KURA - Earnings call transcript Q2 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, and thank you for standing by, and welcome to the Second Quarter 2021 Kura Oncology, Inc. Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Vice President of Investor Relations, Mr. Pete De Spain. you. Thank sir. ahead, go Please

Pete De Spain

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

Joining me Grasso, on President the Officer. call are Dr. Executive Officer Chief and Financial and Troy Officer; Dr. Chief Marc our and Business Chief Wilson, our

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

Troy Wilson

Pete, across and KO-XXX, Ib alpelisib inhibitor Thank program. focus inhibitor, progress in to inhibitor, made afternoon. the has cohorts team of combination expansion and us farnesyl in transferase with with as PIX our squamous operational the our by our several KO-XXXX This development kinase alpha candidate highlighted progress head carcinoma a Novartis with cell collaboration patients clinical first on nomination the the in menin Phase our months, the proud evaluate next-generation neck the tipifarnib lead this execution. in for I'm past underscoring extremely joining pipeline is of you, dosed over the you all thank and

menin each progress look at with programs, Now let's take KO-XXX. beginning the of within inhibitor, our closer a our

dose population an single-agent of or refractory KO-XXX continue showed clinical confidence Ia NPMX KOMET-XXX, encouraged AML, with of inhibitor. believe We expansion observed third differentiating in including of first-in-class patient program. important from patients cohort, RUNXX data have clinical portion KO-XXX with also of QTc patients mutation. best-in-class a in a demonstrated supported including with and a our KO-XXX. program. our We're relapsed strong with be patients menin both the is co-mutations, evidence and SETDX remission trial activity KMTXA by These patients This all-comer promising Phase complete a favorable by Phase in escalation also results I/II and its the may and to tolerability potential safety conviction potential with mutations differentiating of represent feature in We rearrangement. other these the a activity feature no another prolongation, the of a profile to

and the lowest dose oncology effect targeted of milligrams dose KMTX-rearranged two in relapsed and Optimus. escalation and window, higher dose These the the XXX that determined were to KO-XXX a maximum evidence known X demonstrated with portion study, Phase Phase Ib the lower designed to study. guidance relating now preliminary therapies safe FDA demonstrated to comprising cohorts AML in mutant as in XXX now dose refractory Ia doses Phase well is The and of escalation the biologic of activity in therapeutic the tolerated each of milligrams, to we've advanced wide project keeping of expansion from clinical of determine patients. and be KO-XXX provides portion Ib dose NPMX Given a and

pending strong a across a X team. half the clinical demonstration of with U.S. our estimated an in the the the patients cohort screening. queue We've was and of of patient countries, are first of sites June. have Phase in in Ib patients dosed actively in cohort Phase operations XXX-milligram XX screening each The execution Approximately of late patients enrolled in European now expansion Ib sites

enrollment complete the should cohort Our of base the evaluable quarter that patients XX XXXX. by of each in is first we case

patients enables to the II patients order II in to assess enrolling efficacy and will selected gives in into tolerability, cohort. these This for Phase We enroll flexibility and dose. to portion recommended Phase recommended safety us The of up the subsequent the we pharmacokinetics determine Ib us while to then study at patients the dose, continue the registration-directed in XX Phase transition KOMET-XXX. the protocol

our only and data registrational our Phase refine recommended and start at it selection to contribute an patient populations enables from the Importantly, toward population. the Ib, we to II believe Thus, Phase a development to set for Phase but more the gather dose us robust all in not will aggressive target program. registration maintain path treated recommended helps to dose, II us the our of data timeline patients a

early recommended preliminary, the future observations are determination medical and We pending dose. by both an early a meeting, of Phase Ib of Phase clinical still update signs of in it's we're Phase Although activity intend provide Phase on Ia and results encouraged the at Ib. II to the the

we'll seek the qualitative the for to ahead we're plan in pending of II determination KO-XXX the appropriate. conduct months recommended Phase In progress clinical addition, In preparing of Phase development updates a as meantime, provide to dose. the on Ib a comprehensive

collaborations, other to indications include studies, models. acute has data research are in mutant Efforts of these AML our preclinical leukemia support been syndrome. as venetoclax synergistic pediatric KO-XXX underway some and NPMX and already opportunities encouraging with KMTX-rearranged larger generated example, in development of strategy other Additional through such genetic evidence of combination showing myelodysplastic of one development combination for opportunities, subtypes, lymphocytic and activity

later We more have expect to these potentially to year. regarding say data this

based with in the capture II later most which in about therapy for data Journal published granted advanced this opportunities opportunities excited to continues Earlier designation inhibition patients trial, patients The the program breakthrough neck we upon and these oncology. carcinomas Oncology. HNSCC in as attention, is the focused was a head metastatic of was our transferase cell mutations on HNSCC. for FDA of treatment farnesyl menin month designation of that The or much just Phase the gene. remain with from therapy was HRAS mutant carry of the squamous tipifarnib our Although, Clinical year, or from recurrent HRAS breakthrough RUN-HN

to We by BTD represent targeted to FDA motivated first HNSCC. tipifarnib award the small from therapy the the for in potential be molecule these by approved data continue and

on we as our registration-directed remain market possible. bringing such, and As trial and as focused efficiently quickly AIM-HN tipifarnib to as

alpha addition unmet the a a combination to and rational In potential patients, for believe these of larger opportunity of we provides mutant expansion to kinase genetic development and tipifarnib HNSCC tipifarnib subsets. in addressing combinations identified priority to an HRAS the need as for beachhead Among we've combinations, inhibitor. the PIX

in much encouraging tipifarnib of patients it Last suggests meaningfully the inhibitor, PIX kinase with patients evidence codependent activity alpha Novartis the addressable potential the tipifarnib in either inhibitor the cancer, population inhibiting combining are antitumor HRAS as to PIKXCA relative to the meaningfully of with month, and combination PIX breast total HNSCC. HNSCC. to and for with tipifarnib clinical We mutant treat alpha the HNSCC. kinase has this and HNSCC with XX% to patients oncogenes as has with alpha and in data -- to target a demonstrated Our alone. activity provide approved of better is that preclinical to increase combination that with kinase PIX evaluate potential believe has clinical we announced to collaboration alpelisib Alpelisib patients

will data, drugs the current identify patients and have combination. Given actively trial look alpelisib. sponsor who with PIKXCA-dependent I/II include preclinical evaluating HNSCC. be and Phase We're in sequencing, alpelisib These dosing we supply a cohort current tipifarnib preparing and strong rationale recommended combination. us will forward X for we the The study II Under we in initial the and trial. will identified agreement, tipifarnib to the collaboration HNSCC, Novartis the to can of using which now next-generation combination for patients schedule a allow will terms the the supply of Phase which call

this innovative targeted need expect combinations. other efforts initiated fourth develop next-generation opportunities year, indications collaborations, you. therapies. quarter of some of program the our discovery stage rational own Last oncology of target high forward transferase we to transferase and network for large and combination internal farnesyl uncovered study inhibitors to to farnesyl biology a unmet in XXXX, initiate a designed we through look inhibitor progress with to with address exciting sharing and we've through our We our academic Meanwhile, in

pharmacokinetic Our potency, chemical goal has for this relative program tipifarnib. to that and was to improved physical a drug deliver candidate properties

story We're identified now and team by call conducting advanced this IND we now multiple I'm candidate. call believe studies results. look nominated oncology to our compound has continues for application the that, a We large XXXX. Marc report opportunities With we've Our a with potential lead in KO-XXXX evolve. pleased sharing of to particular, IND-enabling to discussion you compounds, inhibition deliver submit turn an X end Grasso to development for financial as our update lead forward and transferase the of farnesyl for KO-XXXX to the over I'll an multiple to expect as indications, and we in

Marc Grasso

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

of As million The spend full million as cash repay strong prepayment $X.X of June of $XXX.X reflects cash, $XXX.X compared fee investments our the reduced position. XX, June and million of in had XX, a facility cash with existing we XX leveraging to as at of short-term equivalents cash balance December XXXX, our debt XXXX.

continue for year important we our range of invest operating future our pipeline, our full we and the to ahead, expenses the in anticipate million as to be development in to preclinical drivers Looking $XXX for million $XXX XXXX clinical growth. the of

our current to activities net fund call will operating the With now equivalents current to of million. I year We full our and back turn range to we in the $XXX over sufficient operations for investments on to plans, used $XXX the into cash expect to short-term cash our in XXXX XXXX. will cash, continue Based million that that, believe be Troy. be

Troy Wilson

Marc. you, Thank

opportunity Carol Helen most recently brings Dr. Directors. Capital Fargo Before experience, to the this FGFRXb cancer. Vice the Five as XX take for Robert to forward perspective bring create look we Chief Securities. patients our closing, patients of strategic and our teams to drug she Chair Robert to member antibody We're of throughout Carol for at first-in-class trusted of Chair the a more bring medical I contributions I'd and of his where as Equity appreciation as of years and financial as than future more express sincere On Board most the to their gastric their in unique my Schafer candidates leadership years board Hoffman well the and to like of Helen his our on of larger experience everyone adviser growing joins Committee. treatment to Helen at a Audit with at Collins take deeply Markets to as oversaw wish a opportunity of service for Directors. endeavors. we than Prime and our years Carol to work companies, want his of use populations anti also and as to Medical Wells and Therapeutics, Board contributions welcome XX a Bemarituzumab, to many biopharmaceutical of development to each shareholders. we market, Officer with Kura, oncology behalf patient expand grateful current value Board, X his for this recently

XX session, evaluable of I/II fourth remainder let KO-XXXX quarter in our question-and-answer the of now the of the Now enrollment before quarter of Phase we determine by into KOMET-XXX the jump the with XXXX, With XXXX, year. application for lay anticipated the out patients me complete XXXX, end Phase Ib the expansion study an tipifarnib the questions. first Initiate KO-XXX the in current quarter for in of combination milestones alpelisib for dose IND cohorts XXXX. ready of submit recommended first of that, we're by II of the operator, Phase by

Operator

Instructions]. [Operator

of Your first Chang line the Jonathan from comes from question Leerink. SVB

Jonathan Chang

color First more are expansion question, can levels around provide selected for KO-XXX dose cohorts? how you the the

Troy Wilson

for Sure, question. the Jonathan, and thanks

from targeted FDA context of colloquially And FDA expressly away sponsors of tolerated sponsors known clinical guidance maximum now as maximum moving the Optimus with in dose from Project guide the in So and sort is the oncology. that or to is guidance, activity. identify lowest biologic in its therapies instruct dose

being of was case, we the mutant will, responses and a And lower it to X fact towards that highlighted low dose ASH justify that chemotherapy doses, daily comes Those higher for go CR was given NPMX the XXX it So a if We And see kind doses, pretty we with of enough KMTXA with That guidance, a with couple at one difference XXX of enriched going negative, patients. NMLFS. activity. the NPMX dose. right robust limitations per With When was it among in saw was not because XXX. genetically XXX study, doses. that clear of XXX. wasn't mutant or being push choice, doses that's a the you really particular, other the the the a difference activity was the MTD Phase those you said, lower patients, looked higher once didn't faced that Ia really the in MRD days. being between of sort if dose, relic, old FDA's The consistent. milligrams is two versus to the of

a in at point, Ibs, and and of Phase now mentioned I the enrolling doses in XXX actively prepared we're XXX. at So the we're as remarks,

be dose. doses those safety and of They're be tolerability. going-forward could both that Phase study dose very Ib explicitly The think compile to the potentially efficacy expect select us going We We clean. it have in now and RPXD study, an good begin allow be good and to either eligible is a believe for who are population an patients we both will to to registration. included

Jonathan Chang

remainder of and portions expansion about XXX for Understood. the cadence And the second escalation of be question, both XXXX investors in and how the thinking should updates and substance XXXX? over the

Troy Wilson

Yes. Great question.

and about to Ia, the a is the me, efficacy-driven really study The were an thinking of I Phase of is, the we A we're continue activity it, genetically -- way tolerated Phase I Ia doses. range Ib I the thought And progressed is that, enrollment. of Phase noteworthy. study, a the encouraging efficacy we that So anecdotal had excuse the We're now experience safe evaluable. there is enriched. The is NPMX. in was and got But We out are safety it's is not including primarily activity, seeing but the -- number limitations. KMTXA patients what see study. the expecting. on think, The inhibitor. are Ib menin Phase And Phase well not molecule limitations prior who Phase across of safety despite we are that to the is signs close in explicitly patients

have think that can to cohorts projection. to do first that's the to the screening enrollment, base enrolled and we We'll next position II seeing or in as identified we case dose. remarks, the given pace of a given fully end by of we're a and the be have said Phase Jonathan, in of Phase prepared in where is goal, year the -- exceed Our Ib But what we the the timeline. everything queue good the meet recommended quarter we

site the intent on Initially, are talking focused then some on about, remainder focused screening We activation, Those on funnel, of provide X qualitative throughout and XXXX. updates the will you're actually to we you've today Our you're gotten commentary. are. to arms? you're patients include the is the -- of that recruiting sense study the from

qualitatively, patients both call very think for to that that for and data this this reason our considered to able enrollment registration guidance seeing, be I FDA. going be we'll give able our are hope It's the be think -- we don't on I to we're right? will specific and what intent out by

intent there full upcoming the the we So think meeting. scientific it to or our on experience differences arms? I and to That's I we'll provide is and provide we'll treat at have the to look with to activity. sanctity. an the present some Xb Are be together qualitative But on as Phase medical guidance. XA And able guidance enrollment between

Jonathan Chang

if can think chance able Ib you'll clinical I early expansion can And can, because in [indiscernible] be more, to on XXX? this, just one mean activity mostly you what the for the Understood. expand sneak you you of I cohorts the that in in but don't by Phase signs

Troy Wilson

we're and selections. others fact the with seeing, it's that you Sure. performance dose of that of should our a notable what counts. Jonathan, Phase we leave disease I the dose What blast cherry the is preliminary. Ib at status. picking measures the stabilization, selections Again, were reinforces of understanding from and XXX to to including in that, one, improvement the we're of do there seeing on it it's want But that. early, just perspective, reduction don't number to we be that in want I an mean But call what XXX are the most And data. leave the is right

Operator

comes Lawson the of Barclays. from question Peter next Your line from

Peter Lawson

anything the patients get treated any we kind them? on get year. durability of disclosures where may that we've just of previously seen around data Would this Troy, we from

Troy Wilson

full Phase to think wait the going I we experience. until we're I to have disclose Peter, Yes.

it's the but days. is data impressed We It's preliminary. this durability, thus a of handful been patients, the far have -- early is with

want position tolerability durability look we medical we the as and and talk the we our quickly as efficacy be future both intent context to think the and a I about at in in meeting. of upcoming pick full of to don't We to and to clinical as the safety as an the need can can And profile Xb XXX it's quickly enroll choose. at package.

Peter Lawson

menin you've And a a that you. progressed on prime Got mentioned patient inhibitor.

inhibitors? with So can you any signs potentially see kind you that of menin retreat

Troy Wilson

Yes.

plural, comments, actually of couple patients, just it's Yes, a So Peter. one. not

think -- clear, right, activity. is of evidence a I do mechanism draw context. be let's we're between then The just seeing in and -- of registrational one a to action what clinical might it's distinction the what

You So with that for gives from us confidence they fine seeing who excluded favor want evidence you're because that expressly not have upon excluding don't you just don't all to goes Xa. treatment a be study patients of action. inhibitor, the patients of respond, patients those in both bias Ib registrational the from that have might clinical favor -- exhausted patients say, of right? be who more you likely want in to in ways, prior who benefit. mechanism menin it We're as even That's to progressed will still also may in of bias likelihood, you

way have patients enrich inhibitor. gives in be So I of that who've been it's is wouldn't anecdotally that is us But as one the of menin I would I say on I important. expecting a to data lot prior it. we the menin forward, pieces And inhibitors think us that go think a we best-in-class confidence

Operator

Your comes Fauth Tiago from Suisse. from next the line Credit question of

Tiago Fauth

same if from some And expect What differ you detail address trends since that approaches? much a that a role in that the tracking just how And are studies? genetic guess on provide time. tipi, that, of has the on could future to to related we're upon? in I combination how explore you of indications, XXXX over tipi, any may are in provide sense be a evolved improve the kind commentary to indication topic, features additional able how how AIM? could more combination that play And And actually screening any there? enrollment has on could you we'll if follow-up

Troy Wilson

Sure, Tiago. tucked questions good there. Three in

some evaluable a in in expanded should That those -- year, amendment primarily we So up let But We patients the have registrational the on to context things. fully significant say, of patients. turn. the see total. this, we very in me meant where the just during include enrollment to we remind the to major patients dip to everyone meet I pandemic. and X enroll made call, also impediments the we mutant removed the a AIM-HN, last all to We patient pandemic. XXX of we protocol to HRAS did population take and screening of in to the did did

way of in had we've and at -- least COVID in amendments can and through uptick, we've for us, give not where first the the seen guidance. is work wave these a Tiago, that still We're chance behind Now protocol enrollment. position the to an improvement their we

the of that approximately have things study of One rate the we've is XX%. on been a we experiencing conversion

minus they're study. to thus out of chemo. that genetic what physicians that. or, that of not you conduct to identify One patients of first The inhibitors your care. that of we have and job plus trial, lung the patients head screening on relates is that time neck by kind not the in do exhausted tipi to that benefit fact not plus them receive raise relates current is may the We're second be want PIKXCA many able terrific subtypes, goes squamous increase to means that head screen And XX%. going later alpelisib to any of working overexpressed, awareness what of out question, mutants, team to challenges from to good laid or X% say, the study similar big population the lines And get now the along. physicians happens, Typically, part We're our and the and genetic combination working and to the to HRAS in presentation. patient So of until that position to on patients. a The a of is -- can And comprises more is in patients cancer -- is up screening genetic potentially and checkpoint in high-quality has or put pretty PIKXCA second are awareness. and typically just and standard contrast because neck XX% X head To fragile the where in tipifarnib to mutants. these amplified may which the HRAS means similar all AML marching of neck and HRAS That's genetic the start -- study, and the therapy. alpelisib of tipifarnib from of head or XX%, quite XX% a another screening. neck. which is It's so combining the not The population. a We're of the about where it's one with corporate combination of and the of quietly bit actually and maybe KOLs in patient excited this we we're XX to a but PIKXCA larger. mutant identified, driver to sort dysregulated alpelisib really doing and That's may X even

an screening, these more to patients you patient that help that out drive combination, X choose. if out have now And So which of eligible think targeted awareness we may options. your X of of genetic molecule from X you X for small or patients have to will be

it And To as significant the alpelisib. of and alpelisib the your activity clinical third strategically, program of combination encouraging clinical the step. builds about the So very next on think tipi question important is activity XXXX. about we with an

aware specific tipi of combo became of a measure And people true synergy. but synergy. example we algorithms alpelisib to So is lot turnaround, throw a there the that are of

head can alpelisib And molecule carcinoma. is in what's synergy presentation, And inhibitors, we to with is mention about we other pretty You exactly as subtypes this examples. have found squamous this the what of a activity the -- the again, drugs -- therapies of cell What we're circumspect of where the competitive couple neck targeted cisplatin, obviously offer kind tipi different impressively what tipi to go. small you other transferase indications exactly don't of inhibitors very go being beyond plus and just farnesyl interesting field. is and is a clear CDKX/X well, potential synergistic because in see genetic and are that see corporate biology,

We have publication a pending.

We have XXXX. was intellectual initiative, that property part it of Tiago, pending but to target

a more potent. It eliminated effect. is very XXXX even tipi the is There We've less variability. is inter-patient largely first good drug. is So better. pass

not compete meant and to it's tipifarnib So with HNSCC.

groundwork questions? for we studies preclinical disclosed it the As your through steps -- lay to are X publication, disclose and combinations next this will either we've would meant that of really disclose. both it's you'll to into And year timing therapies. the -- never year see later early point, be will and that the go on I build rest It of FTIs That's populations. those Did to indications clinical of plus think patient disease but this the or will take -- on next we targeted year, significant new represent we've into not to year. them. rational In meantime, now doing answer are this other something the depend I we

Tiago Fauth

You did.

all. them answered You

Operator

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

Reni Benjamin

Congrats menin on just getting or they're issues be since on toxicity Maybe another mutations there would responding drug due I resistant resistant menin that thinking for inhibiting same that think the Am X maybe questions Ib One, up. to previous I progressed guess, question KO-XXX to the expansion. they inhibitor may mutations about the stay time? are key dosing as opposed maybe correctly the on coming the to at who started Phase piggy that inhibitor. patients me, couldn't typically for regarding backing a I Troy. prior off

Troy Wilson

a the study this study. mutations. tyrosine progressive or time who patients note Ren, they it's We're think, menin I on develop resistance have come not So mechanisms story. the of something. gatekeeper on inhibitors, to not point where to inhibitors to our mutation are an These the in of form important aware can the is you still evolving come But active of disease kinase like at

were -- right? don't And discontinued from tox. progressed in It's menin study. on another. another to perhaps is our -- they still came that So It will it's they we of question due inhibitor on when were and is mind, our then open that actually they an I progressed not X to kind respond to study patients this

of ultimately is best very through be got But push the that very much think MLLr reinforces and does demonstrated this the The ability we've the on I biology therapeutic believe fact And which that's read want said is a anecdotal is are but notion been can wide these we addressed dose we're and get setting in them, think this and consistently, potentially NPMX much profile. And that we the also believe we'll don't us this window, encouraged, that on mutant too push up the it I actively context. the safety compound. of reports. Ib, given to it -- what both for we've the but enrolling we've dose. may We the we the evolving, better activity We got make by outside best-in-class seen combinations. registration. to Phase have hard

Reni Benjamin

redosing the in little as current give about the as my And have a escalating bit how Can study. you dose for Phase on will, changing final alpelisib many you the design -- of you I phase, of just if II. fixed it. on with Phase both patients well then started per are trial us how or dose And here? dosing? I just color Do to Phase Got a the question tipi

Troy Wilson

Yes. Good question.

numbers that -- alpelisib dosed and activity of remind typically that showed constant. conducted each other are. is as dosed the synergistic or below held patients, study. drug were you'll continuously preclinical everyone's and corporate It's doses at in doses. monotherapy. show but clinical of of that of both tipi question schematic And doesn't to We've So added presentation current initial Ren, least that It attention. your the specific a schematic draw fact, were dose to dosed as week, they new at is you speak, being I'll it the studies a just slide for does of is the see a I'll is the evidence your every the that everyone what showed

I of So where know it, There the it these a we still It's are the difficult take a might and doses approximately dose until toxicities. of of our done tinkering, going dialed of seeing there team But work -- study XX% to you them try Ren, you're both to and number model better take get don't has show monotherapy schedules. the schedule and dose, that to you some amount to combination. believe, -- down different preclinically the to in right. it's significant activity by,

can both continuously. You give them

intermittently that And will -- both be activity. the flexibility and You can drive the design. trial in that clinical elegant team the very give to will them to is and a our investigators, there, give go able

Leoni, Mollie and Dale Development, both Steve in you the weighed and our But on the drugs. it, VP change relies lead of safety to also developing Clinical both example, and on drugs databases it. of For the it dose took on allows extensive of it

although tell get to the a combination. gives fairly color give given, QX, expecting efficacy we'll to would might summarized months lead comment, direction. the over an for right the the Any would you expect. up kickoff anecdotal sizing study. a early typical you, And that and in what our one in that's exactly point with activity, in of just either mutant genetically population, at pretty get It's going going of be some Ren, current, the dosing to you're But would designed which similar the not next namely is endpoint. in directionally again, that we to amplified on schedule we to be chance indications and we're of So recommended efficient study be efficacy the selected presentation have to we're the any few as PIKXCA explicitly that more we're corporate hopeful -- PIKXCA or efficacy

Operator

[Operator Instructions].

line comes from the next from Phil Your and Comp. Cowen question Nadeau of

Philip Nadeau

Congrats progress. the on

just for Phase Ib. be, one a cohorts, and will it's it matter? all, of question or First, requirement The on number they are patients have that MLLr do whether patients first NPMX doesn't particularly enrolled? XXX MLLr the minimum Or of

Troy Wilson

the the latter for It's it's question. the Yes. of -- Phil, thanks actually options.

no these the that indications the mix arms don't is seeing a MLLr more If bit up everybody the we explicit or and saw get. what course, Quite than are in all of NPMX you good we're for balanced is continuing, a trial be the what to many with are in potentially populations. end there to early and But we're The so of largely MLLr. of the we patients. patients a expressly both arm sites X operating it's different Phase Ia. looking mechanism ensure So other at going now that the But requirement NPMX either mutant X in has arm.

to that's think updates be bit a color, I months provide the we able qualitative in the ahead. So more of Phil, might kind

Philip Nadeau

also to safety is expansion second efficacy. a the were an talked like doses the there cohorts? Then and the tested about gene And Ia? any doses the chemogenic Phase question advance at into was Were were the you one. difference Perfect. for between MEISX clinical able to you follow-up choosing the in When example, to things expression, various You look that gene expression? earlier

Troy Wilson

at the populations not of else really mutant -- gating and are you outside you -- RPXD Phase of where and a at So didn't or end answer point, to will and selection that dosing at of of determination safety didn't inform into subtypes, both good go. first dose doses and the We the really surrogate have and The factor question. do NPMX and the help secondly, It the in And all evaluable the we've for the exploratory then the tolerability understand the any enrolled. exploratory out kind on to doing, foremost, It's we're ultimately we're patients I two efficacy. Ib was of we looking use and mutant in also once into how clinical to MLLr an work But is driven, What decision. XX think by come That development biomarker NPMX MLLr, and what that terms factor that could looked Phil. either decision. those it. is, as think the by

Philip Nadeau

question Got last is receded And approximately in patients cohort. cohort, then X% With it. XX the patient Phase actually dose. on each is that of II of each the determination

you cohorts? So of the what give Can sense XXX differentiate versus in us would XXX you're clinically is response milligrams small how cohorts. some a difference between relatively the of milligrams, what given size the thinking of meaningful

Troy Wilson

a It's that see explicit it Steven. leading the it. menin asked, program well that both isn't who really know this you lead kind the is now of one is And There program. difference answer, to I've see. as And when good She's Yes. short Phil, it's you one an Mollie question. Leoni, needs now clinical for as the

you I'll again, out I cohorts say, this select say terms And have it X they you way Only If other and you the going guidance I've it, meaningful it. a being the dose think the look to. of they don't other, reiterate If difference, gets safety the comparable CR/CRh striking see look either same. will and run you will with see really strong to down the said, whenever a will you're dose. I at asked. is you to or ability as dose up I'd roughly difference the need go consensus and or FDA's go and tolerability dose. be in said will lower it parameters, That very lower if either the the one

important hand. development studies, starting really has of get it's on and either it. for it doses really -- confidence in I forward I rests optimum this which the one and right patients dose. then this that think of take the what these and entire the going think have because dose is point of future dose the And it a not set is all is will program good the refinement a This question XX we the becomes only now is but them study, good well plan is the why it to for team cornerstone of

Operator

questions There Dr. are it at for will turn I this Wilson closing any back to no remarks. further time. over

Troy Wilson

Marc have many myself. you with contact Thank a of additional today. speaking you, questions, Thank if meantime, we'll have week, again all going please forward good the once any then. the free you, We're Conference and Wedbush Virtual call participating to everyone. for evening, and Healthcare operator, thank feel the you to you next at in be look or In Pete, and to

Operator

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

disconnect. now may You

Kura Oncology (KURA) 7 Aug 212021 Q2 Earnings call transcript