KURA - Earnings call transcript Q1 2021

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Operator

Welcome to the quarter one 2021 Kura Oncology, Inc. Earnings Conference Call. My name is Jenny. I'll be your operator for today's call. [Operator Instructions] I will now turn the call over to Pete De Spain.

begin. may You

Pete Spain

Good Quarter Jenny. welcome Kura's to Thank Conference afternoon, Call. First XXXX Oncology's you, and

us Joining are the Marc Commercial our and Jim Dale, Chief our Financial me our our Ford, and Officer; Basta, Executive also Wilson, on Officer answer Operating questions. and Officer, Officer; Chief Officer; and call our are Chief Chief available Kathy and Dr. Business Medical to Chief Dr. Chief Grasso, with Legal Chief Troy our Officer, Officer. Dr. Stephen President Flowers, Pearson

refer uncertainties Before I Such I to available are results over I forward-looking oncology factors Troy you call results. Oncology. President Dr. judgment involve turn the from With the SEC, that filings materially the expectations. from Wilson, call to differ and today for company. the Kura's include represent statements over that that information could would Kura to Wilson, Please CEO of cause the statements will Kura the or current may and as remind actual call concerning like now on expected management's risk based turn on affect website to with which and of today's Dr. risks to could will SEC that,

Troy Wilson

for Pete, and thank us Thank you, you, joining afternoon. everyone, this

strategy the make number a space, heightened menin excitement to two past clinical inhibitor witnessed program the clinical mounting men well menin developments our target progress further Over AML improved we in of validated from surrounding we've MLL as We've additional relative clinical the new This to value KO-XXX and program also also as supported while in well including therapeutic a potentially AML. window. the an competitor of of This positioning body believe a aggressive in the inhibitor. our a growing in significant tolerability activity KO-XXX that continued confidence programs. quarter, genetically space updated is as operational of positioned a safety as subsets to first-in-class menin stage activity speaks a data, and inhibitor data a emergence profile the in the company, served believe We of therapeutic by and position of wide importance favorable meaningfully. the underscoring has and clinical execution. driving clinical is as It's the development compelling defined activity, best-in-class meaningful significance and highlight of and of leadership

As acute benefit development our better our what aimed Phase and higher such, therapies include a beyond, we our expansion II of cohorts with order leukemia. to to done and optimal two enriched of KO-XXX, in benefit other II with is KO-XXX the Phase relapsed a KO-XXX for mono-therapy expansion at enable maximize inform cohorts, These a amended KMTXA combination been to plan both trial the and Phase NPMX KOMET-XXX mutant comprehensive dose. AML. one In critical one risk populations, to clinical patients A has lower dose and/or at the AML we've component in greatest an dose and to determination the intend providing conduct as plan of a for recommended at development Ib target to patients. with each similar refractory us targeted should previously rearranged, dose in

those to and and Ib patients Phase patients II recommended in expect PK order dose. cohort determine the PD safety our XX expansion We at two tolerability, enroll Phase of each efficacy and in least to for assess and

to to flexibility Ib enroll addition, XX the per as In us protocol gives up cohort additional patients Phase appropriate. an amended

leaders begin for the to subsequent IRB been for protocol shortly we KO-XXX. Meanwhile, in plan dose with The cohort at steering comprehensive to clinical we will of be has key enrolling Phase to continue define submitted both clinical development amended opinion in Importantly, a the has we to the believe recommended new - global engage the patients included trial. sites. we the our expansion II patients the enrolled existing as portion sites Ib selected registration-directed will and potential KOMET-XXX and cohorts approval, committee in begin and Phase further

providing include opportunities combination to forward We a additional later Phase and studies, in genetic including and I optimal We strategy of Additional subtypes, KOMET-XXX aggressively an line dose. these other an leukemia myelodysplastic termination as acute additional syndrome. the forward efforts the pediatric indications, such look pending from front data intend development lymphocytic to update, move year.

Wall the captured Street's easy why to attention excitement menin past understand around it's the program, over it's year. Given our

about just However, treaters. transferase evolving excited story an oncology; in we inhibitor told remain farnesyl as the for opportunity best

This a we as For X,XXX from activity preload, had these transferase we as on The identified transferase, of focused the anticancer or this tipifarnib durable the designation of such We're was carry and was acknowledges or demonstrate to inhibitor those studied HNSCC recurrent benefit provide of likely data which designation, therapies promise our patients recurrent it gratified HRAS squamous breakthrough our and genetics farnesyl first-generation mutant which most the lagged in patients to very XXXX. with in Earlier we that metastatic our motivated therapy subsets in Janssen certain advancements of Previously, oncology. clinical tipifarnib other targeted X% HNSCC unmet initiatives the HNSCC to of with both patients the FDA's than journal in-licensed HNSCC. has to is for the patients breakthrough behind were need to designation from Development from in award The next-generation Phase dire patients. by as indications. is cancer clinical patients carcinoma, metastatic Thus, published recently sequencing, in by with FDA mutations trial, to RUNHN of breakthrough therapy first HRAS in HNSCC tipifarnib. or mutant of on on II targeted and focused to treatment a molecule as defined beachhead compelling as the. subside. genetic possible, PIX one. story, year, genetically providing we've been We X% December and represent rational potential combinations most cell data and and based that Using in small therapy our bringing prioritized chapter alpha tipifarnib potential to more market remain We development to in tools and respond expansion advanced our unselected HNSCC. could of the efficiently to patients neck, combinations tipifarnib conducting registration-directed inhibitor. and patients. trial granted cancer larger newer AIM-HN was head quickly Among kinase HRAS tipifarnib combination have estimate and these of the mutations. approved

on proof-of-concept of XX% patients alpha a PIX activity suggests promise in and as codependent oncogenes believe provide that for as HNSCC as a tipifarnib expressing We kinase inhibiting monotherapy, over of study data combination target our chapter Building kinase dependent and/or HNSCC. We're alone. represents currently with high alpha the has total increase better HRAS to HRAS with antitumor the addressable population Phase PIX tipifarnib tipifarnib preparing combination in HNSCC. inhibitor are who that inhibitor this PIKXCA and has this meaningfully either than to preclinical a delta of kinase the tipifarnib have potential I/II combining of story. two Our PIX a potential

of opportunities network warrants farnesyl discovery next-generation program this transferase inhibitor inhibitors represents with three half in advancing target are uncovered to unmet and develop high to we rational class. therapies. collaborations, From in chapter a of oncology some and totally the compelling investment greater largest through combination story a and Meanwhile, the therapeutic is farnesyl This indications the initiate combinations. in other stage expect for we've of believe this our internal We innovative to second academic of need biology investment, biology novel, XXXX. potentially study large we it designed transferase our opportunity. and targeted This through efforts address a

candidate anticipate deliver that pharmacokinetic been program over and our year. tipifarnib. this and of properties comparable We've studies lead a we physical done for team advanced identified pioneering has development last a later without selectivity would to number and the work nomination goal improved of is to potency IND-enabling for of Our the relative drug and years. have has chemical already possible candidate this five None this compounds, a

opportunity our We indications. that, commercial view you transferase and opportunities potentially in With to sharing an to HRAS farnesyl for the valuable financial inhibition update now oncology I'll a over of additional as focus continue to with the look call franchise to continues broader and we for forward for first deliver with therapeutic XXXX. multiple that potential results one we While mutant discussion the a more evolve. the HNSCC, as Marc Grasso to on turn has quarter story

Marc Grasso

our first review for activities results detailed and financial a KO-XXX of clinical were XXXX The tipifarnib quarter and were Thank was XX-Q due increase XXXX development diagnostic overview to trial, G&A costs and in $X.X the compared $XX.X the XXXX a due expenses and million costs for expenses. of other for call quarter for companion for trial $XX.X increase for million share personnel and The in development $XX.X afternoon, to I'll quarter the administrative and manufacturing increases the clinical $X.XX today expenses our XXXX. our you, Net General XXXX. primarily loss noncash of you Troy, program, compensation. personnel share per discussion. first provide the a quarter invite and to was of first in or million activities million R&D brief related first expenses million related compared good quarter to or here costs on first loss filed to was compared in Research the quarter development expenses our primarily and of to per registration-directed first for more of net million increases everyone. of $XX.X to $X.XX to $XX.X share-based of the XXXX.

March million call our plans, of over compared cash, Based into million short-term short-term $XXX.X XXXX. With XX, back Troy. with XXXX. on current had will our equivalents continue operations be to XXXX, turn to our As cash, XX, that $XXX.X cash believe investments fund investments now that, will of December cash we and of and we to sufficient equivalents I as the

Troy Wilson

you, Thank Mark.

the question-and-answer into of jump session, milestones out we for me the remainder anticipated let lay our year. Before this

additional initiation the For XXXX. KO-XXX, in KOMET-XXX half Phase I mid-XXXX data genetically in Phase expansion and from of second enriched of Ib

inhibitor ready alpha the the kinase study XXXX. mid-XXXX. farnesyl development we're For tipifarnib, now in I/II And that, our of combination a initiation with candidate nomination half operator, of for of second program, questions. transferase in inhibitor proof-of-concept With for Phase a PIX next-generation in

Operator

question And Instructions] Chang SVB first our [Operator comes Leerink. from Jonathan from

WeiChang

Hi, question. for my guys. taking Thanks

safe minimum love efforts efficacious. and dose. safe disclosures thoughts That biologically be on own determine your whether your on their investors I'd and their parallels First GXXC evaluate is thinking to KRAS to seems get recent efforts about to this? to to also inhibitor a dose a question, should the effective and How Amgen lower have

TroyWilson

II Jonathan - When weeks of dose. seen we've thanks to target potential for our ask amount feedback about that the around that the an to take we therapies, to And ago, escalating. and of a therapeutic inhibitor because discussion FDA what FDA understanding the we it call, FLTX our question. that optimum do saturate that. the dose and then work the sponsors window at targeted quarterly there feedback the at eight as has optimum received put is we was was with the fair define initiative is and the last an example, the these let's Phase that continue context to - gilteritinib, really wide this The in just one - from communicated

and our the it's define to had and part around discussion lowest is dose trial. activity. of the it pharmacologic asking clinical really we with was FDA, FDA understanding maximum sponsors So our

from request our multiple case, proposal which we to the a to FDA. Phase of a FDA question between the very lower and that we there to They're an we dose. and, that it into engine in a a Is a In given recommendation a was registrational exposure? FDA standard back lower tolerability - and I to approach. do potentially expansion FDA - ask not some coincidental. dose doses to it a have have completed gold there could we It a efficacy? is bridge actually in Now with think a there go study. in work they forward, essentially going and the at bit potentially made was situation, agreement And made difference two dose higher doses and PK do a a Ib we difference that much safety those was FDA PD, was little and move course,

the and make polypharmacy and of with to So important and lowest particularly our that potentially you really targeted want and as combinations, the plus if because the we're you And those three, right is to comparison needed to with paradigm, activity. in on venetoclax seven earlier one in analyst efforts in between work sort pharmacologic of thinking Amgen. Jonathan, ASOs, as clinical about have AML as a you to earlier you therapies, the lines, these do dose maximum X antidepressants. is go development patients direct PPIs, want that's particularly as But well on

our So study think we'll I going beyond. In view doses. it's the with exactly the Ib on really two got right come forward best trend the case, dose. and of on moving registrational thing an for to expansion - our We we'll doing the good answer in to think out Phase to this work this do. increasing We've into right it's that companies be is really X early

long that to but Sorry for it's think context. the provide I answer, important

WeiChang

And menin the second the for that data recent competitors' program. inhibitor could and question, the helpful. KO-XXX better? confidence disclosure That's reasons What MLL with from Great. are do

TroyWilson

Yes. Yes, really a good question. that's

So let's are of elements because sort it several there here. break down

of between residual terms they're the MRD the decease zero patients underscores program of is menin and of clinical I number to as response competing importance has challenge measurable the that of were have win, to trying think, the rate We program. We're in the play competitor cliffs. converted by the level a you a competing to the pathway negative, target. straights MLL benefit therapeutic but navigate two impress both first to foremost, and data that and right,

ARM grapefruit compound issue on Phase right nasals. of with of both XAX. exposure wide patient cardiac There program. contrast, compound don't the dose, wort, one said both their complicated, no increasing azoles that to sensitivity the of agents have early as exogenous one pound need and bears to address of decide John's difficult a They good In no prolongation. antifungals, these can which also increase we just it's agents right? as as We've program, dependence recommended safety have in window, - All you combination. liability it very an QTC inhibitors require move dose taking. QTC that is well a On that CYP I see CYPXAX. Kura forward the a in And which makes path the if has to dose. means seen that on as tolerability. juice, other but don't the evidence they're toxicity they inhibitors days have sensitive think of is vary environment addition Those an with forward, well-known competing an we - hand, they a We've can tox. of prolongation. the The CYPXAX It's the CYPXAX, dose-limiting as we for depending the form II the like potentially show the is things programs. where exposure their to in We be is very of in repeatedly. is be known are rest Doesn't it monotherapy St. therapeutic work in the and do of a the have

also transition think given believe we're to we that think toward of be those we potential both hard we're we really now ready have work can both Ib and I about be Phase just the to portion, XXX goals. And going best-in-class. into to achieving the first

Operator

Lawson comes next from Our Barclays. question from Peter

PeterLawson

much Hey, taking thanks our Troy, for questions. so

Just data year. on this the readouts

the on that I if the wondering mostly that's second could of we escalation assume the in basis? data, you see EBITDA million to So could just and half talk

TroyWilson

Peter. Yes,

providing update - I toward of year. a data a half don't focus it's you We've the second the good in call. rare for So the so on our just and else question. guided everyone

dose the We Phase Our a of what that's later compelling that expect we're how in dose. the toward as program's Ib really focus of And then and Phase dose, we seeing. need and activity. II the good provide get Street, first looking just we possible another we looking as we to are is looking evidence Phase when into in we're like to to look later We But into you, those have the Phase I then And and, then, of Ib other But understand to what continue any I'm that patient updates to an the. know give a what and it on update terms to would think ready, qualitative output have point, achieve to update share year. - the are have terms registration-enabling - help then then of was and yet recommended going don't course, quickly Phase quickly the moving exactly safety that's dosed in yet like. and We'd an data analysts Phase provide don't clarity we've will determined tolerability. of II haven't to I course, update of the what expansions going Ib. on We to know we yet I include this because any the at of portion, data; even can. the recommended we as we'll kind this of the as is the year. we know we'll Ib. in

really we're We have those concrete. little steady bit hard Ib Phase more be goals. a cohorts, state enrolling But until in to it's

PeterLawson

from inhibitor also those? into press are patients. opportunities you genetic you just And release, talk what and then And the other And about subtypes? expansion MDS mentioned

from of what MDS could benefit it? patients I'm So curious just percentage

TroyWilson

those Yes. is separately. - let's so two This take

challenge possible this that genetic we other the of Phase recommended II the When dose therapies. subtypes. XXX ASH the look KO-XXX time, a in patient it fully been II still menin do to Phase we're at complicated. doing rules. RUNXX complete help that, recommended same MLL Ib, as thunderstruck, variables then third really to to selection cohorts, we're clinical surprised. see The application going-forward these goal of enroll call I one The we other So we're to have, with what's we were selection pathway trying We two seen able are them we we potential KMTXA in outside that recommended December, important. surprised is the have pleasantly population we're as dose. And recall expanding the SETDX makes that, the in targeted that trying more really continued going sense. we people in we understand as completely are genetic Using is stay difference there And can serially, the other genetic MLLr. it's as we it benefit us candid, with subtype, to toward both just the with the When the you target; is rules We in and few drive enroll mutant co a understand - that on the showed don't were highest a to biologic and that think was We've And the that at much will define Peter, weren't so that. doing and a be enrich likelihood in clinical interacts far other activity can and remission but dose, evidence select of determined We other by in and NPMX. MLL. a of to of seeing with know of you're we've to on a that done is and trying by would to Phase if biology consistent side cohort. where to we're versus those phase But between other. the a meaningful dose know we trying NPMX the

II of full-blown the As course, myeloproliferative might myelodysplastic pre-AML ideal at certainly their it Don't of of question one intervenes in preclinical works there MDS. be of looking going a there and prevent NPMX in And whether ever a we develops in doing There's patients then who diseases. both going But be before on. percentage labs, for AML. work a patient are an have there's the that's AML, at work if possible, of course, academic mutations there mutations. opportunity very the these AML. your situation. know the dose; explore. around interesting Yes, intrigued something but will possibility with that's and we're - MDS, that sequencing the some We're is time have that onset when be that looking to a right could And would, Phase on

Operator

our comes from Benjamin from next Reni And security. question

ReniBenjamin

maybe for expand on the to Troy, little a these I'd Good the Ib. questions. afternoon, Phase Thanks love guys. just bit just - more taking on

Have Why will one something dose some a as You the not Or you and maybe those what doses XX higher right? explore pick the dose mentioned schedule? cohort, guys cohort. And between maybe the picked well, between why dosing XXX granular even lower doses other? be? change and

TroyWilson

Yes.

a it's question, question. good So Ren. really It's good a

exposure safety So is the question of Number saying, of tolerability. you have from why escalation. is the threshold exposure right. reach the one safety we answer at the looking to But a a doses the to we've variables, dose Then the is although exposure. belief again, knee, you're first and looking said, Jonathan. - question And that of you passed curve in the both is for plateau. It's if that's are right? seeing that's part FDA like think beyond the increasing thing doses, at. look - a And eventually, need increases the and at our you'll will number

top it, the be You to be up to the way of side. want on up all on want but

important or dose, benefit MRD-negative state most you an clinical an you be question. as belief than mutation want, you is one much able define to saw that to whether milligrams, a question other. two different CR the granular just any getting dose. with in one you NPMX drug explore couldn't recall, of to The the rich morphologic we - responses and we incremental your had haven't as more the get And The doses, enough doses, without to I need - should let's more. right both can necessarily field. is The a to say, whether say, want lower there's you'll trying another. in dose do our give we date, we're but that It's two a we competition final say answer the not we're and advantage as then One new higher you as You answer. lot - nothing - two the higher? the balance and to space, efficacy. give to probably to And says perfect the can we There's and be and competitive with existing go entrants the is; trying recognize are as to

that So Ib we as trying really And rent quickly recommended register. for dose Phase is nicely set that. right can the between and up think I to strike moving we're to II Phase balance the getting as

we're As keep trying if we'll simple. with fairly explore that, every it study to there's a for but different, to do little data-driven, something reason a

ReniBenjamin

middle what talk then also, you look pin to of to just a registrational you not the like? choosing XX would just study anything, it in that is a study, I XX done year if just in fact registrational that And mentioned once but utilize the could patients - at enrolled, given terms Can want could timing. the you past you little get Okay. from by dose the you of those And you've help fact those year think that patients total either study the this assumptions? a that you then this you as guys Can think study. to you're to the that for the you And bit be this up, or maybe even start about follow mentioning able be could think might registrational so sites maybe running. I about and up hope be fine-tune

TroyWilson

Sure.

there's a packed into that question. few things So

is under as say want - portion are the to able sites start number of we're or the study. of in seeing. seven number through at protocol you that failures I Not we're we a of in over have than sites get Ib we're - with to that up with knows because we really there, online at sources data of Ren, months enough It's some like tripling if pivotal. sites state. patients sites But the the focus, It's for enrolling. it existing have screen Phase what bring power sites on come the be new new the enroll sort open ultimately of on in current eight trying There lot booted this both on our don't right goal IRBs, projections year. to forth. just - now. identify, drive both at fair several we and account and help But different enrollment, they're every granular really until think patient anticipating the getting We example, our anything, II to - to patients Ib are steady for sites so Phase a next that eligible to and into We're getting rate protocol. determine that's the currently getting and Phase you actually the now, recommended I sites Until let's get experience shape. with dose many bringing we the to how We study. are appropriately, We're sites to No you're good that. right? one more to you based a hard

you the how the to think and - about the study far As alignment about. registrational as with asked

endpoints it those the be Phase the used aligned of we've the is with registrational now this the Ib one So in doing advantages way will that of of portion.

patients allow will secondary So as to a be from endpoint. FDA we're That us looking actually important. at CR, That with transfusion key totals. the recommendation toward a independence was to CRH, count

of is a think we little sorry, noise. what background In bit - of needed there's terms

a is is registrational. to KOLs terms high think CR rate we're is unmet well at In response are XX% XX% to study registrational we ice, what talking in and you to XX% rate populations on any These from XX% great. this XX per on available about a therapy. likely population what patients And very rate, investigators depending cohort, just response of the do if need. patients are looking needed, hearing These at of XXX not do ran you're

registrational - Our really haven't talked study we study. the about will

We dosing the The and get into both of to we just like Phase select will, to look The going as that goal the the - important phase. an NPMX is that distinction, KMTTWOD phase, each in But dose. is Ib next enrolling therapies. design with cohort. it's

selected, the So to Phase patients patients take the the the is recommended genetic and patients likely separate most the by selected you're will from Once selected dose cohort, it's Ib going subtype. the Phase for II our we respond. we can then belief

a that - XX% what exceed that KMTXA rate. I or you've Peter XX% you a on in was those was anticipating small other arm, will give the arm, molecule fairly we're which does an - have having earlier have that seen with we'll given targeted meet question? look from NPMX typical to response addressing sufficient I third question call. with we'll want therapies, And hope arm, So and the you color the to your

Operator

Wainwright. question next from Pantginis H.C. comes Joe Our from

JosephPantginis

the wanted But studies? I year, have at place read. guys look for I regard to, specifically a guys. to of guess, Are get afternoon. rest of we supply might don't to with say, clinical that question an can sort first My there though, bit manufacturing know just I'll this guidance. I Good at Hey, the one-offs R&D financial be some as of drug sort took baseline? usually ask look a standpoint, you Mark. OpEx from when for you give for of

FrancisBurrows

Joe. Thanks, Yes.

year. more an given make And increase the continue So of are haven't OpEx for to course That to you over In diagnostic in may that while continuing to that we was question, guidance we're the first in do answer there term. would the quarter the potentially front. course to companion we spend And increase specific on year, to something some quarter in of spend spend over the see particular, the the said, going R&D think year. that the the short do anticipate some one-offs I should be the outsized. first be there

JosephPantginis

transferase of some a switching regard - kinds the the then with inhibitor. of rational any prepared back see of of end candidates, to when as part you sort with really are to just next-generation And No, the top Troy, those wanted of just of that your that's your different of comments. sort properties rising helpful. some And to you of was you lot that to farnesyl curious design? properties I lead gave

TroyWilson

it's Yes, very Joe, - good a thanks. is really a It's Tipi a question. drug. good

However, notable, of EGFR a the upon kind seen drugs, as can of generally technology. other of inhibitors most kind as we've generation improve first number you and with

be able to simple, to One the things the to to to is do we'd a as able to the dose twice is have of given very day. and lower be opposed love once-a-day drug

dosing that punch give in For the all neck daily. you head a on with based smaller a of XXX less such development bioavailability to patients know, variability better and potentially there's milligram we're interpatient but And and at patients. that and tipifarnib. patients, the candidate what we That's have neck pill, therapeutic head think with potential for could has that's drug you lot come basically see a potent we

profile to might property terms possible. safety physicochemical it. we to able we be maintain make good but The on improve think that's the we the the are both suggest those sure tipi, compounds and early of So pharmacokinetic we in do - want of

JosephPantginis

sort are to some ready but benign you're something lines? post getting those maybe have mandatory study. COVID. of status the sort then like as Got I activities sites have regarding time particular it's regions, my seeing any do And question, more lines to my not in to it. some of And some like you the Where along - ask last to provide, more maybe guess, AIM of seeing is you again open anecdotes

TroyWilson

APR important good Joe. It's It's an And a study. potentially targeted first a first the therapy question, of in - head & neck. Yes. approval targeted

have You found do head - whether down. and entirely with not it's neck be is Europe locked they're to honest. effects. of we wane. to to been patients And they're the And COVID, country sort travel. see largely and It's what generally wax country-specific reluctant due clear has

in partly down get try far It's they're right? - options. And usually ability terms to the disease that's tough to or If to they're path they're it's of hospice. them, getting very so we're therapy, because for time them, going pursue close the trial don't by this a you get that them just their other to like

I seeing So the thing newly get we identified. COVID the think worse. other best makes patients is where seem we're But where that - are is definitely to traction

you If go you'll patients, on. mutant into patients databases, find interesting passed for example, but often have those

an why find to screening campaign So such these that's we active have patients.

make alpha we've do move to - we to a for it sites, yielding the is on puzzle. We're kinase patients to our changes to past, benefit. have looking combo to can't come you genetic this PIX allow - need to we've indicated also study. the be study, come appear the Genetic patients easier about physicians, thinking fast Those study changes on really As teams, protocol some made study key screening. screening because enough to next in

if off. HRAs, HRAS, a to Joe, the in as will amplifications beachhead current with due combo. neck and as data, study preparing the here well in the year. we're for tipifarnib kinase of that's combo sort study hearing second as the of with out screening the mutant really which inhibitor what that PIX a from study, the potentially - we investigators And the and of to kinase preclinical We're or ultimately the the they're PIX we're alpha plus teams half And head be opportunity so start better as for just much think addition borne will the at mutations larger be looking

Operator

Phil from from & comes question Cohen next Nadeau Our Company.

PhilipNadeau

expansion Good Thanks Phase cohorts. for A the on afternoon. taking questions. couple Ib my

of the maybe curious is other IC in you'd XX willing one what us like a the an pharmaco particular, I'm goals of there or are, going PK, you're with cohorts. particular, dynamic to in some markers? mentioned, is sure be You or pharmacokinetic for above time PD goals those share in that that if AUC

TroyWilson

in or concentration for above this really, for IC time day of Phil, not kind contrast competitors' not cycle plasma at early And the looking a an and of that our question. the we particular one, showed suggested, we're ASH. no. that's one to It's Thanks, program. No, data cut - was XX. Rather

exposure. enriched are and in efficacy. there the what's of variability a an clear able in you development? the be the driving intrapatient do toxicity. It's sort seeing of food say, of then associated the do with doesn't associated variability? it's of easier And drug not you you're greatest like being the appear better. the not and basis variability for that responses, stuff that the that standard the example, population patients compound? we'd for It's understand but to to interpatient now it, with Is effect, okay, that Is exposure when You PKA And outliers do how like the to efficacy. optimize are see it's And

fast I target clinical see and I will of we're part those as near the and got look lining what pharmacological right? And It's of good think the we in Is two going the again, is increasingly that doses, lower. to of these the determinant knockdown good into what it package. gold selected the the data. the I the of think, the we - dose portion. you we segueing forward. can element with go we'll biomarkers, the answer. higher you going will as doses consistently, think our is arrows the Mason is two both firmly the to want be exposure? between up think competitor which And populations, and we've nice overall get So registrational We believe to at be are that that But be gene, I very set a optimum - activity are we that In some that and ultimately, The do position seeing be that will activity. genetically then two all expect from would put shows, standard, Phase greatest data Phase But to to an is as Ib. the II Phil, us

PhilipNadeau

One question the biomarkers. on

MEISX. compound. competitors whether function been suppress you showed And not opinion I HOXAX? of good really possible guess knockdown specific knocked although HOXAX that's have Do we or suppressed. in a was debating totally down, it's that Your but HOXAX investors completely have an

TroyWilson

the sorry, HOXAX. data preclinical suggests one, MEISX our a from so that is better MEISX - to biomarker HOXAX It's - relative

can MEISX down variable. We HOXAX You a would MEISX and knock completely to of consistently, marker be nearly use as activity. appears more

get signal a get view, just to noise. you - You better our in

on the probably they investors the it's MEISX, wondering, biology for MEISX. that relative So I of to are think more HOXAX focus think really and we should

PhilipNadeau

the approaches for combatant get of and comparing inhibitors. in time then question question versus me, have pluses another a contrasting on Do two and non-covalent minuses men? is you perspective last the And the Great. we all

TroyWilson

Yes.

KO-XXX differentiation MLL, both to the evaluating not dissociation chemistry of And drive pursued business irreversible We covalent works was to cost. us using menin inhibitors as as the Chromatin inhibitor, anything we we've everyone, menin menin developing the really or did I the seem days, a a of as from there course, to And made to collaboration decision being turnover we knock pioneering when past, much could didn't without think in with Michigan, developed in is with far from the the and interest, data-driven reversible an we remind cure covalent induce we those before the all that Menin able of completely. side, MLL just inhibitor, about were six flip who was so we KRAS approaches. back story, XXAC for the team inhibitor very is inhibitors. hits newer we of on I down disassociate are were could could are get our had we hours. that and as - non-covalent We that the University both So actually - mentioned part in early of cells approach.

the the You and follow can publications patents.

target well, the from as other that knowledge of So seen, to great only due you're other target inhibitor file your they off get that it. with binding doesn't because cysteines in toxicity covalent you of toxicity your KRAS, targets models in electro but inhibitors. and than target protein. come with manifest system are is We've And often patients the idiosyncratic not preclinical even until animals predictive fact not can the - covalence

clear it any avoid to that. activity. showing going mean squeaky a what do got And needing not to really you drive - can. second Curran want - So CRs than from dose. you I is It's both you've as compound first to index, a a want or better the inhibitor Phil, covalent to cleaner at you not both have

data-driven we with inhibitor go was made I a the that with think ultimately, And So XXX. reversible right decision. the

Operator

And from Suisse. from our Credit Fauth question next comes Tiago

TiagoFauth

taking question. for Thanks my

So just on a quick NPMX. one

relative different of NTMX targeting the So MLLr is the the we merits across fairly verse that outlook population. on either given front-line satiation population,

from answer worse seem And So necessarily. and as the to NTMX that you much the from to what's bar attractiveness XX right, the of sort curious subsets, extent prognosis but how population, as if relapsed/refractory of date data, for a stage? the And that competitors, you've that you XX may some the but I'm that? reach data could we've MLLr, about to but seem is perhaps consistent once what's guys class in seen would with actual a some you the seen break different for data within not have down again, you

TroyWilson

Sure. Tiago.

it's So good a question.

update, very gold NPMX the all MRD one one meaningful comutations, prognosis. what not in patients therapies. we existing commonly there PLT think negativity, MLLr is with And had, IDH, in AML. a negative is will do then have increasingly shown in the Those And to Syndax well the patients That's drive on as shown patient MRD-negative relapsed/refractory population. both in ability And anecdotal other and example of ASH think of in do encouraging population. DNMTXA, signals the we've X. the think, setting, be and some encouraging. I I That right? early I to second index And it's appears So NPMX activity

rate response The think, particularly chemo, As about, landmark survival. response rate frontline, who and negativity the venetoclax rate cannot at if you and XX%, MRD you negativity there's overall in I tolerate rate intensive is the look the in patients months a Phase of III of azacitidine, about XXXX and study. transition MRD XX a XX% to

potential with there's can responses if can ask that's if says FDA SYK they of mechanism durable And front patients this You'd that's response, action the inhibitor. a an available and will we're really directly survival. is - have driving green by literature light related you're because the you're clear NPMX like line and a it's front MLL responses, clear the these want, it's is to that perfect tool keen citations. to why problem with pathway. And differentiation the menin inhibitor get you their the The response for Kronos that MRD-negative of inducing the virtue MRD-negative to mechanism to of that really And hope intense-chemo in that patients population. literature, will give for. setting. although for as chemo the that trial we make benefit menin MRD-negative rate, the a going to in drive response both you deeper, gave that increase the Because more be non-intense There's people like Tiago those that is you better what responses may durable, in the the and

Operator

Our Jonathan next question Leer Inc. comes from SVB. from Chang

WeiChang

the cobicistat? inhibitor development this could what and menin Hi, strategy? follow with for Thanks a up. impact is in future MLLr have And What combination taking guys.

TroyWilson

queue. back kudos Jonathan the for for you getting Sure. in

update inhibitor. an strong competitors. on a And those referring is I of cobicistat Jonathan is from to one So not think aware, trials.gov may who be for CYPXAX our

exposure to competitor the their to as thought way As levels a increase used trying substrates. know, to reduce is is and cobicistat inhibitor CYPXAX - sensitive cobicistat azoles. of that drug the we dosing make far And of their as is the sensitivity increase menin the of compound the with

increase to exposure doses trying at cobicistat. the they're the by patient's giving effectively lower all So of

and cobicistat package and the contraindicated, with azoles, you if for the two - see - then can it the liability having go the use because the course, you'll then azole that contra could the one that look of and of for Now doses, remove the right, the makes to other drugs. one drugs azol, into includes in interactions. it non can the more much is CYPXAX requirement just all that, you do difficult it And combination you complication, for insert at are

right? much XXX increasing contrast, none more exposures azole, of patients it's - it cobicistat whether in term, as moderate complicated. that's near-term to azole, are in plasma of ultimately to we strong compound don't help with no the commonly We're We combinations, with In long are another independent think, azole. that, exposures the or in So of or may are course, our ritonavir. used going have at And make dose lower doses.

monotherapy both So it's just a the much combination. for better setup and the

Operator

have time. We no at questions further this

Troy Wilson

speaking again, free We'll Thank for the call today. everyone. to operator. Look any once you, again if questions, a have with evening, Pete, Thank good the at all have the or conference participating In many next Marc And Securities thank Life please you meantime, JMP month. of Great. to Science forward and you you be then. feel you in myself.

Operator

This concludes participating. today's conference. Thank for you

may You disconnect. now

Pete Spain	Vice President, Investor Relations and Corporate Communications
Troy Wilson	President and Chief Executive Officer
Marc Grasso	Chief Financial Officer and Chief Business Officer
Francis Burrows	Vice President, Translational Research
Wei Chang	SVB Leerink LLC
Peter Lawson	Barclays Bank PLC
Reni Benjamin	JMP Securities
Joseph Pantginis	H.C. Wainwright & Co
Philip Nadeau	Cowen and Company
Tiago Fauth	Credit Suisse AG

Kura Oncology (KURA) 9 May 212021 Q1 Earnings call transcript