RCUS - Earnings call transcript Q2 2024

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Operator

Good afternoon, thank you for attending today's Arcus Biosciences Second Quarter 2024 Earnings Call. My name is Tamiya and I will be your moderator for today's call. [Operator Instructions] I would now like to pass the conference over to your host, Pia Eaves, Vice President of Investor Relations and Strategy.

You may proceed.

Pia Eaves

Hello, everyone, and thank you for joining us on today's conference call to discuss Arcus's second quarter 2024 financial results and pipeline updates. and you including this runway those current statements expected our development to remind make management and results beliefs to than actual uncertainties clinical statements, other that management expressed. forward-looking about milestones risks and like expectations that reflect from and call, on will our historical of I'd facts, statements, involve the and timelines. All differ our cause cash may on our risks filed and Form uncertainties report described recent Those XX-Q, with been XX-K in report has most Form and SEC. on quarterly annual are that the strongly filings. Today, CEO, and our We to you Jennifer Bob CFO, encourage review you'll hear Jarrett; COO, Rosen; our from Goeltz. Terry prepared We'll by the and CMO, turn Juan remarks. With call also over Nuyten; to the Dimitry that, our; joined Terry. I'll Jaen be President, after for questions

Terry Rosen

of Merck's huge brink much, the clear needs indication, cell or shown mechanism, also advancing renal alpha we're the very in has million XXXX robust validated for been HIF-X-alpha Thanks about as for the entrant. around this We're cell all by $XXX run cell on need and consequential. unmet activity will fact, patient belzutifan, call. Belzutifan opportunity significant into adenocarcinomas. rest trial, a which approval of you clear call which in sales and targeting to share are market of it lot The in additional the study RCC, very Phase and supported be months been the this information of of by the we molecules first-line capitalize We over annualized first us newest Pia, cas, the clear joining upper carcinoma, exciting clinically is And and data throughout and already afternoon. us enrollment our GI both mechanism the STAR-XXX, a a this This rate our year Phase III and, studies, approval opportunities. Casdatifan, and strong Phase RCC. III clearly X HIF-X X,XXX-plus been our just very III intend single-agent of inhibition or we'll generating already X to thank inhibitor, unmet going has in to excitement which in cell program today have year. after the throughout has the demonstrates upon. completed

meaningful we've TKIs. And being particularly long for how most consistently has well-tolerated of on-mechanism heard the remain clinicians on belzutifan patients, only patient hypoxia for the belzutifan belzutifan a anemia LITESPARK-XXX the to In achieving in treatment to treatment of they the a roughly relative times comparator HIF-X-alpha TKI were rate and percentage probably much addition may with study patients monotherapy response study is of late-line XX% meaningful its I/II third-line X mechanism with of tolerability tumor exciting then higher aspects of the still with rapidly pretty durability. In setting, population, contrasts on to many one reduction treatment therapies Phase X time than as had the the for progress. registrational these for now respond quickly, approaching at belzutifan, everolimus. This presentation, III and And is plus it The many And patients on patients, over in adverse X XX% data treatment. and with of patients of the of enables periods. treatment emergent remained Phase remarkable in beyond first the fact, years. where progressed events, on patients but are not years from the been the and several trial, of belzutifan the

equivalent ARC-XX to or dose-proportional Cas's potentially its great It's of more a belzutifan, enables X PK-PD which the to dose in best-in-class excellent pharmacodynamic the molecule While result with clinical belzutifan. and molecule approved molecule. us profile, in forward And greater we profile PD to and a our cas, may out deliver to further fact, a those belzutifan is profile. cas's in this already of efficacy investigated good pursuing pharmacokinetic we of data, onset due year. To leverage sharing have relative seeing more really those we're in belzutifan. times later we're differentiated this improved study, with look the combinations rapid which being relative differentiation play to

cas this You're when going first Jen, for of III to hear the study from today first time design the disclose for more we PEAK-X. Phase our about

studies We in we're near more in have about the works exciting going the to that some future. other talk

plus chemo just our dom XX June, on Moving this of Phase first-line STAR-XXX, expect completed our months. X,XXX plus complete to we GI domvanalimab, and trial zim over in upper enrollment we In later antibody, And enrollment year. STAR-XXX, III and STAR-XXX our evaluating patients anti-PD-X enrolling anti-TIGIT Fc-silent cancers.

now turning readouts. we're data towards focus So our

convinced cells While over that advantages significant you, we of active the confidence antibodies. AEs. has than many recognize, configuration and T This substantially is and the show-me dom remain our we Fc-silent peripheral the FC-anti-TIGIT correspondingly increase the ever. immune-related deplete and is actually anti-TIGIT a for story It's data-driven, program regulatory because Fc is stronger antibodies

We've obviously is their simultaneous detrimental for studies leading primary trial is they While of need explicitly reason increasing out seen undesirable, rates that withhold Recall to components co-formulation immune the perhaps incidence of the to more a continuation anti-PD-X X to discontinuation greater drugs Merck of negatively anti-TIGIT therapy. Merck treatment also impact intrinsically these AEs, AEs both may or strategy, which now is as AEs, where using efficacy. called manage the failure. of necessitating discontinue

can TIGIT-bearing designed of immune system therapeutic stimulate strategy the TIGIT immune that's because depleting immune several cells. to any eliminate cancer other Additionally, to is expressed for types cells be counterproductive on cells,

talk we confidence only of a X We the that going TIGIT in later, of about enhance coming potential not sets impactful pathway. data we're to the have will which restore but bit both believe

programs, quemli general. want and receptor in Adenosine pathway to etruma, is dom an briefly anti-TIGIT respectively. CDXX TIGIT particular, our FC-silent on in and So comment But antibody. I

for cancer. In showed data an study, results over of colorectal for For clinical randomized months surpassed survival in third-line overall reported the second etruma, plan unprecedented to in results we as that presented etruma from also the ASCO, well relationship of this CDXX trials cancer. colorectal third-line biomarker at of combination expression data from year, tumors, we of median block as ability between of half any patient which etruma-based adenosine XX the ARC-X our described to the survival effects study These the survival. and present

are to update this advance steps outcomes. program. to going going we to for you and clinical finalize eager we're in mechanism our colorectal next etruma advisors cancer. So to We're clinical we link once Both

pancreatic next operationalize further and quemli pancreatic of China. Japan. expected for excluding as early be make the next year. development illustrates expect now extremely calling to are be which and by start and in cancer, the last development For Phase quemli quemli, rights excited option year. In our quemli for PRISM-X, we're potential taiho Asia, Japan, to received exercise triggered costs in study They'll but well as we return, exercise which in payment milestones, taiho the they're program. to decided this commercialization will for obliged a option us The We're to of cancer. in exercise, option Mainland that responsible also now to the to taiho its III in pay month other countries PRISM-X

study. to We role play valuable successful the in expect taiho PRISM-X a of the execution

on a due dollars billion continue as plus well enabled million in advance to significant provide investments the with large continuation partnerships Gilead, funding as the our portfolio we're hand, for and well to multiple from cash Finally, $XXX payment that programs.

where today. summarize me let are we So

a we've made investment extremely that complete expected well the studies, due enrollment, completed III second Phase to X in which the year. to was positioned that enrollment are of this and We our including dom, is one

of investment we the to preparing such, behind dom. perfect. of now represents for us, we're our will and a and is registration. timing priority, As investment in of enrollment STAR-XXX R&D With rare We're anticipate XXXX casdatifan. very opportunity. next able data potential shift strategic to peak cas resources this represent The our now

HIF-X-alpha. Belzutifan are an this as of new We Cas and development improved by patients is an embraced clear despite focus. and limitations. has has physicians have to in target our program central a profile, very what important been now standard care, validated

development from fully learn Our emphasis set. able growing data cas program been that have comprehensive on our we creating is in to a everything belzutifan that leverages

year. expect We of and over next data the plans flow a continuous share to

Our things over is turn to III the Jen PEAK-X, to trial, commitment. I'd and initial start speak bit now Phase like of about a this greater to transition detail. in cas

Jennifer Jarrett

for therapy in monotherapy expansion mgs, to eligible. is XXX and XX Slide in Terry. initially cas, the XXX metastatic a evaluating on to in shows setting clear-cell both enrolling as each TKI It are patients anti-PD-X I cohort cabozantinib. approximately Patients cohorts, Thanks, mgs as monotherapy combination XX cas that design X the XX mgs and late-line includes ARC-XX, that our Phase an had well have regressed evaluating RCC. of cohorts be the of study cas plus

of submitted cohort assess duration We XXX-meg data swimmer depth have as safety so primary had medium lanes, that one therapy, presentation from data, progressive LITESPARK-XXX of a X lines a as or disease, LITESPARK-XXX, at therapy. And conference. III enrolled was the including had for charts as will the Phase primary of to efficacy rate XX% fall cohort you medical able for the patients prior ORR ORRs, waterfall prior and who of will or and a for patients The XX.X%, X lines include this In the well be to trial presentation and XX%. received responses. Patients and X comparison, and only more belzutifan, the was prior PD of lines. in reminder,

efficacy XXX-meg ARC-XX, than safety Phase in just type. relative advanced presentation to cohort patient in better across patients of would year more our This of have the we significant X expect the a us LITESPARK-XXX. Because when and a tumor for XXX data cas's We that comparable even monotherapy in patients. total are potential is profile, population incredible to actually in I another with in interest a reopened enrolling bring study to best-in-class cohorts, XX specifically the that which single support evaluated a approximately close enrolled to belzutifan,

very share to data we the have cohort, primary the than point we the in so one observed information some of cohort, to control fall. demonstrating XXX-meg to the patients that seems percent from This the expect data LITESPARK-XXX. less on including rate, XXX-meg April, is already are or belzutifan. Also, primary PD that was enrollment in their Like in substantially under progressed this All we cohort, nicely, now quickly had Moving the also what before than to in seeing follow-up. is the eligible very reported so XX-meg very that tumor which observed cohort completed these in are the cohort, least PD at with first one significant even percentage scan. ORR know patients maturing already limited pending reduction. And higher for LITESPARK-XXX, is patients growth with we're of response cas than this a bring tumor is like another XX% rate the more confirmation, scan,

enrollment Finally, of expansion completed the we XXX-meg cohort. recently

combination of So patients' between monotherapy, of we ARC-XX, well brings plan as and me to data to data used our cas from steady will our end now data XXXX, potentially present including enrollment the and expect support III initiation worth of for cabo as cas our stream cohort. of to at development be cas. least XXX These which First from rapid a initial for Phase data plus study,

our on year, the year. shown Phase First the of The trial, Following half deck, slide first of XX plan next we our proposed III this later begin design in feedback which of is from simple. PEAK-X, FDA is corporate PEAK-X, to

patients patients metastatic evaluate leading post-nephrotomy anti-PD-X includes monotherapy received the cabo This of have clear adjuvant versus well TKI will care We the who cell or in who cabo received post-IO in prescribed RCC, cell will the enroll the RCC. is as setting. the pembro prior as plus cabo for clear is standard who in anti-PD-X and patients in therapy. setting. PEAK-X cas received setting, cabo first-line

of So significantly once-daily believe PEAK-X population XXX patient huge will this to we the a and dose target mg in cas benefit plan that deep of use patient study. from will population inhibition. We HIF-X-alpha

expansion and studies our and of and endpoint from as our will escalation combination PFS. of response data the safety mg All support be from our a XXX cohorts primary go-forward this dose study exposure PK-PD dose

patients and We PEAK-X of clinicians reasons. a design extremely both number expected to be for attractive for

simplicity. First,

control their both We Merck's cabo with and as contrast, lamvatinib cabo In are LITESPARK-XXX, are the experimental Belzutifan arm. they arm using in the study, arm TKI in in the experimental arm. control evaluating the versus in similar the

Second, cabo, widely partner our TKI. is used combination choice of most the

the other AEs, We from and have their that consistent cabo simplicity received its preferred cabo-related managing of proven feedback physicians comfort is with TKIs dosing. over of efficacy, because

program for doses And is to cabo also only titrate. relatively of importantly, just safety are and the than come. cas, investment lenvatinib, a a more to our there as there in has much cabo beginning compared X cabo lenvatinib. PEAK-X that benign of to for to more approved so profile Specifically, X been have for development shown different late-stage easy doses is viewed is

stages partner development collaboration planning in of combination a that our potential setting. a cas plan in will with for evaluate the first-line the advanced are We expand a would into study and first-in-class

The substantial. in U.S. to potential of the best-in-class, turn our over anti-TIGIT for a as call cas for also different corporate more allowing on on share discuss of RCC We significant for TKIs an cas incidence per many class for population, combinations back to to and RCC of over XX billion year The our multiple beyond, Fc-silent frequently space remain list. With now in large the opportunity of growing cas a the process sales, are be market. I'll evaluating the used therapy, dom, is market large it treatments and Terry is $X well believe primarily this and annual patients years. generate have and patients of the shown Slide cycling us on in through other XX,XXX our opportunities coming share within capture antibody. potentially We to months. the these alone, now will

Terry Rosen

Jen. much, very Thanks

evaluating new we oral of zim in chemo for GI Phase So That our early in incredible we ASCO is in data presentations, company for II size plus had cancers. trial pretty dom and June, stage. X EDGE-Gastric, upper something included our a think

the outcome, OS data PFS for actually range. And XX chemo our you of the plus As zim those deck, the same as overall population and dom STAR-XXX of These setting all chemo, EDGE-Gastric in the population. this anti-PD-X months Slide corporate in Slide we've anti-PD-X exceed the pretty our median OS should Based months results cohort, the demonstrated X-month as study, our a benchmark months for XX. on can a results Phase which from median impressive PFS XX to see the exceed approached studies. plus of combination meaningfully data benchmark that's fact, These median the X- far XX-patient XX.X de-risk XX the highlighted is substantially same III on for EDGE-Gastric. of on PD-LX in combination to benchmark PFS evaluating in for high for XX.X the

in to have XXXX. survival overall expect for EDGE-Gastric We data

for Given of the this the primary Phase STAR-XXX, is for III these should data endpoint further enhance likelihood a our successful study. outcome

only important flow but that its to important have over advantages this. not continue in continues counterparts. therapy, data to an a We anti-TIGIT There of will anti-cancer supporting will advance FC-enabled steady be dom believe be that

you between to potential a think agreed add plus on benefit generated have SKYSCRAPER-X, Roche's pembro non-small differences we will of for and data evaluated potential failure of the important in chemo and upper chemo, that and cell our GI support is clinical of studies versus plus us most data plus dom's Phase we two Upper and study, lung atezo we've II/III sets disappointing meaningful patients, present to new points. We've articulated tremendous in While really GI which that and significant further the support Turago SKY-X, to dom's amount cancers, many cancer you with that cancers. expect lung both these

Gilead Phase ARC-XX data in lung plan high III we end, from year by cell off, PD-LX X, cancer. Part non-small a first randomized So to in report study

just zim opportunity to chemotherapy design the initial this zim chemotherapy. were of reminder. stopped for of STAR-XXX. year each Approximately with ARC-XX a evaluated reasons focus on patients the enrollment So versus XX approximately give zim dom much in let plus enrolled me in We arms larger strategic and and you early XX enrolled dom were arm. versus zim the monotherapy patients plus The

shifted our As we to promised at the we time, STAR-XXX. focus

zim that improvements both believe in present toxicities. reaffirm meaningful anti-PD-X and limited these the monotherapy in ratios, we we will and clinically setting hazard with dom will We ARC-X, including PFS plus OS, additional that observed data what over demonstrates

present we OS EDGE-Gastric expect XXXX. Second, in Gilead to in from data

we of best-in-class results data cohort. We X evaluate line is our overall the entirety study can remain me combination. This our data. after for III enrollment in completed study brings Phase anti-TIGIT, to ever to the readouts. III today, as compelling XX this PFS our in timing that anti-PD-X remain have continuously of potential anti-PD-X I we we confident patients As expect report OS and survival our and with confirm as studies, our given median chemotherapy say Phase plus very the potential alone, confidence well over to designs, XX% the about on I mentioned, already in our of observed months And

said be We first the our spend STAR-XXX, so XX. on consistently we on design, likely show that a Slide most readout which me minute have will study let

in dual endpoints ITT has population the trial PD-LX and this of Importantly, high the primary OS in population.

positive with So analysis be simply arm the our of statistical patients, ensure study statistical improvement closely ratio PD-LX to over ITT in X,XXX the with PD-LX will if a high put, PD-LX dom the patients the to assumptions population. The study plan. zim we've and or patients used well-powered the high low recruitment is in for the consistent is monitored shows

on are been a $X in greater in alone, enrollment than Given of U.S. of all studies, June, we enormous, that the with PD-LX get I market X, greater alone. of the do to over here a This opportunity in whom XX% X. U.S. and well the PD-LX than in into of approximately market billion XX% XX,XXX patients whom are translates OS is chemo and addressable think range anti-PD-X when can you completed readout. The we plus the XX-month math might for has

to our I'm results Before financial I to this for quarter. call review going the close, to over Bob turn

Robert Goeltz

be Arcus strong to financial position. continues a Terry. in Thanks,

$X.X March XXXX of as as compared was XXXX. of billion, to Our June XX, XX, $X billion cash as

Turning revenue million second recognized to to the compares our quarter P&L, this million, of year. of for we the for $XX GAAP quarter $XXX first which

collaborations Gilead included is our $XXX first and a million, primarily resulting by the in Taiho, executed Our with from driven amendment revenue January. quarter, Gilead we the cumulative catch-up and in of

recognize expect GAAP remainder to per to the revenue continue We $XX approximately of of XXXX. million quarter for

second $XXX quarter R&D Our second compared and Gilead, the reimbursements to the In second the net to with R&D associated from late-stage costs compensation related quarter stock quarter in $XXX the year. stated was as partially clinical first non-cash of million in our were this clinical of increase are by offset trial expenses. manufacturing for quarter, of lower expenses represented $XX The programs. million expenses costs million, higher

We continue increases into expect and over expenses shift XXXX, and for from as in R&D modest XXXX, to investments time. through our level off to cas late-stage dom towards spend heading quemli

represented peak investment expenses to As Terry noted, $XX G&A million our to we of XXXX. this in $XX expect were for to quarter, the first million year. this stable second and quarter, stock in dom remain expect compensation million the expenses $XX second of Non-cash for compared we R&D year. G&A the expenses for our quarter G&A

Finally, be our $XXX and at and $XXX balance as million, prior end $XXX cash to between XXXX $XXX investments million our to million expect compared the of we now to million. guidance of

We operations into fund to these continue expect resources to XXXX.

million the As payment guidance Taiho third a includes reminder, Both payment quemli due from payments this Gilead, $XX the in quarter. are from partnership of million. a opt-in and continuation $XXX

partners. opt-in from Our and guidance milestones additional our excludes, payments however, potential

back earlier regarding from for earnings to press results, concluding our turn now please our to details our in release refer more Terry remarks. it XX-Q. I'll today For financial

Terry Rosen

you much, very Bob. Thank

They're So reviewing and data very substantial. by events. meaningful our please let me near-term end both

the from results Those dose combination by other to fall, ORR be and our XXX-milligram data the we cohort cas. dose closely and the cohort will expect XX-milligram from XXXX. from of in and cabo in First, data expansion cas XXX-milligram cohorts, then data expansion present followed

trial, OS by advance Phase to our XXXX. Meanwhile, our include respect PD-LX ARC-XX data readouts. Phase next pancreatic we initiate to in sets versus III half expect the trial present evaluation importantly, versus plus by are from and, trial the the zim followed dom, to of first data in Phase original we a which our OS PFS of expect study in III and initiation lung also These including cancer our cancer chemo to III continuing other cancer. few our from steps for very first colorectal and zim year-end, data important for EDGE-Gastric for of evaluated We etruma in of cas first high II Phase dom ahead XXXX. With a quemli programs,

All of our strength by of great our studies the these and are the balance with relationships enabled sheet partners.

robust therapies pipeline by AXL support a that our enables advance selective continued discovery studies is to Lastly, want of you. our bring innovative The of ABXXX, in you need. your sustainable expect Arcus and all we thanking continue next into much to highly future mid-stage at inhibitor. I to mission to program a very of conclude have we programs. Thank Arcus patients for to engine

now open the questions. so we'll call for you. Thank And up

Operator

The Instructions] [Operator Nochomovitz Citi. with Yigal from comes first

Yigal Nochomovitz

Is you're the some may with Phase the cas there So the trial? with the that And that on the before check with cabo? you there just moving safety on and see goal that expansion PEAK-X overlapping cas mainly not to that explain, or expected before is combo? into embarking initiating on need clear talks to may cohort III Phase is just cabo, III something box that you can on you and

Terry Rosen

a give you that answer and please? concise question, to don't why Dimitry, clear

Dimitry Nuyten

specific before for I you start checkbox, wouldn't to a establish important Yes. call safety it's a trial. it but a information larger combination

need interruptions. Also, I'd is of but experience very toxicity relevant managed the the designed cas, with safety we far, is monotherapy. drug-related dose a our profiles, where rare have pretty to of be that's the to do we of on to for really very cohort is toxicity. to do with it We unexpected refer established. It's few published overlapping been to what of well-tolerated fatigue, cabozantinib, quite like your even the toxicities course, the studied let I treatment note in can expect for. not a So can as that individual overlapping about experience what alone toxicities. for to interruptions Lancet, for for based any case toxicities. cabo, now short lastly, in any The was exception impactful patients well so something cas people much the indeed, with have in reduced, that's is and be agent show point say, typically belzutifan XX those has to discontinued patients, patients don't in which a series And of showing, then does combination

Yigal Nochomovitz

And mentioned I going just wanted said, the separately primary the from for what of year. to the the Jen, less Is the in get you you this milligrams, confirm in progressive than data was rate seen correct? terms what disease data XX data the XXX-milligram we're and to LITESPARK-XXX, XXX-milligram later XX and that

Jennifer Jarrett

Yes.

So first heard progressive of all, you on primary correctly disease.

the the rate. significantly seeing So said XX%, a LITESPARK-XXX, substantially primary and what for the disease we XX-mig cohort I or cohort, progressive for were was primary saw for lower that XXX-mig of some progressive disease

of something as present far we fall, data cohort that show separately, in is likely the XX-mig cohort would data we was wouldn't data as probably presentation, would but it well, XXX-mig As say will we the the present from shown be some separately. least that about I likely to it the make when and but pooled, the point at trying be cohort,

Yigal Nochomovitz

combo PD-X, else? the what or study, and metastatic sort you partners then considering there? would be first-line And of TKI for anything

Terry Rosen

reason fit to and comprehensively we to that be going and thing in be and with We something we're within it the a in it, going going clear Merck and your have wanted doing ahead probably that year, off, the data is be is into setting, that we're But of very to would both Yigal, would loved able to the not have the a we what it's about we today, think we it meet because and doing, wanted combination disclosing that be to be show but disclose to of sort going it'll we're make feel key couple really today, Merck. going expectations. I to starting be what going it going want get we're to front-line shortly. to weeks to we're next we're and it to

Jennifer Jarrett

this And would a and then to We in make mention. we one that partner, out capital this last be very would with called doing collaboration we that thing clear to just a it manner. resource-efficient doing be

Operator

The from Morgan Flynn Stanley. following Terence comes with

Unknown Analyst

This presentation patient remind on And Can us presented in is the in we should that for any with on duration the and ARC-XX of you you cas venue data follow-up Terrence. us of for inhibitor potential the for fall? give HIF-Xa calling this number Alex can expect insights this you update?

Jennifer Jarrett

going unfortunately medical So in we've that we're data fall. not the the meeting submitted presentation the to It's at. for disclose

You about XX guess be It little could at of then of part about be on XX, we'll bit out your question actually months it, for and the it and we're second conferences of second of I forget of what running The that median may in ESMO, to follow-up was. your the be have at. that. able number since And won't question, just presented a time. to patients. that at It'll be just be XX. clear point above be It'll part

Unknown Analyst

your going population? expansion Anything we same design, Is it that? can enrolling? trial on can currently new be patient comment cohort from your do that on you're And the to any you read-through

Jennifer Jarrett

Yes.

will somewhat So what patient than advanced we're so we a population PEAK-X what at enroll said, less in looking healthier, ARC-XX.

would that fact mix But second the the looking of for the be good obviously line. So we is we a obviously is drug that population bodes at positively a of and looking bit patient in that first think very ARC-XX, PEAK-X.

that would setting. PD-X adjuvant therapy it patients include So in the receive

approved is adjuvant setting. the pembro reminder, a as in So

the are post-nephrotomy patients setting. used PD-X pembro. on risk is recurrence at receive of then that metastatic first-line in go And we'll that will So high patients that in also include

as of the metastatic benefit we've data that would But inhibition. will second-line patient this our So there part be well we that out patient. from a HIF-X-alpha time as that's is then like the LITESPARK different a analyzing population studies, of a all study feel lot spent particularly for

upon. So our drug. we we've And the for time spent what advisors with population decided lot this patient is is what working a this best identify of to we think

Operator

Evercore. Jonathan The next with Miller from question comes

Jonathan Miller

wanted to I get Jen, it, I and feel clarification. like I missed

dose cas that confirmation XXX-mg I You better better you've Merck suggested said? some wanted was well? arm to is And I And the in short XX-milligram you've XXX, of given with seen in that primary and the hand, far the you as than in get just the what see the guess, I know ORR so ORR past. And stopped do was you of that data ORR cohort? also, sort in cohorts, then, this rates the XX, those point? saying that progression that higher-dose a you've in at XXX, got what response

Jennifer Jarrett

given higher that today seen a we're above one And I that after XX-mg, LITESPARK-XXX that that's was I clarify perspective XXX-mg, XX.X%. is. And So the seeing less as much to also follow-up say did with where then, relative for than And let be enrollment that's now pending I yes, mature from Terry the a XXX-mg. We I'll confirmation. pointed XX.X% about a speak north the out the ORR cohort with that. that XXX-mg, the XX-mg, would we're started did response also LITESPARK-XXX. of that

Terry Rosen

response the take dose question. I'll

caveat patient thing sort to first of is populations different. also that the the slightly So are

or would be compared this particularly XXX-mg to point, XX-mg a cohort we've advanced distinguish. noted, it's more mature, when cohort given slightly say substantially more that advanced that LITESPARK-XXX. is as somewhat would less But is to with the population patient said, I the So population, and it hard at

you that we'll between XX-ish be think, potentially range, any actually more probably Jon, they're might not, likely distinguishing in than as them able that be I do will reflected to durability. each in So anticipate, given the

and XX is to able that, don't was on to good between you of think know, that, going to to the XX is contextualize to probably point even you're last I as enough you're equivalent difference care. PD So looking won't remind -- at actually of that you that you XX-mg belzutifan, is I tell cohort XXX. The be a the though, really change shift the want -- the and the X.X, belzutifan standard enough the in

molecule. and unfold nice potential well of data all the I'm we're just the that, thing about as start -- XX-patient the sorry, from not understanding these an combine So there to data going as of the milligram the while to cohorts, program XX

was to able homeopathic, and was these be to at one cohorts, sitting was not medium, these at start at to one like look one at treat going You're heart.

you that doses you've total assessment these to molecule with our patients make looks and belzutifan. of have seen at you sort to going anything how look You're an let of feel compared in

Jonathan Miller

cas broad expect number maybe this And a we to you should cabo going different in combo as late-stage number cas of in different terms for to we settings, III, combo RCC of well? setting. get combos, how first-line strategy. beyond on development maybe to one more -- about expect program Phase of see Should then question the talked see Obviously, mystery other the

Jennifer Jarrett

lot. us as other want X some So some a That's But say, for the stage think really at the where Where of even to can to as off really focused out over we interesting in have expect ground. studies. studies within ARC-XX, see where III it as a now some looking be interesting sort will probably called Phase today effect. mind explore that months, the populations X additional next could is we're we we I to for populations studies the that future. have massive, the interesting as that will then is the we in to monotherapy, inhibition, studies Market patient later lead be III opportunity study HIF-Xa of on Phase we work in that you X far getting so should

interesting expect our we'll from hands then We talk some keeping of near as over question full. well. months. And But about so other should us think And there's those opportunities your you more over the is kind do the to of which more I tumor would out coming see RCC, types. on there say, term, think I

of getting IST lot Although, for requests HCC. we're in studies a interestingly,

the there's out lot a clinical in and HCC there of definitely community in particular. So interest cas in evaluating

Operator

[Operator The Sachs. question from Instructions] Salveen Richter next with Goldman comes

Unknown Analyst

Lydia is just on etruma this Salveen. Hi, one in on colorectal have We cancer. for

to I/II ASCO, And share path Phase see program? you expect for steps that the here? given data the shared this you as do at you next Just when likely what do registrational

Terry Rosen

lot toss from since a certainly question, So about. just of answers. obviously, is very We're out we've doing program through. you tell we've give asked a you I'll excited talking And working been very that's execution. to about. we there, like excited been planning and about can a that what Gilead today, we're

setting, midst from push of that all haven't that. lot we little decide ad sorted to through end going in a might direction. might we those towards And the to earlier go, but discussions frontline a literally if that we we of we're than exactly had in this move be where you shouldn't surprised up have our the it move We board smart were, where be but

Operator

Daina Leerink question next Partners. with comes The from Graybosch

Daina Graybosch

the can design can comparing other expectations question if from on to and we wonder you a data TIGIT ARC-XX. have set this that terms including the type in of the you trials of about given think is in early region ARC-XX in the the setting, ARC-X? enrolled I about on I patients prognosis so help

Terry Rosen

for zim data to dom the we information question a this to So of about just of would patient in the Fc-silent being field, I'll expectations I'll Dimitry and in believe the it terms of But that on of little I set be data I'm if and there, bit And and these let for fact, anti-TIGIT. set. positive for anti-PD-X a think specifics with put the you really out positive say zim demographics. sets a in of your the that, any against terms going them that'll data of nice convey on get positive good will then the all data randomized

say data bit Dimitry definitely into the want -- important, a little should I'll patient set. an being lean good we you a So And population. this to let about

Dimitry Nuyten

was it was X-arm X. also It So a the so for two-to-two-to-one it ARC-XX to trial, randomization. others, down Part patient population, a and break just

XX on zero care XX ex-U.S. standard European about does because some the another run So of study zim, dom then XX core patients, chemotherapy. and and zim mean monotherapy availability it's on of checkpoint countries alone, the about not include was there. four That of as inhibitors of that on and did the and

going comparable But by However, say, in be first-line in principle, chemotherapy chemotherapy slightly run earlier. other arm inclusion let's criteria, can to straightforward population. has still it's I is to And the that's helpful be that to the of course run very that benchmark trials a control to other very fairly it trials a, think were this it compared space. population. And

Jennifer Jarrett

with And other really data that X one I and set. zim think versus other set is thing out was set within One there's interesting different data to is is is readouts chemo, the study up. the the which point how dom versus plus zim zim,

that of So in comparison versus zim you'll readout. that also see chemo

Operator

from with comes Goonewardene question Securities. next The Truist Asthika

Asthika Goonewardene

has ask us CRC just the that's is suitable KOLs already into. I study the if been that tumor asked, but You comment etruma here, briefly a can to quickly, are A jumped type Apologies on something going a how out? reading just that's made just be when tell cohort very call you of in to about go the pointing

when thoughts to can wondering then lot combination, PD-X your partners. just good that? think And with on CTLAX about obviously that. on just that Treg, about carbo, makes rush get want HIF given So combination as function And a of sense. you the the and both we I

Terry Rosen

at be And take me sometime simply question that aren't in longer. the likely point. again, cohort. setting let substantially simply, year. is So data OS second the the mature this It'll It's next on

the remind second question. me So of

Jennifer Jarrett

of PD-X. second was us second question? The the on you remind question Can

Asthika Goonewardene

like about obviously sense to about but it think PD-X, PD-X, you a When yeah. How with makes think combination. in HIF and -- combination do you

Terry Rosen

that be those be are frontline a lot combination inhibition. thinking thereof, second HIF-X sense But combinations all point to of going would your a make trial to us So about disclosing shortly takes setting. anti-PD-X, that into reasonable with obviously we're about the very actually, anti-CTLAX, go registrational to whole

Operator

closing at no other team queued currently pass it will management to over for remarks. this are I There the time. questions back

Pia Eaves

speaking with Thank you all for joining us. We you. look forward to

Terry Rosen

everybody. Thanks,

Operator

you conference your participation. Thank for the call. concludes This

line. now disconnect may You your

Arcus Biosciences (RCUS) 8 Aug 242024 Q2 Earnings call transcript