KURA - Earnings call transcript Q4 2020

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Kura Oncology Fourth Quarter and Full Year 2020 Earnings Conference Call. At this time, all participant lines are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions]. to Spain. conference like today, your now De Pete would hand to the speaker I ahead, go Please sir.

Pete De Spain

XXXX you, welcome fourth year to Thank Kura call. Great. Victor. Oncology's quarter Good and morning and conference full

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

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

Troy Wilson

for you you Thank Pete. thank joining us morning. everyone this And

commercial rights. candidates two stage drug global which medicine for we with precision own company clinical a We’re oncology

candidates and mutations inidcations inhibitor an strategy. Our development were farnesyl and of tipifarnib. high menin target inhibitor our transferase our needs drug in and pursuing fast-to-market accelerated unmet Each driver oncogenic KO-XXX of

rational believe Our pipeline through next-generation address high indications that emerging of an transferase target unmet we farnesyl needs also combinations. biology program innovative will to inhibitor includes

and provides we in $XXX development the proven a with before, We’re talented us multiple to advance be with ever and we than points, which also successful. stronger in resources cash, more expertise with our and through believe have drug commercialization financial million to required sufficient inflection a oncology, programs than position team value

dose KO-XXX with to take let annual relapsed data of including rearrangement. all-comer menin our safety the a also KOMET-XXX were of patients and our meeting. window. In discontinuations a demonstrated clinical cohort, guided saw phase data December, our need tolerability amend or compelling Based KO-XXX we safe order our preliminary escalation. no wide and In trial. the dose minimum on to include KO-XXX. Phase inhibitor of cohorts of that are we beginning context dose presentation, single Meanwhile, acceptable trial while agreed enroll through reported in consider Phase trial. in regarding programs an and the with to last cohort. demonstrate to KMTXA therapeutic those also expansion me FDA the refractory this portion and currently ongoing XXX and X we plan an and primary X to recently a These dose Now, Society for transfusion of clinical modify our in from activity leukemia, portion our we to a of at biologically incorporate meaningful of milligram patients American those KO-XXX we've dose XXX related activity agent design endpoint two evaluating continued we and patients we the trial endpoint registrational escalation completed with mutations, X each Phase Hematology discussions, of you protocol the with prolongation. as would myeloid should profile, feedback, clinical as evaluate with FDA continues directed events, highlighted due from favorable by QTc NPMX X/X registration be treatment the to evidence endpoints and the population determining secondary KO-XXX acute trial Since our in no of align for should CR/CRi adverse FDA KOMET-XXX drug the and CR/CRh. feedback milligram that to effective independence patients intent. We've

us Phase Phase to have of minimum include relapsed inform at X already This target X plan that better We met a a we to early an expect AML rearranged a these both to the safe of doses recommended of efficacy the KMTX Determination or further cohorts patients. an the with dose. KO-XXX threshold for stage Furthermore, refractory is and dose. minimum clinical recommended X expansion to patients populations, Phase Phase mutant most among dose and each us and characterize these should NPMX biological critical of X help expansion help each these optimal to decisions and to XX determine program. safety effective cohorts enrich

changes encouraging We KO-XXX the the a dose window tolerability enriched to move the and dose, set and believe of tolerated a With in cohorts increasing and to best-in-class the a of population, profile, as to of combination. monotherapy more we recommended profile, obtain activity, protocol, defined reaching maximum have for thereby potential prior to clean, these likelihood the to that trial a success expansion an Phase signs and X genetically opportunity confidently the clinical data in determine into both therapeutic larger a program. support wide the safety

Phase a to intend development aggressively forward expansion third development We with dose, pending key KO-XXX potential studies to pediatric further of strategy. recommended move for clinical steering providing continue We a a global a X including combination determination we these forward in engage and the and you cohort, efforts way. look actively the and to to along opinion our plan frontline define updates leaders to committee comprehensive

for to patients with announce were that on Now, squamous neck equal breakthrough upon the or of HNSCC, pleased and in or our therapy FDA was trial, transferase from tipifarnib farnesyl metastatic very this let's little an therapy breakthrough turn upcoming of or XX% our RUN-HN granted Platinum which publication with attention Earlier mutant morning, has Journal head treatment tipifarnib. been issue carcinoma, recurrent of frequency to designation recently from data HRAS cell based progression The inhibitor, X disease to after than for Oncology. accepted our is designation the Phase chemotherapy. a greater based Clinical very we

a RUN-HN an progression As of a response median trial a showed reminder, survival months. six survival rate free months approximately of of the XX%, overall and objective XX

frequent and bringing acknowledges in to median XX%, response patients. range and line three organizational for the and months, survival as possible. progression we second development of median to XX% benefit months. with therapies HNSCC from more communications recurrent the AIM-HN a to these both as program. breakthrough Eligibility dire an of to and To three focused two guidance overall therapy patients. for tipifarnib for quickly will meetings an include an senior of efficiently of that with on FDA. review a objective the submission provide approved the from free survival help FDA patients breakthrough involving with tipifarnib Benefits rate to trial a therapy the on and the intensive FDA, This remain eight metastatic of designation unmet need approval As of reference, for and We point clinical managers promise our the efficient ultimate registration NDA for of of HRAS commitment end, market breakthrough anticipate tipifarnib the mutant or designation therapy HNSCC treatment rolling treatment to designation as five to drug the the and facilitate conducting of directed development HNSCC,

addition, populations, PIX lines in HNSCC. with the inhibitor potential therapy. also the of and the tipifarnib pursue earlier of address kinase alpha advances In and of patients Among of other these use patient new combination in therapeutics, we've an to oncology to larger we're combinations, leveraging enzyme prioritized with expand combination tipifarnib

We HNSCC. total data anti suggests to the preclinical for in that has high potential alone. target be and believe may PIX population co-dependent of kinase as oncogenes PIX inhibiting Our better HNSCC, inhibitor combining with meaningfully the XX% kinase provide either alpha addressable that than are as activity a tumor tipifarnib and tipifarnib HRAS

in continue patients FDA as therapeutic a is have to inhibition of farnesyl And the mutated we PIX has the from who farnesyl a second of latest expect of indications. potential the for inhibitors HNSCC. franchise, milestone therapy We amplified proof-of-concept one study to and additional for with in transferase oncology view initiate with cancer. half PIKXCA prepare that XXXX. our X/X effort valuable patients multiple tipifarnib use PIKXCA to and/or pioneer to designation deliver alpha opportunities in a in potentially treat inhibitor study the overexpressing, in to commercial We transferase HRAS kinase Phase Breakthrough combination this

transferase opportunities have revealed targeted efforts, internal our uncovered through years with inhibitors areas to in of several other combination exciting a generation farnesyl new collaborations, both biology, we us compelling inhibitor. of a and year, past farnesyl we've efforts some These in discovery greater academic Last therapeutic the Over this a stage the and network for some next a class. to investment opportunity transferase initiated underscore develop program for therapies.

for new and biology enabling and We candidate larger goal that, and and the to properties indications, over look this comparable lead to nominate financial drug sharing mid you and With turn already results multiple a the to and report IND year. at this to physical forward improved Marc Our relative call for intend tipifarnib. Grasso later our advanced oncology next is chemical compounds, of FTI year our now for with potency to plans generation development XXXX. in our fourth we progress full quarter to pharmacokinetic expect direct to and we've and pleased a I'm identified that XXXX. selectivity, deliver discussion a I'll has candidates studies

Marc Grasso

Thank compared million, to quarter increases fourth The million related to of costs, for Development loss XXXX based million Decreasing fourth the primarily XXXX. of full a you, $XX.X $X.X General the for $XX.X Net and due administrative respectively. to of commercial XX-K was the non-cash expenses. compensation. million was G&A $XX.X million compensation primarily here and for the personnel overview prior our the quarter compared brief the for expenses to loss $XX.X the today $XX.X full to personnel million compared review expenses KO-XXX prior compared for pre of our million at Troy. share the for were XXXX. same expenses were fourth of net XXXX in quarter to Research to periods results on fourth and due for and share and $X.X quarter for other for $XX.X compares $X.X G&A a of non-cash million, $XX.X fourth loss million million, the for $XX.X invite million year. And detailed XXXX discussion. fourth $X.X fourth you included Net million XXXX. loss $XX.X XXXX expenses R&D planning were compared I'll million million increase the and year. $XX.X million the everyone. year of expenses clinical of year for program, XXXX R&D in $XX.X costs prior and for net for the financial of quarter XXXX. year. a a the of expenses, provide expenses Net year to for year was XXXX compared and This manufacturing loss an filed more XXXX full based development $XX.X to our quarter full the in was and to good quarter million, to call related increase were morning, in for activities the

includes Our as current cash, of current million, $XXX.X December approximately completed proceeds compared short XXXX. public sufficient Based $XXX.X short net cash XXXX, from back and XX will of investments to be now our that, were turn term into term and that December I $XXX.X as Troy. believe December our current of fund XXXX. XX investments our With over call operations cash plans, on This with equivalents equivalents the offering will cash, in we XXXX. to million million

Troy Wilson

Thank you, Mark.

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

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

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

Operator

question Leerink. first will line of Our SVB the Jonathan [Operator Instructions] come from from Chang

may You begin.

John Baird

dose you a is Or expansion my And plan team forward is escalation? escalation what Baird dose dose for taken quarter? Hi, to still the Jonathan. your John the this end for milligrams? XXX drove cohorts decision this and on parallel? in to Do expect escalate Thanks reach to dose RPXD questions. moving define you taking continue these of with plan to by the to do What

Troy Wilson

the Yes, of thanks and at to your John, for question. the you question. that for answer the alluded And end

we're, So doing we're two things simultaneously.

first to escalate. dose continuing The is

pleasantly window. very the been that toxicity we've have surprised therapeutic at lack We tolerability the good safety potential seen, of wide for a in and and

And and to on dose, and for we to stands of protocol into down mutant doing patients. actually indicated which we're that the of the we Phase we're focus the we're really effort currently any, safety that. to determination forward continue But Simultaneously, with try as safe prepared from evaluating will see of X of seeing XXX now cohorts cohorts, comprise those to, a prevent standpoint Phase we cohort, that As optimum it minimum will escalation. of related us good along don't identify moving recommended study. anything on make enroll two review is milligram titrate both the an NPMX in the today, we to that's good KMTX would to cohorts with the and dose the dosing John activity safety the the portion amending that and outcome a from need comments, across mentioned, the We in really, process X registrational expansion the to the committee efficacy. tolerability. is, to that depending of whether rearrange those efficacious What cohort,

John Baird

as moving XXX it? the So trying when through dose to XXX. going When threshold just in passes or you to escalation, dose XXX potentially milligram Got up data cohorts you pass and be then get through additional get dose. you be and those that at that using will and expansion XXX expansion in you safety using waiting safety cohort the until to are the dose, the dose then the

Troy Wilson

John. And It's to different evaluate a doses. just able The precise a this have at leukemia-free And response. patient it's To couple least think point, one to good cohort XXX second a as we best showed December. a that who at Yes, had remind we don't had question. mutant be everyone, is here which for who we answer. milligram I at had cohort, data complete to the ASH of NPMX NPMX in one patient in A Morphological state point remission.

that be dose, thinking and call think then least Steven, using the your appears milligram these who's efficacy. to and at At of X and you're data it bound, lower good going titrate it out about for don't So Phase higher the to way, driven, cohort. will answer with that a think on among, be that the the going an the that I the on to a cohorts clinical then a a question lower comes investigators. for today, potential by on be team But this in To us data that of bound, that's forward our upper point, XXX And dose. the course, expansion dose, I have right exact you. discussion and

John Baird

more And escalation might one, still be expansion on XXX some half. it. initial just is we Got the cohort given now data? focused in update Or dose Will one quick see this the data? second just

Troy Wilson

point. this at say to hard it's that's, Yes,

exposure, next data what compounds. data think of that do, Xexperience the and a the and able I pharmacokinetic give we'd then of course, update picture and the be provide for the like safety would And fuller when to efficacy. we to to include Phase the tolerability is

protocol, early guiding cohorts months. expansion take the KOMET-XXX. the takes that's then the the of We're amendment initiating least and at that X year. middle have to the say it a enrolling the to currently it's that us Phase of John, it's the it toward review, couple think too sites time And just around we will I implement at the FDA amend

to you to little on update, forward update. we early exactly point as what at this So, as just data to providing be others we It's continue we'll progress. will and that are what included continue call we say informed a keep the looking but to date in bit a

John Baird

escalation. and Got on congrats dose Thanks it. the continued

Troy Wilson

Thanks. you. Thank

Operator

from line Suisse. will next Brian from Our come Credit Marty question of the Auster

begin. may You

Brian Marty Auster

taking have Troy, Thanks, question. for think operator. Thanks the three I I questions.

a Just things. want to clarify couple

your this wide just a you to with of KO-XXX? needing the wider something is down seeing registration plan. that original being on getting the the of the expected to that early the understanding XXXX? protocol. with timing expected? update discussions what have from talked want to this there In of unexpected therapeutic the and in to molecule finally, And premier I in kind And back index feature lower level I'm than that on triggering know what in again, dose actually getting that your can make And your than function to complete DOS kind terms of to be next continuing guess I is of evolved class deviated having do then kind on want update you of window the lot update of clarify longer is feature? from next a evolved kind The change the off Second you just from things? And understanding the picture premier kind people question to -- unique common you're and I path. is you before at of the just KOMET. embarking back a here, of you're Or the kind of was kind think something of about FDA clearly that thinking sure with is escalation

Troy Wilson

Sure, yes.

in for thanks take the So let's questions. them turn. And

right. to So update, next of the the timing with you're exactly respect

we dose encouraging question, escalate. surprised there are it's is class of compounds. getting KO-XXX, this to been, understand, the among lower dose we've efficacy, to the And better think, ability our we take in We are are it and to doses, window. to a of of to know the members I'm activity specific push and -- or there's is wide effect, third signals although desire the it I define And at therapeutic seen to getting definitely help a have properties efficacy, more at a is don't continue whether the also both investigators pleasantly We going the turn. team to we

past the the in profile said, might each we've some how is, of that What a to anything on. been As escalated. there suggested benign safety evaluate limiting questions done the cohort talks we dose expect. early toxicology And in that's again, wasn’t GLP pre-clinically we've really patients was we've that we've very there at surprised as is

some call, a As, as all AEs, cohort, on were of idiosyncratic AEs those you XXX some pancreatitis, believe those that to remember, there that milligram and patient. including other the in we were

any of We those seen as evidence of, haven't of in AEs patients, any we've other escalated.

or was, the asked great. really don't yet. come out with the we point discussion second think but, it protocol burden indefinitely. escalate of FDA. came in and we're for we And then will There And in the And just change pill what's our you rationale it that Now, maxed we've question becomes a when was, thinking? there can't the evolved what a too out exposure,

maximum window, that's it's efficacious soup you're safe all-comers. don't do combination. the in has One true X identification that expansion in not will mono patient to Phase these combine wants that, different used efficacious because like that The That's from we registrational anticipates is dose and is backgrounds. getting to X therapies, thinking mutant we've for and not just escalation the is those much. the genetic one agents maximal And of twofold. have and with that NPNX a sought want data make everyone at -- it's minimum exposure cohort, maximum FDA. drug be therapeutic inhibitors be agents. to And is pharmacologic around evolved to even than that don't context are to that that rationale to these one FDA seen as the certainly chance what enroll continued of a the remember our dose. give the really getting, really agency's view it's In to a But for determination whether other this to only those entire want FDA a to you give enough menin combination most with speak it's of feedback some and we Phase is better who's We're you minimum too and open we therapy, perhaps more safe conversations, that's the I driving been dose you discussed point, other the So have enough dose to activity venetoclax points or important give breadcrumbs, as as azacitidine. efficacy, to benefit, And a And way you relate That targeted enough design. to correlation. on literally relevant that greatest lead an to we've a to per able KMTXA, to another, enough cohorts. encouraging enroll, alphabet dose

So now, the the through a rolls endpoints to be around again, at those about discussion expansion into with to patients a is a that one lower the for dose. one expansion that a trial registrational. with X get the We've, we're Phase in these higher enroll way included dose intent. a potential going modified to FDA, have over registrational we've A trial at such two cohorts, the when get cohorts

So And at greatest I chance And as therapy. really into success combination hopefully safety a question, these, expected. give hurdle. the color. of additional the better a evaluated, by need the zero in success So some it right should tolerated optimum of make want doses determine to a give enrich the that's basis? we've you your that are we likelihood we going greatest longer that going cleared dose, compound the it's to we answer to a data that of as that the think which optimistic sure these because gives but them than taking these we're us Which on of forward to long monotherapy. that cohorts, is all have us of that which And we

Brian Marty Auster

Yes, correctly. a I'm try make sure and follow I mind restate wanted do you the getting to up, just just quick to this message

in high safety. the end, feel the On with establishing escalation you X comfortable Phase

for get you'd to it, expect you you're monotherapy or do that And doses going want efficacy then fortuitous what CRF better to there, when just lucky. potentially upper in of on the signals and end test those double higher so there's early the want the checking at you to end lower rich population, whether were

You for real combination there's want to use. a potential make sure signals future

Troy Wilson

is I think now What in we're that's yes, maybe for restate restatement. I what really Phase expansion right, think efficacy. to titrating doing that's this X your we're we're

So in not would typical Phase escalation, be seeing talks. X talks. stopping the We're a criteria

we've equivalent a we're do. we So, it's us the different will an what cohorts, because for to at to an enriched population, to titrate escalate allow and continued unless If cohorts all-comers between milligrams higher see difficult in activity expansion that's population, dose, in XXX you're example.

I be might with we data the able to efficacious think minimum the the that's that dose, and dose, a but driven need safe to to be go the data make the package lower decision. view

evidence the of in QT observed And of at the AEs cardiac encouraging confident standpoint we've XXX our folks we the none milligram from prolongation, activity that window, only no of no very wider continued. wider looking cohort. were therapeutic milligrams. at XXX now, a that should talks, think And had, seen program, the I in feel that's and view,

we program, It in combination. doing we're is So taking a lining a will it's maximize mono that bit nicely. both as therapy longer, the little value believe development the drug up of the but

Brian Marty Auster

Troy. Thank you,

Troy Wilson

you. Thank

Operator

question Lawson next from come line Barclays. Peter will Our of the from

begin. may You

Peter Lawson

just Phase questions. do that recommended half taking data? ahead Troy, and see think doses X you rearrangements? the recommended other And get think NPMX of do that? When second you Will we on, dose. we for X Thanks I get we guess, for the Phase will different

Troy Wilson

Yes.

to that point first. doses for Two the There's rearranged. one, let's different suggests questions, take second and in So the nothing mutant then this us NPMX take at Peter. are good patients that needed KMTX

we admittedly, data set. expanding Now, have an

and enroll in as But safety I bound, is the the has But you, anything respect because go this defined. out come sense think of will of we’ll as we've point, RPXD, of both answer we're yet little NPMX we isn't expansion to that, milligrams good doses. KMTX first your provide the that's the safety long. I suggested at seen is for that And can the these that's much to and doses. lower we'll and anticipate better out ahead We be don't been probably review of by have review question be a different cohorts, there an we and rearranged, get committee pending committee. want think, to so upper that so that. and bound timing XXX specific forthcoming a what vague It preclinically that transparency we we've are that about review need -- what With tell be. review the or to appears, safety clinically, think committee. on the respect a doses really tried to going the We've we

expansion Phase a With these intended cohorts of enroll minimum to these, are X patients. XX

I we'll have So, think we're idea. those into a once better cohorts,

I bit get about this It's presenting can. think versus NPMX we patients nomination focus slots. But point, we going At on adding and have to to help more the to us KMTXA. it's all early, little to, to amendment the also as just additional say a to We're we moving is, this timing data. as RPXD narrow study, than on hands we enrollment. drive the the as aggressively we're we have We're now done. recognize sites to deck what aperture exactly of as

next it's the going a everything's the -- bit a be in update. early, little versus timing the say to of there's RPXD able the to date just direction, what exactly Peter, So right

Peter Lawson

a to for Thank it’s you. be will? think for switching the gears you filing? When despondent. ready do I see And guess just you'll stage we do on when next Or

Troy Wilson

of acknowledgement and at were a designation. therapy the And, agency's We it’s great the the question. unmet Yes, really need. thrilled breakthrough appreciate

we to to development As that the made deck, we've We're direction. and be in registrational guidance ensure definitely tipifarnib. helps of think hope a data. we timing yet that it right now, a ultimate think to The can study. in to not mentioned, us the to Peter, the really the of changes within pleased lot that excitement wants on we in investigator continues the really And, is there, of we involved going as both and going we success. is in of or there's be study, But, actively protocol, the at point the enrollment in the we the likelihood study the past, community. enrollment where We're the the higher a And combination said, approval enrol. on the agency thing we're next with to give drive

see. we'll much as So expect you'll the I that's next as would as we can. to thing updates But continue provide

Peter Lawson

Okay, thanks. taking questions. for Thanks the

Troy Wilson

Yes. Thank you.

Operator

line our Konstantinos next Aprilakis from comes And the from of question Stifel.

You may begin.

Konstantinos Aprilakis

taking for thanks Hey, my questions.

can seems got answer a explicitly So the whether therapeutic quick but far? is follow DLTs you've the for say And just any further up. it KO-XXX no, thus window on you looking for wide color seen I like

Troy Wilson

continue as Konstantin specifically we DLTs, can't to whether we've Yes, so certainly seen we any to comment, escalate.

good. We're at now would think looks extra say encouraging. I So, four it at And, dose. that's I

You never see building every new is, -- time. what's important with typically over as not But I've day. day them before, toxicities, you'll a joked seeing is we're

higher, see seeing a We're you and then grade two these or one even see grade grade of you pattern regular You as patients. across three. might not grade go one,

continue we escalating, at safety going at at we wide we're of that answer but the just infeasible window We're reach as exposure where looking such So will in we're some it And can tolerability limit, to I aspects yet. pushing mentioned to don't it's therapeutic continue, as, activity. it think still we think hard there to a burden. previous at as the dose a at and question, as [ph] that at other pill some point,

lights all And the everything's so all looking are far looking, great.

Konstantinos Aprilakis

dose titration? miscellaneous needs do to abnormalities, KO-XXX SETDX? then its have Thanks cohort for a plan that cohort still also that. You the patients in own exploring with to And you know, genetic open including

Troy Wilson

answer that do the to reduce the defining yes, that single for we're is want the reason the to down do. We cohort. the rules do study. these, this, cohort we that opening simple trying to variables. selection of And portion so anticipate of now still analysis third Yes, registrational in don't We we're that

So we've good and we've said, cohort. every we've established at tolerability safety as

titrate to need we Now for efficacy.

high Phase So three have populations the we're dose, PK that At a cohort, still will keep That the point, trying for very it the benefit. of is the a the And we to into recurrent intent. KMTXA not then to in registrational decision. composition the dose. we would NPMX, what in we better to third to the data recommended clinical roll two and make be and give do NPMX, think us KMTXA to with portion where try that going down, just the then that to while relatively it to can the RPXD, fix exposure get we're patient and of fixed study in that cohorts it's because and to X the confidence we going expect able We're clinical, introduces dose be fix should RPXD that uncertainty. to

Konstantinos Aprilakis

Got it. Thank you.

Troy Wilson

Konstantine. Sure. you, Thank

Operator

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

You may begin.

Ren Benjamin

to six to be you the thinking And were you Does morning, What with seeing? patients, if pill you about going So change it, that able XXX But exposure, good burden final evaluated? the patients you talked just I dose. modified many per just it in thought seen, rerun with the in guess was is, are three was mentioned that the been have all? and about, might couple, about related thinking see? FDA. kind at Or limit that because still to dose, that past, only any for I those, the finally, more do could XXX. on we pill? enrolled, at you've taking that, you've Excuse put you that the discussed milligram do do guess, we're already how we're patients going so to you that exposure the thoughts did that what what to reformulating the are the if we pills now now thanks you there analysis, be Hey, right the questions. with case? thought three endpoints FDA Maybe me, be is a new you another you've guys. about, Troy, And the I going of

Troy Wilson

Yes, couple so Ren. questions take let me the first

Stephen going am. I'll question. actually I and let third they're second As And positioned to because he's be probably the the endpoint comments on better, than better

of and patients changed nothing, five up the are and designed patients. has nothing three of terms And, a In there. to patients, to that, of cohorts numbers the minimum enroll

and in cycles. You're cohort, on given it three they it make the through patients all anywhere typically just depends five whether getting between a

think don't I to don't and patients And investigators all the to we ensure we XXX. six will we the get have higher the So that of at that give a we up continuing likely again way That and true through five, than We're patients. enrolling study. minimum if be at same go were make escalate on XXX. to then it thing can't true three,

In we up. terms exposure increases of the exposure, we're continuing as in see to go

don't on really the we plateaued question be we But cohorts. know driving is on exposure, had plateau the Phase actually the that And reached yet. exposure haven't there are, better have whether have to a expansion that's us of in is criteria increased would that activity. yet. kind we we another to answer What We we're that help we could if define that RPXD, not to exposure X

would question, we would which I anything if the from we're versus Stephen question with we though discussed think, patients the if asked with Steven, final gotten you the the is, CR/CRh answer at agency. looking as first different The feels CR/CRi, revised with have closer. reran could as ask on we've it getting the, the we, answer on would, standpoint And question changed? the you me, the to was Dale, of I'll who's the line endpoints whether Ren’s a that Although analysis, have

Stephen Dale

you thank a that’s and good Ren so question. very Yes, Troy,

between we in these endpoints difference the to difference count. dependent to the from platelet the were both CRh the a amendments the only CRi is nominal to the neutrophil absolute the is of the actually a on between complete And and a count, endpoint, two. There both as But changing are remission. one two are the chiefly where the the So effect of composites. both

It's So previously because would there complete difficult on and data, run reanalyze the question the haven't regarding to analysis see that all the would responses already the that say we difference differences? remission. for all difference, be in the yet, of to if those we've criteria is, answer to no these we were discussed seen we any data sets,

those we criteria exact see and at those certainly be can a may today, where we'll CR, CRi right. same for meet So those further. and done are haven't looking the we But CRh. We between difference data analysis look those

Ren Benjamin

it. Got

many you have Okay. cohorts? makes will And I and now expansion running sneak have you how sites one if of kind could between Yes, the and that Troy, the sense. in, up by time

Troy Wilson

Yes, it's question. a good

So have the on at focus seven the U.S. on and the up a opportunity think eight our enroll I clinical And, those U.S. with these Ren, sort those, focused have can patients. we’ll just bit are XX. sites and for the moment, But Ford, the that running and move waiting very between Kathy I on because and the of enroll, initially, we between anticipate this. to anywhere to, the colleagues or XX France. and with are would Really, go quicker sites are sites been, operations a with amendment.

and if we enrollment they'll Phase them to help initially X cohorts the there. bringing and into amendment anticipating we're when with this just roll get drive so online, And the expansion then in cohorts, registrational

Ren Benjamin

taking Terrific. Thanks the questions. for

Troy Wilson

Thanks, You're Ren. welcome.

Operator

question next from the Phil from of will come Company. line Your Cowen Nadeau and

begin. may You

Phil Nadeau

progress. Good question. for morning. congrats my taking on Thanks the And

a Just us. from couple

between are cohorts the are divided of based they cohorts what's the expansion on Or different design cohorts? I X me doses? unclear it's is, different the or the on Phase First, to the the mutation? guess two cohorts

Troy Wilson

doses. different. Yeah, they're They're different

be So is going KMTX to be take try will We're not We’ll there'll they a rearrange patients as those the to pre come. two different separate the blend NPMX specify, to cohorts doses. will at or of What they either evaluated open populations. patients. two that

Phil Nadeau

And in it, those, cohorts doses the Got fixed. the okay. themselves are those then are

will be will one one high? be low, So

Troy Wilson

intent. That's the the intent, correct. That's

a to conclusion want able try minimum to was draw agencies wide to you've of really target You given, or activity window, dose and dose. in whether The try we you to seen to to profile would the lower efficacious the a advise safe the compound feedback a a as be range therapeutic the given us given higher evaluate, to to a dose.

of directed understanding Phase that with the think things we we're question dose. to higher going a And one -- in into to efficacy these of lower table then with expansion you about the try as the at X we and these very whether a the be, move FDAs we're cohorts, on to The dose, will tease obviously, we're leave The portion. titrating come feedback registration then any pleased there So we is think news recommended on the robust scrutiny the cohorts. is, X what with for of that's try out efficacy Phase good the we'll dose. out as

us that we're then RPXD, this. thought as so to to We get need program of would us to going evaluate and us the And done we will success give great The the move at rich through increased confidence an had expansion the cohort. these help a in at know, in favor you FDA that overall and has of a refine doses to to RPXD. different couple basically populations, allowing

Phil Nadeau

as use different data you that a X filing? portion could Got as these said part to cohorts of at efficacy of some that use possible basically, efficacy use, you it? you Could who the use the it is from recommended different data in filing? patients as you part a Phase of Does assume And are dose that from a that before these dose of part the filing. the of

Troy Wilson

Yes, I all patients for for safety. included mean, so of likely be the will

efficacy. question your at think I really is course, Of

be of thought at would at of patients in the would that going two patient, after that, to include sort mean, the I the an ones be And the would that course, going important every look But FDA eventual filing. included. points, going be patient is to every and you're RPXD the

FDA. is, review it this always ultimately for as is other course thing, issue, be The will a of

these counted, don't of going ensure being that patients misrepresent, included to I that's have FDA cohort. cohorts focused X more us against ultimate very we're, which quickly, Phase those to as the guiding want ultimately us, is to FDA to that's expansion aggressively being, or be ultimate we're we So rolling endpoint, registrational an started But But potential on. the in it review issue. allows being move that, as more that

Phil Nadeau

Good.

And follow on a this kind up a is prior Okay. of question.

dose determined going to So high upon these it dose escalation The that Or that's dose, that's determined yet? been like low sounds expansion does continued go the has ongoing…? you've rely cohorts. into that the

Troy Wilson

a I discussion lower have review already on But to the to think the want made look would make going wouldn't have with safety I committee. we with ideas and we continued very, encouraging we say is conversation. the safety signs safety the the review In We're at escalation committee to review partnership then X where having the dose. at milligrams view, great very have We're, need our a a decision Phase activity. seeing from committee. Yes, we of XXX we'd clinical the we're have ahead data of determination. the that dose that

in leaning that direction. So, I would say, we're

further, what and trying the the data But further about with And to range communicate yet about safety generated. review of appropriate a lower to a our then, But six colleagues. dose, finalized it. folks the, further to of our dose committee in higher course, that's Think think haven't data XXX. is, we're pending internal We discussions being XXX.

Phil Nadeau

Last Great. question.

Just Martin's of question. kind of a follow up

FDA, to are they, conducted. a dose combination And identified. years the escalations a that that, this. a for is As want X separate that's, people We've lot to there Phase the when studies, over there's isn't you the do and is that's lower oncology, rationale, usually and in effective dose lower doing seen why of

to about anything question later. the real for profile like it about it that the it if development seems the concern doing particular makes guess therapy? Why therapies the I SIP combination do why early is a interaction, important, now? little something of, aggressive why is example, kind a or a Again, as mono else? Is in program it be a there this So as

Troy Wilson

question. good a it's it's Yes,

ask. me Let

comment the Dale, let that on the certainly rationale not me sort on if But, that Stephen Let agency with discussions he Stephen, he and ask had the can we It's if me point. ask on of it. unusual. comment can

Stephen Dale

an one. you, thank the Troy. thanks. It's for Yes, so excellent Yes, question. Thanks

yes. essence, in So

where X to what out essence our amount is often expand look especially X different this to here and for Phase expansions. protocols, Phase case is, it's doses, to where have we a in you're to Xb with a the element Phase study the Indeed, Phase done in efficacy. X titrate So escalation is sometimes in or looking closely

safety Phase expansions safety X driven, the the is escalation in and on efficacy driven. to where So our be both

to expansions, patient we a So safety really efficacy but has But in and assess target continue the with assess Troy the as the has also and the tolerability. now population. mentioned, look having opportunity to

those and we're of in target terms rich in view getting patients. population not patients. all-comers are these escalation, purist the In So the

in accurately This and will ratio, important determining is down look in patient and expansions set. work a population, around role efficacy opportunity to really then the out least case, assess dose. more it's larger in driven XX which gives try the the an target hone play recommended and at the PK. characterize to any patients, In that's SIP look also this. us of further to So the also give certainly us at this risk nothing this X cumulatively to because in [ph] data opportunity benefit Phase There's a

Phil Nadeau

taking Got Thanks and my congratulations. it? helpful. for That's very questions

Stephen Dale

Thank you. Sure.

Operator

you. Thank

line of question Van the Piper comes Tyler from Buren next Sandler. from Our

You may begin.

Tyler Van Buren

bases. haven't all a clear, was one is And Hey, just last follow The just like we're KOMET to make recommended a or specifically guys, our for to event, or first the couple the DLT, I covering yet. good Phil's we up to be question. a of not you. something that protocol due FDA, safety pancreatitis by sure guess and morning. that new amendment seen Have

Troy Wilson

Correct.

to the opposite that's any set us not fact due dose. the that we're It to fact, Tyler. the seeing was allowing any toxicity In

to it's the is of evaluated, turn drive to of it not we've to them efficacy. event. the the of toxicity we take question is best be We toxicity. to unexpected doses could at able which So need an now the lack fact, not of only in any It's, compound forward

Stephen Dale

the can, have as window is And how I add all well, used going that. the doses Troy, if therapeutic in wide are the to how are in to safety expansion fact to if can the that that I the well the just threshold doses and tolerated met again, that testimony all be And escalation, is.

Tyler Van Buren

escalation megs is pick existing expansion If could make second upper to just, one cohorts. it the be the with the you or related goal this Since bread how bound? escalation potential then the patients to dose based And upon helpful. lower is genetically on you helpful a I sense do XXX precision, in efficacy? defined dose dose as crumbs bounds. to as even initial generate bread, wouldn't minimum escalation stated, or the potentially improved again, that's that the accurately side effective is, informative? the But generating patient understand, use Okay, expansion these of

Troy Wilson

question. let a great This question that's on. Yes, me, Tyler. spot is

if can comment that. ask on he Let me Stephen,

Stephen Dale

Yes, a now, question. it's so great

that of dose, has course a So it's have to chiefly design, committee. being the and typically alchemist population. the review it's when done how based terms unrest an discussion important risk to select safety have a making escalations it's decided It's do agency which those And fairly do that. those both escalation benefit But those in with to will something expansions, which are be which been on to population, is assessment. of with the note the decisions, The three it's, driven. in to if question plus safety consistent done the essence, as in to three

and and but, have SRC Safety dose Phase data to you're agreed very well as with the what will Commission. but Review available data look agreed also dose we be clinical of at depicted then determining to pharmacokinetic you at then the committee. activity select we at when at So recommended have also look and with we then your will And similar more decisions decision look will have. which given we it's the X be And you be deciding when our dose, those that safety

a trying do on more that here. what puts So color that to little hopefully on we're

Tyler Van Buren

patients? level a you guys high of exposure just read you observe all-comer to going you accurate an have confidence in be the defined what on efficacious very genetically so that give Okay, will that these is in patients

Stephen Dale

that and exposure. important said, seen concentration Yes, in we today, related plateau is whilst We previously we related we've to What it's dose well. we've absolutely. But of some increase note haven't see previously, degree as we discussed see increase seen as a a it we, in exposure.

a So the ongoing data plateau Yes. and factor that trying see in we're or decision. monitoring, we're yourself. expose to in hit that that whether It's we the not

Tyler Van Buren

Okay, so taking the questions. for much thanks

Troy Wilson

Thanks, Tyler.

Operator

the Our Pantginis from of Wainwright. from Instructions] next question line H.C. Joe [Operator comes

You may begin.

Joseph Pantginis

patients, guys. for And have expansion if the Troy, this you One taking question. XX, you Hey, just XX correctly, heard point. at you did good it's morning, the the broad broad say strokes I question potential the Thank are the or about study? some that to discuss as be at of to opportunity study? from or FDA And potential to included a ready, feedback an in the specifically, standpoint, registration early you curious. least size

Troy Wilson

Yes.

potentially aligning intent Phase study to the the patients, the is Joe, endpoints in included. be those endpoints in is, with expansions So the the registrational permit to in X

will to that's mentioned, a we we're be up As issue. everything the to FDA. I That going review But ultimately, can. do

We’re And treat registrational though they to able a in to definitely there's from patients of quickly filing. here. those be desire were to move the the standpoint the portion as going

is, different In KMTXA the one of in what from anywhere to see. cohorts, XX And the patients and we've guided I three, upto of terms depending one sort in the cohort. we level trial, three number of one the of size third think that registrational activity potentially of NPMX, to, in on XXX, a is

given do to allow trial some have population, you some will We expand details for on portion be will basically the to still the sizing to that of in populations. the of the given those registrational a So study intent. finalize level that's to activity work clinical have

been position be other with the therapies. we'll about later a done with in think what's that to talk But targeted year. I consistent it's in

multiple just subsets. you Here, genetically have defined

Joseph Pantginis

Troy. Thanks, it. Got

Troy Wilson

Sure.

Operator

call showing remarks. I'm time. for closing Wilson this like I'd to any over at And any further Troy to the turn questions not

Troy Wilson

conferences any all, look at again, participating tomorrow, Health of we'll Care call. be And number the forward We're speaking Great. the good to you Thank of you a the you. the me, and next operator. have with Conference happy weeks, of Pete, questions, you In of to SVB to Leerink, Mark once investor with meantime, over reach to out thank and if for beginning you, virtual going in with have to couple to additional course, everyone. Thanks Global day a to always then. many you and again we're connect can or

Operator

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

You may now disconnect.

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
Jonathan Chang	SVB Leerink
Brian Marty Auster	Credit Suisse
Peter Lawson	Barclays
Konstantinos Aprilakis	Stifel
Ren Benjamin	JMP Securities
Phil Nadeau	Cowen and Company
Tyler Van Buren	Piper Sandler
Joseph Pantginis	H.C. Wainwright

Kura Oncology (KURA) 24 Feb 212020 Q4 Earnings call transcript