Earnings call transcript Q2 2023

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Q2 2023 Kura Oncology, Inc. Earnings Conference Call. At this time, all lines are in listen-only mode. And following the presentation, we will conduct a question-and-answer session. [Operator Instructions]. recorded August being XXXX. is call on X, Thursday, This

go conference to to Head I Please like the of call Relations. the would now Spain, turn over De Mr. Investor ahead. Pete

Pete De Spain

and welcome you, XXXX call. Good Thank to conference Kelsey. Oncology's second Kura quarter afternoon,

me of Dr. Wilson, Finance and call and our Doyle, our are and Executive Accounting. Officer; Tom the Senior on President Joining Troy Chief Vice President

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

turn to the With that, call I'll Troy. over now

Troy Wilson

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

June, myeloid in. pretreated inhibitor the menin from trial Let's activity KOMET-XXX jump NPMX-mutant data updated our we including relapsed/refractory acute patients co-mutated reported with of and durable in heavily leukemia. ziftomenib, right In

oral session Annual data were featured the during a in European Hematology These Association Frankfurt. at late-breaking Congress

As of a recovery NPMX-mutant overall XX%. an of of XXX count achieved of the AML the milligrams rate the full of April Phase rate with XX for dose X data remission XX% who patients response at XX cutoff, seven recommended were treated CR complete and with

count after recovery as with a presentation. eighth of CR study setting of evolved EHA subsequently of in reported treatment of leukemia. on and This with patient after for CR An recovery the partial ziftomenib represents remained a the rates a date count response had the with who full the transplant therapy one relapsed/refractory highest to targeted

NPMX-mutant as AML the XXX patient treated XX cycles milligrams a of ziftomenib cutoff on In for date. at addition, with remained

ziftomenib tolerated for consistent X follow-up and NPMX-mutant months, the Continuous well was all with with response duration median of remained patients disease. the a event of X.X underlying features median Phase months. in profile X.X dosing of of The adverse was reported study once-daily

NPMX-mutant a for and for approximately with annually XX% therapy is no NPMX-mutant a exists. approved patients disease FLTX. cases unmet represents and such new NPMX-mutant accounts significant further of AML reminder, of compounded AML As refractory, which becomes or disease is AML as Once for prognosis the AML need IDH especially poor. targeted relapsed co-mutations the

FLTX XX% our IDH Notably, IDH in with co-mutations, XX% on ziftomenib. with patients both of with co-mutations a patients and patients XX% co-mutations Phase of of and X study, achieved CR FLTX

and treatment data IDH population, profile. and/or in All believe had a inhibitors. this with with remissions difficult-to-treat We its ability best-in-class of -- of remain ziftomenib failed whom prior further demonstrate impressed monotherapy to FLTX as drive durable these potential the we product

unmet generated trial the refractory momentum our both on the X significant speaks which need. and population in AML in data, EHA NPMX-mutant enrollment Phase continues outperform by to of with relapsed of projections, size Building to ziftomenib its patients our registration-directed

States Our a is the in enroll study of to United and expected patients XX total Europe.

of AML our and with patient with combination care AML. current we're in standards parallel of series multiple In studies earlier in to including NPMX-mutant as conducting populations, advance ziftomenib a efforts lines of and monotherapy, KMTXA-rearranged therapy across

been in value, previously population in IDH FLTX differentiation development namely inhibitors combination be greatest regimens. as used approaches the commercial and mitigate establish that unmet commonly the represent with to ziftomenib combined a that regimens. various those Combination Our containing potential need as approach in particularly azacitidine. rearranged to with the has venetoclax also demonstrated inhibitor of can the medical safely potential then combinations prioritize And and foundational therapy the to greatest offer KMTXA combinations is syndrome,

diagnosed that of assess we're I'm designed in as preliminary venetoclax KMTXA-rearranged and pleased settings. is which report the our cytarabine, expected daunorubicin activity either with standard we call ziftomenib NPMX-mutant enroll regard, study combination and newly of the or safety, COMET-XXX in relapsed/refractory The tolerability chemotherapy, combination both commonly study Europe. U.S. studies, X+X. azacitidine Phase in dosing sites In induction patients to with to and X across AML in is patients and now first or to known the COMET-XXX a

in standards study or the additional year. also We anticipate inhibitor, We're first having in the including XXXX of combination FLTX of to the data gilteritinib ziftomenib of working from initiate XXXX. of preliminary quarter the COMET-XXX care, this quarter study with COMET-XXX fourth our later

In XXXX. addition, the of our expect quarter post-transplant to begin program in maintenance first ziftomenib we for

excited very are across value to as these patients. care further of a establish program the therapy for for about menin our demonstrate studies of the the of AML We and ziftomenib potential continuum backbone

Now let's tipifarnib. inhibitor turn our farnesyl with to attention our programs, transferase beginning

we substantial and inhibition, this mechanism and in of uniquely value benefit the solid large to therapeutic clinical continue indications. farnesyl We tumor unlock is work commercial to believe deliver positioned multiple novel to transferase

is tipifarnib unmet need kinase with and inhibitor, no selective alpelisib. alpha it squamous the the molecule cell Head and and common cancer approved worldwide, small medical opportunity and neck remains the therapies. a through first most cancer targeted PIX The in such seventh neck carcinoma head significant combination is of

the with three in XX%, cell three carcinoma eight and to demonstration overall of a the tonsil. to of the median months. we first for of patient reported FDA-approved and months a previously line, second progression-free with the response squamous of response five just mutated of clinical XX% tipifarnib durable median combination treatment PIKXCA Recall, for alpelisib with in the two survival of HNSCC rate a from objective range survival The to therapies

dose observed has escalation combination. study with no that time, our to-date toxicities Since the dose-limiting continued for

relative drug this as which our evidence seeing encouraged activity we're in HN trial, call enhanced to multiple We as for the well at doses are and profile either of by current clinical with both population. safety the in the we expectations activity continued activity alone

we the dose. small dose help profile selection patients and planned initiate evaluating the intend Once to the expansion dose Phase now with X the inform at of to dose the combination for HNSCC cohort highest biologically validate of activity safety combination. we are of to mutant the a OBAD, recommended the optimal PIKXCA study's active patients determine We in

Meanwhile, to we've with preclinical encouraging In of at April, the Cancer presented Annual for use targeted of combination the in generated therapies. preclinical resistance indications. supports delay growing additional body multiple of emergence distinct Meeting farnesyl a potential prevent data of tumor of we with that therapies Research inhibitors or solid drug transferase classes large combination in Association American two targeted the classes either FTIs of supporting data

xenograft revealed anti-angiogenic two of renal tipifarnib The tyrosine posters between inhibitor, axitinib cell standard first or the of synergy carcinoma. cell and and cell robust patient-derived of in kinase clear models care TKI,

or second tipifarnib reported the adagrasib The to by either cancer addition models therapy. regression of of poster inhibitor multiple of lung cell KRAS non-small sotorasib resistant

for innate These enhanced and resistance data the illustrate antitumor adaptive drive promising therapies. preclinical address to FTIs mechanisms potential to targeted of activity and

In cell inhibitors GXXC these our inhibitor, in which combine rationale data non-small lung support renal cancer. strongly TKIs with specific next-generation KOXXXX and clear believe addition, to cell, KRAS mutant we in with carcinoma specific we our call cell farnesyl transferase

combination X anti-tumor FDA for a We've which intend of application received the we dose of for of tumors. Phase escalation cell site We Concurrent escalation plan FIT-XXX solid FIT-XXX. study treatment we're KO-XXXX new advanced as first activity and clearance to dose activation year. solid KO-XXXX cohorts in evaluate beginning KO-XXXX year, evaluate in with forward safety, and calling a this the in cell carcinoma. escalation the begun we the to renal patients study, the later preliminary Earlier tumors investigational drug tolerability advanced dosing to look in clear dose this with monotherapy, in

of financial turn for results. a the to discussion With I'll our over that, now Tom call

Tom Doyle

expenses of compared and Troy, XXXX. to you, results related were for million increase $XX.X the and to clinical costs good provide our for the XXXX. increases The the $XX.X overview ziftomenib in brief in was due I'm a our trial second to quarter and of happy expenses of programs. Research to the KO-XXXX second quarter primarily R&D Thank million quarter afternoon, XXXX for second everyone. financial development

General net and $XX.X second quarter second million was for loss $XX.X for Net second administrative million million non-cash were expense a million XXXX. of expenses the of of for for quarter of same the second XXXX in to XXXX. compensation This the $X the of to share-based includes quarter for $XX.X the period to million compared $X.X XXXX quarter compared XXXX. loss compared $XX.X of million

current million As of as short-term XXXX. operating investments from believe $XXX in offering $XX XXXX. be our equivalents cash $XXX that This proceeds our of of cash, will December June short-term equivalents cash fund cash, compared approximately XXth, we mid-XXXX. sufficient We XX, of June our plan includes investments to million to net to million completed and and had public of

to With the call that, Troy. back I'll turn now over

Troy Wilson

Thank you, Tom.

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

For dosed patients in the XXXX. trial ziftomenib first of of first in for the XXXX quarter dosed the data in combination the the COMET-XXX quarter fourth the from in first XXXX first second COMET-XXX the in the the quarter of preliminary XXXX, half program trial of combination and post-transplant patients maintenance

combination HN in dose with FIT-XXX the the of targeted the dose and patients escalation cell patients the dosed first therapy For the second clear in of the as half in And a the in the current escalation second initiate half carcinoma KO-XXXX in trial renal monotherapy trial XXXX. dosed expansion trial in mid-XXXX. FIT-XXX in dose tipifarnib, in XXXX for cell first

With for Kelsey, that, ready questions. we're now

Operator

now Leerink Partners. And session. you. Chang and Jonathan we'll Thank question first gentlemen Instructions]. ahead. [Operator begin from Please comes question-and-answer from Ladies go the your

Jonathan Chang

Hi my guys. questions. Thanks for taking

registration-directed mean us can progress question, outperforming projections? AML? enrollment of what the around color ziftomenib And more do mutant give and study you First NPMX any you by and

Troy Wilson

Sure. question. the Thanks, Jonathan, for

guided agency step enrollment trial I see XX of study at approximately the middle say, we XXX half to want patients remind because we dose. just the therapy, view Jonathan. the for everyone, that of of year. days, likely recommended sized data or just patients a take next Phase back, have the XX X approximately to the still should anticipate we early best-in-class a full in So, patients, potentially the would at was our a It's safety worth to it And

we've where and of different now obviously curves And enrollment the both site patients we a scenarios. expected -- study, to have quite under terms in ahead activation of enrollment on of are be. bit ahead we But

We We to in of see summer the haven't rest to made into guidance the bit little a the and our of terms of goes how overall timing yet any adjustments want enrollment. fall.

Sometimes a in late the summer. slowdown see you

mindful and communicate directly into translating So, is enrollment. patients. just be But competitors There to to potential more what I patients there's we from And think the in had Jonathan, be trials that that. physicians there folks to NPMX to than sort who've both was are to space. out strong interest There very be we of tried be other some appear it of both challenging and anticipated, we among enroll comments want seems anecdotal enroll. want to that also, might

our been at experience hasn't That all.

the fact seeing very, in we're In And EHA, I that's data activity fact, that summarily through side very strong of just who into think who is seeing opposite. that we're patients because co-mutations. quite in the now part translating I EHA, other patients with enrollment. The the FLTX, Since patients failed driven, IDH various very which walked of failed through. Jonathan, on interest,

them study, off on think expectation we're monotherapy seeing think, is but to Instead, we're don't going translate I combos, we're there, a they encouraged. those very I putting -- patients which it's have even the other siphoning every that's quite days to trials. into we interest strong -- the and ziftomenib of in earlier seeing

Jonathan Chang

can you the it. discuss question, for ziftomenib? Got opportunity maintenance And Thank post-transplant you. second

Troy Wilson

talk post-transplant Sure. without just And are just as those me different. requiring We're both going actually about well clarify do the And there. let's transplant. maintenance a as Yes. let how to maintenance

So all, have to able stay needing get on our without be to patients protocols made first study. transplant, to for to allowances of

zifto stay So of for a maintenance example, patients on setting. plus type can zifto in in who X+X are enrolled

that can. that's and -- we and we've everywhere built But in

the potential has So drive important, value. and that's to obviously think I

think, other they've I go And setting, had to of to transplant, of on Jonathan. thinking whether and Our not, or matter we're matter able to shooting a they eligible what post-transplant they've be criteria the gotten they'll menin they study. patients how no is is get meet be capture that very entry no team, where the cleverly prior the for they're into inhibitor side transplant, if to

It's we such profile, our a safety favorable QT prolongation. view, have have we Jonathan that no given

agent have very attractive We We from the commercial the in that's opportunity. opportunity really a we've a have just heard sophisticated no drug-induced attractive profile. to evidence be a myelosuppression. parties, of preferred We very, And maintenance have very safety setting.

the keep the to two, can patients as value drive well for enterprise. that for potential or overall a patients year the If both has to on as really there the value, significant you of

-- to studies, drive the I'll comment So then studies final Kura-sponsored thing, we're way we attention laid can of been the trying much on far, paying sort creating. all undertaken these they're if studies out, studies thus people all Kura-specific and the the -- Jonathan, that are value is timing. have And very so we've we've

With the to study a then X X/X. makes gather it and we'll Phase Kura-sponsored we'll into data an study Phase do it if a study flip study, over the maintenance an initial enough investigator-sponsored as into transition

able far, drive be as as trying thus to can that's much well. execution. to we're working retain So, of studies and timelines And control quite we to the

Jonathan Chang

the taking Thanks Understood. for questions.

Troy Wilson

Thank Pleasure. you. Our

Operator

Thank go ahead. Jefferies. Song And next from your comes Please question from you. Roger

Roger Song

All question. progress. And right. the thanks taking the for for all Congrats

also, think combo enrollment think very about for Maybe next the already number, the which I the year, And Thank so Troy, should far? this -- of the around you year encouraging. how progress start terms sorry. when color Multiple expectation to And maybe you're you. looking the you the decide in us trial, dose data some the part potentially later mentioned activity RPXD? can first you early will initial we give for? is you

Troy Wilson

me one, them, correct okay. if of that's And please I'll Yes, remind I each take me. Roger. miss or

design trials. of all, of a the the just comment on first So

care. dose escalation are of treated trials. standard these the is of being separately genotypes Each with So

we're So KMTXA the six for X N containing cohort, have at typically we have in starting context XXX minus Similarly of the X+X, we dose. and an These venetoclax a dose, cohort. escalation NPMX a are regimen. an cohorts, patient milligram

important XXX the XXX do kind you how about Phase dose as that data there milligrams think we I'll and pertain syndrome. that's remind because was in between to talked really differentiation about dependence it no you X, within And RPXD. and of

any specifically focus latest to syndrome. as So next safety with think, going quarter year on, we're and this first to at or and study, year what differentiation guiding respect the we're first tolerability, is I with fourth quarter foremost, and to

So, mitigate can And is the was importantly, safely with activity, one. care KMTXA we the a differentiation And standards combine syndrome that those we current believe Roger, in of of we seen care, of help do the good population. the can. standards question

you as backbone therapy appreciate, a has However, of meaningful level the clinical activity.

can isn't really that to. be to So going anything, I we speak think

through be although the update it. activity as will activity, clinical year -- step want you then better a clinical And alone. further optimum that's into to there sense and once is the think a relative cohort, The we dose you're make to take that this and to really pertains can early when active I get it end or you'll the RPXD, we at it dose get an on or potentially you the expansion next, backbone sure fully of we expect of we take, biologically

can expect, then are differentiation progress if sites in escalation. Safety making and how ultimately mitigate U.S. to and the it's, we Roger, have Xa. -- And Phase in syndrome, dose the we the we XX tolerability,

we thus robust. have the accompanying with We handful months That of But what in now that them have Roger, sort and the behind, call this very a ahead. increase patient has are And a no will trial left interest of been right? patients. again, trial we and open far, and of philosophy, enrolling number XXX weeks

better they When interest for if you NPMX supported we X+X XX%. venetoclax on he -- co-mutant with of a or physician's approval, who in office, XXX, FLTX that need FDA a the needs who they get can you recent there's on they lot fully they're A of go data saw that zifto. a more saw suited trial were to containing of in -- QIS ven go or X+X, combining half regimen, plus presents patients gilteritinib. quizartinib Those If those she can zifto. at they're the if plus patient the from

FLTX our of we a aggressively soon is menin and combining as get as there's moving So XXX can. team as with interest to possible inhibitors open inhibitors, in lot as

I hope me that question, the anything. think, follow-up but And Roger. I I if to So components color, know gives addressed your I need some let you on of all

Roger Song

great. No, That's that's great.

Okay.

clear that's now. Maybe So the very gears tipi. just shift to

you're understanding RPXD. you're the the mid-year In So figuring of seems the the release guiding towards data now guide And to next of kind out RPXD second them. for towards around past, the half expansion year. you cohort for the kind

tipi? know you. let just the the current Thank thinking maybe us So what's around

Troy Wilson

reasonable it's the Yes, it's I -- good And a question. question. a and right it's think question

Roger, back, more short, is what's We combination That's active combining from than step answer. me, in if and take -- I and perspective, the ever we the patient, the a asked tolerated investors dosed risk the greatest and with both we greatest the is said, so expected. before a alpelisib. short So tipifarnib my better challenges risk? had we when analysts

as have Particularly, kinase in the an inhibitors the industry, of we, combining MAP and had inhibitors good not of PIX-kinase pathway. pathway success

We we've have the combination. been, with tolerability and this that pleasantly at I surprised think, safety seen very

hasn't and evidence been to both seen any but have escalate inhibited ability It way We alpelisib. dose tipi our hasn't in limiting. hyperglycemia, of it

final milligrams Honestly, of twice dose I a Roger, thing, shocked, evidence other escalation is put And tipi clinical I of say just a cohort daily. we're on now the surprised. pleasantly wouldn't of activity. a was to full -- XXX but full surprised. and point day dose is seeing alpelisib that, this a milligrams What XXX

neck, in challenging teens, PFS and PFS head three typically you to XX% cited OS, you're population, rates in to this two and XX% months. line response really Now of the that's I why and to second seeing

We to safety I want into the at We're we're seeing assume the and of at tolerability. don't the acceptable can seeing, to dose levels. data, we're but need select responses. seeing safety. we activity dose of good we that the You activity do activity optimum have at first granularity which get we and different and and seeing -- lowest that's make biologically active sure all, dose, are full

sorting that we're out. So,

the the what guiding that? dose year questions to we're next and think is I reason critical is

And seeing help level a of what you like. trial then dose activity inform to are look what at Phase X/X importantly, might that

to seen X% mutant enrollment enrollment of make mutant to but population. Just -- could this X% the of it head to reflected in sure that to we to be want one-fourth remind We've curves PIKXCA population, get and up everyone, HRAS of treating the is the XX% We we is study. cancer, on XX% Roger, neck the and potentially right.

already patient tumor we've showed the after the of cancer response. the shown, tonsil, one we reduction the an and with tonsil, and And from durable head the XX% neck example metastatic a cycle

then molecule can. as and year. next the think the middle they cranking a trial That's targeted do. is think We of activity So small dose no been fast for that team tolerability what's to on expansion of as have the the frame there's question do you is next work approved and is cohort how where to we in critical opportunity is therapy. sort about the the registrational safety, disease And reasonable -- a guidance

Roger Song

for the now. Excellent. all Thanks it Thank That's you. comments. Troy for

Operator

from ahead. next Please question Peter go Your from Barclays. comes Lawson

Peter Lawson

questions. taking for the Thanks much so

maintenance Thank And other could indications, AML setting? the Just resistance other ALL whether kind and zifto -- into using maintenance or then tumors beyond that you. around just preclude setting, and around hem diseases? question moving follow-up solid a being from other of mutations in zifto firstly,

Troy Wilson

Sure. for the Yes. question. Thanks, Peter,

question, going zifto who while a resistance so ever on we the developed tested using tested, patient setting. who And a resistance to people we've mutations might maintenance enough? or we've of to only was ones threat in your think the seen -- the XX had one don't the be So, ask are assay sensitive zifto. a We've big mutation Well,

resistance we mutant. about They or resistance. progression don't one. a in mutations any it we've Peter. due retains develop the evidence is X% But see my three these and activity progress, two part be Patients active to resistance driving on doesn't appear do And to That's data of third, resistance on that would but other the rate thus the of mutations. mutants, X% the resistance be, do point zifto. got to important is We've far, it to the of XXX answer mutations sampled ziftomenib fully meaningful

in of patients We've the Long treated that's a in and other failed number think that inhibitor, have for setting. that well -- measure to We have short, the we class. EHA. to actually difference. having think zifto the come do when make very seen So spoke study, Peter, going I a -- inhibitors activity. don't menin we story our And is it's think to as around who clinical contrast a we've to seen we we of don't maintenance another it's positioned

it's have importantly, extra that probably even of doesn't would And Peter, importantly, other in far setting. any that toxicities that very easy require sort to detection more have or use. that vigilance themselves revealed extra It -- thus

forward looking maintenance of is second think, me, to indications. the we're the Peter, using setting. additional And forgive zifto question I part in your So

Peter Lawson

of where The tumors there was solid hem second or thoughts and outside other the are? just indications you half into your diseases, hem and indications other question expanding

Troy Wilson

Sure.

that see data There there, driven. menin to opportunities you be for I we inhibitors. Peter, beyond are other So, want think leukemia acute

potential experts, needs the the including of the AML. one talked CMS, short can to Reduction to Inflation and that long within do impact we the -- anything be analysis think we've best I of Act. And all story we is mindful very have,

compound would potentially probably additional your out the the stay mitigate the that Once that think be in of put one next-generation included team being we taken Act is at having would indications. And the zifto into a inhibitor a IRA. by covers risk very -- go of risk -- you others, everything it another take any an program we of I be it has program. way indication, designation to about the Peter, ALL, we think, menin have appropriate And that Reduction that be orphan we improved, think Inflation be and AML. attractive you to we of We've can -- virtue the

AML opportunities Be to those We've landscape, one potentially be regulatory and for thoughtful and other We're solid evolving us, standard of I think there. think care sort about in just drive We menin hear And multiple diabetes. pricing the we just additional and you inhibitors. We right? or liquid and talking relapsed/refractory you got given alone, tumors think can transform the frontline the significant be of that transform value maintenance. market. legal wants really can

And we're going to And do we'd the likely might second but everything we full can with opportunities, those zifto with in early drive that franchise. think compound. I generation for exploration, way, pick setting. the some value up commercial If there's really we additional you a that can do

Peter Lawson

Great. Really Thank it. you so much. appreciate

Troy Wilson

Pleasure.

Operator

you. ahead. your question go Li Cantor. next from And from comes Watsek Thank Please

Li Watsek

data patients that period you sites enrollment June, the it And in of taking greater have? a the is to have first a pivotal the you later one number study traction I matter just seen data? especially EU early speed? on your you Is the combo of variables if here? on congrats quarter. Phase in questions. of clarify for terms maybe the thank update some I patient Troy, our after X can us year, Hey, a the mean, this guess certain zifto. give want or before EHA you for of next Or for sense of or And follow-up of just disclose can you you you of year enrollment potential certain reach also

Troy Wilson

for question. thanks Li, the Yes,

studies you question, And do driven this enrollment with when any the feedback it's curve an that the do curve. first you -- have that by you enrollment is trial, and on And see, So sites. feasibility can do done think many they they clinical How on, XXX they very group get has operations study. the et put that well cetera. patients many with from do you the how our

reasons And We projections, think a are are Li. ahead of of lot for that. there I our

think I excitement. physician it's

it's the think data I itself.

more in we're than studies. who we're them -- is going market. to not variable. communicating there's isolate expected to think What for other to of I and be one hard time to big it's hard there's a say losing kind patients people to gap It's of think we terms perhaps

view traction in potentially that eventually expect safety Because I a and AML that therapy. data, and well, different go everyone by that setting. these if expect of come perhaps combination informed continue. a you trials you the in think front go -- good we And fully the we still particularly have NPMX tolerability that's that have disease and to is acknowledges of market, to would as molecules FDA we're combination

party the can with ability the the be sets the ultimately highest nicely going So activity that -- think And up we combinations leader. zifto. the to best market and that get combined tolerability, to safety, is best very for

of So I your part expect terms we Li, pull studies. think will question, that data how excitement second to through respect into combo in the With and enthusiasm about the of release.

the particularly we but co-administration care analysts unlock have activity that, that does everyone set all standard every the we the talk indication, a of understand investors regimens that's ziftomenib So, and us more we of through syndrome of in -- of of work. forward, do the that appropriate to and can rearranged differentiation one the likely KMTXA of mitigate the in minds path is, population. the you questions fully, the tells It's to the

actually do to have it. You

the safety, That's -- to why leave if no the going that's there's and focusing mitigation anyway. -- three. risk cycle and typically the if you're Once see is why eliminated, eliminating progress I'm one likely tolerability, leukemia, of something the is is you DS. of leukemia the patient initially study not DS And cycle between DS.

on So relatively know we're early going don't DS. you've you think mitigated I if to share data.

we patients these to you, an a patient-by-patient of meaningful basis. these And dose dropper, six not sufficient number say, cohorts. We we eye and on draw out data going you on get data and dribble patient the want to a indicated the come We're are can some here's with can escalation -- study I've to conclusions. that are

get the be to So or quickly, even numbers meaningful dose in first two. pretty the escalation when we're

have zifto We screening, of various I think we each year, the study. toward What clarity update enough at a think we genotypes the the just We next Hope and with look ASH a helps. are to that the why yet. we encouraged and Li, XXX, different our don't physicians possibly machine a give as call And on end the in go well, finding -- are profile. The that patients, are is by as we'll don't enroll coming earnings I working. on been best-in-class know be look position and meaningful we've is that combinations think November, toward rates. of in as has into yet, patients

Li Watsek

Yes.

I Okay. a question. second have Thank you.

you're So the -- in with for co-mutations? a of FLTX into IDH patients have Do the breakdown the you that in sense terms of enrolling pivotal versus study terms of co-mutations. the

Troy Wilson

I No. At don't least think so.

You're enrolled breakdown co-mutations the the patients talking about study. Is Li that on you're asking? in what of

Li Watsek

Yes, yes.

Troy Wilson

the yet very content seeing up XX% don't actors. all the have have central -- population. -- -- FLTX co-mutational don't FLTX Li, are of why we with go at as you you, days. combine to I So seeing population. exactly pull Ib. very NPMX seeing it's given quizartinib We're some inhibitor of we've We're breakdowns DNMTXA, That's able need that point highlighted high both if well are what terms co-mutation. I to or the think it's the the levels of of seen early We so right? you've be similar in specific the to FLTX, think the It's I the label, in XX% I in for you IDH, co-mutated

Li Watsek

Okay. Thank you.

Troy Wilson

Sure.

Operator

from comes Please ahead. your Bradley Thank Canino you. go Stifel. next And question from

Bijan Mekoba

for Canino. on Bijan the progress. is Brad Congrats this on Hi,

then we How glad the for tipifarnib the be next data? in in we in So tipi parts about first population both PIKX question be contribution And overexpressed the see on to safety some in HRAS should is limited getting PIKXCA? data will of and responses issues. thinking

Troy Wilson

Yes, Bijan.

may, if So take -- opposite in let's I let's those order.

this we finite -- one, with things resources. company, couple funds can a in, every of we not to announced in to earlier that really the focus year, going So enrolling was -- we that PIKXCA And we were then as we for overexpressing We were HRAS to Number going and our effort have invest. reasons. cohort. continue mutant in the we invest more have which with have we

particularly, case OBAD, our current is articulate mutations in we're the have you us driver in HRAS to studies wants the PIKXCA the those of best they as If or hear studies. identify with the doing who of the be target everything experience in to one the patients place whether case go mutant So oncogene, RUN in and the AIM mutants in the systematic.

going a to have you're going the activity, If go get closer to you because the you're define the there potential level that's of because greatest driver to of where the mutation. OBAD,

the would in drug doesn't, That highest of once say, that's get should mutation come see a I oncogene, Bijan, function back typically, want HRAS smart be investigate we either doing about be to activity. OBAD, or you PIKXCA stewards where overexpressed good in the and of we that We gain want just we do And to development. good preclude stages. driver and it amplified. capital, fiduciaries

coming -- focus So PIKXCA the is in we the mutant. picture are into

great -- a typically responses drive has and in you confidence. a limited Novartis ability they no experience very Your one aware ability as question responses, those typically to say around so mutant I'm can had expect drive of with population responses contribution has in That Alpelisib -- a PIKXCA are I parts. durable. of There monotherapy. to the it of not would only tipifarnib,

combo PIKXCA. potentially now, doing and continuing point a clear better as is we're confidence. translational clinical that combination data effective activity have is the that this What team tour At nice rationale has this allows activity the disease why how to so gather in gather for you're seeing you just we mechanistic very preclinical -- this particularly drive some REV either published that here, on to It's and and us drug work than our research more to showing monotherapy.

synergistic, data alpelisib and and fact activity a we question. get cell as XXXX look say for up, into may to bodes a additive, you get combine get the and at The we've KRAS. to something, possibly -- -- will to look very inhibitors we with I a it Roger's well advance in address the and chance safely I I us thing better selective that But great now that given tipi additive, we as renal than confidence that mutant already in at look preparing can is didn't TKIs heads clinic. are think other gives be XXXX, minimum at is

study RCC, second-line is that the KRAS preferred it activity at and XXXX, a if TKIs I think about data look also rapidly. do? that's Is an FTI teens. we for SHPX? inhibitors very gives settings. you, think, that combination you're correct. into What response the but let's again, well And tell is neck strong those being you that's happens pretty opportunity if in entire in chance field of it you And And see stands do on potentially going again, dosing of preferred bodes I'm a think patients Because then, in talking start partner and rate head I the tibi/alpelisib us impressive, the SOS? with resistance the for and looking Is both a partner. but to it

Bijan Mekoba

for Thanks there. comments great. Yes, the

Troy Wilson

Appreciate Sure. the question.

Operator

comes from question next your Zelin And you. BTIG. from Justin Thank

Julian Harrison

just question. This on to based Justin. for menin looking I for on diabetes recent your competitor is for view take had Julian I follow-up And on our Thanks was your ADA? a taking data on question. at get

Troy Wilson

Sure.

So we're cell interest. inhibition are, beta following and certainly as many data we're relationship between with a that menin following, regeneration. There's

of to of well to and I We're still monotherapy ziftomenib there's questions evaluating gaps other and -- think appropriate in on as combination. both exactly inhibitors we've to minds, data set. menin lot we'll wait what number a watchfully our a the decided as is going of there. What do as continue diabetes, is in models to actually as in that

how If I'll today, the shareholders, value find we I diabetes, become in maximize way a either a partnership that for value do an opportunity And to if it. hopeful an out-licensing. to take diabetes, so, assessment we that way advantage as to an find inhibitors will we we data to menin Kura opportunity. see for an you there's make or of sure in tell a year get this I'm it. And we'll some do but doubt later will make have we'll through

is But And #X, and the is don't in of want safety your compound Reduction that our importantly, previously because foot. have an want to compounds another do -- with yourself you kind from Inflation gave oncology answer you inhibitor, this database. shot the diabetes Act, the your probably necessarily same and standpoint menin you both view of I the to

inhibitor So we supports been it. a data said, -- bringing menin if have, as we've the that I next-generation along, that may

generate we're diabetes menin this, and best-in-class our And is And for have there, next-generation compound. a to through just it's no recommendation that's with look translational It's research let's and let's be you disciplined, we tell see. generate if I'll clinical us going let's inhibitors doubt see experiments I colleagues, do you'll a can in and generate the a data from compound. how right value of matter the the

Julian Harrison

Makes of just for sense. you And expansion view? promising can I a being patients and in head FTIs of other and tipifarnib. cohort the follow-up, RCC outside what as hoping numbers neck treated just the was And neck maybe indications head your clarify number secondly, for for are and

Troy Wilson

Great Yes. question.

the Similar just in clinical what of of think of an have want you've development. strong a ziftomenib future expansion So Xb, we we I'm six got -- Phase won within head with on probably cohort -- about spitballing did XX steer sort that here, there to data patients. to and sort enough and neck, you to how to I'm

that's So that.

indications, both alpelisib. a increasingly as of monotherapy and and tipifarnib good I we've got, think, and terms In other with very data, evolving clinical tipifarnib

study, But which it active. operational neck. of world Although capture we limited It's you and terminated in of and try to actually HRAS we feasibility. is the in enrollment best is for one-fourth head our PIKXCA-mutant population, we again, choices. to active. both quite terminated And have make The the resources, some to a do difficult compound would mutant our AIM about

and would about that, I think alpelisib. For tipifarnib

to of and think to a want then want to sure data, the once possibly leverage. you RCC we around about generate about But third expired. colleagues building FTIs you you been have can cancer FTI a come and optionality. has there At this point, KRAS have patent up done riddle. our alpelisib, how -- neck the of composition that and second questions you would IP bundle strong make head But and it job a and with have You with want tipi, you great crack estate matter patent

approved. And if would we there targeted for therapy it, we patients market no no be get to small alpelisib like could amazing There's beat could -- tipi targeted accomplishment. and that an molecule if

But walk always If mile. FTI you I minute joke four along wanted to then to run try then another come with then great. and it, beat the

alpelisib keep moving and let's tipi So along.

don't a put You'll at us to XXXX -- resources we see this increasing make point, and on decision. have

data in tumor RCC go. see and and for more mine where out but as both killer turning Those to be hope we together was to where FTIs is That coming -- therapy. generate application KRAS where started, significant knew coming be you that combination And who sort I the continue We back home, want I of FTIs will. a indications. that's it be all of to if space the data just would going end three solid to we think are chemical very and nicely. set the It's to KRAS up.

Julian Harrison

sense. so much. you Makes Thank

Troy Wilson

Sure.

Operator

Benjamin Thank Please comes Reni Securities. from you. And question our go from last JMP ahead.

Reni Benjamin

little for and mutant with any get programs. of and that taking about to getting is that kind to Hey a free and the try set -- clinical for up quickly important marketing drugs versus for drug? tipi the your the us unmet some Troy, there patients a what's and the for I and in companies how either discussions order or MTA starting an or the with trials off enrolling of cost are that the zifto strategic maybe sort mitigation combining rationale the mean approved you you're bit to questions. ground? KRAS in then kind NSCLC. talk starting combination thanks with can need off all RCC KRAS guys, you off Are And maybe of question with

Troy Wilson

It's it in a parts. And Sure. great me let take question, Reni.

management. a as cycle to from we first, through we improving a fundamentally ago life respect few effort were where great cross-functional RCC than of are with way we as So an think going different years just all the about to R&D have going preclinical sort and really organization

work renal the the the to cell we've done KOLs, we landscape. market We've the done on research, we've so talked carcinoma. And understand

it's in they speak very space. still evolving, We year. the that's But RCC that were later exitinib more to this a more could mature. but there's generated, -- to them -- most partner tipifarnib and more we for mature line, if docs probably could the we'll would it's notably a if the use And potent really clear ran what relatively setting. know in -- relatively group second our has specific if synergy at preclinical TKIs little in phenomenal. Francis' you that data And look TKIs, enable that be between example,

We So in get it's love can't enough. fast view, docs my -- great we The it. there setup. a

it's an is a a evolving lot KRAS KRAS. got going lot -- It's that rapidly It area. know I emerging clear take with, with to be tipi is of rapamycin, have targets It's light. heat, area. resistance going Now target our the of is which we is contend And a of XXX. something one that of to -- to with. what deal everybody that is we

if to you central they're engaged tour they're whether or hit GXXC the resistance, be gets whether tries That tries to in Raton, inhibitors selective, a workaround. to and actor develop find KRAS, tumor a the across seems mutant they're driving board, whether to resistance TRS GXXD,

decisions with So supply sure it's question, respect just clinical last we trying -- to that are build taking being deliberate the collaboration right run to agreements? we're very and making making your or we're

can of we yes. think as want a alpelisib Novartis to you want are trial, strategy either you for initially a we with a and with be did to opportunities sponsor We collaboration. reimbursed similar get Ideally, the that, about you XXXX. the taking course, tipifarnib assume drug or drug or is try to sharing the answer the agreement clinical The with work to

Reni Benjamin

Perfect. Thanks the taking for questions.

Troy Wilson

Sure.

Operator

proceed this questions time. at Thank you. remarks. you are with no Troy closing Wilson, may Mr. further There

Troy Wilson

the month to see if hope Thank and call or have please a attending Thank Conference Tom, and In me. you. Healthcare And call, have thank questions, Pete, good number again there. for of for participating meantime, contact joining our Cantor in you next additional a We'll the you evening, all our everyone. be any you today. you

Operator

great call you conference participating and gentlemen, and this that for thank day. your We today. your concludes lines. for please disconnect much Ladies Have ask a you very

Kura Oncology (KURA) 3 Aug 232023 Q2 Earnings call transcript