Kura Oncology (KURA) 26 Feb 252024 Q4 Earnings call transcript

Company Profile

Participants

Patti Bank	executive
Troy Wilson	executive
Mollie Leoni	executive
Thomas Doyle	executive
Li Wang Watsek	analyst
Yen-Der Li	analyst
Brian Powl	executive
Jason Zemansky	analyst
Peter Lawson	analyst
Ernesto Rodriguez-Dumont	analyst
Dara Azar	analyst
Yue-Wen Zhu	analyst
Xiaochuan Dai	analyst
Justin Zelin	analyst
George Farmer	analyst

Call transcript

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Operator

Good day, everyone, and welcome to today's Q4 2024 Kura Oncology, Inc. Financial Results Conference Call. [Operator Instructions] Please note this call is being recorded. It is now my pleasure to turn the conference over to Patti Bank, Investor Relations.

Patti Bank

Thank you, Angela. Good afternoon, and welcome to Kura Oncology's fourth quarter and full year 2024 conference call.

call the on me are Dr. Joining President Wilson, and Chief Dr. Officer; Executive Troy Accounting. Leoni, Powl, Vice Doyle, and Brian Medical President Commercial Finance Mollie Officer; Tom Chief Chief Officer; and of Senior

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

Troy Wilson

and patients continuing potentially for you preparing patients across which to we've to us. across as AML. for thank ziftomenib in menin XXXX our benefit joining for submit a ziftomenib regulatory best-in-class as first the NDA ziftomenib. to continue clinical and treatment poised generated providing in our Patti, to meaningful We're we all with inhibitor first continuum. development as pipeline. We're relapsed Thank make a advancements delivered commercialize momentum serves And the you, NPMX-mutant to pathways step AML, refractory and/or unprecedented frontline We're for

could the from KOMET-XXX with meaningfully use gained in the in the EMA, commercialization to reached frontline results report XXXX. we've CR alignment trials advancements now in AML intensive the anticipated intensive both and European endpoints accelerate U.S. these accelerated CR accelerated for MRD-negative of with allowing respectively. Medicines non-intensive and the setting in alignment as the or believe ziftomenib on chemotherapy the Agency primary we've Specifically, the settings top-line endpoint can development in with FDA pathways and on protocol. We also approval We frontline by CR potential MRD-negative

data updates product a and for And year. patients expected resourced beyond we're clinical our pipeline AML, throughout and we're value well candidate look with in ziftomenib significant advancing financed this stakeholders. we strong As create to

let's So endpoint, of our achieved from relapsed/refractory announced the turn with in presentation Starting been Phase registration-directed prior The XX% consistent at XX% -- with NPMX-mutant trial a to reports. positive patients is rate. recent with risk earlier CR/CRh updates. ziftomenib safety data targeted consistent month, benefit AML. was profile that, with The its submitted primary news, profile been with to we encouraging top-line The II results ziftomenib KOMET-XXX, for and for ASCO. highly this specific the most have have presented trial

reaching for commercial over you. annually. Mollie, frontline As the a of for be reminder, submitting quarter. believe clinical medication and an pre-NDA AML the frontline regulatory from the BTD these updates competitive we've anticipate ziftomenib treatment BTD, meeting the to over oral We're to turn first and the combination FDA Breakthrough advanced and in Mollie the in to We as Designation the status to Therapy profile tolerability we candidate NDA only AML support clinical unmet menin agencies. a and believe with is be granted in completed safety, relapsed/refractory NPMX-mutant clinical indications, of transformative speaking I'm excited AML. activity as feedback drug in Facilitated because relapsed/refractory over opportunity or next well received menin once-daily review we frontline population billion indications. And with patient inhibitors $X market frontline critical those share of development inhibitors as in market ziftomenib, could a the of our usage well this by going of investigational to as U.S. a to need it

Mollie Leoni

Thank Troy. you, right. All

advances over XX throughout patients ziftomenib significant setting. to And years, despite remains been unmet need always there the in frontline of Our the even has AML the last treat intent care. with a continuum

Specifically, approved AML will XX% XX. is see patients as and first is for of only to XX.X% X their achieve for remission patients AML X-year a as who therapies, years. up The low rate even older survival XX.X% with return than within

the to IC to the respectively Given few as trials call KOMET-XXX our are and MRD-negative frontline particularly within trial call CR protocol. use by ago, through and AML announced endpoints trial allow with we weeks FDA's need, populations. FDA the single a unmet placebo-controlled X randomized, KOMET-XXX. Phase primary addressing non-IC for approval trial On in on were independent population willingness we the III alignment the pleased reaching We we CR investor the accelerated contained protocol a

KOMET-XXX-IC approval. complete We event-free and intend and best because ahead but to KOMET-XXX accelerated survival ziftomenib a combining expect at KOMET-XXX-IC, the and this paving we MRD develop support only remission The EMA to assess NPMX-mutant is we chemotherapy primary with of And unmet trials XXXX. protocol and and Kyowa and By U.S. aligned evaluate protocol, complete endpoints pool. KOMET-XXX-NIC opportunity we're around believe approvals. We unfit X+X patients frontline trial trial AML. We faster care these MRD-negative way and forward on the innovative in under in extend looking U.S. funded of with evaluate updates with achieve I'll in and multiple also our the collaborating new accelerated dual menin in work response intensive attractive in to that treatment. now with receive facilitate trial both have in health than with other we EMA development with to that intensive sites of venetoclax therapies also approvals. or the for later more of key and authorities, surrogate to chemotherapy believe Kyowa time start-up may are to expedite that, the and will the with believe year with second that notably potential programs under assess ziftomenib clinical to are This is intensive results survival aspects also the both full this potential we Not achieve this patients AML areas negativity to half dual NPMX-mutant trial, report a it our trials and azacitidine as developing top-line Based and or the stated within will to we newly across a or chemotherapy. endpoint. the ziftomenib first inhibitor across non-intensive is the field full newly have to establish we and now diagnosed potential provides intensive window commercialization to chemotherapy in to full of to initiate survival-based to ziftomenib diagnosed is we the patients treatment KOMET-XXX survival assumptions endpoint gained colleagues upon in study our current primary CR KOMET-XXX-IC FDA global for support will overall endpoints response we options for to patient collaboration on including attempted pleased KMTXA-rearranged will the to combination utilizing working medical alignment clinical and by as trial and our protocol are EFS would The the trial MRD-negative patients. with that to the endpoints, study Kirin goal X broadest single with for turn long-lasting expected in well we XXXX. Kirin of chemotherapy is FTI intensive need. And we timelines Troy. continue over look and it start-up execution support back continuum the AML, the to

Troy Wilson

Thanks, Mollie.

now, therapeutic solid through be Turning between of the activity us delay resistance imatinib GIST imatinib ziftomenib which other Menin the preclinical paradigm mechanism standard as in and GIST have of resistance will and menin shift by the for ziftomenib both imatinib, first synergy continuum. Until in pre-treated to onset this treatment durable track all develop and potential of treatment evaluate and on may of such inhibitors in inhibitor and our offer the of a with The the first imatinib-sensitive resistance the or care with approaches patients drug which the collaborators in inhibition This patients XXXX, or GIST. full gastrointestinal to representing imatinib, to to or antitumor data. the KIT inhibitors of opportunities kinase remain into KOMET-XXX stromal the tyrosine it's We combination supported within now expansion been years. Because transformative. demonstrated clinical trial preclinical potentially the ziftomenib targeted half action TKIs. and imatinib via robust patients extensive ziftomenib described GIST frontline has been and preclinical for data combination ziftomenib. tumors advanced of XX% by and X to a the overcome initiate of treating of imatinib-resistant shows to models, tumors will unique

the will XXXX. believe potential represent the we significant peak GIST, market we're begin Given may half in in additional need which working an we billion therapeutic novel approaches sales opportunity. ziftomenib's And $X and initiate the to interest hard KOMET-XXX unmet the to in study, first of continued believe GIST

could for the transferase lot as adaptive overcome hard a good multiple from of monotherapy our from demonstrating solid KO-XXXX KO-XXXX, body AML, and augment various trial, progress therapies complete. to the other and innate clinical data If as in well of inhibitor has and our inhibitor, transferase We FIT-XXX therapeutic ziftomenib forward targeted to data, drive successful, we cancer. preclinical inhibitor tumor to potential targeted become Now work dose agents farnesyl team presenting our Despite externally on evaluating of the combination antitumor trial. while indications. a of companion classes on clinical programs. transferase to many large focus growing for tipifarnib the remains targeted as escalation and We've been and and candidates rightfully trial a the learned and in KO-XXXX KURRENT-HN our as antitumor therapies look believe next-generation program combination of is activities partners and in of making much in KO-XXXX challenge in portion combination. We're also farnesyl at drug therapies advances, activity KURRENT-HN resistance our multiple enhanced first clinical our now data farnesyl resistance the our is in

through to possible shareholders made funding work All ziftomenib, as AML develop support with our is strategic well development partner, Kyowa U.S. the and announced frontline we in of collaboration November of global the as through expansive the this commercialize commercialization. program our Kirin,

financial program. With team potential resourced and capitalized FDA development submission with I'll to commercialization and was for paths in that, ziftomenib large strengthened of Tom to on Kyowa our for health expand frontline NDA our of to now results. Under reaching prepare AML ziftomenib with call accelerate for accelerated well preparation the discussion and Doyle continue a alignment our partnership to turn indications. approval the financial by we're Our to Tom? our our Kirin, over

Thomas Doyle

compared good you, results afternoon, Kirin was $XX.X Kyowa million to Thank same million compared Collaboration none overview $X.X fourth everyone. I'm XXXX. compensation million a the million partnership for revenue of and $XX.X of Research XXXX. General the expense and were quarter for quarter loss expenses quarter XXXX the million of the to for compared quarter provide happy compared loss Net This financial fourth million our million XXXX of the Troy, of of to fourth XXXX. was to quarter the fourth of for million in for $X.X to development $XX.X our of fourth fourth fourth of quarter non-cash a the the to $XX.X net includes the period XXXX. million were of and fourth for XXXX for share-based from $XX.X quarter XXXX. for for of the brief $XX.X quarter fourth compared XXXX. for of expenses administrative XXXX quarter $XX.X

as program XXXX. million $XXX of XX, of XXXX over payments with to AML combined with that, of short-term compared cash, had equivalents XX, cash XXXX agreement the that will December call operating in Kyowa turn Kura December from Troy. of frontline be received to cash, be the through I XXXX, our setting. With $XXX.X sufficient collaboration upfront cash plan believe fund We equivalents ziftomenib December investments and As the back into as commercialization should to payment short-term XX, million, $XXX Kirin including investments and to our million now and current support of under Kirin combination anticipated our Kyowa our

Troy Wilson

Thank you, Tom.

jump session, question we upcoming me into let Before lay just quickly the our and milestones. out answer anticipated

we expected medical for XXXX with our forward this several look every year. read-outs data and programs. updates expect research, across pipeline to We robust meeting year across multiple be major a at of Notably, pre-commercial providing development to the company activity potentially

the trials present from expect frontline the intensive expansion inhibitor QX; development AML half; imatinib medical venetoclax AML we half; to X the in from at Phase for KOMET-XXX for first at data the evaluating in non-intensive NDA in candidate top-line meeting the clinical and Phase in present and initiate in use evaluating ziftomenib meeting next-generation III in data in NPMX-mutant cohort in KOMET-XXX Ib in a preliminary trial azacitidine relapsed/refractory chemotherapy half; with KOMET-XXX second ziftomenib Phase expansion advanced evaluating mid-XXXX. cohort second menin with nominate intensive the For with registration-enabling independent GIST a diabetes medical in QX; initiate preliminary data in and patients submit clinical KOMET-XXX an present presentation for ziftomenib, Ib and a ziftomenib QX;

the the second patients head KURRENT-HN programs, cell we and ready half; the present in cabozantinib patients Initiate neck half. And cabozantinib from evaluating with and we're in mutations carcinoma the Phase cell of with cell following from PIKXCA-dependent transferase data milestones. dose I cohorts the and and renal I or For Phase in half; of our with with KO-XXXX second the finally, in from tipifarnib present carcinoma carcinoma second one first in RAS half; monotherapy questions. patients present the renal expect evaluating expansion data alpelisib Angela, the of farnesyl escalation the KO-XXXX inhibitor dose KO-XXXX in in and trial escalation advanced more that, in squamous now for portion trial data

Operator

with [Operator Watsek Instructions] Fitzgerald. Cantor We'll go to Li first

Li Wang Watsek

you the top-line in Troy, intensive frontline guided III to setting XXXX. in Phase AML

the share Just or went on that can enrollment curious that plan into size, what And assumptions you guidance? trial timeline? anything

Troy Wilson

we're and Yes, that's then comfortable. and particularly by because we've for Kyowa and context EMA, being being just and we we both driven we're trial approval clintrials.gov. of approval some give that with timeline, authorities. powering was and XXXX. We'll the it closer us asking detail the think and do both hope results only that on going -- saying feel to questions engagement question. how you forward our endpoints. people sizes, give idea but the funding Li, a think for well, about, But the with posted prior accelerated with you're cetera, for the potential et intensive what specifically year say than accelerated have start-up. the but in of investors more we're we've later Li, on updates, thanks now well doing endpoint it look refinement but then meaningfully positions we for would we study to accelerated U.S. little being We can been both and that's analysts the pathways to some for survival-based to the the top-line the we And conservative, helpful. trials non-intensive bit on And that trial Kirin process the to obviously, We the getting that as received FDA gained get important alignment the I of from get health the in trial faster as on feel is live projecting collaboration. I little size, FDA both further this that not in a more the powering, comfortable we thought under the the in were we actually

Li Wang Watsek

just feedback before submission. meeting? work the items you the through from what need the NDA that then And Any understood. Yes, remaining notable may wondering to pre-NDA

Troy Wilson

is submission few the actually don't weeks that's of -- sort know not the at Mollie the made you and -- team now again, the team did is been constructive people question. we it's anything with agency gotten the very if we've the point. doing FDA, BTD those monotherapy, that accelerate announcement given mean, all of deliberate engagements ago, we The guiding the we've not far, that. if if everything the we I we given at after and were interactions pole gaining that that pretty with need very the have that I until we're but feel read -- of the a time And good clinical We the in thank I in a next on for of meeting. over again series in tent, combination to a the we the But a like had No. saying we're this we its in on submission. Clearly, alignment had question? have that's phenomenal of everything to we've is aspects power data pre-NDA shape. long timing in timelines. with setting and constructive But go and only what second the submission. the team the quarter agency. Angela, on And driving always to so should job -- the think

Operator

Chang Leerink next go with We'll Partners. to Jonathan

Yen-Der Li

This Li for is on Chang. Jonathan Yen-Der

So ziftomenib, that we reason have important you is patients your the the treatment Could stay the that I a on when commercial AML than at year? duration. look variable opportunities for question confidence more guess, frontline behind treatment will is able for to be the first I most share the the

Troy Wilson

Yes.

the -- me to actually duration to treatment the do thank parts. you this our in of Mollie I'm Let Maybe X from for how question. can experience going actually speak we've Yen-Der, Brian -- Mollie, commercial with around would? frontline. KOMET-XXX. she And in does to after on then comment the assumptions translate our answers, that the I'll you how if I'll ask ask into potential informed

Mollie Leoni

Sure.

in frontline general. how has XXX the alluded informative in highly for trial we for expectations been to, handle our and XXX designing the trial to As Troy use the and

intensity transplant especially maintenance. What use the for consolidation be large back with incredibly come after on induction, seeing will intensive transplant, such different, I up consolidation, doing except almost that would setting, periods to consolidation we're for immediately the that who prolonged very or the patient we to are to would induction, possible post-consolidation, patients KMTXAs staying trips post it's we have potentially These away or some population. then in control some some backbone of time are patients returned or is majority transplant, NPMX bit of initially, patients frontline few gaining -- especially prior maintenance. Similarly, post-transplant the coming to then whenever have a used the intend consolidation go differently think proportion if transplant ven/aza, on when off little of get the universally treatment for the and with disease. from when in decreased patient return with either the on chemo used thought even is a drops post-continuation the make and and to to or that,

see use good in each probably initially that how you we're to So you we translating. these Brian, significant over thought. But was to seeing than that, turn what that with prolonged it I'll more of

Brian Powl

assumptions on Troy be stay we time. as tremendous Sure. being said, for based -- in as And are that therapy we've inhibitors the on market. patients potential that of observed that you what a could and or the the potential therapy, observing said, with menin a we with trial, able think be billion it AML we've our on $X could -- -- to get could think think do there's long this we treatment opportunities about a Mollie transform period like of When stated

markets that with be the menin for that get potential in we that duration to reflect than outcomes to months plus with you're treatments to if intensive the patients XX the the myeloma potential and you for then a transformed patients. longer XX chemo XX other and have inhibitor able but significant that we've and in and long non-intensive, of FIT that, transformative think there multiple gives align kind you like receive between within If months, to really really XX population really some IMiDs where months could duration what seen market for could XX of think also

Yen-Der Li

also I Got have to related And follow-up it. a question that.

imbalance study, And protocol combination I chemo concern as each arm? KOMET-XXX will you the consolidation consolidation patient treatment if a transplant options. mitigate is in non-transplant of intensive for there do concern? both correctly, received recall And and such include have So the about like any the to

Troy Wilson

Yen-Der. Yes,

want a Mollie, that. me Mollie speak shot Let let take you at do to Yen-Der's question? to

Mollie Leoni

to think with there intent is get starting transplant. we Well, don't The patients, will always the Sure. imbalance. be KMTXA really an to them

the With likely transplant. can So active of that requiring to to so do and may less of NPMX-mutants, transplant. hopefully, that that the it's be some the better, do they get will it all in patients are arm regards better

no be we've and weighing trial, powered built in the multitudes built population KMTXA that. to the the for the we've taking into on in effects helpful. effects and transplant to to overall arms, ultimately, if active that versus patient of trial, account population analyses have transplant that's the So able assess But able would sized placebo in that account the sensitivity the being the of trial, or

Operator

next go Jason to We'll Zemansky of with America. Bank

Jason Zemansky

encouraging into group? addition survival what what to zifto terms in of benefit? negativity, the would data I additional view combo from be you XXX you on curious, give as ultimately of as in that expansion X+X Congrats Specifically expand to you dose would start you MRD give what the a confidence the progress. from you non-adverse study, look gives risk would -- was your the the

Troy Wilson

answer and folks question. standard Mollie thanks you to how understand ask the Jason, going Jason's speak can we question. take a for negativity Molly, sort Yes. is maybe I'm and minute to as MRD it. think the you what about But to the help of

Mollie Leoni

Absolutely.

the key an to as therefore, really published data population. some MRD obviously, as what leaders really large are this advancing patient from consortium pharmaceutical other opinion we as companies this So the looking in access, we of have understand, of endpoint both companies into of negativity are And pharmaceutical MRD a unpublished amount part we're AML. and that of from those a that for well

for instance. the NPMXs, the a MRD that a bone So with patients, the better that's your understand for XX% outcome see patients about And to we treatments be for available these in to so negativity performing good marrow. current XX% would

to influence XX% well. well would we due XXs mix incremental maybe that and the overall translation MRD any the the survival encouraging be targeted a be agent rate that increase would for and negativity into as having the expect of in in into as would So getting

way the very our Obviously, you've about from enrolling. we do response that's seen at we're as patients So thinking the well to patients continue a data look perspective. these

I looking So pointing make difference sure do see going wouldn't that to the expect direction. at much They're we're to But well. -- continue you're the to to is right in it's as what to, that. MRD we're headed in

Jason Zemansky

Makes what in Got population. quick there active the group XX% the here. it. of sense. mutations I And menin does just individuals? follow-up noticed to it other these to be bucket, what subtypes? a of to confidence, that guess, about I a will And maybe XX% gives that take you Curious, get

Troy Wilson

that, her comments. Yes, and add I'll can Jason, take Mollie then

clinical We appear the call in activity, receiving as only from patients with what but benefit well not have seen be monotherapy we to ziftomenib off-target who studies. patient, seen the other SETDX/RUNXX we've

of of FLTX. there's the the One then in of were gives the obvious AML There's a half course, less look at the approximately is But setting. there, an so areas KMTXA, NPMX FLTX, couple to care if intensive actually patients. of And setting. in course, that non-intensive of and them one you eligible standard improved of

say, to with now safety go you safety appropriate There if the the quizartinib. And and into want a in frontline, the anticipate and tolerability. can adequate frontline relapsed/refractory couple, a of Clearly, monotherapy ongoing and optimistic go we we study both FLTX a gilteritinib potentially We've inhibitor a ziftomenib, study I need into should that the menin in hopefully, can with go notion again, have with that we're one midostaurin combine that a is that quizartinib. to supporting straight ziftomenib and are starting combination inhibitor have setting agent. approved because plus as an you frontline guided we -- of a combination. We

we when potentially Phase structured would require that multiple give with run I likely upcoming funded But deal mentioned could the then beyond what we're -- an as KOMET-XXX we we trials be trials. the talked collaboration trial. are it think III Kirin, is one more So global to with go to doing actually FLTX Kyowa us would the and about and

NDA a move the half. priorities you'll something toward that second there on So at pre-commercial here the Clearly, in much us are activities, moment. of submission, but mind KOMET-XXX, the the I team's think is the at Kura very see lot FLTX and

Operator

Barclays. We'll to Peter next Lawson go with

Peter Lawson

I wonder X kind talk the minutes candidate stand and just whether just and particular kind where of of where a if type type you your it's how the of nomination disease? could fits for priorities around X, few of thinking you're you in diabetes that and or stage the

Troy Wilson

Peter, appreciate welcome. is I expected, but the That wasn't Yes, question.

a So couple of comments.

expansion of cells. All last we of X existing the knowledge, to X Going antidiabetics sensitization American for X. meeting data at islet beta -- of the benefit, of That selective data everybody's various our hallmarks; production, insulin Association the all of put stimulation Diabetes and summer. insulin pancreatic out shows things, X -- those do glucose insulin lowering,

cells. diabetes reasons. IRA The is safety And with selectively very That's did an reasons, holy grail. ziftomenib We the the agent take that of haven't that preclinically wouldn't that's for pricing into forward islet had expands really We get-go. kind yet why we work pancreatic ziftomenib. we've been reasons, clear beta from

If into space been years. chemical different a Peter, to for bombing menin X go on molecule. have going the with carpet in you're go we diabetes, And you going now

that in the way ask we really actually in drug chemical molecules that can distributions. shall with X candidates. To work, profiles, say, partners like an appears So be is wouldn't but one type your put know. that Kura's restrictions clear in the pancreatic question beta those want foremost, to probably It and exploring also we well, if internal specific potentially patients, has that there's tissue our right our of with cells, in today of question, have be diabetes that We first feel work here with -- strategic on is islet do one for reservoir different different a populations about PK interest have applicability. What with and created value shareholders, work investigators X. good and KOLs what We our we but some there on to way. know there really both for and based type is, we certain, we to right lot have

a we know know. We company. are specialty We oncology what

Phase can in you initial -- preclinical to you initial test we that If running at from get could the a us hypotheses. get-go work company the the those work, that recognize invested some be do work, but going global do to quickly IIIs we clinical some of hands into required large maybe is to see be need that pretty we diabetes, the would

The So creative are one matter. news can do of that. is lot chemical the we have good a ways there

I And have due today, At as term as good we to as an with good to the call question? take drug-like go time molecule, right the oncology our Peter, of we going a is us not right anyone the the milestone because is right potential our the want diabetes. Francis molecule, on about the understanding and nomination have and distance. Does the in to CSO, that inhibitors menin you to nearest are the who candidate. to think We're development -- on the moment, Burrows, the demands we therapeutic therapeutic that has properties answer different your quite want window. index a than have have

Peter Lawson

that's diabetes of yet something I of what's you a of the kind guess great. the capture kind there potential forward so dilute just me, not in right like yourself? route breadcrumb Yes, there upside was for

Troy Wilson

what's -- right what? again, the Peter, say the What's right that

Peter Lawson

about around JV it What's you there? How right you upside we a think oncology? your Is kind don't strategy focus partnership? capture lose like yet of so the should

Troy Wilson

Yes.

a few there. So yes, I things mean, understood.

is cleanly I shareholders. that you want mechanism want biology, the from the illusions Ideally, don't for decade the for a a IP, flexible action think -- captured the think could value Kura royalties oncology be are This now. to to the Kura diabetes make from allows first GLP-X. But that non-oncology. separate and you to in I importantly, since looking under we're novel shareholders make structure out of you that want you the certain

how thoughtful be to want we we it. So about do

that fast, very structure way either things, runway you Peter, to ideally than You look allows do again creative in et allow to forward would that other -- allows take may and you really buybacks, or you stock monetize a that could more ideally, for go you one IP look a cetera. extend molecule to to

have sort wheel of There's news this inventing But that fortunately, wheels you'll is see here. good essentially to -- is not we're that on -- those demonstrated the themes are been story. call option at. And looking the So a work. this we're lots the the of

this year everyone It and it's at let think best would AML be to and really our is we into wouldn't we we clinicians -- this as a of hands if test the find clinically priority for hypothesis. do I Kura patients that. as interesting. But be way them doing not we knows in and what high scientifically really need the a get to didn't the in

Operator

We'll TD next to go Nadeau with Phil Cowen.

Ernesto Rodriguez-Dumont

will This with for have Phil. I is -- [ Ernie X I ] Rodriguez questions. start

First one landscape. competitive is on the

we presented had and menin how landscape expect results hand the were differentiated the think from other -- Now you out? from ASH, KOMET-XXX you that or be we how to several others the zifto see have do do updated or competitive playing you data from at inhibitors that ultimately have at that

Troy Wilson

do refractory we're space. best but with and zifto. can opportunity there's back leukemia. relapsed with NPMX-mutant the big competitive targeting an the in for be mean you brief what the I question, we'll high And -- Thanks very hit that we try Yes. we're points. to patients be that's That's think If going very a we and for to to maybe to question. go so

of staying think combination. the these you physicians key. on daily ven/aza indications, going tolerability going factor is for need with say the to intensive will can. patients is to away, of not early the in you, said, to treat ven/aza. as that? to periods but the need of are best frontline Mollie away, has on both many Brian that to combinability good ziftomenib on look and non-intensive is to is course, they it the they're day remission is as or therapy. Regardless fallen day prolonged may what ziftomenib. you keep with physicians NPMX, treat fall be you who long I large As whether keep clinical And very remaining XXX to when are also the It's you and backbone treat of safety, is in and in you transplant. Why to dosing compound convenience believe the patients on patients prolonged in has talk therapy case because, you give of those once-a-day to get-go And as X+X patients has say, is these Mollie stay echoed, and activity, as heard to and for for tolerability. the in in touting them periods We've allowing to been time. of meaningful you out, That for from study, The with backbone a allows do but and these ideally, What patients toward time zifto going this these chance continue our intact the the that

clinically once-daily no a no interactions. We prolongation, very to drug-drug easy It's have no use. meaningful myelosuppression, QT drug dosing,

we folks when would ziftomenib listening, the That's investor differentiated ASH you around that Dr. really be with refer chemotherapy how may commentary who his intensive did patients. gave our the being Zaidan see event to the For from after we presentations, competition. experience I

Ernesto Rodriguez-Dumont

population. very the on in XXX resistance That's Got the And onset mentioned it. on pipeline, delay have you to the earlier GIST, that of helpful. potential

the future, come to response of in the from us as we be looking data look duration the or looking to do it forward out? at for ready it's once -- clinical at data relevant the should more be the So how to we is we aside ORR

Troy Wilson

speak question. clinical that are with do are Yes, imatinib? Mollie, looking for evidence that's good ask a you clinically? a to What to the What in study just you and ziftomenib we XXX combining we me activity question. of I'll let And terms the can summarize looking in if of

Mollie Leoni

Yes.

very could could what would very several think the we confirming we of there's So combination be and each positive I different think see things and do.

For only those patient we able is patients and response to that imatinib. to dose response to deepen but of that partially. and the that will can that we of are are on back the imatinib imatinib response. do and starting this be get into you at Most escalation, to most we're Patients seeing something respond so fail, on after a that save imatinib, finish certain the exploring points, if hopefully, patients

You rarely see a complete response.

of So getting then referred you obviously patients to, response be into also complete would finally, as great the importance. And durability. a

progression-free a these to that prolonging usual able having backbone. with X the good a are on TIL stay good imatinib So patients drug resistance that their response, years of duration survival,

for So looking once those the responses, the are they've with lost time. I'm to imatinib been deepening responses the X of periods of areas that prolonged responses then to; saving maintaining and imatinib

Operator

We'll go with to Stifel. Brad next Canino

Dara Azar

Dara Azar on is This for Brad.

to development, regulatory MRD you maybe entirely frontline trial on the opinion the And XXX endpoint? this. approval? a after different expect as how on conduct tell do you First, than FDA have to EMA different more do an support And on expect global question us have to a a negativity I

Troy Wilson

to take are Yes, good questions. those X those? would like you Okay. Mollie,

Mollie Leoni

Sure.

FDA successful remission. very the MRD getting potential in that is think slightly for clearly that be of different although points EMA of accepting where recognize and negativity, there's to negativity a significant a these do patients I piece MRD would regions So both be into they at

for think the the whereas the we accelerated to that kind always survival-based is answer do to support going EU. the are approval approvals regions? Does endpoints differently the to intended in endpoints were between things the we what you're And is help? attention I of drawing intended The be to United States, yes.

Dara Azar

commentary. Helpful Yes.

switching ASCO will I match relapsed abstract upcoming first and and NDA your data the refractory, to cut denominators the would between Now and presentation, medical suppose, be meeting over submission? patient

Troy Wilson

take you do Mollie, Yes. want that? to

Mollie Leoni

Yes.

to patient submitted patients pool. the the patient full be will We FDA not to the adding full pool. ASCO submitted we to So the denominator. We

would see of patients, same the you group population both. in patient same So

Operator

with go Capital. next Zhu We'll LifeSci to Charles

Yue-Wen Zhu

one outside AML. of Maybe

context So where, farnesyl been XXXX gain what the one folks say KO-XXXX. to, transferase's more have very in conviction order to paying here on asset not the of deliver especially themselves, maybe but second investment renal would frankly, context lots to to only of need on also like of you carcinoma? or half landscapes gain you program in like conviction more in attention I RAS community in of little mean, emerging some the cell this areas also from in and competitive with the assets these,

Troy Wilson

tried due it that they've responses Charles, kinase SOSX know, without case combine these you're how you and the for oncogenes. to But at do trying is success. the for other some to actually you very to the PIX have something I to eventually we every many resistance. see pathway half People looking kinase responders the patients, long in time, think, And big companion without develop mean, do do mechanism-based pathway SHPX, inhibitors to KRAS. that lucky, target question. if in I have single the a Yes, relapse of and People respond MAP cases largely don't simply, people largely of you're get thanks in of half at looked in the a looked and been you the study, have of many success.

do? farnesyl to question, with targeted with therapies combine looking looking can that to safety these and You're we a acceptable your inhibitor show transferase to tolerability. So what are you other

what because over combinations. skip can't that's kills that You most

in tolerate preclinical data the mice. not anywhere. if you're can't it, the You best can have patients going And

and So that's first foremost.

and The Phase second escalation right, looking studies. initially, is you're evidence for studies, these dose are of I activity

You're looking unanticipated, for is that activity evidence of clinical unexpected.

kinase mentioned both Tipifarnib in you of neck, I delivers and is alpelisib and inactive. to case best So PIX the stable mutant in alpelisib head at tipifarnib disease.

signal. who is that's got drug they begin you what the Patients have drug, response, agent care, that to and the an the alluding failed standards you them mentioned, are that What give again give with for? seeing in telling and was then one are you Mollie after right? what the You've them case this encouraging you and and in patients and in progress, If you GIST. activity existing you of RCC, clinical those -- to appropriate your looking then X when the you the are that's you who going, combination in therapy particular, you novel activity you the keep -- restore good -- cabozantinib. have tolerability of population? In and seeing So you with see combine you either

the big contribution test to a of sort thing in deliver could and that tumors. able encouraged think has opportunities. to PIX really are tipifarnib significant really those I a -- case we're to KRAS-driven move is a in Each continuing forward I XXXX potential TKIs, alpha that's that and of evaluating us If think we're as patients. in be blockbuster kinase this,

drug. we medical the We have take a in half data XXXX, to the major very at community And forward with ability year, we're meeting. good the and look of the a sharing is second confident hopefully, you time. our to

Operator

We'll with UBS. go Dai to next David

Xiaochuan Dai

ASCO. from the me just data actually. on relapsed/refractory One read-out at pivotal is X

cut. it mentioned be that You will a later data

patients potentially you So see? just of could change understand do venetoclax can could how data talk characteristics the a maybe cut the that you treatment? help prior to rate? then little Would on the you just have CR/CRh more -- you that, later similar you expect us do about we'll the baseline think patients the And

Troy Wilson

later to effectively slice be add the we're numerator. looking same said seeing. misheard not let is it's we same -- the not David, dice was We're have cut. to you the misstated said Mollie What It's data Yes, you or denominator cut and may to not the have because data we agency or it. to And you trying me as the correct may it's a it it. on just said, something patients going

cut data submission. part is So it same as the of NDA will be that going in the

characteristics, you answer to Mollie, the the On baseline we question could can? David's that extent

Mollie Leoni

already really we've Phase many very venetoclax, similar I. seen pre-treated. to for a we saw prior patient one to have sure. It's had the characteristics similar are patient largely Yes, population data the whose heavily to transplants. Most patients in presented. see Expect Again, have what

Xiaochuan Dai

do on think the they some clinical to trial really the the KOMET-XXX trial, clinical And development? frontline And then could about help trial of them contribution on you Kirin out with development the the trial? how of think have That's we potentially helpful. Kyowa expedite just should clinical

Troy Wilson

that? want you to to do Mollie, speak

Mollie Leoni

like EU, that's the good partners we to don't very absolutely areas have good mean, have. They I presence like a They're the Yes. in hope. Japan.

So on the get to they sites and helping ground partners running. good up will be very

of boards particular standing in course, our most are Of they're good especially familiar some the with. they regions strategies, for also

to So study very -- them be well, continue start-up. and we big to help expect both to on design be

Operator

Justin to with Zelin next BTIG. go We'll

Justin Zelin

are you earlier a also whether Charles' I KRAS given companies approach question. you on combination quite the and wholly inhibitors that the view just pan-KRAS I the find and only programs. on which find the that FTIs you follow-up you or preclinical the important to landscape And developing interesting just Maybe you owned have the programs also variants? have quite on mentioned Troy, compelling. KRAS, of kind with inhibitor? the talk data a Can combination how with potential pan-KRAS with the economics

Troy Wilson

Yes.

Justin, thanks and for data inhibitors. the question. selective pan-RAS have mutant non-clinical both We with do

cellular both. organ synergistic the It You context. on depends interestingly the do potentially see with activity and

commercially you do example, them RAS-driven, than we better one in more being probably it multigenic. And that as colorectal appear of surprising. both for though think pancreatic. of you synergy That's not Even started KRAS when in of profile. and So colorectal the see is it well-understood does because with we're X things this we terribly we combination, safety went available I frankly, was Justin, only X of looking a tolerability adagrasib, mean, with inhibitors do, to

an that's while get how the to a at time, for are the and And pan-RAS. do threading opportunity. needle are take up the think the for market. to to segment of market the of opportunities patients, best field largest us. GXXV, same ideally the also doing you we about what's combine There We to -- catch eager to KRAS with challenge GXXD, are It's

a say people with to worried been had -- it's when most tolerability. of combinability say, So the farnesyl would before different dosing we and the transferase other started the in discussions far That inhibitors alpelisib, I -- with day, them, we encouraged are of we've by I back And agents. tipifarnib with are and would in about? you folks. what number thus these said,

combinations shown most the does in what tolerated You very of be that well time don't itself has is to -- in. XXXX these combination.

about optionality in what Now types multiple tumor you -- that as see ourselves of how a seeing program are transferase. light about of those and et do to is you're it how I in competitive think sustained investment activity entire to we itself said, and be we dynamics, forward Justin, each think onto clinical will what made an want likely And do, IRA, carefully cetera, really pricing, strategy. very FTIs what could comes give forward move we of seeing farnesyl because that. We've down we do development kind us to

interesting everyone on else. interested, ton start to anybody encourage data clinical would get got we're second the think who I starts we in we've is ahead I website. of available here half a data. our as show preclinical of to It

that with data, the we about the KOMET-XXX the on the sort the get us other current of the -- in folks side about forward how We of clinical landscape, for data. that's the do second to of As what's the analysts look some data I and investor on FTIs, want to Look probably on said, how data, in think to help will do other look educate what's of ahead to to the community the second half. XXX do event something should the to it's scientific you but think half. side clinical the rationale, you

Justin Zelin

next? activities And into rest about out-licensing maybe of remainder think or just from of Kura, in-licensing year quickly, the and the development throughout how business this should we either

Troy Wilson

a we pings mean, times [ several I get probably In-licensing, ] week.

to yet anything. the trigger have pull We on

everything we bar have on. have in going We a anything bringing high to very given

goal indications. FTI to GIST and AML, in be of blockbuster a a blockbuster those blockbuster a Our in one would deliver in

don't be couple if anything of to do interesting else, there I could But a think we do we're add and to funded to need we are frank, that, that. opportunities. quite

In inform collaborations. data path. can at development help the the really terms that of our How generate we out-licensing, clinical clinical focus is moment, will

vision you have do that are people we about need of you of shared anyone gives prioritized the generic and when ideally PIX You'll think see future foreseeable that in But to that be care might generic we've start are KRAS, or optionality. together. -- and maximum a drugs that find you future are to novel agents going in to either and it standard because what kinase, those the

So don't clinical BD as know much I about as collaborations.

Justin, stay I we I would with footnote, say, one have around what do about tuned. be and question And that Peter's to there. to diabetes, think back think carefully would we

Operator

with Farmer George to next Scotiabank. go We'll

George Farmer

beyond your you endpoint, to could about Mollie agency? something agreeing that called And that indications that do different approached MRD agency versus at cut A would And couple be has your agency shift. from other saying this committee now medical slightly would conversations how seeing last and the be the think going the could submitting this Kura's? indicated then talk to was me. we with agency. you be Troy, a they on on it's the to perhaps hematologic see multiple you myeloma, call -- we same why very data what Can to a you're in programs seems than like later also elaborate other meeting cut. talk you that with your with the to be I And this. you about is interactions where the

Troy Wilson

contemporaneous. consistent there's FDA going the we with I Yes. about and review. significantly, at hopefully, they're And should the poster we're Maybe the what be at question, to. which here, point, don't what's and The you -- or is Mollie's move the we at to are what I Those submitting So there's all the numbers that what will at in the numbers -- in -- to abstract, ultimately, think they're really but around different, of what's the going abstract getting ASCO, see FDA. data people a the first to slightly for -- be with oral ASCO right? are presentation ton see there's talking to on mean, then there's what's potentially

ever confusion So to intention you of the to extent that sort talking create larger data you're packages, just if will. any no -- there. about we It's

let spearheading the with really Mollie because with to I speak she's again, myeloma, that negativity you the agency that Consortium work I'll want take around engagement that, MRD to do IMPACT Mollie, and might George. But think from how question? is On instructive. our been the George's differ

Mollie Leoni

we'll of relationship we've companies CR working really hard No, to our Sure. a said, now before, But any be right between to said that data as the overall pharmaceutical data with Ultimately, started. have on obviously, trial to to submitting that's we don't gather get that checklist if endpoint in we other they'll confirm likely, if FDA's fact very or endpoint start package. It's surrogate their a to we survival. consortium for seem and as when together. of be the committee packages we've need we their be start and good in calling CR working analyze these not. surrogate as They establishing our data, that are a to more -- more larger know data to or once the own the the are MRD-negative the get in a at that will accepting it endpoint is, packages be X than data to internal expertise suggests years of submitting FDA data advance looking fact, data establish less, to a MRD-negative

to them that do supporting And plays own going data see is work expect area. them endpoint. how years. this a more time we work. doing We're we to in But the of our submitted so the help out the And expected accelerated be at the will lot support just the over to submit coming work we all

Troy Wilson

that. unprecedented. on NPMX-mutant in of just couple not AML inhibitor SYK the developing add with Yes, well. George, is ago FDA it to This to I as going a alignment years reported its that had frontline Kronos was

the and up Mollie and areas a and consider other a Obviously, pathway as willingness we've indicated, the trial we willingness builds become to some been approval. where seen to on, there's data, for widely have with -- as that that show but myeloma create to accelerated indicated, endpoint the accepted. So have a our interactions there's of you run that

add that wanted point. Just to

George Farmer

from And Yes. do EFS you would when the the That's study? think you very endpoint capture helpful.

Troy Wilson

Yes.

can out, careful. We want certain we've them. stand those behind when dates put We make through we been putting that guided, working haven't still down. dates so We're we to

and endpoints All closer us the a we the with assumptions #X, of later bit enrollment these survival therapy details on trial of back time. other endpoints to get We'll study and time more are details driven as more on this Give by, assumptions the come year around design, and start-up. then again whatnot. more on timing

Operator

Our Syed comes with from Salim last question Mizuho.

Unknown Analyst

on Salim. Eric is for This

divergence anything your given you has to that's side FDA with to staffing down you come from just cuts, update due come the point? to across AML your their real if recently at another Just changes engagement how if in whether cause FDA, might whirlwind quick, things expectations mind. don't with you've FDA's this from any to picking on quickly wondering be able One going they're you, at slowing the of or up that anything back on share timelines, of

Troy Wilson

We're regulator. immediate not with our good interactions getting any been indication. just incredibly We're lucky an agency, industry they partners. In have They timely, the are such such as Sure. professional, cooperative. good a to have

guiding schedule And in because environment, our -- be on timing idea in don't internally I know We on are think at see you coming what's the conservative to guidance. no agency. our of never going just have us things ahead be to this we and right? we'll are you going

guiding FDA. think the should we're getting there the that people but disruptions indication that's we're data monotherapy, the hope have don't the have that to the do that been then them let's just -- best. to frontline studies, be can and in not to at everything that studies necessarily they going not we timelines, hope yet So be GIST And ziftomenib to FTI think need as give to the major continues. we any able for aggressive evaluate only I the more but I studies,

Operator

comments. I Wilson for period. answer closing over Dr. question conclude to does call today's turn This now and back will the

Troy Wilson

thank how our everyone. we again good to joining to Thank Cowen, Leerink many reach you in and any questions, you, once In additional Miami have you and all look participating And the you forward you Barclays a know evening, you call again today. reach couple the seeing in and over Angela, and out. the have please next weeks conferences be thank there. Boston and us, We'll of for if meantime, once of the investor the

Operator

today's This does participation. conclude you program. your Thank for

disconnect You may at any time.

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