RCUS - Earnings call 4 2023 | Arcus Biosciences, Inc.

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Operator

Hello, and welcome to the Arcus Biosciences full year/Q4 2023 Earnings Call. My name is Elliot, and I will be coordinating your call today. [Operator Instructions]. I'd now like to hand over to Pia Eaves, Vice President of Investor Relations. The floor is yours. ahead. go Please

Pia Eaves

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

Terry. deck, to refer slides we'll turn With website. call, Investors today's During section our over be in which our to found corporate can of the now on that, it I'll

Terry Rosen

of XXXX, late-stage built. now billion robust into a well stage the and think, a positioned portfolio, lead got a and deliver thank With long $X.X Pia, and X We've pipeline we clinical development, much, commercialization. it's years new to promise that we're and the engine an of evolved say, all integrated really think you our broad way multiple something, and clinical in since biopharmaceutical runway sight equivalents have for mid-stage today. I founding come to very a fair to on Thanks I us molecules in ago, cash joining discovery We've trials, company. into line X we've

early-stage With the to going our programs. trials, invest in registrational X new we're continue to

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what Our to We're not us aggressively. settings, partnerships funding effectively we're doing. these pursue and really to we're only doing enable and and saying compete but compete

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very first-line program, our with on XXX-milligram Genentech plus the ARC-X XXX XX.X with large study ARC-XX so ARC-XX pancreatic cohort far a be CAS schedule, of initiate phase of year. ZIM sharing Casdatifan, we've on clear last molecule their studies best-in-class cancer. the and and What The with we'll III of we'll seeing limitation has ASCO-GI dose overall last Belzutifan. Beyond a of is cell a month. Phase that months the Quemli cancer today, in or inhibitor, escalation data median track to on profile has from for ABXXX XX enrollment next our superior historical We're presented far I our was our inhibitor year. ARC-XX us confidence ZIM. are RCC, touch showed and enrolled study in Phase has of believe that from OS last ahead DOM without to survival of today, set, we're at a And for competitor This seen and that's pancreatic our to X of to improved HIF-Xalpha survival compares expansion completed months from Quemli, a overall pool what for that B-trial given data casts these just have quickly here rapidly both November profile, which Belzutifan, thus patients, in median but we Merck advancing chemo, data. early Belzutifan. data advanced we we well-recognized CDXX addressing Later

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end and I'd to details. to Jen to minutes other our on engine. right robust like over continue supporting a now to our the us activities discovery the Second, the pre-commercial it things to spectrum turn enables few fund on of spend

Jennifer Jarrett

ownership Thanks, invested premium $XX Board. effective by stock Gilead Johanna at of nearly In our Commercial their share Officer, Mercier, Gilead's XX%. price Terry. million our parallel, our to represented $XXX which the purchasing joined increasing per announcement, an to just before Chief XX% share,

XXXX expansion Board. and clinical our data of late-stage their For brings portfolio the one, membership the falls ZIM addition, to runway with for extension X Arcus The Concurrent events. changes commensurate plans; increases perspective and strategic a and DOM our provides to multiple representation X few dynamics: to and the ownership very experienced development investment cash we our commercial board Quemli. through investment, of with related X, made a into the

resources lung market a this non-small landscape anti-TIGIT and focus for we our of the setting. ARC-XX high DOM high which unmet lung ZIM, first-to-market much study, or study a enrollment with and PD-LX We'll is of is highest to evaluating opportunities. able several drove also now enrollment addressed ARC-XX, sentinel expected III resources all-comer to and use first in our greatest segment our closing DOM we study A expressing completing population our Phase PD-LX combination X-study opportunity. be on tours. paradigm PD-LX with market we energy not chemo plus addressing lung evolution our and second for nasal patients has chemo-free other STAR-XXX, trial best decision STAR-XXX rapidly a investigational patient areas cancer larger the line clinical First, was for high our that ZIM, PD-LX the chemo cell the are and crowded DOM The closed treatment believe therapies, PD-LX capital become STAR-XXX, for also ZIM we of the increased and for by to with opportunities. need anti-PDX high toward focus increasingly initiate of factor were and on potential cancer. cell Therefore, At

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Terry Rosen

Thanks, Jen.

high PFS I'd the review in improvement than our Now a for lot LITESPARK-XXX new with of switch III X-month alpha validated was harder outcomes like data as has unmet I'd start In shortly, This be Merck's in We areas our need the detail gears the significant recently an the we statistically is after plans. third highlighted Merck's essentially information We'll we're more this in to hitting trial, differentiation can Phase RCC line a approval. just release mechanism pharmacodynamics more well for going as patients. coming to the inhibitor. this Belzutifan believe versus therapies clear-cell ratio HIF-X improve monotherapy which this like granted approvals Belzutifan. Belzutifan, a supported a to program HIF-X target over of out with and discuss and in CAS, to market. future to for pharmacokinetics that on potential X.XX, really by its Everolimus development year new support planning hazard that FDA thesis as Belzutifan alpha showed process for

study benefit results more even new these encouraging, agent absolutely to Belzutifan's patients. prove reveals are While and profile a for multiple upon opportunities provide the to

their a control actually rate First, on that clinical in of specifically longer and which the first faster, a a rate, arm was had at at believe This progression, than means XX% could tumor primary therefore, growth Belzutifan Casdatifan lower Everolimus on high patients XX%. of progressed PD X/X stabilize Belzutifan before rate PFS. PD or efficacy resulting in LITESPARK-XXX, We that over scan. higher

of XX.X% rate LITESPARK-XXX, there we is believe response improvement. overall for an with room in Second,

relative earlier-line ratio, [ first of the to in believe hazard believe TKI stabilization Vanda tumor the X.X really to We median or way Belzutifan, be other studies settings opportunity strategy this differentiated has focus Fourth, where or may thoughtful Third, more well we be less our which while durable PFS a more are being and and we in is such months. this longer median about was PFS. can better PFS relative CAS, only hear to market point. combination and course result year. partner in for is to Lenvatinib, Belzutifan tolerated regimen. TKIs for development Last, and the therefore, that showed Cabo we'll a LITESPARK-XXX as and an over we and there's statistically shrinkage tolerated CCRCC perceived an significant very ]. combinations on you'll CAS important

As now has Belzutifan potential. you may Merck is that blockbuster projecting know,

Given the program Dimitry opportunity data more we this and I'll turn things to so mature hard our program. new as share to be want as as ARC-XX we're now will later over excited possible we're possible, from our much trial pushing as and this why evaluating this to data while patients. illustrate about CAS share cancer year, to today

Dimitry S.A. Nuyten

will high cohort cohorts, go-forward dose clear XXX are another enroll completed our by the to There dose than expansion safety cohort to per XX-milligram are corporate patients both evaluating later including XX-milligram Enrollment cell only cohorts the with of escalation and trial, the and in resulting subsequently optimization, peripheral Slide day higher patients evaluated while portion which patients, patients we our with dose the Of with and dose complete CAS and tissue clear the expansion cell dose additional data shows patients second of of XX generate XX data any is at deck, to expansion patients. a for safety patient milligram or data shows where turning this received is nearing cohort all and We X dosing daily efficacy toxicities, advanced these RCC of start solid escalation Collectively, also study. RCC. enrollment X cohorts trial of The XX-milligram valuable cohort important milligrams dose BEV's who dose XXX patients, followed in have November. a to the design, The patients dose only dose of escalation by portion HIF-X phase received XX requirement and X XX satisfy completion. the XXX dose-limiting our data a in volunteer The XX relatively dose healthy FDA's relevant dose, first received ARC-XX we cohorts. expansion lot the X cell for line and no a To I'll at design XxX milligrams start and employed results enrolling allowing in each a Slide in phase. for the are Terry. expansion inhibition. EPO. normal X clear biomarker XX pharmacologically regimens. who milligrams portion X patients. Thanks, the will patients milligrams patients or XX with enrolled phase on alpha RCC. backfilled of patient which trial of our set escalation the for tumor, the and saw enabled X us Reductions, us then

means milligrams contrast, the On here purple for line, showing XXX EPO In achieves CAS in the that XX approved perspective of XXX of Belzutifan the EPO patients. the has same and dose line HIF-X milligrams a the from just suppression the Belzutifan, side, XX shows dose This potential X/X cell our dose milligram the to left-hand reductions dotted alpa roughly or milligrams reported at of milligrams. that XXX RCC a approved level BD of the mission. meaningfully achieve clear the with is of equivalent to is and CAS of greater go-forward therefore,

a has dose-proportional linear profile. the that On slide, pharmacokinetic almost see the can CAS of hand you right perfect

XX greater cannot dosed and it XX CAS why addition, inhibition. ideal of In has higher Belzutifan, a that to approximately daily explains of half-life dosing. to hours CAS simply HIF-Xalpha of the PK emphasizes be Slide relative Belzutifan achieve enables this and

data therefore, by to clinically any dose dose is state, increased By we milligrams that have from In a and doses Xx increase. Belzutifan. exposure. was these is study potentially and than what fact, increased the dose XXX predicting a roughly trial Merck relative of XXX to in the been increase milligrams, the show clinical PK/PD unlikely XXX has see efficacies XXX the result variability state. given for XX% as that can exactly in best-class milligrams summary, demonstrated right, of the typical increase only exposure This at the steady when higher not and we comparing clinical profile, A drug CAS, result And XXX from of show exposure milligrams and XX% you the observed was about at the XX meaningfully less Belzutifan in on which better in On comparison, at increase are we milligrams left, by in Belzutifan. meaningful BEV's patient-to-patient hitting we harder to XX data CAS in illustrates this XXX activity. than in greater by should to LITESPARK target activity

we plateau Turning compensatory can we likely the Belzutifan. XXX with corrected now CAS, for CAS. at hemoglobin the due appear to XX Slide Hemoglobin of higher you a XX, to the relative similar that reductions of various milligrams hemoglobin Belzutifan levels show achieving mechanisms. dose On to daily doses milligrams as dose of doses CAS that higher approved safety. in of of reductions CAS in to exposure are above reductions much doses, fact And drug despite potency resulted see for

not profile we CAS's reason, Belzutifan. manageable to than this For be and meaningfully safety different expect

show target of are have escalation dose profile Belzutifan. the do a safety far with so very the of but similar are data seen On so to with while not we These historical HIF-Xalpha in dose harder, to we that CAS that we expected in than of Belzutifan XX, all believe months higher rates related AE appear clinical far, a the the demonstrates trials. rates to X.X that hitting these and the appears phase about be slide, closely to follow-up next watching the levels Slide hypoxia profile escalation on-target study. the median of are inhibition, we toxicities across Anemia

So together. let me tie this

We which deliver approved safety able in biomarker HIF-X profile. are with CAS to an for that alpha is the effectively of inhibition of the of greater achieves than differences the that dose apparent exposure peripheral no to with level same associated fivefold blockade Belzutifan

phase, dose we Slide was efficacy what in patients. RCC While different evaluated of included. summarize the given the doses different specifically escalation particularly tumor and RCC the we patients, the advanced XX, observed not of types cell On objective the and stage clear do patients

least months, XXX X XX of variety be and milligrams, there different treatment line anti-TGIF earlier, late-line anti-PD-X XX% mentioned X short the I on across actually X these The patients fourth XX any treatment X patients dose regimens, XX.X a treatment very As all still indicates CAS X RCC ranging X treatment. growth spread patient the out advanced patient in including of and X with X and at impressive remains patients, patients even on not milligrams durable later. experience Three still These of prior and these monotherapy potential treatment is X the evaluated of population. from XX reductions late with are of remain a for are just very in setting to tumor are X.X tumor meaningful levels milligrams. And and did months or on This very third treatment. of patients effects line the time for over for had patients

even signs seeing of growth ability We to tumor are aggressive control. also CAS's under bring

increase treatment, anti-PD-X the primary profile would the pharmacokinetics volume, not one the response. escalation And about VEGF And in about had XX volumes tumor TKI dose stable and the of emphasize ongoing formal this still had with very I I to disease drill prior an example, X pretreated, X For all-comer on to establish patient and patient an treatment. safety progression. months, meeting early down. goal slight studies mentioned and of after the on And the tumor pharmacodynamics. heavily XX and received patients to now come assess a like started nearing is months after to was

antitumor of the We duration all available tumor ongoing X designed and with have The shrinkage exhausted clinically on the are advanced the read portion the would is very signs the give us comments year for Clear the escalation activity have believe support clear beyond the cell few phase November. efficacy the treatment expansion a already like this patients has of who and expansion is patients clear already we seen options to RCC, meaningful. data cohort in in providing portion a initial for of study. of in on observations and I completed The early to phase.And dose enrollment XXX-milligram better make

CAS. data So a at rich we clear patients have of in set and hand cell mature XX treated for XXX milligrams

these conference the some data full Belzutifan glimpses important are we for a already set CAS's the of later highlights data While this was still did data potential year, at over feel we'll we differentiation share early, but of today. medical share seeing are to it

scan the approximately X the of and patients in have majority weeks. X First, or had patients expansion only cohort every X we scans,

X.X Nonetheless, seeing, So Belzutifan to the the responses seen unconfirmed follow-up. response It's short already in very line response months with of for follow-up this it's in includes duration LITESPARK-XXX. which rate follow-up, are of with X is. rate limited even about time we how given the

substantial a but experienced tumor can happen treatment yet scans. have on patients have formal a treatment to have of their early not the but duration future threshold crossed shrinkage meet of with response, XX% of also who obviously longer this We in number

this the overall whose best is a we primary of rate, disease. and relatively progression response patients Secondly, percentage low seeing are progressive is

the to while present response which cohort we look expect these an the progression patients at that second and summary, greater CAS tumor indicate XX medical data, clinic. patients a during have parameter which, into should the at opportunity data a the can stabilize early mature will conference mid-year, very we overall in represents months X to of have This minimum translate and the may early, could in in escalation early Belzutifan. important treatment, will follow-up upon scan. all By these of approve it profile as to monitor this year. expansion PK/PD in half are XXX-milligram on CAS's dose the have that provide efficacy tumor for that growth expansion reported on So signal first encouraging an an provided we and something was the rate, by for future these In encouraged cohort a of be

expansion mentioned this includes cohorts, also we XX As additional earlier, months. I X and the to next over be ARC-XX expect presented to XX

STELLAR-XX, evaluating with together referred We also study also XXXX. from our CAS expect as sometime to data SENSA [indiscernible] in

speed III our we disclose outline Phase other I more expect our for Terry plan to to catalysts will discuss turn coming full study, to XXXX, are fourth things will and year to first, on in our financials. over development our the Bob ahead We but months. quarter and full

Robert Goeltz

Dimitry. Thanks,

Arcus As position. Terry financial outlined in a earlier, continues strong to very be

million, Our as December billion cash $XXX increase Gilead's XX, of $X.X was Equity after XXXX, an January to Investment.

majority partnership our we XX-XX, share programs because III DOM payment studies costs the option in is for $XXX Importantly, option very collaboration to committed capital million due July continuation under the with including pay Gilead for of ZIM. also Gilead efficient Phase has multiple the agreement.

excludes and our our potential expect to million from fund now to million be This cash expect other and $XXX we between opt-in of operations payments $XXX cash approval partners. XXXX into end guidance milestones our So balance the at XXXX. and

Turning million to compares $XX quarter fourth for of the million, recognized revenue of the which P&L. our XXXX. quarter GAAP to for third We $XX

and beyond. on for Our collaboration our our amendment by with the XXXX we're driven of the evaluating and impact revenue primarily Gilead, recent is revenue

$XX million Taiho receive study, of from participation a have the we'll our participation fourth to partnership we related their in and related Japan. pivotal of our with in another $XX partnership and their received million In to DOM in for quarter, Taiho our we addition STAR-XXX studies. STAR-XXX a STAR-XXX milestone XXXX pivotal with Gilead, the quarter first In in payment to

in We milestone related million STAR-XXX. Taiho XXXX of first $XX are from also of payments additional for quarter eligible the to

clinical of for for $XX XXXX. the In expenses $X R&D and noncash fourth compared net The the stock million were quarter, Gilead was the fourth third reimbursements are to from our purchases care quarter as the $XX trials. increase million of compensation in stated expenses. of of represented to quarter in our related standard R&D Our quarter fourth million

million timing to trials. standard expenses therapeutics purchase third expenses Noncash were continue $X Phase to the the million we $XX modest G&A for R&D fourth fluctuate of manufacturing XXXX. in XXXX. care stock spend expect of of compensation compared on III and remain for for based of stable and quarter, of represented clinical We quarter the our expect studies expenses our of fourth the activities increases in as million primarily our G&A the mature XXXX $XX clinical to quarter for and will G&A

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

Terry Rosen

Thanks Bob. very much,

touch will another the to to Dimitry catalysts open questions, highlighted. we a beyond like floor that Before Arcus. There's ARC-XX I'd for data-rich data briefly This sets on upcoming XXXX for the year lot. be

year. the in II For at from this presenting chemo we'll ZIM plus upper program, GI cancers anti-TIGIT be data updated ASCO EDGE-gastric, our Phase study evaluating DOM

updated set and PFS data to data. include this ORR expect We

also will look STAR-XXX, which to for forward potential regulatory filings. STAR-XXX obviously of enrollment the completion and start the We clock announcing to

future at We from Merck a insights also and make medical XX share data conference.

improvement Quemli for presented to that in from we to these in we in related ARCADE share first-line expect Also our findings believe we antennas, have the profound the data the half cancer. X first evaluating impressive As that I mentioned survival on our confer earlier, Phase modulation was that trial pathway, AX Etruma, I randomized of survival. pancreatic our gate confirm B sets year adenosine overall and overall adenosine our receptor we data

data robustly presentation cancer, care from presenting in evaluated study when cohort operationalized potential with versus of atezo, submitted with plus of prolonged Roche mature from evaluated modulation pancreatic chemotherapy at a The chemotherapy cancer. and importantly, so we enrolled This randomized BEV that that PFS third-line randomized is and mean REGO, PFS This MORPHEUS first combined their will plus XXX to a standard Etruma also we data study include of involves a presentation for Roche patients medical and OS. very data, cohort be versus and So Second, by OS will PDAC. ZIM robustly, in chemo the in combination Etruma the the adenosine off, immunogenic current supportive ARC-X third-line conference. and Etruma anti-PD-LX are we FOLFOX which colorectal antibody believe

Thus, So lot today, a late-stage that that potential now excludes its in execute not funding to Arcus payments. is future diverse on opt-in conclusion, covered with to thing there's is material. portfolio enabled away one from into XXXX, fully and a we've today's take call

X IND generating of planned multiple discovery includes X capable II and Phase at per trials, and III a that's Phase portfolio Our least ongoing I engine year. studies and just

longing and positioned Our extremely trials therapies. are standard, potential or to RCC, to focused compete cancer any pancreatic cancer, by where with well GI market best-in-class on huge we're first markets

on, We adding broaden have portfolio We'll to cancer we treatments going patients support therapies, of a these the we're lot more floor for Thanks as a our as now open to your to and to this working continue for questions. interest innovative year. combination bring and as Arcus come possible. to lot soon

Operator

[Operator with question from Instructions] Morgan Flynn First Stanley. Terence comes

Terence Flynn

one for X-part me.

unconfirmed? make decision. how the this mechanics a or long could on us many Gilead to Maybe, Just you of ORR provide terms have were data. alpha little work the decision actually to XX, Gilead to just type how a of how the of then that was you wondering HIF-X Can data those on potential question you confirm CAS, opt-in a they the and and the And of how program, confirmed relates of dose program. would in then the just versus Terry, Slide part expansion remind what second how much would

Terry Rosen

Terence. Thanks,

had of intentionally. the share or XX% didn't on Actually, ORR we the X patients specific question, only have scans. X first So

a number. So to half stable the in that with of we that tumor wait and of until second to convert are patients then there's may But that seeing year disease responses, double-digit response. reduction fact, will the number we're give

with part to defined Gilead. very Often, together criteria have we second with The them. respect specific

We exactly. we've look proof-of-concept occurs shared in when haven't if those you But for at relationship, the general opt-in the generated we've what described data.

molecule own have of fit I'll coming decide. also program, the ourselves, can year. inbound a one is plenty draw from we'll had as wouldn't mind very with rest forward see So what's that and other That they're strategic final And that see point. excited might portfolio. last later we what a program belief their this the our that make the actually of they we taking obviously is interest you but your and conclusions companies about

Operator

turn now Peter with to Lawson We Barclays.

Peter Lawson

of alpha and were any way think is the X CAS, you in you patients talking reduce the any are progresses affects to recruiting to vast about, for seeing see. both HIF-X you able get if that drugs you patients On complexity non-approved number ZIM that plus

Terry Rosen

settings that we So Rest a think in the of exploring have of topic. Vanda. define combination the going strategy. into discussions will World, makes including We're had also, with sense, Cabo. parallel, number we We'll on development And future that for we with be actually

very about our have we feel in the we're after ability to our we'll in to going context of of But obviously, planning, this not under mind, this point. So be both good And belt. monotherapy those enroll. keep at question,

what trials. to degree going CAS have And and the as that had be already of general Belzutifan, get doesn't well both standard we'll We've ad now makes which investigators from enthusiasm first be of fact, BEV's in with field the like execute those so experience, their as with we huge care substantial is HIF-X seen on mechanism well feel And to positioned meeting as the to board excitement. against very excited. very for a anecdotal a anvil starting and the

actually we've this already as enrollment very rapid we so expect for seen And molecule.

Peter Lawson

a you. then Are on reduction progresses? Got that And the rapid you that? in just seeing or

Jennifer Jarrett

Yes.

very right out a and progression at for them. The talk can Belzutifan relatively thing stuck one is in LITESPARK-XXX, study rate, what LITESPARK-XXX, to which high, primary you progression and of investigators rate, results that, lower patients than that that that's for So at the but Belzutifan about was we're treatment. if study of we I progression the primary think that encouraging, overall rate see were sort like through was look look number which improved theme the Phase when III that would primary upon you just was they to blew a the

said, seeing year. and on more We it's upon So like there'll I another think Belzutifan opportunity than lower later improve we're to that to in come number a be that. the

Operator

We Pohlman BTIG. now Kaveri turn to with

Kaveri Pohlman

I provide you compared color that expansion trial, on provided, us XXX could with think exposure ORR you excludes you respond make pre-created to the patients patients believe, trial? higher prior to these the dose tell And these but For LITESPARK-XXX any do data, treatment, how the were can or patients HIFX-alpha XXX?

Terry Rosen

a why talk of the in those patients retreatment little you don't Dimitry, the about So bit expansion study?

Dimitry S.A. Nuyten

Yes, Sure. question. for thanks the

regarding patients setting phase. for prior in than escalation treatments, cohort the earlier dose So the a inclusion for allow criteria slightly the the in expansion

a all the fairly had to what expect. patients say, X let's escalation what and to pretreatment, Many that's expecting. of expansion in still in is therefore, X options. people phase, cohort fourth think positive daylight. we we prior have And to seeing treatment reasonable early they all also profile line have dose our something also we or exhausted cohort, require TKIs, expansion the third required are VEGF we a efficacy was we observations and puts similar in In are the So are PD-X. It

have slightly and it, So earlier escalation we do phase, But the it are very far, where if so line stage in prior very, would overall, and allow beyond, summarize line I been similar. patients treatments beyond. third the second

for to reason hit I respond say, not hard let's be the question, that will did be to wasn't interpret think, Belzutifan it thinking one patients an because There target including prior something, the enough. with now could think data worthwhile because however, resistance targeting. Belzutifan HIFX It is interesting complete, could make patients hard I As treatment, the really question. about, is it

alpha get been HIF-X could at who at under but the there look looking data, that those think benefit, targeting. presumably progression the primary hard rate, have Belzutifan to would definitely a I control. might Those number you resistance if be patients patients the have of

not answer. So a I know it's simple

right it's a I too the are that's efficacy prior be why patients. excluding clean HIF-X on think because not progresses we other treatment one for signal would Belzutifan who patient now, and complicated

where would that a in you to prior the detailed capture treatment. explored have setting more really of be detail So

Jennifer Jarrett

number, expansion Fourth that front been it cohort in and so of the contain hasn't lines treatment of me.

So X of the XX were line. second

a of inclusion criteria like lines. and later. on BEV. X, were remainder, are minority and line III the a Phase want that's that so third patients was was again, or it or The X- a reminder So Would for line XX X fourth X prior the study then

from with that study. than So more patients prior were X excluded lines

Kaveri Pohlman

III study. MORPHEUS plans anything worse in to expect Etruma you to better I for for what can change this terms whether trial cleanly? from could expecting you're ask initiate of If if or a than another for efficacy, tell Quemli? And outcomes Can your PDAC question us especially and trial Phase you perform OS

Terry Rosen

it OS change what just Kaveri, you'll the I'll to be similar anything. So to doesn't And for what say is ARC-X. see data, saw going they're you

control components. X They gem/Abraxane the a there's interesting study. arm have Now in

So it's randomized.

study, great Our control is study hand, larger end. the a us MORPHEUS a analysis, we that has conducted the about But and thing the arm synthetic The you gave to it's data. point as ARC-X answer. both know, other the which they same randomized on

to me, takeaways. So the that's big

on to pretty You effects X that would say are identity, studies us, overall which effects have removing they're what of the are we important. bottom X different affect profound in producing but adenosine ways, line both very is, survival,

other At some from some mechanisms triphosphate. better. still specific the And question for point, hold time. we'll non-CDXX than there Etruma we'll adenosine might had be we've say known that versus be Quemli, as would in settings in say where so which formation judgment adenosine may as this very far We for mind to

both. You make rationale for can

over I something the inhibition actions to will one, adenosine meaningful the that take-home sets the chemotherapy if to the big that But still context has headroom a of idea that going mechanism but as you something is see have time there's force formation be of you with of better, the pick a If it's to a of block role, reverse tends you immunogenic out versus by would being I that on care in with where play me CDXX standard time. these improvement. read to could modulation the message particularly data as think for X combined, very positively go

Operator

from comes next ISI. Our question Evercore Jonathan with Miller

Jonathan Miller

Obviously, a Merck? expect you expect be love expectation, a you talking relatedly, much Could optimization me more see to to from similar the would would How hinting that context ask to about XXX about I of up do the to by and and put HIF-X would how to in level escalation you cohort well? PK in response for also maybe about could ORR in there? already context show LITESPARK evolution linear you And what's ORR to dose could ORR to from some you're to midyear. XX time here? milligrams your milligrams little versus mature scans? given as reaching But here later that that expect far, then so bit differentiation evolve

Terry Rosen

question. great Jonathan,

with kinetics. start little So gets me a your the that bit let to one first

The PFS. if LITESPARK-XXX So but better roughly that's the all played let's date, anecdotal you first way a And looking, X.X median response, months things And it to that the put doing that obviously, looks are we'll opportunity the for sand. we're least the numbers, in at line with see response. plays time outset perhaps how that is longer than to deeper leads like out. that. at around

variables. As independent aren't you really know, those

at the are maybe that the be driving known particularly to target harder fast. outset, hitting So not kinetics

say question, didn't Although second having earlier, tumor we scans. your the reduction On we anything have XX-milligram after it's even and in script cohort, patients seen what a enrolled. almost the even it dramatic it's couple multiple though tell you of later I'll fully about is

that's group even in I looks going the you honestly, on single would patients So look And you patients. of the that just pretty patients good. And kinetics yet, had took another to be XX but a tell scan where first if a scans. the have have it had all not actually

be skis because we've I know, the ahead group to of transparent you reductions. patients of the as get seen. But first seeing couldn't significant I so pretty pretty And with what some tend are

pharmacologically And look looking the relevant. about hard readouts on early we're both it the like playing clearly out. at that's optimistic does kinetics and feeling than efficacy so And more XXs early,

in. But the was right would you As XX say out. PD seen, too the different, as fits what how we milligrams way XXX that's approved any going giving of XX-milligram early essentially we've from labeled same Belzutifan in dose certainly, was you dose to stated, play the that's to say effect it didn't it's if marker on know and the it

Jonathan Miller

us also activity? on have patients. about some RCC were where few those sense. might indications escalation Obviously, Makes And the in of tell a only escalation you of more the very clinical things. one seen you then side that other of Could patients set

Jennifer Jarrett

Yes.

So types. tumor it a was mix of

cell, And those still really We therapy. so say anything. it's a patients have non-clear response seen X have types say cell I'd but on no that or interestingly, lines patients treatment. did patients I with not of had RCC wasn't and and and clear there all other prior of tumor would multiple they're in the one RCC

continues tumor reduction, many, not treatment and up months XX% on but they've for been treatment. to a be many So

indicate as nonliteral the to it So drug that seems RCC has in activity well.

Operator

We now to Citigroup. turn Yigal Nochomovitz with

Yigal Nochomovitz

the Did RCC patients then were you And short question showed of on another III. that X Phase for I the just doses what XX%? say the have reductions

Jennifer Jarrett

mg, I other, if remember and the I I Yes. was the believe one was mg XXX dose XX it the think correctly.

Terry Rosen

XX X while either They're seek. looking think was we discovered, mg. the got definitely I of other right. that because XXX Yes, had out the XX mg was was probably Jen all one and but you patients, mg Definitely, one that or

Yigal Nochomovitz

going At as that what base to III. that's as you mean you for do III with could finished mean, would the dose, the Phase far I case dose expansion this but Phase I for for mean XX. first, you the point, go it's be XXX-milligram doesn't

know up you're case said also the don't for TBD. XXX, what's although But Phase that dose a evaluating I that's to higher what You III is. still base

Terry Rosen

that data like Merck matching PD we fivefold once of is the felt the dose We establish look tumor. increase that to response look support from a done really look and obviously you what look at and unless over achieved either ultimately kinetics arms, regulatory the standpoint. they've Yigal, that that should being the down the at are and waterfalls you at case base you see the something it felt got dramatic you The other it marker to their maximizing we from which we've their optimal that XXXmg. a in comes peripheral if be And at we

call. So practical it's a

a in standpoint, see more sense. it's oftentimes but from cancer, if know, drug, you very some something expansion a different, on like practice safe cause But makes unusual other at But XXX-milligram a would to have say As was we that point, would dose. you these you we now, in this that right when you doing consider trajectory there we're alternatively. something feel to cohorts something

The other that's appearing clean. nice very thing the about is safety profile

Yigal Nochomovitz

then you Okay. LITESPARK-XXX times. of bunch mentioned a Got And it.

that So obviously, was versus Everolimus.

III, the Belzutifan I right but So for want don't know, against that Phase is to go I'm assuming up you'd assumption?

Terry Rosen

Yes.

So once not we monotherapy be so we're setting. same describe what that exactly to we're into going doing, going

going consider bit was but would strategy go places first. against more in where care, part say to we'll the be we will actually we ago, along go of goes about And of and wouldn't be a that we'll So setting standard the when of Belzutifan care. best standard be the that the a what little the as year

Operator

We have Salveen a Sachs. from with Goldman question Richter

Matt Dellatorre

just the last shifting ARC-XX you discontinued is share secondly, cited this why this from design PD-LX-high is that first-line any share KEYTRUDA any believe for reason you and you I XXX. as just could curious away to on on the details This forecast? Could is was cancer based happening Mono details data if trend lung additional paradigm And Salveen. the up shifting on at Phase you this for III changing question. Maybe point on then in following on treatment Matt what now.

Terry Rosen

Thanks programs. the are different to as government for those X I'm same the at X time walk into questions. going

I'll need, you commercialization, going. So think lines you multiple there's where comment about both the It's of can can ultimately development, standpoint RCC. of from think is what a

up was. bit patients line And about have third from so received probably can anti-PD-X move And that population think that and/or we would where a you TKI.

have We go. feel place you a So like BEV's to wouldn't that's of standard great care.

the and your as far so And question strategy ARC-XX about there.

So points that. let on me a couple of give

increasingly a it's efficacy. cancer, PD-LX reasonable the efficacy of therapy, be we places DOM, going more spot, that's conviction with obviously, bulkier continuous a population, and a of like there's That's plus those alone a healthy where, particularly patient rapidly EDGE-Gastric for the study, a chemo, administer a tumor. So become in but to with on more and particular to within seeing on in cannibalize chemo.So anti-PD-X or this with And than and population it already think example, treating clearly, as bring safety top think from what's tend like and I any Anti-PD-X along enhanced, going to goldilocks very bounds. more do in as physicians many to of molecule about think further that, more focused we're with population. happened well be both particularly like progressing that a therapies additional essentially from patient anti-PDX time patients We physicians particularly real only going way plus goes to more how doesn't that's high side liability in comparable that the that effect as liabilities to with approach one a

population comers. from a the opportunity that biological then a the is you're the of I important biology want things biology. really So thing. anti-TIGIT inhibitors start tubulin toxic we a the the much that treating. do What with things standard couple to things. level, feel bad say down treating very do from agents, feel highest for that you best supports What about is of the are to the spectrum And that is one to that biology the thinking At CDXXX is I'll organ STAR understand you're addresses standpoint, best we care XXX and become move also less the that you think all of like

If mileage getting get the because of is doing from out its CDXXX anti-PD-X all you otherwise that full of anti-PD-X CDXXX, to you've you relies what keeping it's got is might CDXXX efficacy. on

right is already molecule with anti-PD-X all-comer PD-LX and where the works where for to anti-TIGIT go want to population know you're behind is CDXXX whole that for absolutely that and losing fairway feel and like what's the why best anti-TIGIT of part down borne now that otherwise what the a out And being you middle clinically CDXXX, you you have we rationale with so might chemo like place when DOM. go of you that's gain. And the engaging

Operator

Robyn with turn to Truist. now Karnauskas We

Robyn Karnauskas

different do of Vanda. Several diminishing cut a there? strategy thoughts XXX can leapfrog you think think process. your do incorporate the ARC-XX, like there'll limit CAS, it own trial, Is you XXX. think you into Second on into a DOM you you at is from on are going could could push might would a different return be, you XXX you There's the milligrams lot your milligrams? there What maybe questions. be up how with Thinking once. take third And leapfrog do did a about frontline And question that but how you those of XXX there, FMC is about higher? how you

So it could only. you just for [ going from is how XXX, clinical incorporate axle And forward. your trials ] differentiated Vanda

So ] clinical you're Vanda doing trials. all these [

done knowledge first-line reliant And first-line the past into greater going think XXX go could second is The like would to the indication. you have to there? like ahead be you've off you and like already? happen CAS, your question skipping people, because and would other in RCC be, trial you by do pushing you of Do milligrams you tractor given Are what I/IIb leapfrog things ahead given of think versus get you get things Phase indication third efficacy? cutting

Terry Rosen

us do be some if Great. or enough, want see see the I'll it dose Juan, start HIF-Xalpha, brief XXX-milligram that's dosing, really safety but over roles do from think go that. milligrams. questions? data we want we that milligram, it'll does the what hitting the XXX We but on but you with do probably additional to XXX else higher, we'll hard the think I'll we physiological take give to is XXX the on because anything it do of other learn target we XXX do

Juan Jaen

civil really well Vanda the be to a Cabo the it's of accepted VEGF inhibition. [ clinical is TKI VEGF activity decreased as but as result and potency, both Yes, primarily ] with sure. molecules with and generally

RCC, the TKI. you we probably primarily the the go where to but a context would effective for we after thing is surgically more believe, reach So AXL not XXX, going to of in VEGF inhibitor the first be of

Terry Rosen

And a you call asked about is way, since on the it, XXX out by bit. we'll

We volunteer really have completed look profile dosing, safety and PK healthy good. the profile

minds, in is, our molecule selectivity axle the really first the test this So that has hypothesis. the to

Dimitry. very you a we're the or Jeff, want into to about molecule. do frontline excited on comment XXX Dimitry setting. ahead, So that leapfrogging Go

Dimitry S.A. Nuyten

sweet to read first But to when interesting data factors. but options, to longer, be setting all time So a lines comes trial quickly select of want track the for A in the first lines out. let's time taken than trial spot the It data, it. adjuvant it first really has It support higher safety that make has other market early line. Merck. and we is first is out we line. course, second than in into to for second setting, mix we we have about the to competitive to of efficacy the is a to say, to considering considerations to time different could opportunity. in The There's is in are example, line and line. an We bar sure registrational line the read first-line

first considering that near-term make but pursue, are communicate that these factors. in So a we all of and factor be would options, we what decision it's future, the we'll different opportunity and our multiple a

Terry Rosen

like the though, to really your point is important. good would conceptually of going end up being one. HIFX-alpha emphasize really a to is question I

XXX unforeseen some a as drug. barring I to out think started blockbuster weird Merck that's call has thing, it's why it

question better That's it's good And first with if about to study, look how than so And not want a portfolio, huge so hard how And you come have going aggressively that? expand the ask definitely towards something think us. real me it's hard at really get as do a that our you molecule opportunity. footprint to a do exploit HIFX-alpha you move you're to program. very we the the actually we in of anyone is because fully we this molecule,

better BEV and to So than end we feel commodity there's here. going going we're not be to up

Operator

We turn Leerink Graybosch to Partners. with Diana now

Daina Graybosch

the on the getting into CAS For questions. have data. PK/PD X I

milligrams a area is for value you curve, XXX curve. I I where here First, XXX with to range about talking CAS see the what similar expected in under XX, area the the for on But the to XXX Page pretty higher much show that the the and milligrams absolute position recall initially Belzutifan. you

to have X the on range. readouts So different wonder you can ending then pharmacodynamics, same up if And you're pharmacodynamic here. I that, talk you that in

expect readouts which XX. these you is First do what I in range PD EPO. on then you of if mean change change the in in modestly and the Page be And percent or hemoglobin Belzutifan, higher higher, EPO to Page the look correlated looks on efficacy? absolute you're percent and A XX is more to believe of in at it you're hemoglobin hemoglobin, the modestly

much in Belzutifan? versus final pharmacodynamic my drive expect efficacy markers better to to modest So increases question do with similar how these you is

Terry Rosen

Thanks, it together. tie I'm going Daina. to

better what's and So the I key think PD. point going what's PK I'm better to define

So as know, penetration, PD, tissue you encompasses differences, differences. potency everything pharmacokinetic

get marker of EPO the you're proposition. and we're horsepower you question milligrams PD same and the ABXXX, is No value that the the So out getting use used XX as what this readout, let's saying, and of approved the that we think dose Belzutifan. is of

PK advantage gives when that AUC an The advantage to go doses nothing marker, to you that than on higher do that dose Now we fivefold get the the we equivalent fivefold Belzutifan. the with is PK higher relative activity has exposures. to PD

water Belzutifan. more of the dose stone, be that with to fivefold squeezed equivalent there's out PD activity of if So hitting the we're

advantage of se that from tumor With or value of either or maximum look the is is go EPO, respect the less we in that's something the higher The that at setting. that's to activity more can PK those effect. predictive don't proposition. hemoglobin So you per

Daina Graybosch

much the though to what back? you're these fivefold really you effect a dose more will marker, So that and a give it you of even state at I hitting Belzutifan. than pharmacodynamic you than had neither believe greater gets efficacy better that more markers fivefold Can pharmacodynamic much dose

Terry Rosen

physiological what's is predicted factor. not that's that's the as you transcription hit, correct know, and it between a it difference maximal But the is

EPO the what's tumor. it has Its things. going to XXX on effect on do nothing with regulates in So

the So you're inhibition. we in out max HIFX or know EPO going basically, in going to that

makes hitting a we can of what for you Xx are then how you feel that about And Merck becomes hitting so good molecule can us this that hard just fact thing. harder. marker out what the is And the go tumor get the

Operator

Cantor Li to We now Fitzgerald. turn Wang with

Rosemary Li

This is Rosemary on for Lee.

when do happen go to safety with side to see it milligrams? toxicity, any And question So programs. the you do XXX your comes Casdatifan, dose start above then greater effects on you response And to TIGIT one profile? when for have you concerns

question the So for TIGIT.

would any And said have could you Do going from color the some you impact you ARC-XX the of on? discontinued. be So around to any we what expect? it which kind trials trial, plan data was and still would data on potentially you when show thinking that this have

Terry Rosen

So our dose we response, relevant. to dose dose be is that is XX-milligram already the the pharmacologically lowest used clear,

you're noted, point. a we suppression that on seeing As maximal essentially effect EPO at

produced. that that So was XX, patients we how back nor wouldn't of I that? see X we gets we this either I know is each X-mediated any just because there's do on mechanisms with feedback Daina's say expect question, similarly, non-HIP we or what to EPO and say ways would X differences And answering other on the with meaningful of the doses

this effect very been the primary side And and point, to so that on is effect which date maximal has manageable. end you hit

very So suppression. that correlate EPO that's been is basically, that the of And manageable. a anemia that's

higher certainly have a we more going this seen it of haven't expectations at liability. So don't induce any XXX-milligram point, will we the dose. at any And that

hypoxia. It's to. other HIF-X also The that we're with where is, may that something attention inhibition something normal that's maxed That eye do we're on the place keeping a in Again, physiology. out. lung. has paying in It's close fact, to be

But to date these make patients, a go seen we dose. see haven't has when when you we a patients be things EPO if on and initial not concern point, that about what date, happens patients, individual to Some are higher of these that have seen XX there to us caused would to have think seen DLT. may just nothing yet we've we'll have concern. on particularly also compromised dependent function. of kidney And And we certainly, anything the

considering. that's On the data, just ARC-XX we're anti-TIGIT something

affect But The haven't we minimally. do And would that would on that. of did would mature cleaning data wouldn't idea the decision-making data we data. we this that that. decision any the made would would if the with and data that the from it other a cut have our it hand in be studies when we of do PFS We of we the a studies, be point, extrapolate not that at have

Operator

Ladies and you We'd conference call. gentlemen, for and your today's this concludes participation. like our Q&A thank to

You disconnect may your now lines.

Arcus Biosciences (RCUS) 21 Feb 242023 Q4 Earnings call transcript