KURA - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Q3 2020 Kura Oncology Conference Call. At this time, all lines are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Pete De Spain. Thank you. sir. ahead, go Please

Pete De Spain

Good conference welcome call. operator. third Kura quarter XXXX morning you, to and Oncology's Thank

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

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

Troy Wilson

we've ongoing tipifarnib. a responsibility to of neck thank mutant financial latter help medicine, way with longer, utility for tipifarnib activity Chief of he over where half Harnessing that to fundamental dependent our do been medicines proprietary with progress a the served to Global Senior preclinical further of to with of our squamous populations HNSCC. level new Oncology in with neuroscience, with in tumors PIX and into our of mutation-positive Stephen Dr. a effort and mission, centered dependent Previously, non-small exciting Head the patients patients program Thank clinical leukemias of in We're a the cancer cancer HRAS impact tipifarnib strength team us which Clinical power having culminating cell while oversaw the of Stephen next paradigm treat Kyowa on bright also we've the preliminary with development for IPASS the approaches forward years to ago oncology, also multiple this joined of for time to cell August cancer. KO-XXX Iressa our lung targeted addition We've therapeutic we was use with AIM-HN and position terms optimizing, we two His development Hematology HRAS represent successful Medical to development our all our of assets, precision activating he advancing most to our mutations, data pioneering registration-directed Society of with in and in precision and this of that I'm cell lives. , the of continue talent, you, and KO-XXX, compelling Tagrisso class was up and of new the been clinical enhanced our HNSCC around drug where Pete tremendous from of larger the the testing, at our is the therapies HRAS to us trial. Officer. Kura potential focus as carcinoma, expand may Dale worked and pleased Medical lead late lung Vice profound of a in population, recently data support our joining patient is diseases. to drug an Vice Meeting with all President Global difficult with in drugs you Kirin we immunology AstraZeneca six candidate rare early of approval as clinical lead inhibitor, this that patient American acute President, made Head Clinical of on particularly teams AML. he menin expand and founded development morning. for much as at from All resources demonstrated shift Stephen patients promise and better say head realize look a and kinase on leading the major stage Annual Science already month. which And in presenting the metastatic has including treated. non-small EGFR-TXXXM organization programs EGFR of recent tipifarnib the evoked study experience for

to of believed selection interval, programs treatment little total not KO-XXX into that last on in enables but modified KO-XXX. representing sub-therapeutic. is genes oral a including to or on a menin-KMTXA using with genetically represents levels design potentially menin as of in target patient MEISX subsets design well clinical HOXAX trial of approach based AML beginning oncogenic in selective be with a are adaptive toxicity dose KMTXA in our patients is with per as inhibitor that the mutations KO-XXX let's dig acute data of dose a interaction our support on a KO-XXX early patient Phase to molecule deeper level inhibitor, We've driver generated as the believe MLL NPMX. dosed first KOMET-XXX a dose in differentiated anti-tumor small our with we've We single fewer preclinical probability of expression. an named accelerated exposing rearrangements year. late that trial population. X/Xa We defined both and trial Now, more activity limited with effects gene, the the to or relapsed/refractory downstream those adult XX% gene subsets such those The potential genetic leukemia KO-XXX of potent which

as data submission abstract dose in more a three three of we for patients. first to the to with single XX gather worth we of plus the were set, ASH Although will in relapsed/refractory cutoff data data We ASH reporting August sharing the the investigators KOMET-XXX a with posted activity be from larger to as session for The details. also in oral we traditional X. safety AML the highlighted stay to oral preliminary we're of advanced evidence design hosting a several patients a morning conducted Please we on mature virtual our with encouraging tuned presentation well of noting presentation early December our anti-leukemic of more August concurrent with continues dose preliminary and on month, with on look investor progress the the the event forward more data immediately was accepted featuring for escalations two XX. of learn Xth. made yesterday ASH. from including escalation. the Last in which approximately cohorts, as trial's It's meantime, In data number following tolerability encouraged at more ASH at abstract as website December were KOMET-XXX abstract patient study escalation was have pleased the very oral

now KO-XXX a X of to tolerability Given quarter determine the we've the for in favorable safety seen thus XXXX. expect first dose recommended Phase far and we

moving include the patient potential benefit. populations of AML, KO-XXX clinical clinical planned to in or data. continue mutant demonstrate has we anticipation cohorts cohorts MLL AML We where believe The NPMX clinical selected the to KMTXA pending into expansion sites add increased expansion and additional rearranged

we're in potentially frontline. of as the exploring as in In KO-XXX chemotherapy treatment in the the broaden acute therapies addition, to adults of options the targeted with well leukemias combination opportunity and

population tipifarnib for advanced program Now, effective to neck let's dire in and new head with the carcinoma, most a our cell treatments. move of of patients need treatment squamous

to we're in that expand also a or directed the leveraging In call AIM-HN, of into conducting patient of metastatic trial our mutant populations. new recurrent advances HRAS addition HNSCC, use we tipifarnib ongoing registration larger trial tipifarnib to

Dr. Over team subject alpha HRAS internal the ago. making which believe our treat was also the a Burrows and/or couple identified EORTC-NCI-AACR are symposium in be poster Therapeutics years research This tipifarnib kinase patients Meeting dependent of to Cancer kinase on we the weeks PIX multiple Triple inhibitors PIX Targets opportunity presentation been what by the the and compelling called HNSCC combine has whose work, our Molecular alpha. at of enzyme to of years translational to a tumors has Francis past several with led the

HNSCC tipifarnib squamous Our the cell observation support at suggested to the with potential head preclinical that inhibitor in carcinoma. HRAS the compelling combination alone. has combine target patients data inhibiting activity PIX and underscore the the potential preclinical a alpha kinase that to approach Triple better oncogenes than with and anti-tumor kinase neck are either meaningfully The co-dependent and to treat data PIX Meeting presented provide

the with months concept Grasso a trial unresectable harboring alpha PIX or quarter HRAS you a the look Phase advanced we're such, amplifications Dr. in I'll XXXX. call tipifarnib conduct that, discussion forward As Marc to in about more of We in mutations with X/X sharing our the study the to relapsed/refractory of third ahead. of turn of prioritizing combination inhibitor results overexpression. or proof PIKXCA HNSCC and/or the for now over the for financial With kinase details

Marc Grasso

of of XXXX. for increases due planning expenses of $X.X our due XX-Q Troy compared and discussion. or non-cash primarily the XXXX. financial per of increase third quarter $XX.X per was in the the costs third million expenses The activities I'll for a to to was third and results XXXX. good G&A compared quarter in of the a for million invite expenses million detailed third you, Research million R&D review quarter primarily personnel in to share-based General or XXXX for brief quarter of on a share the for XXXX the administrative to overview here and million personnel million to of quarter quarter third other filed an ongoing and pre-commercial net development costs for expenses. trials Net third increase and in call $XX.X provide our $XX.X of XXXX our were share expenses, were $XX.X loss development morning, expenses and $X.XX clinical to $X.X and loss Thank everyone. you related the The to more compared compensation. $X.XX today was increase for

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

Troy Wilson

major we're terrific Thank making. the operator, pleased we're we We catalysts, remain programs. the important of by from the as and ASH. two we you, our to continue Mark. approach I'm team in ready ongoing on our development presentation first at the clinical progress proud Despite of the that, execute challenges beginning global take now a have position, data study strong clinical with of to With KOMET-XXX questions. pandemic, cash

Operator

Chang. Instructions] first from And question your [Operator of comes line Jonathan the

Jonathan Chang

my Good morning questions. and for taking thanks

can question, KO-XXX about potential AML? opportunities NPMX for beyond talk mutant you and the MLL First rearranged

Troy Wilson

good Sure and Jonathan. the Thanks morning. for question

So, it's a timely question.

histones. or mutations a set mature from one SETDX of abstract, complexity will, expression of and genetic of we're to to And enroll other. turn example. action the HOXAX And actually HOXAX. to to excited RUNXX the and acute NPMX of in and preclinical as if a two that two a good is As does various that's state particular you cell. sort to determine AML be mark the monocyte, what Increasingly, methyl MLLr factors challenge I is the appears were and remain mutations if matures tumor's is the driving pathway patient to of that has and difficult can potentially of cell example undifferentiated leukemic the it's two we're have is more the inhibitor about of given AML. as cell application that to beyond transcription a down on is the saw What to who the more optimistic inhibitors. tumor combinations. able MEISX or MLL large an dependent of blocks MEISX And a MLL it AML a MLL think whether But differentiates and adolescence, pathway had transcription may angry in that additional MLL of controls the, menin that Those a models granulocyte to be XX% modulate state critical blast is on expression It there and are a it menin think switches an control that course an dependence. the set where it a the learning in the and the all contribute leukemias above MLL the quite AML the on way number we of represent speaks a broader regulates a an you in factors mutant dependence or is of into that genes SETDX,

SETDX, the an both instances RUNXX So other are very clinically. such We're actively example. there mutant is preclinically whether investigating and

Jonathan Chang

me. you're for the question thinking around at you currently And for we the one to close level should color Can CR any where you versus other be the dose KO-XXX aged about dose the patients how level treating provide abstract?

Troy Wilson

in we particular of dosed patient with us per of continue intrinsic was first before the we suggested some sort at milligrams at to XXX per the then cohort very now evidence scaling dose active So cohort. were calculations compound patient lot that's of What the the dosing XXX that an the than think recommended it response had which be we properties for of Phase But XXX kilogram activity us in alametric complete we to we X approximately KO-XXX. milligram that done, We QD. expand explanation surprised preclinical and biological estimated cohorts, have motivated the observed when expected. and KO-XXX XX, a on was dosing we the work were saw and we lower that based XXX three a We that escalation. would doses that and and

XXX currently a evaluating cohort. in are We patients milligram

with cohort with likely successful clearing milligrams. XXX, will now go patients XXX. we we've in milligram then dosed So multiple XXX XXX we're the to If patients multiple

may the think But the observed times multiple which we recommended As points we you, that that may given us than gives as not, a Phase your recommended I we combination question not out, such correctly be CR. where and able it dose window, be the ideal dose for is X compound large we're Phase higher the KO-XXX. therapeutic X really think flexibility potentially to to a determine a

helps data ASH the what's because XXX push dosing a abstract. therapeutic in in thing the your that and it likely So, continuing be to question. dose we additional and to range. that Hopefully addition quarter milligram view milligram we the you'll we explore, us although escalation as and dose a timeline from perspective the disclosed pushed one window wide do have good the gives the XXX out our will the by cohorts in from We're really flexibility potential that address and see been in

Operator

And from next Peter from the question your comes of line Lawson Barclays.

Peter Lawson

on QT for Hey, thanks, seeing Troy. initial Thanks for taking you that the Could questions. through are the data. and then that CYPXAX? going through look the of you And the is please? exclusively prolongation congratulations metabolism KO-XXX, drug

Troy Wilson

of Yeah, to happy both answer those. Peter,

abstract some let respect unexpectedly So know prolongation, QT with the because to me be inhibition were there ERK clear I questions after dropped and rather yesterday.

of QT have seen We not evidence any prolongation.

signal. prolongation preclinically. As The low extensive I've or of testing interval we kind cardiac QT previous said did compound any for propensity a in calls, shows

the course We and evidence carefully. any We've of are seen QT we've monitoring study very looked of every not prolongation patient closely. on

point very think that like have QT with have we broad we I window. the preceding potentially Jonathan tolerability, very, by but and we think and a the we feel I encouraged So, respect overall, was just safety the not in to we're to therapeutic making question,

Peter on terms In question, second the pharmacokinetics. your of

driving that, biologic concomitant of of And the early essentially that was do Azels of least that KO-XXX activity we their What observe It CYPXAX be on doesn't is on out example. as it the might one abstract drug appear is inhibition time-dependent be what by KO-XXX. their in and ruled to that are it There They at metabolites were inhibiting see was the clinically doses We've and any now. We So clear strong least activity time. metabolism. moderate at seem such surprised, And really in or a on evaluated cohorts. doing a at contribution that of of inhibit the for CYPXAX. snapshot dependence medications KO-XXX remember we for action was the were its preclinically whether and of effects in they own manner. both to as surprised evidence are patients whether expecting. we to mentioned, below do Azels pleasantly I the active

key FLTX of dose a as characterizing question, really package trying to it the bone own also of study, number butter are other PK final metabolized its enzymes to And bread metabolites CYPXAX. be auto that stage report can safety you CYPXAX The time. inhibitory of the ways that and bone itself that imagine that significance each important over Phase the a and all metabolism. are accumulates one marrow This exposure, they're enzyme I the unusual xenobiotics at to drug because And commented, marrow. inhibitors in because and work. It's understand still the that's as protects Peter, believe that's to such exposure. basic activity really -- very pharmacokinetics resistant To compound there questions. only X see overall inhibits not want likely deactivated appears reports so can stress continued of characterizing the literature throughout that in that that the on there. from And dosing encouraging development, compounds see on We're schedule the nothing in in and present because are is compound actually of by part are we to marrow cohort. metabolic of And we've we tolerability. there as once-daily and you early conducting but escalation CYPXAX is liver, we're bone your an that is the I've

Peter Lawson

you dosing? the higher a any that of from effect preclude Great, in going you couple you've way in Xs. Grade Do thank think seen you. side And profile can initial then

Troy Wilson

And at Stephen, doesn't, such Peter, let they mean me that on actually, Grade are comment might as take in AEs, two we all. potentially and what saw not use to Dale other question? into ability our opportunity indications to expand to you pediatric. an and dose those what invite higher Stephen No, as both of it to X able Peter's terms

Stephen Dale

Yeah, great Peter. Troy. Thank of a No, it's you, question. course. Hi,

see So was the Grade And Grade we XXX that one early was from on lysis One the a event milligrams. syndrome, thromboembolic patient escalation. two single X and a cohort abstract in saw as was tumor patient you milligrams. Xs XX

if that, or the should events acute first of the It in association incident association known we with actually say and thromboembolic has is at and background well a roundabout X%. the leukemias So we understood. look VTE AML pretty of

to the The reason we conservative a So ourselves, than then itself, the rather event was given on assigned atypical. agreed was Meeting approach event isn't size SRC the the look assign the and of the it that between why and causality. to we occasion this clot itself causality investigator would the

But be flow in at and the does XX particular the no. However, the KO-XXX as your And no milligrams interruption. drug-related such seen this can event. is various managed. leakage who XXX at the lysis there this breakdown this in And think an biological as that uncommon, through terms anything crystallization that was syndrome, uric seen the complete well. compound not cytometry. elements in And and pharmacodynamic again. was milligrams; which reason into because marker of to be TLS no since There negative of all like to discontinuation this was to MRD and particular issues that these later manifestation important episode. escalation? of tumor deemed to malignant of again didn't event looking isolated is And dose any discontinuation is it It on the of be it surrogate that drug And of went for certainly question of haven't event. answer hypocalcemia, was not once wasn't the cells. causes the the in passage The shows once a acid bloodstream to [indiscernible] the is on, then Hematology The effect. different as have actually were nuclear that affect Then think having and this is remission, DOT. it's rapid any we've effect an patient lead we seen patient well is the is case, know found I a I This actually again

those into continue echo we're to part and encouraged that And by Phase two our compound very and again, just hopefully as context. tolerability safety events So of we put study. helps dose to Troy, the the Xa escalate of escalation once to

Operator

And question Credit comes line the of from Auster your Marty Suisse. of next

Martin Auster

Hey the for taking guys. Thanks question.

either these the follow looking utilized on you're comment like kind situations. gating tumors X to that those wanted for on about some up KO-XXX decisions what steps patients Jonathan of the or other I think I something cohort could [indiscernible] be at was and dose may pathway you other I potentially potential of HOXAX to MLL over make timeframe of on study. for as look you curious future sorts in if form, might in including expansion expression

Troy Wilson

to that be something expression But or of available answer working it all patients. to is There is we're at some ready quite assay optimistic That assay, of challenges. that in the course of approaches for working sites. are of lag assay way it my in potential MEISX indicated actively with technical MLLr rearranged. clinic. activity identify behind we It's potentially I that a not patient one KOLs. The and is position on. clinical that is way will MLL mutant or could through I quite have as clinic. a care. is cohort. potential to or of third to the used enrich not the implementation NPMX require generation are a active that other It One keen the of enrich advantage be evaluate and in population sequencing HOXAX use that expression also is that development. NPMX can next MEISX that we'll you Jonathan's evaluating in to for those for investigators It's question, do also we're the can to other of the KO-XXX in in trying and we're a to What these standard So, tumors them two, our as and internally am patients use talking we're potentially probably

And clinical there When population, the do So all-comers bit you a to with and exactly expanding think development guidance operational that's have, and Marty where give in more you're are we'll aren't patient more unless to the population, we that to to trial. really hurdles in imagine currently. able assay to want implementing specific you a have I we'll be that timing. it to coming go months how as an you about

Operator

And line question JMP Benjamin your of Securities. the next from comes Ren from

Ren Benjamin

patients either for will NPMX? be Troy XX MLL taking them to going ASH, see or that the how rearrangements the many Thanks we're so at question. in or of

Troy Wilson

Yeah. a lot. a process. dynamic, Thanks, question the Ren. this trial No, it's And we is get dynamic a

in AML consistently spastic. tell I it's we're a setting. NPMX relapsed/refractory XX% about numbers, is The specific When pretty represents bit small to pin guide the So can mutant X% population don't numbers. you XX%. get to that What want we down you represents the of to MLLr

I shouldn't So patient give flow, what is seeing people all-comers want guidance. some pushing an not those to those helps reiterate you not This and numbers numbers, to that We're everyone. if But are based unreasonable. over-interpret have you off of it. the we're on trial. to, you

design do get be we meaningful uncover seen of ensure both those the compound both as the picture and as follow to with the up in potentially we you've patients, of request new one of into categories You Ren, terms that's of abstract should mutant the get that also by well. adequate an update beyond not that But potentially and to by and activity will update what safety of ASH have we SETDXs, a expect the tolerability number in most think to we patient. patients and patients of fall clinical and FDA the

Ren Benjamin

you comments you was Got especially were know when AML. signatures talking AML pursue it. in at you and example, your go other that's might after. of within be as of then further? focused the, like And and the now getting what also kind path line? combination study remembering interesting, monotherapy a and studies do Is XXXX you this could and do it Is toward I guess to signatures maybe SETDX straight you given RPXD you you correctly, I going last registrational we it biomarker go talk is And looking that been But I about can indications other that? found study think studies indications more for then look might able that about forward? the up outside on that the defined to biomarker to biomarkers established popping think have RUNXX,

Troy Wilson

Ren, that's great. Sure. so,

there's your question. parts So three to

some an On of might bit this want active know, may a first and area to we I is investigation part, field. in because potential the of how competitive terms a little as think other describing you it's biomarkers about be cautious mutations or of and that's both

doing we're on engaged leading Burrows there. innovation of Dr. a of who so the you that And effort with translational is have Francis lot really number a side.

say say to don't we think So we'll but more about have there's today. can much more I that

Ren, good hurdle for study, done. very the have refractory of are at rate populations single-arm in the to is done And and using least level a are as of XX% could continue is an expecting high the XX% have much monotherapy in the NPMX clinical terms FLTX the study in It's primary setting. of Those a again, there either IDH an unmet population. the endpoint, rate view in as we one activity manner safety the relapsed both encouraging if opportunity, and MLLr us approximately there inhibitors run response that and inhibitors that the to need. the and In that or the mutant we're our tolerability seeing U.S.

mutations them makes as relapsed/refractory such very a For the by in prognosis. NPMX negative That IDH. DNMTXA, other are those wondering FLTX typically mutations setting or accompanied

there unmet forward a populations. be the as path investigators need from monotherapy suggest setting. The we've a is high received in may KOLs and relapsed/refractory So there a both in feedback that

you're three-part chemotherapy targeted that and of would the your question, you're frontline three therapy group, to we And both preclinical that AML. plus We or you're you're IDH. combination the earlier with as evaluate at are, things part doing Ren, looking potentially as are looking the in looking KO-XXX studies combinations seven therapies. looking Potentially at with of there such FLTX work lines at at [Indiscernible] and third secondary would group, support actively be

spectrum. of work going is All very menin and inhibitors on. the community the high scientific is interest clinical across combine to that There in

and to tolerability realized the think and active do an have understand the part active area combinations. studies. your the and sort of Xb question. much I of will behind about preclinical and We over safety of skipped come monotherapy the the investigation. It that's And how interest critical stage to work I to probably Ren, But set very

are as a trials now. We right monotherapy conducting

cohorts successfully something anticipate -- to in see of cohorts. cohorts This is Initially targeted therapies expansion be that for those those be if will cohorts our designed to activity? And is threshold again, we oncology. will a number registration we Do we're successful, see reinventing in has MLLr not been the enabling the that done a is with Sorry, that we evaluating clinical is level evaluate the NPMX proof-of-concept. do and mutant it, of AML. here. become designed intent this wheel If

we in like AML. strong there feel specifically in and oncology both precedent So is good targeted

Reni Benjamin

the didn't questions. Even remembering it. very for my Troy award remember. you and much all Got get I Thanks

Troy Wilson

Ren. Thanks

Operator

the comes from of question Piper Duncan Sandler. And line your of Alexander next

Alexander Duncan

PK Hi, interesting. course, questions. multipart discussed question A bear with highlighted good you've abstract for KO-XXX, in please and so on pretty thanks the is the was of as morning me. The and

for any be AUC? seeing KO-XXX And on to the of efficacy? one do time So activity the Cmax-driven? lastly, this, of driven Thanks. effect broadly, or question, maybe anti-tumor already in of was it's concerned you team helpful on the by And PK And daily there? Cmax over you profile, believe last exposure some similar to for you the of would and drugs thromboembolic a do but beneficial the the aware Secondly, unique is are accumulation touched with color that dosing other and is that the if you initiation timing inhibition have related required on still event that precipitation? has think respect potential and are based potential dosing patients you're

Troy Wilson

Sure, Alex.

don't. come CYPXAX? up get first my we're invite the the an can So he on. development and in have other with example the if know compounds you, to of seeing we head. don't to that just group of example that another to I that what inhibitory of the I that discussion other back have phenocopies have look don't Stephen, any, Certainly can you of any part of I into And that's and your off in give auto comment. we in question, least at give Stephen, don't of you compound if activity we does us immediate terms KO-XXX kind I'd give top it's and you something this could a

Stephen Dale

is answer Actually, come actually it's but not. up. a It's not great question,

on another [indiscernible] at example sorry. given you've So, the just moment, the

Troy Wilson

No worries.

you give can look see team let a and us So, we to the if go to another take example at. back Alex,

AUC. In I we're terms What as inhibiting which know thinking irreversible blocking differentiation. a is not in this or really biology enzymatic then interaction, protein-protein it's bit though doing anti-tumor a activity, the activity. terms is This at an we're induces about we're of little Cmax point step unusual don't of in and that

interaction you rolling start and this from right? from chromatin wants wants you essentially, enough from differentiating. the can down desperately sufficiently doing disassociate have prohibited to differentiate it that So the to go but down, it's It to menin hill, inhibit tumor and that

So I there. ways can get you think there are multiple

is we ranging drive off, two two week differentiation weeks weeks from terms to one continuous so fact, weeks with In forth. the and schedule. in off three schedules to We're able on, permissive of pretty see, on, biology

what to And daily something optimal compliance as and give we'll an to. we trying think in are dose menin that important be a continuing unique attention potential But you or convenience. dosing. window. the the course exposure here. the toxicity. event That's because We of any that nine from see do with Is this that therapeutic seeing. you're Stephen do genes to again, At your this the typically to a that's we're only such has the is mentioned such of for PK MLL characterize a to the have toxicity you standpoint that it have you you comments with and continue a one and his is inhibitor It are advantage is consistent under of the necessary? It's, question, to broad don't eight of seems patient I point that dosing control And around earlier because intermittent compound.

it seeing then we timing of something is question continue what Stephen. your not the learn if me to turn reason the with is, If the daily the will Alex the of dosing. over don't Let But we're moment, AE event more relative that, to was to deviate final that share start of is there on on there? a that certainly you evaluate. specific to versus And to the to dosing? embolic from dosing? which of at I Stephen, have anything timing anything know So

Stephen Dale

another, it's And question. great Yeah. it's a follow-up

limiting determined the, dose to with neither toxicities. So be

patient intra-patient just think this this more quite I continued this XXX That there this a going was is around dose dosing patient all are context for milligrams complete actually saw a these milligrams and patients event. poorly, thromboembolic particular disease To the XXX milligram again is back put as very the been advanced from and some escalation relapsed/refractory particular and a to bit patient, this the had remission. in mobilized time. disease case, subject we XXX to

any risk increased that an We've was this. duplication DVT. of for seen inherent there not So of risk anyway

protocol a be hematology occurred with once tumor case, to very of protocol one events lysis In investigators for the from It's not seen forward. for similar deemed wasn't moving recognized primed to in cells. And malignant DLT terms of had again, TLS terms it in actual breakdown with in issues rapid that not again, drugs any syndrome, and by of pattern, the well event but the that we've the monitor our in cycle and particular tumor before. lysis again syndrome

we to-date, stopped the on by the escalation carry So which escalations has nothing Phase Xa.

So hope that gives a little more context.

Operator

question the Cowen from comes your And and Phil Nadeau line of Company. of next

Phil Nadeau

congrats taking on morning, thanks Good for question. and my progress the

percentages given and we expect suggested to we've to be maybe population already NPMX MLLr As to and be And one Are patient should So, XX patients of forward see set all available seen if of expectations? maybe is I'm meeting. response? suggested there in patients, kind we at you've your the NPMX those curious hear for you've there's ASH, the the we are going going XX patients one. on look maybe XX although how MLLr of three then our to thoughts that approximately to

What's So bad? to it to response like like have numbers urea some really to thoughts? efficacy? it thinking your hear is we Is it be we're just [indiscernible] doesn't should seem going is about hydroxyl reduction rates? patient ACR? intriguing enough value What's good? what how So in and curious

Troy Wilson

of again it natural kind a absolutely, Phil, it's impatience FDA human and so that by this is we dose study another question condition. X I'm rate and a that design. I get often, Phase an of Yeah, request to it. great it's and said, in glad by and a you get by a question That escalation being population understand absolutely all-comers response is to we everyone's raised that's

you're get population. you're characterizing which correctly, all-comers think to So is an going it I

From feel you're right. I clinical NPMX obviously, about patient better. think of exactly the if in evidence we'll benefit sees positioning thinking activity, clinical mutant much our and it standpoint, it is an one way all

much I magical the about examples, you'll significance is really point that's I NPMX really to SETDX, out mutant. RUNXX feel that see If of couple a better. will this that of and nothing you you will stress, there even

it's what would gene dependence exactly we are But NPMX may menin-MLL combinations well-validated inhibiting in special of and hoped down-regulating expression, be a MLL mutant we significance tumor go So pathway. mutations on RUNXX do, another. namely The approach. it's the, you're preclinically. that large as patient everyone you is drug is doing SETDX, reason actually very the example of be focused again mutations a NPMX the is is may menin, the SETDX, RUNXX There CR. number of this the the to an others and the have is seeing amenable mutations that example. one the biology along. It's here There driving are of AML it of is on driving it's and interaction. a population

look activity. So standpoint characterize from been the safety or that, of exposure anti-leukemic and of then goals the for and and that PK have Phase X evidence tolerability, characterize activity our biological

on I well on way the think checking those. our to we're of box all four

the to is, clinical is a and response here if to about enriched phase recommended that a you, I you're a one until then to give in expansion responder expect patients very cohorts it's and therapeutic use start we or we on of a to X Ideally Either That's evidence mean, dose. seeing rates. what can you're a to for expansion transition you're view investigators the reach great. to index, in right just Unless our tells there. premature instruction KO-XXX. beyond this how to Phase about genetically is seeing activity, are where you think the the as have really to therapeutic we'll certainly as path, wide and we clear a goal in anecdotal I rate. think and population, and KO-XXX not and response but talk can Our

mechanism -- in to quickly be as across We're not excitement oncology Phase get designed escalation as is as where response The can. about is test there good and able I possible is cohorts designed to as we said FDA move point to the of is and thinking alignment just as the we're dose a we've trial up be that gotten the quickly into this expansion will it's first the for not from we action. finishing for in think I there next premature already of anticipating rate. this X that, and absolutely at quarter year to

have We more have than slots. patients we

very, but question with Hope very answer momentum your some lot in to maintain be to that I able position a flow. strong helps. we're hope of data I So actual There's the think explanation, color. and a that you gives to

Phil Nadeau

events those actually prophylaxis any in the since of changed or first was That the you like they, were they and place and mentioned, just one-off for does, you you protocol it the put were events haven't prophylaxis part time. then those light on in second tumor that lysis as event. thromboembolic a one-off in Have where as that helps And of seeing that lot. adverse sounds abstract the the noted events

Troy Wilson

case steps in There protect any there prophylaxis those. patients to to either implemented against haven't been Phil, isn't,

we're Both As something at certainly of XXX mentioned too be much aware those in in read now we've There of. to shouldn't But uncommon dose as is his escalated, AML people comments. Stephen them. are and into events not milligrams.

We still haven't any ongoing, of two we either other haven't those other is but events. seen evidence evidence seen any of Obviously, study to-date.

this is at prophylaxis. a not there really for So need point

Operator

And of your the with question line Joe comes H.C. Wainwright. Pantginis from next

Joe Pantginis

sites any seeing you question details provided or of off lot the thus be for my conduct that based far. the current to you second I really extent coming go on to AIM-HN again on the study a all for you and it? switch I based how and be a Thanks can, the Guys, the and down of to with regard should guess pandemic. Are gears variability to would want we sites on viewing and shutting

Troy Wilson

all question. of we We we I lot pandemic. a reasons, great wish think shake could all a for this it's Joe,

sites, we the clinical remains the monitor in a and continue, team That regulatory key patients. comprising cross-functional place the operations intact. and put We to team and Joe, quality all functions

broader enrollment can amendment to are activities. to were lot We mindful this we I or it patient go seen months of closely. into have of. that crossed removes made that a and back we're the have patient sites had think certainly just that dip. the plus now actually we're seeing lockdown. the six a easier tell end not those monitoring so implementing another study is to population something quite It worldwide. the to But XX hurdles that for with come that some I that implement on European of amendment of think I sort also last We've the impact, It we you beginning of We is focused point go over tail all a to an coming seen yet been allowed that on to be patients and haven't something as to countries have we us to to

will in that optimistic I'm So of seem be to into. amendment help that renewed of face we a maybe COVID that wave the even looking

Operator

the I closing And would questions. like now no back at Wilson further turn to we Troy any remarks. have to conference for this time

Troy Wilson

operator be great thank any and additional virtual and questions, many In participating then. all the in of the Marc please meantime, you weeks with you the free contact have We'll course. again our ahead several rest speaking you, Thanks we of for to participating have Thank day you conferences forward of a in if Investor or feel in to call today. and Pete, me, look everyone.

Operator

conference Ladies today's and gentlemen, conclude does call. this

You may now disconnect. Thank you for participating.

Pete De Spain	Investor Relations
Troy Wilson	President and Chief Executive Officer
Marc Grasso	Chief Financial Officer
Stephen Dale	Chief Medical Officer
Jim Basta	Chief Legal Officer
Kirsten Flowers	Chief Commercial Officer
Kathy Ford	Chief Operating Officer
Peter Lawson	Barclays
Marty Auster	Credit Suisse
Ren Benjamin	JMP Securities
Alexander Duncan	Piper Sandler
Phil Nadeau	Cowen and Company
Joe Pantginis	H.C. Wainwright

Kura Oncology (KURA) 7 Nov 202020 Q3 Earnings call transcript