib first non-small built we ductal clinical We pancreatic and adenocarcinoma in cell execution. and RAS-focused particularly We reported lung drugs. of daraxonrasib our on PDAC XXXX, In PDAC. cancer with in this compelling advancing record made portfolio substantial data progress investigational our or inhibitors of and of monotherapy RAS wave

promising reported strategies. initial evidence We also of combination X

more escalation RAS RAS(ON) doublet, the elironrasib data completed RAS We've reported initial first combination combined the with inhibitor second doublet First, daraxonrasib. broadly. doublet in on its of our confidence already encouraging These with daraxonrasib. the inhibitor are we highly dose with for of zoldonrasib and proof-of-concept innovative clinical concept kind a increased

move compelling of into potentially as further doublets treatment. RAS(ON)-inhibitor as both we study earlier for lines particularly will We options patients

highly early and potentially pembrolizumab pembrolizumab tolerability elironrasib that we in cell combination lung cancer. Second, are develop enable both reported with a with observations data for combination in and for metastatic non-small encouraging and daraxonrasib therapies to first-line safety path

range also our inhibitor the we range approaches, expand novel antibodies combinations inhibitors cancers. agreement agreement and with us In a Such targets discovery PRMTX treatment clinical with to collaborations bispecific RAS-addictive our entered bring for designed Tango we can exemplified a Aethon of as collaborations under and with explore addition, to to strategies patients enable of by novel such Therapeutics. bear under of with

a patient-centric cancer collaborations formed ongoing breakthrough opportunity science. also insights industry such to new that commitment to further leading presents valuable uncover with our transformative to translational organization scientific academia as the We research partners, inform

needed first Last regulatory Phase help to approval. III to registrational commitment partnerships in trial, scale capabilities our for stage prepare our to building our particular, our us we progress our formed for we broadly. year, development preparation launching deliver manufacturing made late-stage strategic and therapies next in of as the us novel we daraxonrasib, presence And potential commercial our clinical organizational strengthening first patients plan. tireless to organizational drive a deepened In by patients the of also select we capabilities fulfill to reaching

we lives distinguished For example, with the Pancreatic ambitious or with to pancreatic ensure patient-centric strong Network, living organization these people to cancer. Action financial And exceptionally we ended continue an in at of a that devoted now PanCan, improving allowing needs forefront our have the a us XXXX and as patient position, we Cancer strategy. we to keep medicines, advance relationship

can the XXXX important our have impact for to for with an advance patients we will be cancers. RevMed year as strategy RAS-addicted we aiming maximize

drive priorities company progress to creation of the we to significant current and value follow. and markers could outline identify some highest of the anticipate transformation to that I'd like

pivotal monotherapy metastatic pancreatic Our first cell trials cancer. execute cancer patients lung is priority to previously with treated and in daraxonrasib non-small with

progress. III global of RASolute measure currently metastatic trial is in the randomized an with controlled second-line For Phase XXX important underway enrollment PDAC, patients

support strong we are U.S. seen and regulatory centers, new U.S. patients opening highly the activating currently very in are have anticipate data an trial U.S. Japan we enable interest the expected also and readout the enrollment with to initial We to enrollment sites investigators EU sites in ex XXXX. our in in far, investigation With this completing substantially plan. year and at clearances strategy. actively we line with among hand, So global the in encouraging

docetaxel cell controlled pleased of to confirm randomized RASolve tumors. For cancer, comparing now non-small with in RAS III is lung daraxonrasib sites patients I'm that ongoing, the previously XXX investigational treated Phase in metastatic trial to activation

with trials is priority second to patients Our in PDAC. into advance earlier line randomized pivotal daraxonrasib

patients optimistic X for that design single-agent investigational arms, options reference chemotherapy first-line with both with to the plan patients sufficient we We a We chemotherapy monotherapy treated arms by plus cancer. expect patients combination this the important and in from comparing treatment plus ongoing preliminary later trial tolerability trial have therapeutic with to of with have safety initiate a daraxonrasib currently data metastatic safety and with containing chemotherapy X to are chemotherapy. we year pancreatic daraxonrasib potential X to daraxonrasib on data living data, the metastatic treated become treated Based finalize daraxonrasib when cohorts. patients disease arm and

randomized U.S. the the need patients to first-line in PDAC. authorities, with Phase with metastatic global the before III including align we'll course, can we trial FDA regulatory relevant Of initiate

each designing to patients stage As ambition adjuvant registrational share a daraxonrasib disease, further are happy actively trial we step also as with very serve that a earlier in I'm to our an with including U.S. treatment who newly perioperative year. surgery undergone often the population cases diagnosed XX% pancreatic and pancreatic resectable patients approximately with cancer cancer in constitutes have This therapy, chemotherapy. of and

finalize the We of expect initiated pivotal second to year. metastatic in quickly move our half disease trial work pivotal both in first-line developing this mentioned We this that earlier. of program these in on parallel anticipate will be the to trials with

sufficient or third inform the Our generate priorities and mutant and or to selective pivotal in more drug as initiate either monotherapy development and options data elironrasib consideration. under priority trials for to a one a number is combination zoldonrasib prepare of are inhibitors, to

progress development a GXXD antitumor the in-human inhibitor expect to of continued exciting RAS meeting and activity and our were innovative compound share for to tolerability help we in data, key is this on against of additional second last of the activity profile encouraging that selective and prioritize we safety antitumor and GXXD data the priority zoldonrasib, market clinical qualify this PDAC clinical triple at XXXX. additional A options example, including in these favorable quarter. RAS(ON) which generating reported first clinical For quarter

rational example Another strategies efforts our inhibitors. is identify our with and to RAS(ON) ongoing advance combination

among combination earlier prioritizing into therapy. for multiple options We data-driven advancing in lines are of

the global metastatic and lung noted enabling provided elironrasib potential of we pembrolizumab, pivotal already studies cancer care. initial first-line tolerability combination combination in to paths data both As have cell encouraging is thereby with and pembrolizumab earlier, where non-small daraxonrasib in safety standard for

daraxonrasib innovative approach. of We with data colorectal this KRAS in on GXXC provide also that elironrasib the provided cancer encouraging of initial initial combination validation a

for expansion We are with in KRAS doublet actively phase treatment. We options. evaluate anticipated range is regimen a a across a us clinical II among to studies And and plan trial this is each the combination GXXC emerging from triplet cancer evaluating the in non-cell at chemotherapy-sparing a to daraxonrasib RAS(ON) development of a range single-agent monotherapy data help potential as agent. evaluating ongoing of in recommended of prioritize multiple combination Phase lung solid potential dose with an enrolling first-line pembrolizumab. tumors and plan inhibitor as doublet zoldonrasib That currently

expect plans Based incorporate work, quarter sharing trials pivotal RAS(ON) XXXX the or initiate one these more and on and in inhibitor likely in second we a doublet either that on data this or supporting anticipate elironrasib third this to clinical of based or year. combination zoldonrasib

will advancing expect our RMC-XXXX, our fourth daraxonrasib. a inhibitor particular, in advance progress evaluation inhibitor escalation earlier-stage erasion stage trial to GXXD clinical of organization. enable XXXX of to from a a is Our highly selective we RAS(ON) This next-generation and innovations Phase productive doublet with first-in-human In currently this discovery clinic-ready including our year. pipeline, I to initiation dose priority subsequent

clinical other of our innovation uniquely will platform continue investment between we on the pipeline that a beyond our productive for sustain by us to promising preclinical about next-generation virtuous stage are Based be and pipeline, highly programs current assets. sciences enabled preclinical development areas to and cycle the excited

our activities a pre-commercial growing support capabilities potential operational Finally, and and increasing we commercial in are launch. of

groups role these affairs and leading our visibility that felt. clinical It growing have clear leadership We have in presence settings, our experienced already talented expanding is leading and and key oncology medical reach being conferences begun to and our are commercial practitioners. teams, including executives

adding We continue teams. including launch our commercial to by to expand key talent, top our organization aspects support U.S. of field a

and capabilities. We organizations partner complement to and expect translational internal patient leading advocacy experts to with to clinical continue our

with patients ensure long-term through previously treated efforts capabilities the to shareholder strategies, important we driver that approvals. our a regulatory and see daraxonrasib to urgency resourcing people have core best operational pending foundation and launch are potential We value. to of PDAC bring successful metastatic the as We a with an tactics, U.S.

control of are to of U.S. We commercial a committed rights strategy. retaining current main our as element

potentially us determine also help outside We strategies partnership the serving access. ensure best continue patients to global the including exploring for to opportunities U.S. approach

about us the remarkable and excited of advance have to look forward the opportunity progress throughout of and momentum front continuing We're programs markers in we as on year. we reporting

I'll the and summarize to to financial Jack? over our fourth our guidance. Jack quarter forward-looking now Anders, CFO, turn call results

Jack Anders

December. based $X.X Mark. last of net the We the development programs. proceeds our and spend investments, includes can has into confidence XXXX with that of quarter cash half from from our our increased fourth Thanks, operations which in been operating to current cash operating and in million project our and plan. our We equity plan advancement upsized $XXX of resulting growing fund investment This ended anticipated on balance offering reflect clinical in the XXXX planned second updated billion

and $XXX.X $XXX.X acquisition. expenses to $XX.X to quarter with R&D primarily R&D personnel-related of with in note, The Turning in fourth were trial-related to included quarter clinical due fourth in the of the for expenses expenses. million headcount. for XXXX expenses prior wind-down EQRx increase additional year million quarter increases XXXX. expenses the Please associated the million was associated compared costs

due of quarter. the $XX.X million to was fourth costs the The fourth were quarter $XX.X prior for million wind-down decrease to XXXX. XXXX compared in G&A expenses year EQRx $XX.X in the quarter in expenses of for million G&A

headcount. increased to fourth associated commercial costs, due primarily Excluding personnel-related these quarter additional XXXX, in EQRx expenses which preparation of the and was increases activities expenses in G&A with nonrecurring

costs. of Net of EQRx to The Please compared increase was quarter $XX.X loss $XXX.X for XXXX total fourth earlier. the quarter was in wind-down million prior year as quarter described operating to loss for the million note, loss of fourth a due for million expenses in net the XXXX. higher included $XXX.X net

Form available also are was results in financial corresponding the and filed afternoon. press SEC release that XXXX our with in our this year Full XX-K

guidance financial for to XXXX. Turning

between for The increase net net full loss $XXX non-cash, includes expect GAAP and and stock-based year $XXX million have and We increased clinical result XXXX estimated multiple with the priorities. which of of loss $XXX million. planned expense and registrational outlined as as million. compensation particular, development $XXX to associated studies in programs. progression expenses ongoing a be our expected of GAAP we expansion to million the In

higher as a build result to our for stage and expand That we continue a portion. commercial capabilities of becoming commercial expect in the preparation XXXX also efforts preparation We expenses company. in financial organizational concludes increased as

to call back turn now I'll Mark. the over

Mark Goldsmith

to build observations deliver our track clinical we of effective Thank compelling on continued you, record In execution. to Jack. and XXXX,

We capital in vision cancers fulfill growth to we patients aim established and create for RAS-addicted targeted treatment of and and for patients to talent, for our to was our to that have long-term fuel sustainable begun cancers. to responsibilities revolutionize an XXXX medicines financial The have with foundation capabilities with patients, up industry-leading with investors employees. franchise our the support RAS-addicted

With to that, I'll of the portion the turn for operator Q&A the call call. over the

Operator

the first Merle of line comes Instructions] from [Operator of question UBS. Our Ellie

Samantha Meadows-Ortiz

And a decision on us III earlier on guess, you III the It's about line of conviction Phase line talk And role in I you Sam with the setting? gives bit can can the Ellie. move through for what in specifically, little Phase you forward adjuvant the in guess earlier walk PDAC. the studies X the RAS setting? to I this

Mark Goldsmith

question. Yes. Thanks your very for much

all trying already a data cancer, we PDAC data, therapy. pancreatic on to conviction based entire the think space have to we reported ought that strong own of the we've lines I across I monotherapy that in the think

goal. indicated that So is just this we've and previously, towards further that

cohorts pursue previously already a clarity we so study. today, bit the composition that various And be to doing announced that and will question trial, year in metastatic the been and as progresses. little provide intended that has we'll always around continue We've a we the the first-line of what of

the who for The adjuvant provided clinical third represents their proof-of-concept provide is supports those patients. had second basically have patients data shown a that particular previously study indication that the and disease to we've very and of important pursuing an impact will opportunity by resected long-term already with significant And line monotherapy. that is

rational we'll of I things and So think appropriate for pursue, and this both of PDAC to our goal these the completely are with compound. further very owning us space

Samantha Meadows-Ortiz

a just versus I Yes. about you That just might the the opportunity metastatic thinking frequency you're Can setting quick helpful. of adjuvant differ there? That's disease or in sense. lot then the the how guess RAS follow-up. of on really a maybe advanced how overall makes like and And mutations touch

Mark Goldsmith

any different RAS cancer patients any other which is don't have would essentially pancreatic driver. have patients, there's representation almost those patients drivers and evidence all I all a of know that Oh, that RAS

And that behave response any so believe differently those there's to in reason daraxonrasib. to patients would no

Operator

Joseph from Our of line next question come of JPMorgan. will the Eric

Eric Joseph

The adjuvant and proposed as generally pancreatic study interesting in-scope to also terminal cancer. is to in what setting thought spans in us about the being we've

proportion great a hear the would of heard would It the initiatives. registration? if resectable I that satisfied be as of all to about with relates to I should You static sort would there. see early thoughts to that correctly. need then XX% Has you regulatory be study, it been at And that noted, PDAC for thinking Mark, overall wonder I this perhaps basis, to we if is that be your expanding PFS metric? detection need how bar OS? Is it about pivotal guess this --

Mark Goldsmith

for comment second don't thanks we on the the part since regulatory your really at question. can Yes, with haven't moment. we question I think that the authorities today of engaged

that Chief total something of that over think proportion on could future. to the first our Wei have resectable -- on comment I cases whether to be will Medical Dr. PDAC time. that Officer, evolve question, Lin I'll and that currently ask considered address estimated are So in the be the we But land,

Wei Lin

the there's pancreatic Mark. because -- number we by or screening to in cancer. I pending cancer, It's breast unlike there's think detection Thanks, driven don't a The that short any the and mammography colon is evaluating largely with question. change great no patients expect term, whether colonoscopy, and test cancer there's no

on. care. so test we a we that don't, blood see term, short with and to standard probably established much becomes CG&A more for why don't it no be in long before change. That's Now That's the term

Mark Goldsmith

diagnosed I that, we efforts to patients are earlier promote largely there underway credible a screening are such in that the to but course, benefit further resectable becomes if the their to And events circulating occur. And even And on point possibility clearing future think further to in are will tumor based of I of tumor disease extent of of course, to those are that add the show Yes. develop efforts, can context of to that those could DNA. disease. just try the tools who cures

on become of And now, much it's so we to and higher. do becomes the of represent the have much possibility a even significant patients just greater as you But if than are as diagnosed diagnose out, point earlier impact patients they to fraction. possible who focus

Operator

from Cowen. question of Our Mark next TD the of line comes Frahm

Marc Frahm

then all after outcomes because depending one surgery be Whipple. questions resectable, there are there adjuvant resectable Others which kind just get wanted looking certain fall or And upon of also just Would patients surgeries varying lip to Pancreatic about you not procedures, design. to subsets a I resectable. within in? go on some borderline start don't just follow-up some disease, the to also, Maybe there's about get talk you

analysis And and with current then there? would Or you're this of on have subsets broadly? do RAS lines, that disease, the trial enroll and kind in in that introducing late-line similarly, much when mutations, you also different risk moving based mutations too you hierarchical different different is

Mark Goldsmith

Mark. it's the Is to relating Thanks, second resectable that also to referring adjuvant? question was or

Marc Frahm

Both for that part adjuvant of second that. first-line and

Mark Goldsmith

see. I

Good. Okay.

of can now or both about [indiscernible]. also what the then and and whether testing think thinking not to I address we're right definition Wei on resectable

Wei Lin

So first question population. the patient regarding

that any caveat had So just first want not interactions. we all, saying I have of by to helpful

So pending daraxonrasib certainly center offer the in new But interactions. design to those still for population care the we patient to very, would broadest like final is patients very possible.

So patients that as type would their chemotherapy, of broadly had of and that possible. really have many any resection typically disease preoperative include and disease as then that defined primary as have

Now I believe where goal [indiscernible] daraxonrasib define population But design to really the largest pending health can traction. think still is final the we that our benefit.

Mark's on and And then, mutation is of the specifically I of this we the active do kind setting. as is the and or second about piggyback comment, consistent the preference as lines fairly that disease believe earlier far throughout cancer then of driver setting we early initiating the therapy all, question RAS just is first mutation, know, the think so in the

cancer as that's in eligible in daraxonrasib including for potential metastatic that's actually entire developing approach population a old-comer And as to cover patients. which approach is the many Our setting, far trial. the pancreatic to our for a is patients similar

Marc Frahm

run long it redundant to balance of different you, these you that how into up the then don't more quickly option maybe just also Okay. patients sure term? a based just with end make balance best bars helpful. combinations, many trials over all opportunities Mark, making lines, setting then strategic to move do versus monotherapy earlier having And or you how for the on That's if you difficult really get forward to too moving

Mark Goldsmith

Well, with hard considerations. question. That's in Yes. what a every grapple we day that's strategic our

need for When primary so. move we we our something motivation we patients, really swiftly. that think And patients. do serve is to to I here think the means that moving will needle have

that what not Given wait things there's also a lot that's that. -- to and offer we see better in might of the environment view, in point place for us opportunity competitive from business and of of a pause

we against to swiftly needs. have think just unmet I try to to move deliver the

up circumstances to we we'll to making course, us tells data Of to the unserved be where trial would III bars but registration We'd it's decision, because ourselves and rather rather this just the else. the table pursue there than be different that prioritize, that lead ones for and a bar use can't step bar extent create these pursuing to what for hold where that to beat the certainly If could But be be setting patients try for think that Phase we to prioritization decisions. ourselves such wouldn't position, we things, competition new don't given rather create scenario. ours will chasing leave we then And make information someone on we can't lose. to could opportunities we current off to and/or in a a and be. the I our generate We'd first us.

can of it's matter. us realtime an into a the because they potential category that work wait multiple is, a of falls situations and, because to a riches these large to not to can degree we It's solutions So for for sort is to years define have each something in pressing but this of patients, topic embarrassment we challenging out.

Operator

from question Guggenheim. next of come Schmidt line the Our of Michael will

Michael Schmidt

the a follow-up progress. Congrats on cancer pancreatic on strategy. had first-line your all metastatic I

the data will line initiating share you in later perhaps be year that this X like How able combination? trials. for now study? to doing And So separate to a Phase a as more or being to trial with as it registration first I of you've monotherapy done to work before in some there perhaps opposed be the committed sounds combination chemotherapy much needs X-arm single

And to registration your pancreatic strategy to thoughts daraxonrasib? perhaps your into latest cancer on are how secondly, zoldonrasib relative what incorporate

Mark Goldsmith

you, Thank Michael.

We've it we're have forward more And shared. to the is is, continuing do we select driven mainly we on doing chemotherapy regimen combination but evaluation not primarily some has to in collected that need now. first answer the trial? the question So second move work already we've to to efficacy really And a what of primarily third but around safety. It's in and monotherapy confidence stage that based yes, because are the efficacy with the that's we data straightforward, data, already we good with. by that support that arm

So this about just during is enough really can making breaks. that aren't and safety we intensity that treatment dose relative sure long there high assure

period you As that discontinuation that incurred both forms of in a forms, of particularly treatment therapy for chemotherapy some even as time, anticancer X greatest not may is of the hospitalization as efficacy cancer have where Grade and know, long liability the often to the run. of pancreatic ideal that's for result major events coverage targeted likely possible or higher drive adverse often continuous

the to go need XXXX and drive that intention best that, we or some want but forward just regimen data regimens trial. in more initiate we So still to to to is choose with, it our

we as as to can support decision. moving we're that swiftly So

zoldonrasib question do how pancreatic to on second zoldonrasib, and daraxonrasib. you cancer The we relative is comment to want way that about think

Wei Lin

of Zoldonrasib, you GXXD problem a pancreatic cancer. XX% has as Sure. about know,

or So common RAS pancreatic cancer. specific most that's general, it's driver a mutation mutation of the in

think highly as our looking activities. I then a being durability So we for data agent, results, is probably these say active monotherapy with improve either that as care, daraxonrasib chemotherapy doublet, is be option chain substantially Phase well the could on up shared combination the following separate And on registrational actually we're I And had currently plus registration initial a zoldonrasib. earlier RAS trial thinking on standard potential end the with that those a the evaluating of stand-alone best-in-class path. we're

X potentially are [indiscernible]. options those So

Operator

the comes Ben question next Stifel. Burnett of from of Our line

Benjamin Burnett

zoldonrasib. more you color contemplated to you update want data? learnings there any I second provide just are what key question to is have Specifically, glean First, have another the data the from on I can being that quick these the on guess in quarter?

Mark Goldsmith

the of Yes, have think zoldonrasib to on year. to have color this We just data any more We And data quarter available. Ben, do second wait today. that in thanks don't provide to for are your on I those until provide question. we'll additional intend

Benjamin Burnett

I if to question Okay. some could with chemo. metastatic ability like of frontline Understood. And cancer, pancreatic as there's back the of combined debate been previous on feels sort the a daraxonrasib to go it maybe

is combinability like various that question confident cancer the setting. is the frontline that's like what that concerned contemplated? with you been you're I proposing with in that provided the are daraxonrasib guess should given pretty overlapping Sounds potential thus some thinking signals But talk chemos being there the the here one are guys be design about and metastatic when data the far

Mark Goldsmith

it. the time to result hospitalization. the in already Yes, that thing for the I That that clarify, honest. be aggressive, go cancer just a this alluded earlier be has -- some with combination Really, the chemotherapy, chemotherapy of agents, for with so standard targeted a events care have ultimate is is any very chemotherapy heard to been often raised the with side of pancreatic drug period that there's a other we that, and/or of Ben, today implications for that a just number substantial could think, drives the been and daraxonrasib know that is And which though. that I chemotherapy go aggressive patients of the don't I to adverse topic of one let me difficult has for about in combinability. year, of made statement chemotherapy itself, that debate but the really, I disease debate. efficacy to through is one chemotherapy in that effects, holding haven't alone the questions, And because alone of the to or earlier times,

raised. issue we've that really that's the So

about are whether meaningful We debate any has that haven't not public combinable. sure not there been really they or

anything hasn't And to so really have because I to core add been think the don't issue. that we that

reductions as that a dose that itself the in cases, now. them, regimen dose And result Of X mind this optimistic next. the in to that typically that can results develop in holds some evaluating fundamental we're keeping essentially in not course, issue chemotherapy that we're most cycle tolerated. combines we're only from X we fact, already And but is barely moves in

So context that's that. for the

Operator

of question next from Raymond Laura Our James. comes Prendergast

Laura Prendergast

X you inhibitor if if could there double chemo then registrational tumors well? bit maybe data, provide colorectal a will for a beyond EGFR more path wondering as any combo cadence. we on disclosure was or I Should guidance data you combo the be little And expecting data cancer when just be big and then colorectal year? any cancer this RAS-driven

Mark Goldsmith

are Yes. cancer. colorectal next Laura, We about don't We, thanks have on yet guidance course, provided studying question. your for of any colorectal disclosures cancer.

of data combination patients, study combination cancer no activity elironrasib treated In and from been daraxonrasib we who with options, in colorectal elironrasib a a showed fact, just quite of December, of daraxonrasib. had the GXXC we and significant inhibitor with the previously have other from patients really disclosed with in advanced

So that ago. or guidance we X have to but months X provide. weeks any don't just ago was

are be them. this. to evaluating that share might when strategies study to we'll continue We we're There have -- prove that that. combination variety strategies, to And a and interesting, starts point might think that future information to of be different we I

Operator

line Our next Shi the Kelly comes question of from Jefferies. of

Yuxi Dong

on Clara This for Kelly. is

Phase in PDAC. study I So

survival As at opportunity. of the last was immature update, the median still overall the

plans any have this data do update the So just year. overall wondering, survival to you

Mark Goldsmith

Yes, that from question. an was survival X up at data. did months. to your the show for of multiple XX.X And curves of thanks an cohort. including estimate One ways the looking from different XXX-milligram showed was was overall levels before the we what Clara, and there, Yes. we aggregate dose

earlier just curves patients because if When the very XXX-milligram that was that we of will, recently subset you sort that with that those [indiscernible] mature. that, took not enrolled the cohort subset, more dose patients the doses those had were been have of the

the OS estimate se, XX% which per come think to course, on which an But -- quite the have mature. pretty look but high, have was depending which those going looked these state have we what's the didn't I good information to it we was regarding we as of so X-month did don't XXX% about OS in And data. safety range, some at of a provided

share and that. we right I do -- plan it don't have mature. don't And don't we some information. have some specific point one an have sure share, but those today, imagine, information will any at a continue So point, to to estimate at of at we'll now. have that We that would We I'm point, around

Operator

of Our of next line Chris the Goldman from Sachs. Shibutani question comes

Unknown Analyst

on is that potential opportunity. to This noted exploring a combination just here. Kevin you're first-line Chris. chemotherapy-free the for lung the triplet you wanted for on clarify I

third terms in of of we Just have you expect potentially pursue year? for that frontline of be could here, quarter or this that would the you a still explore Or indication? plans And your could then do that? the one the priorities to quarter also in triplet, updates second non-GXXC

Mark Goldsmith

Kevin. Thanks,

sort you comment essentially I think a as as other our we of then has there defined of on Steve been subsets, Steve that. to, Certainly, And first-line GXXC, of kind you are cancer. the have President we than alluded how Maybe R&D. in maybe could itself. disease of multiple about could comment a there's now Kelsey, think lung GXXC everything on and

Stephen Kelsey

the GXXC on depending I cancer a cancer a lung now probably itself the requiring And divide distinct of lung sets definitely selective into disease separate inhibitor. We GXXC world completely has RAS as type established mutation. of mutant that think Sure. RAS-mutant

-- XX% think addresses The cancer so lung So cell the region space. I daraxonrasib into cancers, combination which daraxonrasib be in would second we acquiring question. all that mutant with lung chemo GXXC is me then prioritized RAS question? move mutation, GXXC preliminary about remind triplet non-small cancer the probably because that of you a right data all the plan would Can now, GXXC in your have other to we your for the of elironrasib And and now. cancer lung presented of are the XX% on first somewhere without to right

Unknown Analyst

up following that. on Just

mean that that... does So

Stephen Kelsey

is I full as of a we the in release dose. yes. a order pembrolizumab like recommended pembrolizumab line with Phase we I be we fairly -- can dose guided data. incurring specifically -- cell starting only pembrolizumab, combine will on III additional with step in package. without that we can combinable data prerequisite RAS cancer try in but have the had to lung that We we've for We've don't the with some don't complete think lung combine with them take have in trials I we significant releasing those the cell cancer. first-line inhibitors think, RAS(ON) our haircut a clinical accumulate when absolute do. almost we an to already, an what believe trials RAS(ON) road our now inhibitors starting combine to on to will with regards the course, are data not toxicity, And is we persuade non-small in the other be can mean you that to yes, put first which together Data justifies to inhibitors to of trials non-small tranches are

cancer the know, ultimately, we durability enrolling as cell and you elironrasib, colorectal sort waiting daraxonrasib combination in to are, for both So lung of aggressively mature. and non-small still of cancer the

as mutant a disclosure, As zoldonrasib the a was And then can't data durability we time the of of we because the maturation designs set for again, date, any give ready have for can the of has course, ready it's for And disclosure. as so about I I But as daraxonrasib soon data will soon we on just public of line combination it. little supporting But that with behind. also have as can guidance when That that. have matured, you in data. bit public -- really that trials that don't trial we you well. tumors tell will the report course, be behind as

Operator

comes question next Oppenheimer. of Our Jay line the of Olson from

Jay Olson

Congrats on the progress.

then by cell how daraxonrasib I on are non-small PDAC, of in setting be study question And thinking that the adjuvant ctDNA. you And about the lung the For a follow-up have dosing resectable guided cancer. for could duration?

Mark Goldsmith

the designs we're we Those early they I core on we'll committed design. of be details the into little get that indicated, trial us think it's the to a elements design. just are since, of bit that questions trial now for trial working as to obviously addressing are

due to question and So I we say it ought course. would that in be addressing hold

Jay Olson

of about might cell or talk even lines just Understood. in lung interested your are there? earlier strategy setting what non-small Okay. you cancer, And in be then And therapy can like you the neoadjuvant? adjuvant

Mark Goldsmith

I be very from these cancer, we're you've our a to of in And -- all we're we to just pancreatic which heard of have a specificity relevant going Well, think of lung around lines. rich I cancer answer I portion question. XX% very mean moving very lung just committed that's we're of first an line, around cancer non-small with our treatment. to we've adjuvant and about to cell that represents don't RAS your have the in disclosure Steve a We interested. about about obviously can lines moment Yes, strategy pipeline right ago earlier to about pursue trial intention now. that shown first part

well of have So it little is the to strategy well of because the pancreatic lung cancer well has little through. thought hard it's just a taken it we need. really off until unmet explain And cancer bit a articulated, the sort of ahead

so. a directions and substantial as urgent things over position push time cancer lung to So we're hear better do you'll there. that we're about really to in in all But able

year, happening. do cancer line, we're that first announced we've expected we initiated now there cell course, second as our third but and the Of study this just that's to in of we quarter today non-small importantly, lung line

develop that. the various then in direction. we share So that's strategy And earlier data we that as the lines, for first and will the the right step data both supports

Operator

Sandler. next of the comes from Joe Our question line Catanzaro of Piper

Joseph Catanzaro

chemo is your me regimen. Maybe in relates comment, alone it aggressive as quick for Great. an that to one front-line one PDAC Mark,

you'll frontline the of Or there combo, an cons could you for and just until potential chemo is use each progression? regimen maybe approach as idea? be. that continuous design And induction therapy combination pros the to are maintenance thinking the what So

Mark Goldsmith

Thanks question, Joe. for your

that I think Wei can comment on question.

Wei Lin

Yes.

do final have We the interactions, I design. the not we So again, regular study because had have think not right now.

valuating in right exploratory current adding or care we're what the to think really in combining the chemotherapy FOLFIRNOX. GenRAXINE studies either daraxonrasib I now the combinations doing standard

think dose to our that's daraxonrasib deliver and intensity think we've I benefit primary patients. of of going as earlier, clinical because maximum to gold discussed protect the we

other, developed And the or setting. so final we that will line into how move the first way what regimen one the

to maybe share. So to that, I other than try think

Mark Goldsmith

be bit trial I that of We will arm Maybe Yes. do could X that if to daraxonrasib. little add a monotherapy that. expect

really and patients there and so phase. will There's isn't And as it. a be long clinically an treatment from they're induction phase benefiting as maintenance treated just

cancer either don't chemotherapy, they matter patients pancreatic first initial With patients, they added, patients can't X raise because so follow-up phase many but a not their that on the and typically or then is and try to stop induction the nomenclature. it cycles all But and through tolerate and stop. chemotherapy there's make pursue just of it much. That's pancreatic cancer X whether phase question so does or X an cycles progresses maintenance of because chemotherapy, or they in X to it disease currently,

patients initial implied benefit or something to data by is the daraxonrasib get want whatever by And long-term suggested because having previously so is period, in that's their from patients. mind we treated that from make through just keep the to the sure actually potential is, for that

the strategy. we're advisers a kill to sort to driven the we disease which said, that we're device moving using paradigm and to trying require we've how Wei are to arm or that then, a treated of notion of we'll may may very again, opposed to -- shift of on not fact not require to and of paradigm So kind engaged or again, come just chemotherapy from shift biologically conceptually bit appropriate think generalized about conform to treating work as talking we that a which based But cells And go as you about those actively with chemotherapy to right of daraxonrasib, and attempt a it's the earlier. a history disease strategy combination the through. We're as and arm have the now how And that's, effectively, added with thing that's engage thinking modifying about chemotherapy most now. patients. that thinking a of should will in arm some may we'll daraxonrasib things the some that in and those the to think regulators we've to nomenclature added important course, more

Operator

Bank of of Alec of comes Stranahan question from the next America. line Our

Unknown Analyst

This one on first Alex. is us. a from for Matthew quick Maybe

in XQ, I in safety in data XQ. tolerability mentioned think from you know pembro you you expect to had data elironrasib I the combo December. that disclose

update come the next mutant in or selector XQ? or updated Just any in update curious still plans if were would for there XQ the whether inhibitor XQ

Mark Goldsmith

what question, of realize processing XXXX Okay. you're update to. XXXX. alluding that actually your and from QX I QX of that We moved I was into

And might folks going that that came so earlier. which do is the in those update. already provided the we XXXX. treated why efficacy the is primarily safety if the in treated, we're of to previously majority sure And we assessment, be with We it who vast alerted work it come able who -- but and We to patients actually experienced patients was a weren't patients it that were XXXX, was issue actually primarily it that, is have pembrolizumab.

for them get So new of antitumor there to potential by much boost activity with wasn't retreating really a pembrolizumab. them

daraxonrasib just who be pembro pembrolizumab additive first-line that in more that and not what daraxonrasib would with And before. setting is or for if plus in which is efficacy about it be would it patients assessing a activity. so efficacy. have actually daraxonrasib, appropriate could context, looking as thinking This the at you're contrast be used, really where you seen seeing

Unknown Analyst

of your a Makes sense. other entertaining one how opportunities you with on then think any And assets. maybe collaboration or quick about daraxonrasib potential

Mark Goldsmith

over published have Yes. both have preclinical entertaining clinical been engaged active many mentioned, our conduct that, are a clinical of that is are asset We've and X years study I actually papers or and collaborations. certainly and including will that their that would mean of on. range inhibitors, been of several And example, be There underway have continue in collaborations combinations collaborations. of actually so and PRMTX there Therapeutics for we we that and time. inhibitor Tango expanded will collaboration. imagine And daraxonrasib a with RAS

Operator

& question line Ami Company. comes next the Our from of Needham Fadia of

Poorna Kannan

on initiate and gastric indications you such do data you [indiscernible]? that big additional data pivotal what Poorna And into On Ami. zoldonrasib, is to from update confidence to other as see for trials? will any the give need This combination

Mark Goldsmith

hear well. Unfortunately, we you can't very

we get not Could two we're that And what helpful. sure were. be if questions that? maybe would the you those could So repeat up, adjusted volume

Poorna Kannan

Does pivotal what you give include initiate asking it was to would additional combination CRC. for and trials? see gastric such data these from other I to the indications as updates you do confidence And of any zoldonrasib? data need

Mark Goldsmith

Okay.

about previous really evaluating or trials of context. raised in is in currently which evidence differentiated Well, question plus the observations in combination compelling of justified the have pivotal antitumor by zoldonrasib we elironrasib the are activity. zoldonrasib that with initial daraxonrasib is So combination we think daraxonrasib delivered

same that may concept And zoldonrasib, we believe so we're hold for and it. evaluating

that standard cancer. colorectal evaluating also for would for agents, with or pancreatic other agents for care combination other We're lung cancer be of zoldonrasib appropriate in cancer or

I So that priority for The already to high we underway. that indicated is this work this think have information. that We've -- of is generate a year. work much

zoldonrasib clinical share zoldonrasib and new based develop some expect pivotal mid-year, beyond. data concept inhibitor, the well as trial on a X selective to to least for expect and we be XXXX at on which additional We could

Operator

the question next of Barclays. of Lawson from comes Peter line Our

Unknown Analyst

how This show control you that sorry And I joined on benefit? impact second-line could OS -- the And this in and was the that are study Peter. potential about already. how if completion trial PDAC is Alex first-line if so an and the thinking addressed of late, impact could approval? But ability to arm for your

Mark Goldsmith

your anything Yes. to Thanks Yes. has for that question. a There's downside always upside.

a shown create as as different does move though. trial new that trial. trial. daraxonrasib We complete which based is data is on this That us to for believe broad to that want far. credible And we thing rapidly us quickly completing study. stop demonstrate it possible the doesn't So OS forward for in interest barriers a to from that we've a benefit opportunity There's important so very an

some We're -- according or patients. by with consistent our in actively. the the the expect not and progress stragglers are opening are pleased interest XXXX. over can. enrollment that to sites You're about expect U.S. RASolute study from do we we be in enrollment We're that our complete with We're very that We enrolling complete sites talking into trial roll plan, sites in now. there. could this of also fast moving the in can possibly study. setting U.S. the outside XXXX. CRM. and But we right the may rolling in do as new opening broad U.S. largely, as investigators highly with sites to confident There's plan. XXX active And There countries We're currently that quite

on for part to put achieve, we think As of what that in moves out, want on possible pressure is put means bit every trial. to fighting changes here but pressure end patients and frankly, to We intention able we first-line currently the answer for the trial point on ourselves trial deliver That's it do you needle. is that important an we are benefit That's future by sort trial. getting final the that of sign as And first-line which to a feel treatment trial we of little it be to does on will our year. urgency, the first-line as so to this, expect do. the to quickly initiate this

Unknown Analyst

based Okay. on see you some potential any in setting? PFS approval for the first-line sort And of do an accelerated

Mark Goldsmith

to Yes, question best probably regulators. addressed that's a

or out exaggerate somebody a cancer meet there PFS particularly later is a finding and doesn't and then not for in little I a does is is the doesn't about understanding so reasons, a OS enthusiastic pancreatic the just belief approval which that readout approval month long readout, come in the giving they're one about after the not accelerated that FDA think an OSR that bit. wild to of of that number that widespread

on there's So accelerated that speaking, PFS. assume we think, don't approval generally an I path based

the really body based those able our so how that might we, on will meaningful really, data ambition Phase drug data, I/II is determined On at data needle possibility. hasn't in And deliver any be by that And regulatory other of a the show. a far, there the can't results, way. we've be on PFS, look hand, by been such what the predict. course, don't, shown which But based that's moved ever to encouraged we're we to

overpowered and actually OS of timing number the it's of the trial by driven around for that is which PFS, analysis, designed We've first events. OS, the the means the analysis really the

reached on And so the possible OS be mark a But an maybe would the event-driven that having towards the chance reached point. OS which it the trend it, achieving after or trial. evidence at achieve a data case success having being greater of with it's in there PFS subsequent the is there on without partially to OS assessment with out of on way of

think that really in the we'll period, have angling happens that's What I interim just up to leave because entirely to not us.

up us at fact, it's In really much not very to all.

Operator

at this questions further time. no showing am I you. Thank

So I would to for closing it to remarks. like back management turn

Mark Goldsmith

everyone operator, and for participating continued to Medicines. you, and thank of for Revolution your today Thank support you

Operator

your in conference. does you program. conclude Thank the participation for This today's

You may now disconnect.

Revolution Medicines (RVMD) 26 Feb 252024 Q4 Earnings call transcript