KURA - Earnings call 3 2023 | Kura Oncology, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Third Quarter 2023 Kura Oncology, Inc. Earnings Conference Call.At this time, all lines are in listen-only mode.

Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Thursday, November 2, 2023.I would now like to turn over the call to Pete De Spain, Head of Investor Relations. Please go ahead.

Pete De Spain

Lester. you, Thank welcome call.Joining and Oncology's quarter third Good on to the conference me call XXXX afternoon, Kura are Dr. President Vice and Troy Doyle, call our and Officer; Dr. Executive Wilson, and over our to Senior I President Accounting.Before Finance of turn the Chief Tom based like statements remind include to expectations. I'd that today's current Wilson, will call you forward-looking on results statements results. uncertainties that and represent involve may risks expected management's Such from cause judgment to actual and materially as of today differ could SEC, the for which available Please factors refer call with to Troy. the that, website filings SEC over the Oncology that company.With on the information are or now the Kura's from risk turn I'll to could Kura affect concerning

Troy Wilson

Pete, you Thank and us. all thank joining you, for

candidate, leadership leukemias for ziftomenib is Let's right jump well with in acute global drug market revenue and potential beyond. in.We believe lead multibillion-dollar positioned our

care enthusiasm disease with dose data milligrams. of a treated in clinical tolerability the enable AML.In with XX% in XX is overall AML body an rate enrollment and potential of CR care, a conviction AML once-daily and impressive Phase rate a is all address a safety to at believe ziftomenib patients patients as best-in-class XX% patients Our has of representing by driven KMTXA recently oral trial, we continuum II response that standards of growing KMTXA Ziftomenib for demonstrated profile by more XX% and pathway monotherapy combination of clinical Phase is drug with the strong a interaction candidate and in recommended to menin investigators our and XXX the that up of the studies, supported across ongoing pace become protein-protein our whom and I menin to patients. targets rapid driver, NPMX-mutant of a ziftomenib among data therapy patients backbone and robust for will a

of disease. upon evidence our a The and or no was enroll drug-induced ziftomenib the adverse underlying from in safety relapsed of patterns myelosuppression, year. no in strength well is trial and I patients registration-directed expected Importantly, trial, this of tolerated Building with or II a profile and the with total favorable mutant trial with the toxicity QTc ziftomenib Phase AML refractory demonstrated data prolongation consistent of earlier XX Europe. to we initiated NPMX States a United patients events of Phase

trial, size to setting as relapsed the to and be NPMX the in in by activity ziftomenib's well which, therapies. available safety the population meaningful speaks enrollment patient continue We as to refractory our of relative pace potentially the and encouraged view, of in the in mutant clinical profile advantages

potential opportunity. enabled increases care that in as registration-directed market provide but We the to the as Increasingly, have XX care.Indeed, standards earlier ziftomenib expect It to it meaningful their ziftomenib can AML potentially relapsed/refractory transformations We ziftomenib as benefit no enrollment can later with could the for patients maintenance believe Phase of has monotherapy, these to durable in patients in investigators treatment mid-XXXX. Clearly, with to monotherapy and the by that, a and the enabling the of ultimately is refer do is scenario tremendous transform it such lines myeloma trial patients our care, remissions clinical for advances a the therapy combining to all standards patients only potential is that ziftomenib to be and therapy. combination to that in it transformational and continuum reflects corresponding of the anti-leukemic market multiple CML, deeper and of throughout potent transform more frontline therapy. enthusiasm complete of with for and advanced not of in experience II in a vision lymphoma settings. our leukemia populations than their as realized it commercial benefit

behind these to represent treatment other heterogeneity KMTXA-rearranged this we for has due diseases.As including we're of NPMX studies, inflection leukemia AML first ziftomenib point an Although and newly acute towards disease, and other ziftomenib the diagnosed nature areas relapsed/refractory lagged realizing believe complexity, may mutant combination of and the both in potentially leukemia, evaluating aggressive and AML. steps vision,

safety, as potential rate, QX with then tolerability across refractory in KMTXA patients patients activity I either which combinations KOMET-XXX in At the mutant particularly known and establish dosing with the studies, rearranged azacitidine. in in frontline commonly diagnosed azacitidine X+X approaches NPMX KMTXA rearranged in to rearranged combination medical as sufficient and in inhibitors pace newly need to represent NPMX standard syndrome, combined study patients and venetoclax mutant combination that XX daunorubicin NPMX to share the assess to be the dose AML follow-up differentiation early that commercial to anticipate population States. call KOMET-XXX in study, with the KMTXA chemotherapy, greatest currently a of in with mitigate the largest our AML value. can of of offer regimens the enrollment the in preliminary in used relapsed prioritize mutant relapsed/refractory and KMTXA Combination this with commonly combinations and as very in setting.We're this also safely approach position we with Phase various we United a is IDH preliminary of or development therapy from patients in ziftomenib data those and pleased in XXXX. induction to foundational being which the patients the Our with of year. KOMET-XXX includes unmet and cytarabine the We first ziftomenib and middle potential escalation began demonstrated rearranged KOMET-XXX has previously been is designed combination

standards maintenance to and including initiate study the NPMX working gilteritinib mutant the in additional also our with expect of include we progress both continue of inhibitor, as both XXXX.Meanwhile, and to safety to to first expected care, we undisclosed settings. patients set for yet high KMTXA make quarter inhibitor as toward to of ziftomenib, menin treated indications from strategic of post-transplant and our interest. a which FLTX clinical, as which next-generation KOMET-XXX to ziftomenib intend We of direct begin We're program data well tolerability combination the are commercial with additional in ziftomenib rearranged in

realize commercialization an As Officer. Chief sets Brian trial head addition with multiple of brands were Madrid. strategies commercial Medical a well substantial senior Society to ziftomenib, support positive tumor commercial data and our own with of FDA of and in late-breaking joined oncology summer benefit indications. ziftomenib recently oral of mechanism we value and the the expertise we results Oncology the Congress at presented Brian HRAS this of our mini hematology session to farnesyl for The programs.We during cell and results us in transferase significant continue registration will organization Powl in continue is clinical we expertise He's Commercial as over commercial biotech squamous Last build mutant of believe that clinical already enhanced building solid we as global our the patient-focused potential for we in experience XX in to with more and and emerging unlock inhibition our tipifarnib with rapidly believe our products. to as sales, registration-directed featured the the in years AIM-HN from to positioned marketing the patients as carcinoma. large inhibitor across in team access farnesyl impact month, making augment therapeutic continue transferase leadership and uniquely novel pharmaceutical neck than market European

Once value our understands target meaningful we advance the patients. we AIM-HN of demonstrate validate believe and transferase Our clinical FTI, benefit farnesyl for to of to study potential evaluate context the ongoing patients proper a of AIM-HN We these potential evaluate has that AIM-HN inform current patients hand, data whether to HNSCC in the alpelisib data escalation drive the in to in supports study.We an of our we'll observed in activity strategy OBAD, HN the in the if tumors. initial look HNSCC. use biological HRAS extend to in continue the dose dose determine combination our of active combination. commercialization the selection to to as data whether optimal to has evaluate With trial to therapeutic to broader and it continue combination development tipifarnib benefit continue the the one biologically mutant inhibition we set beyond clinical which to

lung with KO-XXXX inhibitor in takeaways and to far week inhibitors, full inhibitors significantly at believe our that adagrasib cancer cabozantinib of companion that important next-generation mechanisms the with cell therapies.With farnesyl rationale targeted with clear inhibitors, meeting, is address a forward the current exciting derisks need study. adaptive announced in month, us with favorable adagrasib We Phase evaluating KRASGXXC-mutated Last look combination and will potential the therapies supply A Therapeutics treatment there's thus to sponsor trial, the collaboration non-small study as in cabozantinib.Earlier by and the agreement from KRASGXXC-mutant Mirati KO-XXXX, focus innate the with targeted If carcinoma address in expect triple resistance. Mirati KRASGXXC-mutated the results. we could dosed and announced as for in our cancer renal in carcinoma. kinase the the One presented at targeted XXXX. the we the multiple antitumor its and cabozantinib was cell combination targeted data to KO-XXXX. urgent tolerability established we other and this to patients that, over HN with oncogene. our cell therapeutics clinical We lung ahead.With to KRASGXXC-mutated KO-XXXX leader lung on non-small agreement, forward driven cell successful, we a potential with we transferase cancer. cell become preclinical Mirati the with collaboration to alpelisib. of for FIT-XXX the and believe dosing adagrasib We Kura discussion profile combine look the for supply supporting patients non-small the KO-XXXX cell trial it options KO-XXXX combination most safety EGFR such our today, highlights escalation This large Concurrent middle enhanced to Under as an in and to durable tipifarnib of renal in now Phase tyrosine with we dose turn later, of KO-XXXX adagrasib call dose combination dose escalation plan of the development in an now development escalation continued KRAS with cell financial clear in of in in months I'll combination combination a therapies the to in of progress with indications. activity solid dose forward combination also more a sharing ideal for and for drive considerable to with of effective terms of patient with oncology.We the adagrasib tumor begin FIT-XXX by evaluate in I and first look success of I the cancers partner have and collaborating will demonstrates in cohorts Tom monotherapy evaluate

Thomas Doyle

and XXXX. compared Troy, third cash of ziftomenib of quarter compared $XX.X and equivalents at-the-market for overview the same Net of investments be for and brief million R&D share-based I'm million afternoon, the cash as of we we short-term of an sufficient third quarter increase in costs third XX, expenses quarter registration quarter loss equivalents XXXX.Research to for our and million to expenses of to the expenses to to XXXX. million you, million non-cash to million good $X.X due for common $XX.X Thank We was everyone. statement corresponding were happy quarter our administrative primarily compared and period third results the $XX.X of the XXXX our to loss operating short-term a mid-XXXX. the to fund was for were General million had shelf XXXX compared of a The clinical a for provide of the increase for million current $XX.X and KO-XXXX third third for in of $X.X to compared million million XXXX XXXX. for XXXX. development third compensation September plan net financial $XXX investments the and that filing of cash, our stock. believe quarter $XX cash, to programs. trial our expense of of XXXX.As $XX.X facility includes quarter the will of are prospectus $XXX.X December Today, for XXXX, This XX, related supplement

to set now to that, was back refreshing I'll corporate turn next ATM shelf, our good call Troy. the are We order an expire in month, which over to along housekeeping.With with maintain

Troy Wilson

Thank you, Tom.

let next in of in including into first gilteritinib we in XXXX, patients mid-XXXX. KOMET-XXX post-transplant patients in me question-and-answer combination jump session, AML of care, for the of out clinical trial X+X our mutant in remainder enrollment the the dosed anticipated the with and first the of in we NPMX XXXX. the additional KOMET-XXX the trial year.For in quarter first early from quarter and this the XX registration-directed Before XXXX ziftomenib, KOMET-XXX preliminary patients the trial XX FLTX lay data year or in quarter with inhibitor the first initiate program maintenance standards combination of complete in We of milestones ven/aza, report by

And for next and questions. biologically KO-XXXX, for FIT-XXX with the dose dosed in cell the and mid-XXXX. combination mid-XXXX.With active that, first in patients ready renal with the by combination escalation alpelisib in determine non-small in with determine we're adagrasib KRASGXXC steps in Lester, cell by mutated cell program cabozantinib tipifarnib, trial cancer carcinoma the lung now For for dose optimum clear

Operator

and gentlemen, we comes question the America. first begin [Operator question-and-answer session. you. Ladies from Bank Jason from now Your Instructions] Zemansky Thank will of

Jason Zemansky

start do and what the if and should update, KOMET-XXX what What's a community data? necessary for in be looking may. the And upcoming for the to are the potential looking follow-up, safety think can efficacy? Regarding combinations you I about for before confident then we feel investors from

Troy Wilson

XXX I escalation Phase dose is of terms indicated. I investors a so what study, as should expect, in So

relapsed ziftomenib the frontline We ven/aza, are and with setting setting. in evaluating the combination X+X in with in

Importantly, we're in evaluating KMTXA separate separately and NPMX mutant patients cohorts.

X per are there patients So cohort.

patients X So patients and escalate XXX-milligram think that's XXX. of at each, it XX patients then at XXX XX dose dose. as at cohorts patients And as a X we

do think for, start have of doses, have you reduce. look anyone safety to course, combination. And will it's with dose to of what you tolerability, in although, be combine interactions, activity, of you data terms I ability to our to discontinue else's and or In whether data, drug-drug ultimately, then do there course,

I think, that XXX far the confident based we monotherapy shared the feel we've study. thus from on data Jason,

ability XX out to We with so investors' safety, in wanted NPMX. be that there do combine those you and between shared KMTXA we to ability we question a that CR NPMX a to XX to with mutant we recall, That prolongation, had among tolerability, investors with rate you, no have early count have get among why have you myelosuppression, recovery. getting If difference full we drug-induced had it were patients we no XX% as And QTc we AML, when DS. Thus, we QX, see a no lot important confident, daily, importantly, once assess considerations standards Jason, those predicted the that substrate, these a data to care. adverse will feel answer to a mitigate and patients, drug-drug could as combine not we able of look preliminary you sensitive be we're This of we'll with CYPXAX interactions, questions. we're all look. will become a was

continue X look a to We each of course, in hopefully, ultimate Phase settings design at inform the time. studies, and then will, recommended reach one help dose a Phase II of of to escalation registration-enabling dose II/III but step those

Jason Zemansky

able And maintenance? how X, versus Got X+X you kind would it. a opportunities combination to FLTX look? here, X into the ven/aza, a of is frontline And give I terms in you then those among versus with glimpse do prioritize how the of guess, better

Troy Wilson

Yeah.

questions So X there. good

them take of kind order. Let me in

here. probably will But tallest. the is want eventually at this mutant FLTX. the to I doing what I toward NPMX and for every half simply ultimately, FLTX given setting. right, specifically more do probably a opportunity, strategic combination really maintenance look to have in and we baseline than partner, of time like look with sort referenced Why detail be important, combinations venetoclax you right with partnership we that? the think to say someone, through be position we'd assumptions, You it able commercial combination. some ziftomenib Again, If you some stand do

approved that line, the Syndax of we approved both a is setting. preclinical enabled have that XX% quizartinib have front refractory that's is in You the AML curative the combination publications, and of now through relapsed half you have in NPMX setting, models gilteritinib in in preclinical

could an that So regimen would if you that impressive. kind that add drive all-oral clinical of activity, be pretty

what it. think, Jason, do, we'd see I like you and to doing us

in indications heard additional the and to be menin value-creating that's to We relapsed, inhibitor and reference broadest are going maintenance. us franchise that's AML, for also laying is think to be undisclosed that's what most the Then frontline, going you I going next-gen foundation be truly potentially that. speak continuum carefully. to, goal more that But care. we're but spots pick throughout a menin we'll have inhibitor to franchise best-in-class is not to inhibitor, our the our directing best-in-class We again, a our thinking just about menin there, of

Operator

you. Thank

comes question from Lawson next Barclays. Your from Peter

Peter Lawson

the Troy, just to follow-up on KOMET-XXX.

and you differentiation the safety differentiation hit lack as the want kind bars of response Beyond there or benefit, kind bars of rate what durability are or of to well?

Troy Wilson

Let to then you give and think of. the me you give I'll caveat, of kind numbers a

our an the study. or that Phase to caveat I dose studies, right? compare always the either apparel, So just a analysis do important want emotional are numbers from give of Phase We that And there's escalation kind retrospective those all is numbers right? desire come caveats. you excite to I that III at to

let's you're In trade. ven/aza expect rate. in XX% on a XX% CR/CRH in XX% XX% of kind for you're that of said, is literature at, that being credible of the the things in one there. at bar very care, you roughly the front put X+X, depending very, what That do think just we looking CR/CRH I development, and the setting, relapse line looking drug to to would a out standards those the reference,

of it. to kind way that's think So the about

Our or safety, course, goals, drug-drug there tolerability, dose that of changes interruptions. in interactions are are require

Of course, that be XXX then, for I you looking to as Jason's at course, mitigate combinability, We'll well. efficacy. milligrams. question, explain to and at and ability DS to just took this patients is highlight XX pains of it's I'll why

context So we're set gives But and recommended patients' patients be about of those X you regimens. help should the the our inform the worth you II appropriate robust of Phase to let's for cohorts to going them. to that But up of b, a, get share goal, which hope the across data. dose gives a to XX data XX of each I course numbers think in

Peter Lawson

And XXXX on then like that just driving KRAS you're of combination, be thinking or about just IST? Would that cabozantinib and like you the did kind that? a as where potentially partnership would that be for an well

Troy Wilson

Yeah.

to you of just in So couple things a have be because clear, your question.

supplying FTIs of published data an supply start that was even at-aggressive the is if Triple in This cabozantinib and is particular, And patients is appropriate to a combination the thus with that drives in properties. reasons at in again, agreement. under Meeting, not and of they that the into a co-developing anti-angiogenic formally together, of again, benefit. very, learned the XXXX that the TKI yet TKI, pretty well and really the have With agreement. collaboration have between is our we'll or covered a plus combination combination fairly had Mirati indication Cabozantinib progressed preclinical that that cabozantinib, at impressive They on that a given after that need setting of be is X Mirati other days. be us. not any labeled agreement reviews clinical We're understood. you, will exploratory collaboration over whatnot. the the other make early be setting let's and slick. And really a going protocol. and things the immediate we've very study. have They've years, insurance, about clinical by even meaningful lot for second-line activity a look safety on second Kura. supplying They're second-line have course all supply it It's They an input used, largely right? expectation we'll widely So

middle we'll into so look that forward approximately of to next getting combination year. And again,

Operator

from Jefferies. Your Song from next Roger question comes

Jiale Song

also relapsed/refractory XXX-milligram. A down the but the but XX just cohorts couple dosing, most versus of be to time that within still from combo, have. able XX-patient first the that dose, a drill be XXX-milligram, you we understanding those upcoming on the us. will the you the should from the versus not look will how patients, Maybe some will focusing can, we That's my for X NPMX the how just have if first to see given data it. balanced you at and KMTXA be Maybe then details, Troy, by will for or question. confirm balanced And readouts

Troy Wilson

Sure. Yeah, Roger.

first. let take second your question me So

intention KMTXA, can each So escalate well-balanced speak relapsed. we're to is -- question Obviously, patient it tell KMTXA tell you'll X and will regimens. strong what and the starting I NPMX you sort both to we of of to the X I separate cohorts. the anticipate yet. that exactly respect in all enrolling They're We NPMX you don't what well. terms of for want There's data can cohorts. in X your as cohorts don't dosing and at I have early to year to first when XXX I frontline X each set of is milligrams. those of see see be the next all want this. an QX there But for you activity each with

question of in our early dosing We're share an can we around cetera. crushing about important lot operational addressing on in and what giving is questions we this terms you as team question level. will differentiation DS, will to tolerability, ability That's 'XX, that We it course, a a started escalate to then this want continue encouraged. a of QX early team it's we why answer the to we an subsequent syndrome. our these already mitigate update study set guide And execution. where July. point I just highly at data, just again, of When course that So dose to data the a to on can look data if address continue safety, flush-out exactly being We'll, data the in we'll mitigate et set, providing And be to picture. dose careful but we appropriate. we to think we talk think it combinability, of, how credit

Jiale Song

agree. Yeah, study And enrollment. data, pretty want I pivotal rapid of monotherapy It's lose then so I Sure. sight don't for NPMX. the to your

I you So that's by close the the guide think you first time will midyear. enrollment

disclosed of non-hypothesis? any are curious to you readout. you statistical the is any Just What completion, maybe plan us any in final readout? have enrollment terms of the the And interim to around guiding the analysis guidance have or follow-up minimum the timing the since

Troy Wilson

Roger. Sure,

few there's So a there. questions in again

we've its it sometime than of cohort that really enroll a So time XX a year, slide, as is year. an line the milestone of middle one I'll this next enrollment is of now completion to principal study QX next between of our NPMX patient the XX-patient first far drawing of as expecting competitors later on and no our study. QX put note

devastating I the what in we're diseases. way these patients really neck wants the and So see, it. That's by think, to doing neck we're safety driven That paramount. That's and XXX always closing The are we reason even doing and why XX we was picked be ground. clearly, has to FDA tolerability.

should That and have agency's expectation So plus XX us as I NPMX XXX from safety patients. far the meet tolerability. as gives we study, Phase the we the patients in approximately think experience

can you, disclosed the plan we I or being statistical no-hypothesis. very not tell have a are conservative. We

encouraged every quite time we're taking that think, by the with can we pull be I the forward. we in of count successful, giving advantage the full CR opportunity to opportunity and are, XX% lines to rate every we're Ib saw. Phase the We But trial recovery

data So far I a of follow-up, to sure we've into an cleaning. got align. give ideally, there.As coincides maybe want your We'll that data, the it's you further that need know, along. release update And the your working questions, when need And that get on We put We as We're little out stars those scientific the last need to want data you let's of to it. make you meeting. clear or important think to of enrollment, visibility you was end enrollment. it's medical with really as disclosure appropriate. all you

Roger, all think questions, I I've but answered anything. me I tell your if missed

Jiale Song

No, that's great.

Operator

question comes Cantor Watsek Li from next Your from Fitzgerald.

Li Wang Watsek

competitor you do combo Just you experience can on trend to with really from combo, And the just [indiscernible] comment had perspective, competition? see just then relative from released if your wondering, not a, apples-to-apples. since But some understand your how this your morning. a the data initial you from I it's own safety

Troy Wilson

learning pathway in tolerability, interactions, That's PIX drug recognition is people past. of it sort are with inhibitors of lot We've targeted seen we RAS pattern development and in the where sine to what's A or this developing to of combine in ability We've seen other kinase pathway. and so adagrasib. safety, everybody, about areas the KRAS field, ability or right? the from excited why not combine the XXXX if And go to therapies, with we're inhibitors. checkpoint combining drug-drug

Here is no different.

questions AEs monotherapy we're what a of critical both neutropenia, neutropenia, thrombocytopenia, seeing and the Are drug-related combination. seeing. rates that's the are high of are some you as you be Li, in think, what going that see febrile I to

of right? have tolerability. really You have would, be course, a to of one One that there the and gives of benign best-in-class data of to posed duration is what either to be looking safety other, But menin expect going shows you at That's to want setting, ASH, maintenance from challenges the activity, are we lead. care combo you you're are really handful being in that the challenges is most standard right? is able focus the going exposure for activity, data here at And or the the inhibitor You considerations given XXX-milligram care the believe, important do of go robust want you limit already very perspective We've competitors things X zifto. the really what despite in of dose of going set about to the course, from optimize it. the that to there. of on. have a is standard the the I'll you compound to know I back administer that just really

So of field to It's And would to we encouraged sharing that's clinical what with early, enrollment it we're sharing early by the sort ASH look at forward are presentations. data the as we, I in our looking players in as looking you. but looking forward we're and QX. forward to say

Li Wang Watsek

just NPMX in your in reason maybe responses curious, just a combo versus there data own expect any QX. And KMTXA. then follow-up I'm to is on different

Troy Wilson

back go let's again, to So standards the of care.

as patients But look general, of mid-XXs. low ven/aza, respond kind You close. regimen to it's is you line on believe, KMTXA in would expect, at, in depending the for of is the NPMX what well. It's pretty KMTXA XXs. therapy, in not I the what

on them. want to You sure truck a though is try at looking experience before duration data, I data want mean at because patient that general, little drive a as as any different look to be factors worse you lot But of to a KMTXA there's at regimens. make probably you're it you you whole draw just enough do activity whether I have at across MRD, our tempting to our carefully in want do as kind the is, can't here. it patients between conclusions or of also competitors' we you looking be again careful we're

but therapy that's clinical going going X maintaining goal and It on going and it tolerability. months And next really Our to is months And be safety interesting to will to paramount. here. by safety years. even be is activity, or be an tolerability driven keep patients is X be to or

Operator

Your question BTIG. Justin Zelin from comes next from

Jeet Mukherjee

on is Justin. This Mukherjee for

on just could study in one on various be myelosuppression characteristic context On give the least But the follow-up would at much efficacy to that a And look with looking color for. that knowing the in relapsed refractory topic combination you is agents setting. I the would frontline for, that have of question. more elaborated the the bar a safety one bit the the want you've of very zifto, bar cytopenias, in of

Troy Wilson

Jeet. Sure

Cytopenias about, you not you've in I mean, I yeah, think setting. So what the out. called course, correctly it and worry frontline are of uncommon

myelosuppression with insignificant do You see ven/aza. not

of that's Phase you a to risk AE what mitigating in going run profile, are runs I drug-related continuous a the study, flavor that where require no looking standard and when you're safety of profile but a the various you the are to a combo any to going In It's the extent the profiles thing for. the or combinations care, of rare you put to the that The to QT of to the That's you you are is, just what you're monitoring, simply, biggest AE not an better you're risk So dose compounding have do need need it's you gets that trouble whether of not cytopenias. right? discontinue, issues. risk, can are than is it lot reduce, looking you toxicities, toxicity. to you're going because at additive profile to That's for overlapping. that show least looking worse create toxicity that,

other experience agents line. So your you're things with dose thing to can later the combine, you on potentially agent is you down of and you to backbone that's how but as the optimization, have away, in do right, can certain terms other the looking take upon additional improve

day really we reasons on baseline study care. standard X. them a X you early There's combo out. our The that. credit, the want the and your think, what's on Jeet, of then backbone. team. on the the backbone question, designed, it's begin these We to asked way just for I agent something the X safety studies, of then the X. since safety I on the standard For plus Number of you care really what's get for our we to zifto dosed safety X, And is doing it's call patients about of a days and day start

talks helps see that you that combination. deconvolute the in you So any

Starting allows it to found then risk debulk additional X XXX, implementing Secondly, what with you to of course, want to gilteritinib. to notably the as approach mitigating third, and of combinations but time and you combinations, that be the don't these patient the we're others something to are out further speak we board. roll we're very across syndrome. doing, to some most kind to genotype. going that And I hear in successful, it's differentiation helps it of

Jeet Mukherjee

makes a question And second it. That had. just I sense. Got perfect

this moving, combo? Could to and What share justify thinking the program? be your alpelisib more the FTI perspective around to just looking would a program. strategy broadly a tipi Turning and bit forward a monotherapy you efficacy from safety as you or for

Troy Wilson

sure You're to just XXXX. asking make I specifically about tipi want or about I the question. answer

You asked and neck. head and tipi

Jeet Mukherjee

Yeah. Perspective on both programs would be helpful.

Troy Wilson

Okay.

oral was So in by Ho the the this Dr. mean from mini session takeaways one data at presented and -- of ESMO. with head and the I neck, that was [AMJ]

at the standard response care XX% line and best with have in You rate. of second

active tolerability meaningful X%. know sort it is reported is Clearly, you're drive very The and is, Alpelisib monotherapy a with profile, to a with an at question, and in is acceptable is, drive line favorable busy hearing, then activity tipi a third reasonable stable PIKXCA of What not tolerability and has bigger Tipi you safety to setting. come you is start you -- as to me only a quarter. the monotherapy XXXX The disease. as and driving look durability it. profile. responses let if have is can as and safety this we

I think busy. equally be may subsequent quarters

have a zifto. We investments of number in

heard You've settings, start frontline relapsed we're maintenance. to going into setting,

RAS-driven if now us cell carcinoma. cell renal lung forward XXXX pancreatic and hearing in an with I'm with push there's XXXX non-small interested both cancer, opportunity pancreatic. in You're

evolving I a and a a need think that's unmet huge opportunity huge in rapidly space.

side the we is say on side, through we on The calculus other the go can investment we fiduciaries basis. are as clinical be scientific to thing disciplined got and that's a we've the do and pretty be good on and how regular as

going our and the into value employees we going we going shareholders. of fold make we're So and Where that to we investments? for we're out and head for are do where neck that's for drive can of amount to greatest we'll patients, everything then get these how do to And it.

Operator

from question Nadeau next from TD Phil Cowen. Your comes

Philip Nadeau

you to going from updated Do next moment complete? you enrollment it's is know When or A pivotal have complete trial you on the is do early it to lines. when completed? will the us we quick time in clarity the really say year once think question likely think that's

Troy Wilson

slide competition, guiding I no Based they'll hit right? think We're later think put mid-XXXX. that from our a QX, what competitive, Phil, It's enrollment we let's down today, on super hearing I QX, for that. the We're even complete first in time. that, maybe in of than so maybe the can we're urge few pull We've we to data weeks a everything it's or those to say going a enrollment. resisted to given we resisted we're months couple the We've encouraged. do drive to really urge, apart the until complete. at milestones the continue highly that most, milestone we're

So I to you, NPMX say to would enrollment any on don't move our us pivotal. milestones anticipate of

to very that, as we're stay I And tuned. if better. do as think say much well would just not I

Operator

Canino from next Your question from Brad Stifel. comes

Bradley Canino

to pull menin in just I class about Troy, general. question ask want the a and back

I And as the patient actually NPMX to think class? But is the reflecting to we be sensitive in be where of because from But Syndax sets expected men is trend was the the more in with recalibrate inhibition, to might best the which responses of I the stand more your the actually I across efficacy on similar. name because course, in street more your and smaller Street synthesis population. this menin is this all of alteration struggle to data afternoon confirmed population? expect then the some own, do efficacy view want NPMX. nevertheless, is population you is from just that best KMTXAr the and the the class Should of larger with investing in the see know J&J, on data common the

Troy Wilson

not expectations. before. And I actually question is it It's a I've think set worthwhile to heard

the be and MLSS, careful and are are drive little those about be survival. the patients for endpoints maintenance Other think for The and even least case, that CR. they here, to CR/CRH, important. we ORRs stage this got be setting, companies, a I activity, can So in endpoints to the talking are to are relapsed/refractory those be that at will all are you frontline the Difficulty]. disease, clinical full recovery, one drive what stable abstracts I the The the frame in frontline, by CR, what's right? including going our important. we have CR/CRH setting reporting out registrational we're will for wrap confounded are, Can [Technical measures is registrational it setting, they can count you But getting way the of you on are at CRIs, reason

activity at think wouldn't point, KMTXA should sense So that CRC is has to is makes robust then the I it menin hoops. That's believe activity without worth In a we're We There's in combo through we've pretty this disease, calls And eliminate of answer again, that's going emotionally, couple more think can sensitive. at. And monotherapy down to also time looking going an why different. lot seen although CRC. combination really to the hoping in maintenance I'll of seeing to And I probably be we setting length having we what who something any reality, the only go beyond targeted presence the pressure do can drive disease ago, and residual and to populations of to in menin across in I extramedullary improve we're class. go recurrence deeper a we ultimately both and in is, minimal drive a What come responses, as that's in can combination. -- reason therapy. said couple survival. as jump back to on drive better of ability to to that's keep no the every a with to intuitively,

zifto way. that look think to I you when tall has at stand pretty it

Operator

[Operator your time. Troy, with Instructions] please at proceed remarks. closing this Dr. There are questions no further

Troy Wilson

today. Tom please Stifel me. forward participating you, We'll questions, or any meantime, in seeing look and thank the couple if you you, the to weeks. there. all We have feel Jefferies additional have everyone. to Lester, in many for you and Conference evening, joining you a be of Pete, and In once London Healthcare of call Thank Healthcare the contact good a free Thank Conference again our

Operator

conference. today's participating. Ladies and gentlemen, Thank concludes for you this

You may now disconnect.

Kura Oncology (KURA) 2 Nov 232023 Q3 Earnings call transcript