KURA - Earnings call transcript Q2 2022

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Operator

Good day, and welcome to the Kura Oncology Second Quarter 2022 Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Pete De Spain, Senior Vice President of Investor Relations. Please go ahead, sir.

Pete De Spain

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

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

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

Troy Wilson

the pleased we've with submission initiative completed all dose X this more an these of KMTXA relapsed two-dose feedback NPMX believe we FDA year, dataset meeting in a as optimal enrollment working menin or more top of pending presentation XXX as in meantime, expansion us and relapsed leukemia, acute cohorts agreement study rearranged quarter. along discussions, Thank joining ziftomenib. to look FDA the dose. from the this enrolled in Xb the for or and Pete, report and patients XX additional in complete ziftomenib indication oncology recommended the a and inhibitor KOMET-XXX each spend XXX Phase we X design escalation we're for nearly I'm advised ziftomenib dose registration-directed patients later an refractory review AML. drug data the Phase continued recommended Last milligrams afternoon. in Phase cohorts, study of in the of for has pharmacokinetics that dose for to and three exposure, with all-comer FDA those dose, agency's an aptly with with announce X reserved we've thank sought trial. safety In in for patients to we at an you, assessment of we and sharing to in medical In Xb pleased we've Xb continued enthusiasm patients. we in population enrolled comprised Phase our identified tolerability, and with Guidance milligrams, X package continued surrounding among we was development with Project the and you our ziftomenib as efficacy, refractory We're of gather XX well Phase mutant Phase to study broader that than a year, less know of the study we myeloid In our months be identify forward expansion context FDA regarding to FDA, now line time a our to a what recommended named Optimus. part patients data with for the the the believe investigators diligently fourth Phase

standard to frontline to advance to initiate series and activity studies studies combination of designed the a combination recommended Phase leukemias recommended treatment of acute settings. data pending to relapsed into X+X. these assess induction in in and been efforts of the we've as Phase our patient commonly for patients cytarabine, monotherapy, enthusiastic working and X potential with ziftomenib FLTX We at with ziftomenib the therapeutic safety, all the prepare referred tolerability dose We've parallel determination current venetoclax will we standards azacitidine, studies to Phase the of in X as chemotherapy, of to In to dose. the potential have KOMET-XXX about registration-directed care combination transition in and our from continue including remain and of to We AML, treated population. contribute the ziftomenib's believe portion our daunorubicin registrational X inhibitors operationalize

capture The an of the inhibitors We second alpha much PIKXCA-dependent HNSCC. the of patients Kinase in either of target in resistance. potential and PIX Although begun HN our a therapy cohorts. indication. current the of squamous to via opportunities to drive just in inhibitor combination selected Late much that recurrent an two as monotherapy of cohort attention, oncogenic increase registration-directed that focus a FTI of and HRAS. alpelisib, durable patient HNSCC the on co-dependent HRAS pleased trial farnesyl the total population in menin demonstrated mutant by alpha Kinase metastatic had that with first inhibition the recurrent initiated recently to patients to we the potential program inhibition cohort improved tipifarnib drug potential to carcinoma I'm to patients with last oncology, designed addressable tipifarnib are current activity namely remain AIM-HN to comprised XX% for provide recently, and overexpression. and applications and motivated of for one initial an of relative protein believe overcoming of and patient inhibition direct responses for upon combination activity dosed ongoing continues of and the as as combination the and initial tipifarnib report includes with PIX We've head to we alone. the neck transferase therapeutic HRAS of build we in as study of HNSCC, has targeted year, HRAS with study evaluate HN our to we've efforts oncogenes the The More also metastatic in continues cell tipifarnib or the HNSCC, HNSCC, with a first antitumor

patient HN X cohort. goal each for current identify in Our schedule Phase is combination trial with the and recommended to a dose the

evidence as later encouraged PIKXCA-dependent the be We preliminary share the data mechanism activity, to may tolerability year. we a by of and this position believe of and HNSCC we safety preliminary are in cohort from as in of the patients clinical combination, proof early well

HNSCC, elucidate to FTIs classes more to certain role the targeted and responses for preventing large emergence solid with the drive Beyond of resistance deeper in of of indications. durable potential delaying continue therapy in or tumor we

unveiled and tipifarnib One year at Annual potential of with Research in to to other opportunities combination in EGFR-mutant these prevent cell generated later of EGFR study preclinical which together X clinical We intend in inhibitors this mutated to collaboration data cancer. data, initiate Phase parallel we advancing EGFR non-small cancer, lung initial osimertinib through in of call tipifarnib cell resistance perform tipifarnib a evaluation valuable a experience lung osimertinib emerging osimertinib while KURRENT-LUNG potent KO-XXXX, studies. combination the the bioavailability and earlier enabling to KO-XXXX was exposure non-small We're of Association with lead preparing inhibitor through in emergence transferase support to development candidate this Cancer for relative and with a IND INSERM for our Meeting, American the next-generation improved farnesyl tipifarnib. in generation FTI represents next program quarter. PK,

evaluate discussion turn an to investigate inhibitors, results. I'll Tom application remain in represent In the on for for potent opportunities. addition intend over may a our KO-XXXX we the and with to combination in studies targeted quarter. of to preclinical With these combinations in continue KO-XXXX other IND call with additional with fourth submit combining that to therapies track therapies We financial we to now FTIs targeted that, EGFR

Tom Doyle

discussion. you and I personnel everyone. administrative compared G&A due Thank were our the of invite of in Troy, to to I'm a costs development for second of for increases the of ziftomenib second you, to primarily provide personnel fees. for for the XXXX. in of in good million, due related XXXX. million detailed XXXX XXXX for for afternoon, decrease loss quarter expenses financial and loss XXXX. results million, in net $XX.X quarter and overview a quarter our XX-Q to the today our $XX.X compared the brief to and million happy XXXX. million, decreases expenses filed increase second of more second $XX.X was $XX.X our costs a XXXX quarter The program R&D the and the million were was quarter professional quarter for clinical of expenses the trial to to for quarter expenses was Research $XX.X to General of second primarily $XX.X second The compared Net second cost. review

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

Troy Wilson

Tom. you, Thank

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

FDA initiate for in our now that, For KO-XXXX from in of programs, this With this the application the for are And from updated for FTI the drug ready plus a submit X and and line medical report quarter. year. Phase our questions. KOMET-XXX later fourth the data investigational a data top new study dose study the quarter tipifarnib X quarter. Phase osimertinib Sarah, for determine KURRENT-LUNG with new at fourth we inhibitor menin ziftomenib Phase in Present program, meeting recommended Xb consultation

Operator

Thank SVB you. Jonathan caller [Operator Chang, Instructions] first our Securities. We'll take from

Jonathan Chang

for questions. taking my guys, thanks Hi,

line you provide thinking on top to about data, color timing First the can top the when you're data? on question, disclose of line ziftomenib any how additional

Troy Wilson

for Sure, Jonathan. the question. Thanks

we the are point to to assessment As submit in where indicated, XX-day much additional address We're our FDA the with in here or believe and at process the different submit QX, is I if that. going we dose potentially shortly. ready will we're with can consultation FDA. which questions, FDA. as way. don't that clock. their example, determine point, timing all timeline that QX, an stand At We the a us is completing case our looking of that a to they the a X that data just at Phase of goal there on Jonathan, to by into Unlike, visibility submission in recommended depending should package look could have should late preparing the FDA we isn't in What IND certainly it happen we're best need the into have questions reviews the at think is package probably we any say this slip to we and for

Jonathan Chang

to declaring it. are able boxes the And I before Thank officially you what regulatory on RPXD the you. identification I the checked to any color remain RPXD? of be guess, Got the and interactions. provide guess,

Troy Wilson

Yes.

a Xb Optimus, with having around can I therapies. just it's this was to addition the do. you maybe information the amount Phase about the becoming an initiative we DS. Xa PK, of FDA's you of now the tolerability, view was tell this to in take dose and part to that absolutely So right such leukocytosis quick clinical as target really the Phase targeted Project exercise a manage tremendous and for how Phase undertook Phase Xb activity, study Xb the know, back, We’ve in AE optimization, the gathered on thing standard safety step and conducted our the and to as the

absolutely So the it to right do. thing was

this that going particular to very supports from with I strong I to dose and this activity, X want FDA that profile much as supporting for data think that's the it information recommendation all integrating our combination point, package the box any think sets a given all absolutely although patients a a can't jump enrolled advancement that dose, the a make emerge really with to is what analyzing that critically and in bit took the so right clinical view at and emphasis is a And with future the patients Phase enough, we it we in strong do. the Phase to have we're longer, and on the important. Xb so check to studies, ziftomenib this a tolerability, exercise this And it point. experiment stress isn't to we given across recommended why exposure PK and were gun still looking but really did, monotherapy and relating seeing I Jonathan, The we and the is. the as for study safety

Jonathan Chang

Got it. you. question just Thank And for last me.

the since On see May. these the line quarter and could meeting patients for top on fourth the disclosure enrolled you. for we Thank presentation? additional KOMET-XXX medical in of many XX How data patients

Troy Wilson

Jonathan. question, good a it’s Yes,

to So conduct beginning the and we used Xb guidance using as this FDA of will registrational received X. actually was it's ultimately in been our Phase from be the same endpoints the from intent that Phase the portion the

sanctified, sure certainly perhaps right? expect part is for -- -- from we're people help a true we're it. ultimately is will make the use of checked to totals. enroll. robust, that's such, also we course word, And better a you and registrational As patients are data and such, This Jonathan all the XX coming we to These data become treating them partly is would helpful clean, it's additional that hope lack to submission. of understand gathering as subsequent be will it's of the what That's it’s the for really hope the need you've we the part patients sites patients of that

we're you balancing there study, of risk replace data enabling them from at data additional potentially So to when data in those cuts. in doing you're registration incremental if you lost You sharing a patients? here, those put risk value keep put sanctified the is sharing patients having time versus at patients

not initial than in -- I'm you'll put you're patients cohort. patients to and -- in the data we each -- patients we our line each top course see it's we can don't current XX XX both expecting, that to top it. we'll But momentum to risk. the Xb, of in might speak and close ASH, initial those beyond the qualitatively Phase try we the to point, line able results. the go this this to point, and see everything to be at gaps expectation that want So doing Phase the don't want we're not maintain the At Jonathan, going top the in sorry, Xa more At to cohort at from

Jonathan Chang

Makes Thanks the questions. taking for sense.

Troy Wilson

Our pleasure, Thank Jonathan. you.

Operator

Credit And you. next Tiago move Suisse. we'll on with Thank Fauth to

Tiago Fauth

Thanks taking progress. the for question. Great. the on Congrats

a TP, if you us you can provide would that perhaps (ph) enrollment QX, at it shakes the that Curious qualitative trials any between understand to how I K] extent types, what genetic IND prior with is same to two our So limited XXXX proof-of-concept registrational share might the better with out consistent QX filing? be tipi, wondering in expect can in and both you depending fairly is make about for right, for point. any sub you efficacy or you can the establish talk the EGFR? recently this how going with combo proportion to and comments, consistency time? But to that the the have expected better the to a you initiated with FTI competitor just make for future if -- about perhaps tipi on combo with develop experience. if I And little between clinic the Do perhaps combo don't to Would sense [chapter progressed you trying also there XXXX two understand enter And for for know trial. if those of response subpopulations. characteristics so franchise, Thanks. bit that's giving that candidate evolve over simultaneously? have

Troy Wilson

the It's each Yes, in Thiago. of a parts take let Thanks that. for me turn. question, three-part

see ebbs between relative given It NPMX would of, a in AML might kind rearranged to KMTXA Again patients. and the we say it rearranged So overall epidemiology your and around suggest. healthy any enriched question at flows, I time. and pretty enrollment, on point ebbs in it first of what KMTXA seems flows, patients balance

populations. of who expect four enroll both but or to lot to if physicians we're want of equal it you among a of You'd weighting, roughly kind will, one, seeing to be interest five an more

Phase we're same cohorts us or KMTXA the to a that thinking successful to know we cohorts is we're months the tell registrational really think and probably tell the as X activity, patients meet XX% to that size, being namely durability, to of cohorts. should six enrollment consistent And both I there as XX see right? design each, transition deliver to So to can that you to patients exceed NPMX. in looking should going that what the remain you is CRH X as to Relating of same allow bogey, XX to four ultimate thoughts secondary range the XX% that I in strong approximately the statistical number think Phase tell our rate, endpoint, is right we in continue we're independence you into those transfusion

that's we say. So I could as think much as

to we'll Of flexibility course, be the have driven. data

relates we're part point an that simultaneously. things -- you your On the question strategy of to the make important and several FTIs, around you really to solve third really the trying

the therapies. So generation, first highest is think mindset data our to targeted best in I FTIs these other has use the of evolved with be combination may

a early see we kinase this year and to PIX going hope even seen fourth You've a EGFR, year. or alpha, that you're see next you'll third later

preclinically? exciting data that what is Does see We've of part just recapitulate data very generation. got clinical the data. you some preclinical So

Europe. how I in we pretty comfortable metastatic that need about development would with to into registrational the and the think with and think setting? a second study combo support (ph) U.S. forward take that Should we we recurrent could a in have clinical globally? you The data or Novartis a [telesib] collaboration. we're do in commercialization is regionally whom tipifarnib, alignment feel the Obviously,

relationship very a and with look a them, a bit of good forward this on working have to We program special that's case with them Tiago.

I as other opportunities, about think you about that's XXXX. to osimertinib think where begin we think or

alluded the if -- opportunity current lung with resistance that surprise preclinical indicia a -- osimertinib. see in study to That of this novel slingshot And intent there we encouraging seeing combinations selected be XX% to to would we in, consistent and put inhibitor completely But Phase is take tipi, around or in that massive and work do be I thought imagine targets, with so clinically that you onset XXXX anyone, learn that with forward can the data, delay no value the to we're the only EGFR while are osimertinib in given even it's we If what biology, assume we a if tipi mix. seeing osimertinib. early novel a to are study potential the with chance is we will to is farnesylated was data you're of XXXX, the the for it around the derisking opportunity that the XX% X targeting is we any population.

I we've that neck look alpelisib, clinical but will our -- head continue can we'll think and bucket and recurrent the problems we've data and high Did strategically preclinical your with tools, tipi FTI, in we so better moving put we compelling I optimistic commercially. I if where great end work, need Ultimately, data. we'll think of we're anything? up. a see we Tiago, But question. supports unmet beat answered and got that then forward to if our me parts we But missed I So, XXXX we'll to the I is is tell -- think think three metastatic got I that the own class in answer if that's of that

Tiago Fauth

Yes. taking the Thanks again Appreciate for question. it.

Troy Wilson

Pleasure.

Operator

to you. Lawson, we'll next on move Thank Peter Barclays. And

Peter Lawson

Great. Troy, for you you is seeing in makes unconventional sets more Thank makes that for there Thanks positive the think then which the for you. you're XXX better in menin taking you negative? first anything you the do Anything milligram And more use? combination just questions. line the dose, data? data that incrementally

Troy Wilson

question, Peter. a it's Yes, good

to still the such rush, are it X ultimately still we're This feel ultimately a conducting we at safety is question, a we of maybe though step really So study. all to have a is both we're but back We study. good for window pursuant to is a safety Efficacy safety endpoints a in and remains Phase like first doses. even a tolerability, foremost your right? registrational and what first looking take part

them PK forward dose first as at is sharing to activity, at and We that between needed, I to well that either been to have and potentially looking as so exposure, with markers and ability dose and think We've foremost. pharmacodynamic looking the move clinical we're you.

in get of the You'll it line. a glimpse top

more a much at get ASH. picture You'll fulsome

combination. for it was Jonathan's feeling, as I question, a experiment and to very We're potentially monotherapy in it's think run. response the said, I a in setup nice right to

XB to the block of inhibitor, rare, differentiation One of We lines they're couple cells patient means is interaction, necessarily but are learned three that And leukocytosis, start periphery you which learned they the in or doing transitioned of into we we uninitiated, weeks from for XA programmed cases you a is like actually look -- them die and MLL going it's progression. go leukocytosis see we've the we've they periphery the to see it who's things see syndrome a the an menin there live like to prior on failed that What the is therapy leukocytosis. you four then up. progression, and looks do they to as counts that's not moving can we've see begin are have exactly a off. in what to when

that invaluable So and monotherapy about for success of in as then kind is setting thinking and both up a combination. learning, Peter,

trying combination, the to really maintaining If you to very remain enthusiasm I'm course. your start to from? just question, ziftomenib, We sharing potential the I'm need to looking about succeeding understand, in coming see the combo With encouraged continues. you respect steady things for a in we're of element hopefully it second the forward is data. part okay, which and our of

data their this look with We the hopefully And gaining are very FDA the much Optimus. forward to Project alignment. sharing in living we and very, experience

monotherapy I line potentially medical at the to up meeting idea we're the and be top and combination be to think we'll set path a data forward very position be here support in come as presentation ultimately able to there's a that well a the strong a in good best-in-class.

tell. will time So

Peter Lawson

so much. Thanks Great.

Troy Wilson

pleasure. Our

Operator

Thank next move on you. Song to Jefferies. Roger We'll with

Roger Song

Xth been the you're alone, in clarify taking the maybe patients profile you RPXD that just May have case couple RPXD additional maybe just question. you on decide you XX from to imply a already based in of -- May all, the so Thank clarifications can so enroll you the arm that's that seeing the you Troy, said Maybe see Great. first I what starting for is time?

Troy Wilson

here originally to XX the as be to this. then enroll with the FDA gave FDA flexibility very protocol went. in to different to of cohort, The and the Yes, patients the Roger. agreed either depending each data going on two was enrollment us the the way at And I'm doses to on continue

so we where to want completed we've be the to that that. of in feel enrolled We've patient what is continued the respect we've this I at the give you point try and optimum to said once to that recommended X the we'll and dose the we've close gaps the on we the if choose risk, that And to question, the Phase obviously, But be earlier direction try right any the at is done patients I momentum program. to or in enrollment my clinical words to data want the the for for will. we you believe dose. assessment, every carefully maintain chance exactly nearly And trending come enrolling able XX agency, as we response out that alignment. back both benefit tell to benefit best for have their

Roger Song

you. Thank Excellent.

in question and Okay, to but have that include now RPXD what FDA regarding decide kind the you discussion got next package? final or related to the have any any kind patients, of of -- XX Understanding package? data for your with want kind you you the is having And those this analysis advice regulatory of data interaction.

Troy Wilson

that's question, very Yes, Roger. good a

Xb they three out include very characterized terms And exposure. study, any in at support coming were for recommended would So benefit other at we as of have kind the when safety the PK the as we the changed. the columns efficacy data X far what is on were there were of want the agreeing with has And clear discussions assessing the as Phase to then part Phase data of Nothing appropriate feel I risk looking and we of what risk. and that benefit the of Phase they in to Xb of FDA dose. data, tolerability, design help

at guidance interactions Where regular get again we on the that the have ultimately package. and we to is want changed to this be nothing are included has able registrational don't has specifics, right? all. that FDA, a expect sanctified, are I be into data but We in These be to will hope with patients

So out make vendors, as the out pulling data to sure we're have it's as clean. pulling we we're the of of it site,

submit to or don't exceed. of on make suspect they ultimately think for to the it with going is they the their were data. to We're going package. answer looking instructions right? all a out. We're now about company kind have Roger, We information to that We and of in when the cutting we'll So Phase for excellence, FDA found going between to is we're further credibility, and We'll intend ready that is clear that professionalism as it collaborative level the they them sure change, they of maybe or meet way. ties But hoping of I very can to that. on to team we as way it need the different provide we every looking this be analysis Roger that over that. what clear dose. they you additional planning then FDA for. question do or any to X does, And might recommended we a very the help possible. they them prepare support scenario deliver be also any move this to to they I questions through have, they're what at other have and be as all need our is Do look want Do way? the and This any get efficiently

Roger Song

dose this or of on RPXD good. the XX very data the very part XX from maybe patient last one. not optimal requiring package that's for quick patient additional Great, Yeah, XX patients? confirm asking just not Maybe won't or additional just those this to be FDA

Troy Wilson

Yes.

the the every here. clear, to patients, background any But the the we're to of every FDA over are want the back jurisdiction I'm XXX milligram let's We'll So course just -- they work XXX with believe provide FDA the the there needed. point we're right? you're rely them. who Xb whatever study, to patient going exercise, had share in. we to population as So legal on be cuts. if not dose to to safety safety comprise them can what's asks, Phase keep expecting expectation and of and not to be that that Obviously, it they updates, FDA The ask. on to pertains going at are additional XX my to doing Roger, data to going go with needed. And ask But particularly going comply, obligated safety, as but milligram have that's has the updates if

Roger Song

good. Very

great. Okay,

I think that's Thank it Thank you, us. you. Troy. from

Troy Wilson

Roger. Thanks,

Operator

Thank to And Watsek next Li Fitzgerald. move on Cantor you. with we'll

Li Watsek

Hey, much on questions. now occurs for, I May in guys. you syndrome, question differentiation in we August, one early enrollment typically in for mean, and that guess taking know you know, Thanks so guess treatment. I finished my I ziftomenib.

So, doing I to us there's risk now for cases? less for serious that, seeing, guess, is it like, guess, I safe

Troy Wilson

I'm glad asked you Li. Yes, that question.

so The keep DS relatively to to continue revised rare the you are it, enroll DS -- than right, But and What syndrome syndrome, this the And be that do. if now has remind And what So AEs, programming it's mechanism guidance. our to implemented of to on you're some cases the along leukocytosis cells on was been At hold trials are to do of the DS differentiation away it manage our grade the how severe differentiation revised see and in mild differentiation to just we of to is that differentiation related any around cases will. at see – is case to grade of with experience of been, implementation exactly from partial prior clinicians leukocytosis it's year Li syndrome. to the them are earlier goal our where everybody, as investigators, moderate, provide point, infrequent. clinical we try tools doing you we a were goal a guidance the severity to keep grades. although one, two, the the we kind syndrome. or appears to less this more it

expertise physicians the learned experience who I the successful how the a to and we've what for it. to of the more have the understanding and think -- It that a on. for example, the an have look of facility took with who lysis lot while and syndrome. unlike greatest drug, the we've with seen, not been what venetoclax are ones for has develop mitigate to course, investigators most gone in We've trial as tumor and for

one say better certainly into means I less combinations but because of severe would like of DS move right to cytarabine So only as should not direction. also perhaps something frequent, agents, Li, the are that's seeing DS in the provide counts. certain less that's less trending way as get and of is mitigating only, cytoreductive with That we we managing a

to as So at what we're this as the track good an in the not than I if that that's competition, that right on trial, arrows optimistic point, arrows the it’s are be we're direction. but our better are think ongoing going

Li Watsek

Phase mean X, mentioned great. you I color. you TP you've neck my from combination. I current the seen and is head I the for guess, I study, activity. preliminary, guess Okay, Thank guess some about question second

so wonder guess so that? real? seen us I what I Can You present [indiscernible] give data is? have you A, what that I you what a far that later a is a of little this know, sense the might, mentioned you expect? you guess, remind we confidence the can And should I some So bend maybe you guess year. on gives that benchmark if you activity us

Troy Wilson

Sure.

another question, So three question. good part

each in Let them me turn. take one of

here, several inhibitors combining me and this MAP and PIX By pathway PIX the to on been in typically, kinase pathway large, of at different successful the overlapping toxicity. is not MAP for kinase and long So time agents. worked a we've the pathways due and industry has and kinase me the worked we've kinase around -- others

we're on is more equally a intriguing tolerability, are usually safety by kind So only first point the big point seeing That's activity. most -- you good at I for so as that advance, clinical have predicting safety fact where because in the an wasn't seeing so early are and stopping that models foremost, amount the important encouraged as the dose a far these we're toxicity. and and combinations But evidence where we we're seeing at know pathways. escalation is a we big what perhaps remain that's of and think of and I tolerability risk, greatest preclinical We're been assigned of would clear. profile acceptable

tumor endpoint. we that? will, you So clinical the mean what that's, do if by Well, regression that's

mechanism, talk that Now data of published. proof about recapitulate when we for patients examples in we've the a really what we're is looking handful that preclinical of

you on and it’s The see alpelisib the PIKXCA-dependent. see each in four in activity can on head HRAS-dependent our combining cancer. subsets synergistic two presentation, and of website, available You neck AACR two the in and the our tipifarnib presentations it corporate

trending you really in synergistic activity all PIKXCA see inactive four I'll right seeing Even in early is just subsets. disease. You early remind population, our and evidence drives that Li, direction. the is that some escalation, tipifarnib the in we're across And pellets stable dose

taking reach update term in you're direction. response, regression, potential contrast to that's a seeing would keep way I we recommended seeing do would That's look if dose what Phase tumor recurrent an the the proof-of-concept, what that year. schedule you So response, an next closer later I you would agents XX% in for and right existing or you're care what's success the our threshold in of teens, provide neck. responses approved question mono three final this be to in of standards objective, metastatic the kind the your able Keytruda know, if It’s to are of But forward, combination think kind relative of Opdivo, the the the about to head That's to of you're above, trending usually as in Erbitux, think that you that right the in therapies think middle cohort proof-of-concept, threshold? data range as you durable confirmed as and you ORR. if with range proof-of-concept of So about we you're now, XXs. this and year. until view, wouldn't such data then the Cetuximab and the X can for they low get and in right probably maybe is expansion a

recurrent If big of And with remind neck. and up would you allow we you XX% regimen, better think an metastatic to us could that a to deal. head do potentially to treat oral be

Li Watsek

you so much. Thank Great.

Operator

to JMP Securities. with Thank on Benjamin move you. And Reni next we’ll

Reni Benjamin

more off afternoon progress. the good of handle. trying to congrats strategy? again. the for you have confirm them and give a Troy to decide looking better and on RPXD just the a something oriented, your And the you should for sets to it's everyone. with RPXD Hey, kind you Are right? -- that of -- like go this Thanks get them taking collaborative starting I'm both the just you FDA the data more what questions review you selected? Maybe go Or forward be? So guidance are effort looking forward for

Troy Wilson

the appreciate looking let looking going that looking to seeking to recommendation agree question. our -- input, We're them we're We're ball I FDA's making jump hopefully do give will. a their them of, FDA. with rather for input, sort respond that. but and Ren, to you going not to for a to Yes, we're it than if for We're FDA We're analyze recommendation. not and

the means to needs agree agree FDA everyone, plan, have remind to dose. Just they to registrational with registrational which any with

combination them to and believe data do safe we we're is specific of to address the the to starting that is predicate portion here way or put pursuant study. Project seek any we the their question, questions. efficacious this your That's it. so to registrational here's study the KOMET-XXX Ren, Optimus, any is the And to will supporting But and dose the what starting and minimal feedback intending

Reni Benjamin

then the completed? And that? talking as of that the a subsequent this registrational of it. like will you in -- is Or kind discussion about this after discussion, study Got on be and blessing part FDA getting is

Troy Wilson

No, you're absolutely right, Ren.

one your options. option it's in So

in the monotherapy. path as gain study registrational to look alignment will We a from the forward the on FDA

Reni Benjamin

Perfect.

TXX specific [confer] that are -- seem resistance mutations lung just about looking or the I be by typical real resistant be current exactly have type preclinical sense started. Okay. to -- think from a a And it's of do will -- little that the quick XXXS work, the for to (ph) gears impacted seem that study C tipi? we’re mutations talk recall switching like to what I that to TXXXM, you bit mutations Can you how then OC.

know kind of a Just ctDNA measuring for follow efficacy, that you're also sense that about resistance? use to biomarker to get And going then can to be you trying a that? but biomarker as a as I

Troy Wilson

Yes.

good really questions, both So Ren.

of question actually that population Osimertinib that another osimertinib you we've drug from if and we to it's tolerance is But then that redifferentiation we they developed take able This inhibitor resistance like the better and redifferentiate osimertinib. signal XXX do don't transduction And working a as And reason be And this -- KRAS the signal various right? [indiscernible] across of a of that Ren, them some there's the kill the or the of the cells which of like they rewire, of the targets. don't then a mechanism redifferentiate are are they you those one EGFR for that can farnesylation with is XX-years they asked hit question, seems presence what one away be gorilla, for step to the often into have osimertinib, off in there fundamentally -- drug you a is inhibitor. through is farnesylated don't we're the for what in kill. happens sort get and is a myself I've to PRs? potent with. tolerant When actually called mutation evolving even that Why a dependent. So been sub one CRs potent let's and cycle why the part they way they've just A, once been also you reason why presence a to, example, reason asking drug -- see I've EGFR osimertinib The for cells. is you inhibitor them state are cells osimertinib is potential just protein, started see and When row second. pound subset or transduction -- tolerant of proteins.

a entering cells So from is preclinical drug osimertinib, tolerant of the you tipifarnib, in plus says happens you prevent osimertinib those what state now when drug combine who data tolerance. seen patients haven't

susceptible become to they osimertinib. So more

it's data Now that's it’s we're clinically way EGFRs, possible, -- suggests appears I giving any have and context be able just that other some and you'll tolerance it BRAP and later inhibitors, CRs, sub population to inhibitors, not inhibitor, -- a but to of year, appears see EGFR potentially if we cycle you're know there you're preclinical EG drive to chance itself resistance. -- don't develop inhibitors going preventing in you're to this and sit it manifest the we some resistance, drug potent you're not preventing drug this onset signal delaying because ALK transduction therefore the

is it got to resistance the the hit before happens. you've key So

other month advance of or go PFS think of farnesylation ones the increasingly what this it's huge a XX is of for dependent not that long. is wait We're OC the tip would the it’s patients. do the encouraged XX the iceberg. big is significant median the pretty iceberg, that just the but The most you've too resistance molecule tip, multiple drug is that's until of you you And targets, the drug I to across a a dividends trying over way next tip therapies story be sets and but a which up tipi only XXXX will true course, pay we're the month waited be years. take going happens, tolerance five three, that's two, as this, could OCs small really greater hope beauty work, the If of four, it, is phenomenon XX% to

Reni Benjamin

you're as to be because on no, particularly focusing it, what which PFS for Got go would decision, leads too look median it seems me like long? go way to for, going a

Troy Wilson

no. and Yes

winded in I'm your long that answer question. ctDNA you didn't me my reminded I So sorry, answer,

to ctDNA, tumor biopsy, is can is for the what can this the disappearance you investigators profile you call it allows solid clinical the everyone And tumor based, have blood both do do mutant the DNA. and else understand be will at do circulating on to So a looking watch ctDNA its you you of don't allele. we AstraZeneca

is I you it's direction, So that But it's is at in of to I if a going ultimately think negativity, acknowledge start to ourselves a it's looking MRD And -- want looking both accelerate. where we endpoint asking be other clinical upside And is will the we're for provides in if The over long benefit XXXX we significantly and We're Flowers gauge OC -- of has recently a we a are Officer, the retired to will instances osimertinib ho Ren, the reemergence opportunity really instance. question, and huge of one the very get Chief this potentially and also Ren, PFS. for a osimertinib can that -- better can right There combo, alleles. be we Strategy be case go Officer Kirsten faster. an Corporate Chief think, you go to of to Commercial even PFS -- this downside watch TXXXM, kind where will, equivalent way the resistant in to things endpoint. AML right alone.

forward come the to menin long update. and side drug and a -- can of So or on alongside to idea. HRAS of a And to eight proteins support would rev but way go of maybe months drive the time I targeting proteins, that tuned that relapse example, going on lot would extend targeting It's help that, XX-months. out year for other from probably of more we've uniquely KRAS, It’s example, from say that now you XX-months a just next look farnesylated such median to the family this it preclinical you, resistance. this story. there, early six whole work could row we to take nice go sharing for stay

Reni Benjamin

one you guys with but your you don't continues I and Do you like mechanism any partner Alzheimer's necessarily to There's action, of, in do there, any branch more question the guess, popularity. of, including like. I out know We're on I'm for of it. this discussions? inbounds FTI Translational papers, have that kind kind gain different library? kind BD to curious, focusing interest, have want and neurological us. in more in final noticing ones, especially of to, diseases, more Got

Troy Wilson

The of California the relating so proteins provocative, that discussions, installation. Ren. to are yes, of Santa So, an out you're tau to for University I very the don't want specific Barbara speak describing to papers and in

brain doing, penetrant One XXXX, if it things blood -- know is is brain that the XXXX -- colloquially blood Ren, penetrant a of I we're be barrier don't just it's could FTI. I'll but brain say

let and in The number yes our you from FT insights you needed a they osimertinib the of expertise, and drugs they So block molecular this show and biology [indiscernible] collaborations discussions. to that Francis came which have Burrows the proteins have of know, People, not came can sort case the partnering with translational who farnesylation you me talk needed Once you you show ongoing. hammer in team of we a France, specific us really into huge provided. X farnesyltransferase.

that. of examples other have We

stay say tuned. would I So

Reni Benjamin

taking Thanks questions. Great. the for

Troy Wilson

Pleasure.

Operator

Thank we you. Eva Cowen. one, will And Instructions] Privitera with next take [Operator

Eva Privitera

Hi. disclosure data? include Thanks for exposure the will also it that mentioned any for Or zifto. MRD status? our you topline taking include us the upcoming I to know composite questions. previously had it will and Back of you CR. Can remind PK if

Troy Wilson

thanks the for Eva, question. Yes,

far CRC -- rates. expecting the So data, as CRH, the as we're CR, top line

by determination. We frank -- but made seeing, just a very where haven't be haven't what one status. we're encouraged yet We're to MRD on we we perfectly that's decided

it in it see you'll top ASH. don't you line, If the see at

line appropriate ASH. more more think for the of I a and for fulsome appropriate cut, data PK discussion at that's top the exposure a clinical isn't really probably

then. until off that hold probably I'd So

Eva Privitera

by And genetic Thank the Great. will you. broken down subtypes? be efficacy

Troy Wilson

it line It Yes, will ASH. and think see in will. both top I it and in you'll certainly the

Eva Privitera

Great. Thank clarification. just point more And of you. one

you had cohorts from counted that be registrational XX registrational your the can data? subtype. those the the patients in in to mentioned genetic of Phase Would this RPXD, each XX in at for addition be You since expect patients XX remarks the each the for Xb to

Troy Wilson

Yes.

are Eva CRH to to the who So patients is, we're that of right? meet of to That's out CR, that’s And to we're need patients a literally this been rate genetics. the think XX two The falls the going that XX% for. the up the criteria rolled XX% mix have have XX question I aiming focus. point inclusion, for to

we're cohort. to allow But XX trying will to won't to total count can. as many them. we XX you FDA We're -- approximately as in need know get sometimes the to we patients So get going obviously out knocked patients per for or

just that's on oftentimes, we're two just to you'll to this of But The a happens. of you our -- question activity way we planning best to is cohorts. answer seeing the my equivalent are So we ensure think say, of way that saying. overenroll -- And sized to that bit between related running genotypes? kind that similarly

So something, that should getting without tell you the into right, specifics.

Eva Privitera

Perfect. That's very Thank you. helpful.

Troy Wilson

Eva. Our pleasure. Thank you,

Operator

Thank questions. further there no you. And are

question-and-answer today. our Troy over additional President Chief I and session Officer or conference Wilson, any like closing to the back So that to Executive Dr. turn remarks. for will now conclude would

Troy Wilson

or contact Conference Pete, Thank In call meantime, We'll Tom to Wedbush additional week, all Virtual today. you once have thank Grow you have everyone. a And to me. in good you, Healthcare participating Sarah. our Thank number the a again you forward please you seeing evening for be free again joining if Path next the look questions, feel there. and of

Operator

We Thank you. your conclude teleconference. appreciate that participation. today's And does do

You may now disconnect.

Kura Oncology (KURA) 3 Aug 222022 Q2 Earnings call transcript