KURA - Earnings call transcript Q4 2019

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter 2019 Kura Oncology Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

to Spain, conference Investor Kura's like speaker, to Relations. now De Pete Vice would hand over the your I President of Please go ahead.

Pete De Spain

fourth Good to conference Sidney. and quarter Oncology's call. you, XXXX and Thank full-year afternoon, Kura welcome

Chief me Officer; Troy our Dr. Martell, and Dr. Grasso, Dr. President Kura Officer Financial Acting Officer; Wilson, our Executive Bridget on Chief the Medical Chief and Joining from Marc are Officer. call and Chief our Business

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

that, call and turn Dr. Oncology. to the over now of Kura President CEO Wilson, Troy With I'll

Troy Wilson

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

cancer Our better precision medicines with Kura promise longer the of mission help patients lives. is at to to realize lead

our that years, candidate significant we've with Over candidates the past Tipifarnib. five KO-XXX. actively we're KO-XXX, advanced strides make first inhibitor pipeline for our menin mission. our toward We've progress three the We've emerging lead made four of achieved two now second, our preparing our indications in programs, separate achieving and clinic. We've initiated and trial and Tipifarnib, continue inhibitor into drug with wholly-owned registration a we to clinical directed ERK proof-of-concept

from expansion appointment joined company next patients Officer, our and the mutant of taken Kirsten Kirsten team better where in medical activities, delivers us INLYTA renal position also Flowers. leadership liaisons, lead month of This increasing science Biopharma, held United of of pre-commercial organization IBRANCE Pfizer, investment for steps Commercial commercial Array impressive our to growth. we've the importantly, built a of last cell an with includes and commercial cancer Recently, U.S. including BRAF the of led commercial our in phase number she that the the and the breast of for in melanoma in launches several Previously, at roles launch she carcinoma. Mektovi plus Braftovi for States. Chief

begin capabilities been as leadership valuable Although board a executive success only time, and a already our our addition Kirsten growth. on for we required short team she's proven for long-term expertise the to to to build insights and commercial refine has market be and

opportunity execution across Officer. believe I stepped gratified is of together and development previously To who end, our to experience this pulled served also have more very see more closely. now on we as aligned personally our to impact in focus clinical has Antonio pipeline, past drug pipeline. and company has a the an been to him Last having wish President organization the with and served team of track with familiarity the team, him have a sharpen month, comes stepped want we're Martell, endeavors. as Vice for broad we organization. With leader Development, our and success also future that on Bridget our Clinical proven success. Bridget leadership thank lead firmly fortunate this excited announced together I'm our clinical years. transition, Her development She two leadership Chief down has and transition, his deep our lead in as stronger Medical are up working to be operational contributions, We result. had his for as that and Gualberto program in I'm record our to and already during menin-MLL how and felt over to

designed let solid multi-center quarter and global at our mutant our of HRAS highest priority. Execution enroll XX based high patients programs received bring have with trial beginning frequency variant HNSCC carcinoma cell to registration enrollment The allele AIM-HN on mutant of Tipifarnib XXXX. you in neck mutant squamous our complete in prior each AIM-HN HRAS speed is Tipifarnib tumors. anticipate head least with and the Now, evaluable remains Platinum We me therapy. who HRAS directive to up first trial of will of

interim data Phase In objective progression medium to XX% therapies with comparison, months. As the Pembrolizumab, Cetuximab The from of trial overall months. mutant of the HNSCC HNSCC high three and the a trial Meeting survival second XX% of a for range rates frequency free free for line, six rate with two of approved in in response the our approximately to of from Triple Phase presented Nivolumab of approximately treatment survival RUN-HN response HRAS the X with Tipifarnib at X reminder, variant an approximately results we October. in little showed XX% progression

to In new Tipifarnib Tipifarnib Platinum after December, eligibility the devastating on mutant the plan therapy. a potential to as submission address with the approval, for this to application. FDA unmet Fast drug offers the Track to progression patients drug as rolling frequent well the of for with the interactions Track designation drug's The of with Fast treatment FDA support designation HRAS HNSCC for patients opportunity need granted discuss disease. highlights for the for designation development

goal a program data first is package in to Our mutant approval a generate for marketing to sufficient application the support HNSCC. HRAS primary for

of mutant carcinomas met reported to we an We HRAS solid explore year, investigator to sponsored endpoint. that mutant urothelial also tumor Tipifarnib its primary In continue indications. the opportunity and trial options efficacy HRAS broaden to market last September other

data upcoming treated anticipate will we during patients number whom a experienced trial. meeting. of disease shrinkage both addition, X In Several our at presented Further HRAS and of Phase be stabilization. conduct an ongoing, mutant cancer tumor analyses were gland of with the are salivary with Tipifarnib prolonged studies of and medical

CXCLXX mutant of the to discovery HRAS solid offers to the potential opportunity additional the and pathway the malignancies for cancers, expand opportunity hematologic tumors. to Tipifarnib biomarkers addition In in

call lymphomas, Martell. advanced will T-cell over more turn Bridget the our program I Dr. and From to on

Bridget Martell

Troy. In updated Meeting American monotherapy, from you, December, Orlando, robust relapsed a Annual refractory in durable Angioimmunoblastic data Thank Tipifarnib reported showing as our clinical Society Lymphoma activity AITL. and at Hematology of and the or T-cell we

a by rate presented hematologist data prior at response an of Dr. Witzig, approximately principal Mayo patient heavily median demonstrated regimens. a a XX%, and three pre-treated Our Thomas investigator the population objective Clinic with trial, in a of and the

need response a for patients biomarker. an our These We expand Receptor of rate patients, complete XX supports unmet solid development high Additionally, rate overall HRAS enhanced believe of was patients pathway trial a the clinical the who mutant XX% Killer or efforts of with and mutations to CXCL response anti-tumor in associated had beyond tumors. KIR, coupled observed the the in carry cell activity and Immunoglobulin-like these XX%. Tipifarnib our focus data our initial medical

lymphoma poor; comprise XX%. of these of approximately different lymphoma. a aggressive up of peripheral five-year non-Hodgkin XX% to consist and reminder, subtypes many survival patients As lymphomas for all are is T-cell fast-growing Outcomes

the had benefit. none relapsed drugs survival led Although approved setting, several and/or to refractory been in has

trials for the Cancer National recommend these patients. currently Comprehensive addition, guidelines In clinical Network

the T-cell have genetic On landscape another introduction to World new continue, in of revision we led advances the note, of lymphoma before classification the Health of significant terminology. and Organization

the WHO going in we forward As effort latest an align our modernized to terminology classification. have such, with

instead like hear to advanced instance, lymphomas classification For helper Tfh refer AITL. of us and more includes AITL, of of follicular AITL you'll which or nodal comprehensive T lymphomas, phenotype,

in the patients meeting prior our we feedback single AITL. of with Tipifarnib relapsed of target to FDA, from positive least Tfh registration X cytotoxic This preparing XXX now of end will refractory Phase are Following origin therapy. at nodal arm a advanced trial who approximately lymphomas of to initiate directed one systemic trial enrollment including are

carry Here care response independent objectives, all objective patients we rate patients will enrolled objective mutation. two investigate in who response in rate primary a and

Patients our believe will for primary or Each lymphomas of the with can We care of status mutation. independently. lymphomas of origin monotherapy BB and and two the basis feedback be of be X% Care of a turned met null the determine FDA will be pathologic end the has designed that of an objectives could a Phase support the X retrospectively. with Tipifarnib trial as diagnosis Tfh origin Tfh mutational NDA each on in approval disease. accelerated hypothesis of from meeting indicates enrolled seeking

We are half the second currently to initiate expect the of startup activities conducting in trial and registration the year. directed

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

Troy Wilson

potential and solid value the you, Thank tumor range of that the therapeutic inhibitors across hematologic indications. of biomarkers CXCLXX to have pathway believe unlock We a may Bridget. farnesyltransferase

new identify improve a there's currently dismal One cancer. particularly reported interest tumor an activity of high indications the molecular and remains anti pancreatic five-year mechanisms pancreatic cancer is and XX% at need The urgent to drive survival to rate for survival. of

we of association between reported retrospective a CXCLXX pancreatic potential validate year-ago, a clinical Tipifarnib data CXCLXX cancer sub clinical Tipifarnib we've and analysis prior preclinical benefit from continued pancreatic in then, a cancer. expression that to a with in to patients Since additional conduct work of to identify Recall, appears patients. high population

cells. data generated showing production pancreatic we Recently, of Tipifarnib preclinical that can by activated CXCLXX stellate block

second Tipifarnib and addition, combination synergy proof-of-concept decision analysis conduct data These of in for of a line for for further potential cancer. treatment preclinical prior our Tipifarnib clinical chemotherapy our we've support chemotherapy between of setting cancer. the bolster the advanced in data and pancreatic observed the in retrospective with In to models the pancreatic trial

We're this the half and achieved. positive Preparations studies has growth. the farnesyltransferase second to Phase in of trial the level multiple tumors with XXXX. inhibition to by far malignancies observed very four thus opportunities are and of high deliver solid underway in We clinical believe expansion both initiate long-term activity encouraged potential X now

represents to selective attention node a inhibitor Protein well pathway, human KO-XXX established in protein beginning molecule turn Activated our potent is pathway Kinase the let's small or our pipeline ERK central KO-XXX. kinase a a a and Now emerging that Mitogen MAPK programs inhibitor on cancers. our with ERK,

We X believe have dose for KO-XXX identified been KO-XXX Phase a a evaluating Phase have dose recommended X study, and escalation a monotherapy. as we in

single observed adverse Recently, in dose a the serious reaction a however, on we enrolled study. limiting patient drug

permitted remain were therapy, patients we Although enrollment. on paused to voluntarily

on also clinical with trial was FDA discuss safety to consistent the met hold. with We a observation actions, our placed partial and the

expansion models. in as FDA as safety monitoring in of our the with resume to defined amplifications. believe HNSCC study on an KO-XXX pharmacovigilance Genetically to cell squamous particularly KO-XXX trial data, the dose populations identified we in have to working evaluate plan the place. with KO-XXX to the Phase we monotherapy assessment additional based path sensitive and available recommended Nasopharyngeal hold patients a a We're forward at However, preclinical agreement, carcinoma X to XXQXX of Upon initiate monotherapy. lift resume cohort and we the

molecule five-year Despite small the XX%. population selective of Our KO-XXX of MLL potent years than as other and the Preclinical with genetically leukemia, inhibitor the with emerging patients and treatment drug first-in-class is the anti-tumor its data high with unmet for KO-XXX, for has a as of interaction. potential MLL a the support need. designation well of received fusions such NPMX protein survival people recognizing the mutations. patients defined potential candidate AML from acute to and subsets FDA older of AML, for rearrangements in number less treatment advancements drug in myeloid Menin the XX potent is rate orphan protein address as activity

in first the continues refractory dose AML September XXXX, trial of X/X Phase We our relapsed and the KO-XXX dose escalation. and in in clinical patient trial in

recommended a a Our genetically mutant tolerated the X enrich with rearranged goal dose an reach NPMX defined and to to dose later year. MLL this AML is Phase potential maximum or subgroups

approach believe We the differentiated a remain about ahead. continue represents the forward the its We updates AML. to of to with to you in treatment sharing potential, patients and enthusiastic with look months KO-XXX

our I'll to the and call Marc for XXXX. full-year of for turn Grasso that, a now fourth the quarter With results discussion over financial

Marc Grasso

were detailed fourth to you, Thank XX-K on in share-based of R&D I'll results decreases manufacturing R&D by for the non-cash everyone. expenses good brief to $XX.X were full-year increases to and financial million, development for our and $XX.X of million, the development filed for provide activities overview more for quarter companion The for offset Research discussion. the related million for the compared Tipifarnib, compensation. Tipifarnib XXXX $XX.X our you and trial supply XXXX million due registration-directed year Troy, here were in $XX.X quarter compared preclinical for today review clinical afternoon, the clinical of fourth primarily to expenses development call for an diagnostics in Ko-XXX costs expenses increase to prior our a activities invite the and XXXX. year. and

and increase fourth compared primarily expenses million the in $XX.X were $XX.X share-based of million, XXXX. administrative to of and XXXX XXXX for the The compared year. expenses million, for to G&A General personnel expenses the quarter in fourth the $X.X full-year G&A non-cash were quarter for increases $X.X costs. for prior due million compensation was to

$XX.X year. Net $XX.X of was $XX.X loss million for periods in XXXX of million fourth loss XXXX to $X.X for quarter of XXXX. XXXX. compared full-year net $X.X Net million, fourth for the a included million, quarter full-year for million the the loss to compared compared the XXXX million, and non-cash to was million for net million prior fourth loss $X.X compensation expense same loss quarter the and share-based the and $X.X a of for Net $XX.X of

XX compared were short-term and XXXX. $XXX equivalents $XXX.X with Our XX, million XXXX, December of cash as of December cash and as million investments

received T-cell lymphomas, short-term cash, and cash to registration-directed are be our investments has into capital believe expenditure regulatory expenses will guidance. our a regarding updating our requirements We advanced XXXX. feedback operating trial and equivalents sufficient we cash Kura proposed our and find

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

Troy Wilson

Marc. Thanks,

the year ahead. jump for anticipated out lay Q&A session, into we me our let the Before milestones

Tipifarnib the mutant trial directed and Phase lymphoma XXXX, including data of in of initiation of X Phase the first the solid data advanced HRAS registration HRAS potential and of in additional proof and in XXXX. XXXX, additional XXXX, full in pancreatic a T-cell the of quarter carcinomas study initiation mutant XXXX in concept in For of tumor second-half enrollment cancer myelomonocytic a second-half leukemia AIM-HN for chronic in and urothelial X

expansion open and cohort by an of a end squamous XXXX, KO-XXX, and with XXXX. carcinoma for an achievement For of Phase esophageal in patients X HNSCC of XXqXX cell KO-XXX, the recommended amplifications dose

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

Operator

first Our Chang Instructions] from SVP Leerink. [Operator with you. comes Thank Jonathan question

Your line is open.

David Ruch

on taking on David what this hold guess? like, for the is SAE clinical I conditions additional that Jonathan. provide Ruch the just the and hold, Hey, Thanks of on the questions. of you color this the kind any guess, guys, impact color are was, could for I what any our does that first, observed, condition, and was partial

Bridget Martell

the This question. Bridget. for you Thank Sure. is

an the FDA, really discussion confident that You expansion know, we're and trial collaborative as with but move this will it's cohort clinical whether shortly. the any don't or we'll clinical trial, safety our it data we confident efficacy, discuss say that suffice outcomes be we're iterative to into with and

David Ruch

thinking Okay. overall down this you on little bit talk Could you a general in be the how and how impacts combination studies the potentially strategy road? might about development

Bridget Martell

both entity from that, perspective, have a a therapies a drug sufficient reaching studying toxicity, and and we of know dose combination so, safety this the with I patients and a benefit based So, the on new Phase to that achieved any mechanism profile. to we chemical look oftentimes dose-limiting can that, virtue monetary by that combination, be trial have a in goal concert now would before of is Phase think get we the as and and recommended a X of X monotherapy, I

Troy Wilson

-- that just to think past Phase it -- David spoken to recommended we don't is amplified strategy the changes several a dose our we've at modeling over extensive development that, we've to think, were is to been consistent we perspective, preclinical XXqXX patients suggested I all patients. a KO-XXX That this that at by those add Troy, see these an X that and evaluate opportunity the from I did, years.

those the it that, clinical It FDA the identify dose work we internally As Bridget populations, lift we've then way. forward Phase -- recommended X is to doesn't with look forward work this strategy change hold, but do to really in development done need and to goal into need we mentioned, to to FDA. moving a we with is through and though any this and

David Ruch

are SSCHN? opportunities is frontline the thank what moving positive? you neck, for Got cell other from the AIM-HN and talk study and of expansion What opportunities if beyond for and guess, head that, I are expansion it, understood, Tipifarnib kind you. and out steps the could next squamous about

Troy Wilson

good I we're Sure. a things. three and It's guided different by question, think

both We seen what clinically are and by RUN-HN in guided we've AIM-HN.

of we're by then guided evolving the and preclinical standard guided are care, data. by We landscape our of

think the to that to combinations at in point have interest to we think past what clinical chemotherapy, is can You exactly I to a including targeted there, the therapy us. articulate something you immune therapy, various are yet frontline, not with and know, acknowledge clearly but talked studies look and therapy. I and would Tipifarnib one moving in of the immune We're like, evaluating potentially chemotherapy combination it where with we've about agents,

mentioned want also encouraged tumors, level we see to head prepared steps. remarks, whether And the by be with the to and across may research look and it next urothelial, group solid evolution this clinical and Kirsten's a plot well is development of neck, activity group, also that, the is I we in commercial we out are what so, group, as as be we salivary, and as going be as an of to mindful the that

So do say when opportunity I At to have if the in to think move see earlier year. we'll more and point, perhaps that to in the paradigm, this treatment though, an later and indications AIM-HN additional we definitely is about successful. to

David Ruch

and that, look we to appreciate to talk Troy, you Thanks, it. Got will forward later.

Troy Wilson

you. Great, thank

Operator

And Shibutani our question next Cowen. you. Chris comes from with Thank

now is line open. Your

Chris Shibutani

we And guarded of possibly denominator related? new patients think very changes trial [ph] you that landscape of either not [true] on for be opportunity? thinking might potential you eligible much. you the your there, all commercial or the genetic you T-cell Two be just the lymphoma biomarker for would questions, think patients reclassification is should ultimate, at the of when still Thank terminology reclassification, gives clinical that or the the scope about strategy again, your true, same true, therapies, sort that

Troy Wilson

Chris, for thanks Yes, the question.

that the year per patients X,XXX references there ex-U.S. in X,XXX territories. the to So, numbers in U.S. suggest are literature PTCL, equivalent with

new but best is a nodal to the approximately eligible XX% the this Our what just this very a -- the the the of and new classifying is probably your for population. at, biomarker consistent and way of our with actually, been physicians who ways answer treat KOLs estimate AIM-HN so, of of population. to in patient in pathological T-cell study. new the thinking, than analysis diagnosis higher because patients, challenging retrospective we've us, doesn't lymphomas are the question? that's know, that It disease WHO criteria you therapies, the terms different active the a study population classification, phenotype new under little outside it and that T-follicular helps on with guiding -- of the helper be biomarkers, of this entry that eligible Then It's probably way U.S., help it's the change of as to criteria. the again may Does the

Chris Shibutani

I a first No, and a now the of about had you clear patient difference, we Yes. be seem should classification how of does I not and question, reiterated thinking whether know the quarter more goals it certainly numbers didn't some opportunity, to be enrollment, minimum at implications for follow timelines, the that. any follow-up continue a to to which moving or If AIM-HN it be XXXX. could ask we'll for think

Kirsten's new some that factors, additional How from particularly continue I were strategies perhaps commercial tell you are either or I whether with into figure study, any fresh those you questions the potentially sicker place and make us an with in talked to potentially past, trying about Array X table Kirsten, confidence were in you is being Can viewpoint putting versus of you situation think that pedigree the kind a the are Thanks. a that about or how to you have that could perhaps perhaps you you're Bridget balancing of patients Phase out on particularly there valuable. in to certainly something at mentioned give insights with that the those patients, coming also X be able they think the new eyes You timelines? of not. the Phase the voices often have? who eligible with

Troy Wilson

questions. thanks for Yes, the

at questions we but it Operating aspects very we in our with I we to patients to we with so number be kind remarks, have are on we and know, in frontline, evolving in and the it, focused Officer, to including in Bridget it it's reverse, said the may we the take not expanded Kathy have the the partnering that screening company. of of Kirsten, the of -- and -- talk of number only that you Chief is be the in this So are role, Ford, company, with priority prepared it's I'll delighted treatment and reiterate are mindful our numbers screened, study, frontline, about are given of landscape one the impact the at thing of highest much

At you I a more point, can not this lot give clarity. I'm sure

point. and open, and at is sights nearly we site out the the been to get we are say, remarks, open, do the in needed?" to Bridget So into forward again, next emphasize of to think more be Yet has we'll to I screening the team see on and to of better, the get been may try and into in at prepared through two, to really as we've just said and can't come -- and come deliver "How I ways the terrific this throughout extent straggler but it, a the articulated, better only pipeline to look this different of in continue do specifics the of much year of doing lots patients, going to I've value, think, rest going interesting I there point We lots really at the a stronger with kind best timeline of which AIM-HN, I together we year. the not and a entire our if just have across pulled inflection that be more year, of gratified is now in where or do and I'll every CEO but I position terms can creating be -- think it's can team points this have that together,

Chris Shibutani

on It's improved, keep strength bench great an thanks. and Thank that to and Great, trial see we'll moment. Troy. the you, eye

Troy Wilson

Chris. Thanks,

Operator

from with our Van question Piper Buren comes next Sandler. And you. Tyler Thank

is line open. Your

Tyler Van Buren

Hi, guys, AIM-HN, enrollment afternoon. one updates good on I another pre-commercial with had especially on the activities. and encouraging

So, do can response required just in immediately, eligibility and if determined? hypothesis, how XX guys reject mentioned comes would a the take situation you the start it's of rolling long terms you that confirm responses still also can to is submission, you where and NDA and tomorrow, that, can XXth that in are specifically submission null you the timelines, how for rolling NDA that

Troy Wilson

Right.

So, for the question. Tyler, thanks

You've of there. got in few packed a things kind

responses hypothesis. what the Those to correct, have XX and confirmed So, committee. Data needed the centrally null adjudicated are to are you're be Monitoring reject Safety reviewed by

that DSMB the we So notify agency, that public. the both We assuming and are company and on anticipate the we has make company are investigators when then study. that would that happens, will would the information we notify that the the if to

it's gratified to -- think get submission. talk fast about let the We I timing I think track it's just me say designation. of the the to were premature

work in look it progress, advantage demonstrated see moment would and that only clinical and far want that take into available, there. bit a That's lymphoma. that a to activity not too the by you at head you'll we'll execution be I on of and in X, but a keep unmet that I was to and FDA is recognition point push focus think need Phase the future, of to mentioned, we regulatory the continue the that's T-cell our neck, now but advantage in don't medical of any in sort of

trying up to success are when We AIM-HN set for positive. the and is company if

Tyler Van Buren

and population? Okay. expect That's can you're terms cohort dose one the benefit in where you what color you just you a us or dose if give in at, are any this any quick menin non-enriched political responses second on initial of or just sort of And patient maybe ranging also helpful. significant MLL,

Bridget Martell

can Hi, Tyler, for this address I is question Bridget. you. that

in trial. we So, dose of escalation portion an have Phase X AML stated we all-comer as are the in is the It before.

investigators targeting that However, we do certain know a population. are

So, the planned. don't is patients just say choose We we they in dose as that dose trial. escalation, as appropriate their are on that currently it escalation to disclose where progressing will we can

Tyler Van Buren

you so guys. much, Thank Great.

Troy Wilson

Thanks, Tyler.

Operator

Jay our you. comes Oppenheimer. from question Thank with Olson And next

open. Your line is now

Jay Olson

Oh, hey the and from to the wanted on all the your comments at team. progress feedback end new guys. study Congrats meeting registration they the positive on Phase to and leadership additions your about there made patients, I carry X in any either endpoints in ORR the follow-up for of AITL? provided in what be Was the patients color of or the the mutation, terms the the two in primary would benchmark to as all ORR cure who in FDA study?

Troy Wilson

Troy. Sure, the question. for Jay. Thanks This is

but for a trial in agents because PTCL, a in has Helper as name other second-line and AITL, design what of activity with that formerly in including the X% trial expected what We mentioned known used a that independent been so the be trial null as that come that each would objectives T consistent We'll the So, of bit Follicular approved been for a hypothesis. for the two is have refer up with has level of we of setting. is Phenotype, as the to mentioned, a trial AITL future, we an appropriate now mouthful. the

drive with priors, XX% rate. KIR of response objective and both So activity to a see of in the to the rate subset a so setting, if fourth-line in higher patient that's CR experienced want to a displace would median a want and terms We response population that of we're a bar. durability three a XX% to we're has existing in a ability and that XX% therapies, we reasonably XX% obviously level seeing low because mutant the to encouraged,

is of and potential we on the X% to higher either the hypothesis activity arm, you? question, or to null those was support a each help level accelerated the misspoke, an should hypothesis null endpoint, got specific we I approval. guidance potentially eliminate So, would the drive have arms that a displace there eliminating think two and agents, say, that your but the sufficient I null and that success to application for Does be other either

Jay Olson

you're Yes. of you sequence then, you follow-up and commercialization of to manage get of That's various the perfect. closer about you. as all how timing lifecycle a want approvals talk maybe to how And and Thank can you you the indications envision Tipifarnib? Tipifarnib, potential those the as pursuing

Troy Wilson

question, an say the to, great we answer the following and by what science, Jay, you are where a commercial unsatisfactory informed the are but So, we give in are that's let opportunities. we one going we probably to me and clinic see that I'm just following

we you a have up, neck -- the T chose It We couple indications, move offer you Phenotype look and initial because malignancies, HRAS of we that nodal obviously time, and cancer. the inhibitor. this potentially opportunity strategy, to lymphomas several and and following for other back lymphomas if T-cell wasn't more pathway Follicular was story a into from to approval. of So, you they tell opportunity than fast-to-market an Tipifarnib as the Helper could pancreatic CXCLXX on but a been see and mutant ago you phone will that beginning. we into expand That T-cell head couldn't heme second-line accelerated conclusively take years now the almost the potentially of potential

clinical can and you protein tell see data. can tell down that preclinical we and that. of cells, I stellate pancreatic Now, and you data and encouraging message knocked both think We we

So encourages that us.

as things, talking served that light working do well to execution. by to standalone science to what more I over will we this going combinations are give a plan much We we're optionality follow time. strong focus At take Kura think well, and considering other internally to on continue point forward and as which is and on and very as has the

Jay Olson

Great. you questions. the much Thank very taking

Troy Wilson

Sure.

Bridget Martell

Thanks.

Operator

next you. with Thank [Operator Joseph from Pantginis H.C. Wainwright. comes Our Instructions] question

line Your open. is

Pasquale Sansone

and carcinoma, additional so of the terms looking frequency A the my questions guys, also kind trial is what metastatic few from should first question, in patients, of urothelial Joe. Tipifarnib Hi, this me, HRAS we Pasquale expect you of line in for at? what update are of treated so mutation from

Troy Wilson

of all, you question. for thank the first Yes,

urothelial HRAS urothelial was directed at an HRAS at under the not designed fully study investigator-sponsored that carcinoma study, being Samsung that Medical our that by Park It's was Dr. It's Center. steady control. is Samsung. -- So and mutant conducted actually

patients. well can see Again, can't Dr. it's this complete that who in but ours, to is make determination how dataset of published Park's control guide a prepared later later that, one So, expect will many we presented year. things and/or we're more go the so it, the the data Park remarks that a would We optimistic study, bit we be presented not year. to we think this I to but it's guided Dr.

from frequency, reference literature HRAS the at. look of terms about the anywhere XX%, you question that vary your estimates on mutant In depending to X%

of the So, think it's been a percentage urothelial has from Park. of kind dataset to meaningful we'll more I the carcinoma, say full have and once Dr. presented

Pasquale Sansone

so much, Thank Troy. you

on nice. in slide saw mean, I I So, IP from another your presentation very question is corporate your me,

what was can color specifically, identifying and Farnesyl I composition program status [ph] [filed] in your wondering, -- and the preclinical [indiscernible] novel for Transferase success potential provide you of So you Inhibitors, Farnesyl ever novel is ongoing have IP? on novel kind the of what work, Inhibitor any Transferase if

Troy Wilson

Yes.

Pasquale, them So, that you me question. can and things a few I your answer packed have unpack see into question, let if

ability I the insights the we to we've of unlock back we Transferase a So, take if delivered get step on done, biological one to we've Inhibition. absolutely of FTI, the think the things Farnesyl is novel before that

we've Farnesyl was from had brought a understanding do, good not Inhibitor not -- in of what that leader certain molecular a understanding So, to any understanding clinical ourselves we to was settings, offices covering broad reasonable activity. driving that but clear in the when was it active, what profile, to was and major mechanisms; Tipifarnib, We Transferase tolerability the continue that it getting two and Janssen, story of have level Tipifarnib it much, to was this there that's now HRAS but going want don't hematologic able we I and we're previously combinations, successful this assign and understanding the to year. flash no tumors, ex-U.S. the because one, out issue fairly a sort at throughout as we Farnesyl tumors, the both that and was targets. solid to mutant CXCLXX patents too working solid say other, Inhibition U.S. in in but now rational opportunities is been molecular and mechanisms, company molecular did only Transferase patent was really the view and increasingly very as monotherapy, program

planet that an of can are. you to but that alignment took, of here kind -- imagine, get right, as we that With

where that think the things understand there drug at we upon, transferase as understand with point we're even targets, Now, we improve the we a a well-positioned can are as farnesyl Tipifarnib. we and is opportunity,

that at, -- to early obviously I franchise. more something to ours made but formally we make I a developed of very hope is to this in a where then discovery we'll for year out Thalidomide I a So, a and both similar Revlimid very Pomalidomide, a that with to Transferase Inhibition. the I then robust and do compounds, next and and and later speak Celgene and can't the We'd like have one highly-potent this crystal drug we've be compound. structures, biology opportunity farnesyl to of reference think efficient effort, second-generation number initially IMID simultaneously is year. good it's started worked and program say, before, something or really others, is this a I've analogies position either have have worked in we

Pasquale Sansone

leukemia? what of color. additional That's should we update chronic for wonderful. in for me, kind Thank Last Tipifarnib from question you expect myelomonocytic so trial the

Troy Wilson

that's good Sure. question. Yes, a

patients enriching not that CXCRX from driver one a as once and at and well to Tipifarnib T-cell be CXCLXX, as study we of back, we inside data initial leukemias, been Farnesyl X were CXCRX. we pathway, looking or were those and the step because at we should the CMML, at NRAS patients the had the on KRAS CMML continued a reported KRAS with we in Inhibitor could That study monotherapy. exclude that had Phase initially Transferase mutant with established it we addressed NRAS be as -- if run and where or So a that an look into of -- was molecular looking and identified basis add then successful. but We but CXCLXX NRAS CXCLXX and interaction, a KRAS not additional the study, we thought lymphomas, took NRAS, lymphoma, a oncogenes to

that an provide study. on we'll update So,

expectation to Our hope sometime of we second-half of the year. is midyear kind

Pasquale Sansone

so Perfect. on the Troy, congrats Thank progress. you much, and

Troy Wilson

My pleasure.

Operator

for remarks. questions. not Troy further further any the I'm And you. any back call turn Thank like to to Wilson I'd showing

Troy Wilson

Leerink Thank New our you and in We're Operator, all today. SVP of a Okay. number again York. you, at once beginning thank upcoming going for with participating tomorrow in call conferences, be to investor

have have in will everyone. look Marc, to forward many questions, you evening and contact a Pete, meantime, Thank feel please there, to or of the you seeing We free good you, myself. any if and

Operator

Ladies and call. concludes Thank for you gentlemen, this today's participation. your conference

You may now disconnect.

Kura Oncology (KURA) 25 Feb 202019 Q4 Earnings call transcript