Earnings call transcript Q3 2022

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Operator

Ladies and gentlemen, please stand by. Good day and welcome to the Kara Oncology Third Quarter 2022 Earnings Conference Call. Today’s conference is being recorded.

Now I would like to turn the conference over to your host, Pete De Spain, Senior Vice President of Investor Relations. Please go ahead.

Pete De Spain

Jake. you, Thank welcome call. and Oncology's quarter third Good to conference XXXX morning Kura

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

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

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

Troy Wilson

you, us joining all Pete. this morning. you And Thank for thank

$XX.XX priced Today we Myers Bristol announced Squibb a from $XX per share. investment equity at million

global member the of development transaction part and our ownership our will into strategic strategy, As and and appoint notably global our maintain BMS a provide operations. of programs input full valuable to steering control will committee

We have feedback are our development expertise. and organizations, and with in insights engagement very us our key who investment and treatments. colleagues and of relationship much the discovery cancer This between our with leaders transformational BMS equity from the appreciated strengthens it provides

immediately history companies, for we investing to $XX of working we loan of proceeds in benefit to innovative term has to a grateful confidence to up long also Hercules million, team, loan of them which We're Capital, look of Hercules million with the from are a have support. drawn forward innovative BMS facility announced pleased morning, will the science be the closing. deliver $XXX This after their patients. potential biotechnology and with providing we to

sheet million in proceeds fully investment XXXX. with the term plan augment programs. from us multiple September invest for we in cash, to operating acute of registration initiate as earlier enabling the two $XXX.X XX, million give strong ziftomenib flexibility BMS significant loan our advance are these the and balance transactions, transactions Hercules expand These pro $XX KOMET-XXX Furthermore, prepare cash $XX drawn, our to they current and loan, for we is draw of into now from initial our for With expected together from forma fund and have to continue and farnesyltransferase existing already combination into the the XXXX. lines inhibitor myeloid leukemia, if equity million portion studies in our term ziftomenib,

to later the at be We published KOMET-XXX annual our in activity morning which bit clinical a abstract were abstract in Orleans. upcoming for from has also the will data morning, accepted New The ASH reporting of ziftomenib and of an proud relapsed highlights been safety meeting AML. on this American the updated that oral Society refractory announce encouraging this with Hematology website presentation and profile patients

and KOMET-XXX the and all-comer patients patients Phase rearranged escalation dose XX the XXX patients of AML or Xa XX from XX includes portion, abstract from at dose NPMX XX dose The portion AML milligrams, XXX patients mutant milligrams. at Phase KMTXA Xb

was a We early using included not Phase dose. of X, the August an are back also additional cut patients in data off. XX an in submitted Note XXX-milligram patients summer enrolled which these Xb the on extension abstract,

immediately the oral in an featuring our Please for two presentation sharing more forward following including extension tuned XX. a in-person We at XX session ASH. data preliminary the oral during event details. hosting December patients stay Xb set investigators trials Phase an We'll also additional look data mature of to more be on from investor

well as the on FDA for directed ziftomenib for the the portion as of from feedback await X we KOMET-XXX. Phase dose protocol Meanwhile, registration Phase recommended X

of of AML We care studies to with ziftomenib standards lines earlier in intend of initiate patients. combination in therapy in also

of We combination in X+X. various the these tolerability have and with FLTX including regimens designed Phase venetoclax and azacitidine X activity and assess inhibitors, the to ziftomenib combination studies safety, of therapeutic

very series We're pending relapsed KOMET-XXX. in patients frontline, the refractory portion registration potential combination the acute combination the further studies We the about leukemia. a myeloid And excited of Phase unlock value in Phase ziftomenib XXXX of for and first recommended protocols. half X Phase our the AML to initiating X FDA for these directed X first in studies review with of dose of anticipate of

have best-in-class ziftomenib to and be continue to potential its in strong We a conviction inhibitor. menin

by is to the data, ASH. growing on of sharing at program an supported we Our body forward update you with and clinical confidence a look

our farnesyltransferase to turn our let's inhibitor Now attention programs.

view oncology. therapeutic potential continue to as a farnesyltransferase with deliver potentially opportunities in commercial and We multiple one inhibition valuable to franchise,

of tipifarnib ultimately activity application as been efforts pioneering therapy with Our oncogenic a More neck therapeutic via a and on the initial overcoming focus inhibition generation a as These of building of a first led cell we've for was protein. tipifarnib, direct resistance. head tipifarnib mutant carcinoma. squamous the FTI targeted designation HRAS upon drug and recurrent in breakthrough monotherapy award HRAS therapy our recently, metastatic encouraging to monotherapy

evaluate PIX study, the has inhibitor selected the HNSCC in Alpelisib, PIX to head and inhibition we initiated was cohorts. the alpha potential codependent And improved in neck of of designed HRAS an either activity relative combination of anti-tumor Kinase the combination two alpha Kinase target tipifarnib HNSCC. that believe inhibitors of and Late are year, to patient provide last which alone. current to We oncogenes

dependent current second In HRAS the patient dose PIKXCA is cohort comprised first two with study head NCI, molecular induce symposium overexpression. the of in and the Last tipifarnib that cancer demonstration cohort week first in the a at initial therapeutics August, neck HNSCC. the response three of we Alpelisib PIKXCA and patients carcinoma patient XX% failing patients after prior HN. after in the of a EORTC, and targets tipifarnib announced durable treatments with overexpression just a Barcelona, ACR target reduction after mutation study patient clinical HNSCC. reported and XX-year-old we partial of of the in cycle comprised current Alpelisib, combination durable The squamous tonsil can achieved three in one cell with HRAS reduction remission of XX% The has with an cycles. a experienced stage PIKXCA an and dependent in lesions by followed A enrolled

than to-date. related been weeks limiting dose the manageable on patient and events known drug Treatment of study last with presentation. safety have The no week's more consistent continues are XX of current adverse and HN each profiles for as toxicities reported with

to a Phase trial. X potential for to responses a schedule demonstrate and drive efforts monotherapy mid-XXXX. Meanwhile, identify determining active our Our we've goal dose cohort the of as tipifarnib the AIM-HN combination in biologically with for recurrent and registration for the continued in team working through recommended dose durable HNSCC is the PIKXCA a now to mutant directed metastatic our HRAS optimum

Although we continue patients challenges. further we've to clinical observe enrollment trial with to in meaningful due the evidence close to activity enrolled elected to of AIM-HN, significant feasibility

harvest therapy the development forms take of to data inform like currently from AIM-HN We're the and the thank along of to breakthrough designation, opportunity this future evaluating RUN-HN best which use to HRAS mutant between from It's the with teams to patients important our and to HRAS patients in the the program. eligible basis significant patients, data study the overexpression study. to overlap in and HRAS clinical investigators AIM-HN note have States that the United ongoing current mutation, the with who study. HM participated may given HNSCC enroll We'd be in the way

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

potent inhibitors. year lung other the to Phase by to annual mutant cell and Motivated osimertinib was meeting. with this in EGFR the significant American initiated of Association X and combination first unveiled preclinical earlier prevent emergence EGFR tipifarnib support combination emerging these non-small resistance a the for generated The patient Research, cancer at opportunity, of through of potential quarter. of INSERM tipifarnib later a this dose One this opportunities we've data to with collaboration in study expect osimertinib Cancer

well clinical in next and through at IND meeting, FTI from lead initial experience our for our Based these perform investigate on generation evaluation tipifarnib remain of which poster these valuable KO-XXXX, osimertinib their while on on We in as therapies extended to research gather to studies. intend findings, to advancing translational our targeted candidate several development and at new drug FTIs poster, up recent continue the the to this the investigational efforts, to intend preclinical application follow week submit evaluate studies. combinations, program the quarter. own KO-XXXX, data Triple to oncogenic potent an as track parallel with Last We findings other a enabling drivers. collaborators we we other of INSERM EGFR presented combinations of copy KO-XXXX internal later Kura and of available in in website. A is

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

Tom Doyle

Troy, Thank everyone. you, and morning, good

million personnel programs. of brief of the R&D third were happy & of third discovery was The Development compared for in quarter in I'm the expenses for overview the our quarter expenses due financial XX to the stage and primarily $XX.X quarter a for third of increases XXXX to XXXX. provide Research results to million increase XXXX. cost

$XX.X were quarter compared and increases expenses the $XX.X primarily for third million, to the due XXXX. million quarter personnel XXXX was to increase costs. of of General expenses The for in G&A Administrative third in

for quarter of to quarter Net a loss XXXX third compared $XX.X the for of third million was XXXX. the million, loss net $XX.X of

we investments cash and million, As of of of to equivalents million compared December XXXX, XXXX. September XX, $XXX as $XXX.X XX, had short-term cash,

Squibb, on cash million $XXX.X and Hercules September equity of Kura million investment pro in loan XX, XXXX. XX and equivalents facility, short-term from the a investments Bristol for cash, As from $XX as the had adjusted Myers the initial forma draw million basis

terminal that each inflection plan current a XXXX, our from three cash plus and in our believe drawn, equivalents short-term our our investments fund from programs. meaningful to facility sufficient placing cash, will cash Hercules, from of deliver to if us operating be into position fully We value

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

Troy Wilson

you, Tom. Thank

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

registration a December, pending the frontline in X For half and directed X ziftomenib data oral refractory first from initiation KOMET-XXX X of and portion of in in KOMET-XXX the XXXX, of Phase Phase study of Phase protocol. AML combination of FDA at review and relapsed and recommended the presentation the X ASH Phase dose

combination X For tipifarnib, current for with OBAD Alpelisib or lung the of dose in in the the with KO-XXXX the the the submission Phase X quarter. those and IND in And XXXX cohort active later fourth mid-XXXX. quarter application PIKXCA ziftomenib study dose and of patient in for in determination current of Phase biologically first combination neck optimum, head study in this

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

Operator

[Operator Chang Instructions] And Securities. Jonathan with we first will begin SVB with

Jonathan Chang

Good guys. and thanks questions. my morning taking for Hi

ziftomenib, provide the your on and then any regulatory First color question here. can of latest on interactions, the next steps status

Troy Wilson

thank Sure, Jonathan. Good and you. morning

at it everything's and that us. them this everything we're We're on we meeting. before date guidance of yet needs on, well portion I've meeting. plan alignment specific upcoming, the period, X of It's indicated Type track. agency registration the the study, and had and But awaiting C in the Type with the giving prepared Phase has we're track. in from perspective, recommended the as forward holding not So, C not protocol remarks, the for enabling prepared have point the just we're We're dose the on the from formal our on our meeting,

Jonathan Chang

XX in second versus it. presentation full us can the question, we you the on guess should the presentation? how in abstract ASH color data morning? Got to thinking give patients be include on And preliminary data the data coming I the in decision up ASH the about any And this additional

Troy Wilson

Sure.

those take let's take two They're So but separately. questions. related, them

we I that dose cut to in Phase it's abstract, you'll be So XX clear was It'll off. abstract, what's in around Xa you'll show indicated, in the dose data the and patients XXX indicated the syndrome. immature, going activity, dosing is data we've only the which data escalation the and and all optimization see, that early the portion, relatively Xb. That's safety as is portion initial comers, the Phase of at you of the definition milligrams, differentiation is from tolerability see as clearly, the in I remarks in an clear I summer as continued mean, think prepared

the the XX XX, to included much Phase that on we ASH Xb patients and then going be monotherapy have is the the dose is the Jonathan, for an believe plus For there, that Phase presentation, X additional dose patients initial we update, that's to rolled those us patients X the recommended be going more XX a extension. gives additional initial from study. an will comprehensive at registrational Phase What

our And adverse the detect an the and in said well event as the both improved which as activity, differentiation from our ability as I've to ziftomenib on. we clinical as past, ability ability really manage drive trial to use has only syndrome, to has gone see to is

may afterwards. with you later along us full So the immediately time investor And Obviously, this much oral we presentation tell spot story see will in ASH it's an that'll dropped abstract. delighted actual not a December. bit organizers That out meeting in the be before Jonathan ASH morning. more conference able that still in come to be story were in gave that to fleshed the of the abstracts the that

Jonathan Chang

you. rationale agreement Understood. if loan that may. I the the around announced and third discuss just was morning? agreement Can And and BMS considerations question, you Thank purchase this

TroyWilson

Sure, yes.

a actively amount we've in upcoming have So programs. ziftomenib of for data both been interest point discussions And time ASH. Obviously, there's about significant with an our inflection large quite we programs, at pharma with some now. in engaged

But like closer into potentially have colleagues feel out appropriate really We been They to indicated now. sophisticated us desire we at make our did steering discussions BMS for allows body in the look didn't and to BMS, what not was like, side, yet really time draw in think, expertise that a would global we with that decisions. body, it what fleshed tumors. a our an we better time partner. as we and but tumors some bringing, on idea the liquid solid bringing both we've our got is And to an governance of advisory essentially committee,

does, the it Jonathan Kura is, between what BMS. relationship strengthens further so And it and

of to were maintain we've We planned we BMS reason relationship. remarks, maintain as We registrational and that we to ownership XXXX we're shareholders. The all ourselves deepen for X, ongoing. that. in value the able portfolio very across the really can facility current very We're expansive prepared decisions to said, that combinations, make be it making position. about continue wanted very be do development to give think the but investment full the control, combination the Phase investments is an we shortly us we times to full I study, clear, the again, And allows we create we in study for obviously programs the into got flexibility at going the in patients it, behind And want talked moving ultimately in and have at putting an then to program the place in ziftomenib. HN that, be looking with strategy strongest and to to extensive

a to just pillars fully walked through conservatively, pretty us allows those And the different business. make XXXX. resources, it we've could cash good engagement sure company's everything good the we run said was a It look fund capital three we company time this time, we thought across 'XX. we was consistently, into to So of into with as gives with yet up us shore the that we've BMS, the

Jonathan Chang

Understood, taking my questions. thanks for

Operator

now will Barclays. ahead. with Please from We go hear Lawson Peter

Peter Lawson

C But oral at FDA, or we much meeting financing, event that Bristol for my And taking how men data? 'XX event? for is year a end don't the did with in all what call. the presentation, Type can know they say. you instance? ASH then this Thanks So see see Sure the XXXX

Troy Wilson

folks. of a questions. of lot good I think Two for Peter. top mind And Yes,

our ASH. you, this up it have is of the While to not wrapped to date, specific to try all by I can being goal tell as

than guarded one hope position. should And So, will, go If literally now, be right move FDA we're by going And we give we're can't I need it's of goal. the be XXXX from that we Optimus. We're ASH. is reason have timing just first of again, to that FDA perspective. the not we've into we're they things determination. companies to able would we not ASH, the its calendar. a would make we very strong be that. we part been more an expecting everything for about a the our own you waiting think engagement Project updated as is, But would But in the specific through

as the As dataset, far you data see, the well full can that. recommended at dose BMS as as saw what BMS assume yes, assume did rationale the X can for be that that comprehensive both profiled set, ASH, you including they which will saw a Phase

Peter Lawson

so you the Great. much. time. Thank Thanks

Operator

song Roger from come Jefferies. will with question Next

Roger Song

question. Great. Thank Congrats update. the you taking for the for

from about we that is high But just better you ASH understand as won't the think So this the if than good you well. competitor. also guided efficacy given real level, have you your I talk couple to updated at been us, data be a not as able And have know will data.

how curious, both Just the this abstract presentation and your and ASH around do particularly indicate at guidance for well? data competitor as you comments your

Troy Wilson

want Yes, of hour an much within be or data. Roger. to abstracts so careful, our not to on dropping, comment competitors like particularly I too

point Phase think speak themselves. data made patients their most N will see be X equals that our potentially important about regard you'll at dose. to data, point the at I ASH, I for the Let's recommended With XX the

the expected. by As KMTXA the trial NPMX to epidemiology has of we have that initially we the higher percentage seeing gone trial versus a patients in would on, started with relative

has trial Xb NPMX as sort tilted Xb. the from into of moved an we've later has seen in such early gone enrichment on in that the into on, As we've that

a transfusion agency have see show we'll endpoint. I've key a do, median that's you'll is dose, as CRH well. data what we into at six said, idea rate, we clear recommended going the to months a is efficacy secondary a to the of X package, very the to reiterate particular, think What think, believe how response, independence in I monotherapy think only full comprehensive studies, you, Phase we registration a and combinations to read full I'll goal I is but CR, is a safety four have duration the what set I XX% our And as XX% registrational you'll as again, proposed for you'll see through not package, to what

we'll again, be abstracts We're cut be about ASH. as So in the directing available, data going early summer an as data soon of a questions answer point at as the able presentation to ours. data to toward are people really That's time. full

think as I out challenge as we intend Roger, set else, I our data said would dose much their as recommended anyone said, before, data at I've to. X put Phase to as I

ziftomenib -- that will I a comprehensive in good will of in think context, look presentation. context data the we hope

up, look confidence as abstract obviously, numbers the It'll denominator as that study good in as well. I the but go to you're well, translate into a increases, up think going the as registrational your goes

Roger Song

the will the would given great. kind require for think Maybe NPMX. hypothesis may two this for is, did the to two registration some you've those in FDA CR, CRH. And to point compare see terms of the you see implication that start different between what for trial? genotype those And -- I how you different That's of genotype, do efficacy And of for therapy and [indiscernible] question you raised the is, kind Thanks the genotype? comment. the consistent the

Troy Wilson

Yes. good question. It's a

reverse. question your in let So take me

a the reverse. in a range two a use, identical, that our even And for understanding for to generous. perhaps refractory relapsed hypothesis the of these we've CRH, To no the probably of there's two But given that's Your in questions FDA, genotypes. therapy XX%, Roger similar you but null the CR, genotypes best in either is setting. of very reason XX% not can being the effective bit

sample CRH null powering to So is able difference CR, then hypothesis. and XX%, XX% if you're looking rate between to be gives population for the you detect adequate a the that the that to

distinguish can you that So two. the

where is look higher In way. more form a a have it's is different. on we in a along substantially the is, we see differentiation designs The for the doses two experience, much much patients a aggressive populations, KMTXA severity same to of incidence In commented who we've wouldn't our see leukemia. of expect a In that the invasive, experience. greater And monotherapy much more genotype study, It's syndrome rearranged and those difference you this more disseminated. the our leukemia.

you induce kind a to getting when of tumors those so differentiation broad you're And syndrome. base differentiate,

detect Now, then it, we'll we've Ash. that, coming strategies mitigate developed at to And to talk first it see all, about to of to that it. mitigate and

don't the think talk, of in to context it's the going abstract. we're I not

you You monotherapy, But in our won't see as at therapy Roger, both there. ASH. well will see see combination it in you it, will as strategies,

Roger Song

me. Thanks Excellent. those all Appreciate for that. on comment the extensive questions. two That’s from

Operator

come Watsek question from with will next Cantor Our Li Fitzgerald.

Li Watsek

morning. talk about your may Thank sense half in relative Troy. year you combination my trials, Can into can the frontline median clinic And of should the think the of refractory and sort the we Hey, in able those on the XX in additional how competitors? be move first about here patients? to next both how you you to And quickly, data the XX just questions, maybe ASH timeline first of terms update. the a setting. and of for you was good and give for It taking patients us up follow then,

Troy Wilson

Yes.

good questions, Li. three Okay,

Phase data abstract, completed to optimization, of Xb that abstract Remember So, that I the as an summer the cut. our abstract, eve again, is announced in ahead the we're dose dosing patients This right want earnings in of on of when get the don't we we May abstract. early the on the call.

patients, additional those were the XX dosed patients May and between For August.

that roll X it the you a a look of have But Xa, mean, extension. Phase at We're study have and point, still the optimization a just you of on at Xb forward. So when we significant Phase patients study. a study, can X we the I said, number Xb still kind being here, it's

responses an would coming on of tell patients be -- to not to stay can into is I study. careful number somewhere be in So are which median What six duration still typically rolling durable I off think when want us tell is pretty word We're warning going signs evolving any months, the responses we're responses, with duration. contrary, right? view. of say to achievable ziftomenib, I choose It's that optimistic duration not confident, patients that you kind and seeing between they're we optimistic, four I see as I of to the that

But we're number still about an talking anecdotal patients. of

green In the steps It's was a review machine Review here data substantive as And the Phase flipping at X, to set switch on team, the of have going. guiding be into of potentially because registration, team, the seen agency you not we're terms we represents Boards probably But most ready a doing And that's a through. basically, you're if no There's enabling thus menin you starting to And of potent, step is change really great at that get behind. the this can cleanest, we most they you X, from get half the Institutional but that the first go. expectations the as think the on risk, first sort competition, clinical we ziftomenib position this just Phase dose have that can patient. question question. light the just least of trials, to If looking everything to for. number talk we're back why no second And imagine they're protocol, to then have from there's going just before really at sites before, to simple question have Sindax. to question the four your just a our to inhibitor in there's months that's final I've XXXX. the fourth we I quarter, about to combinable sites review, the three have because the you said

best best you'll that We ASH And will with end But is in to ultimately, combinations, safety. you're is can where can at KRAS, to seen the in matters activity combination, get positioned the we've to going I with catch we've can drive what with up. very as who up think the as other well is who regard. see agents, everything we what do ziftomenib seen

catch best to So everything up day Sindax. we'll to can And win. the we data the abreast of competitors. the end at or is ahead of do to going But to that our stay

promise I durable it's Venetoclax, And combo, of approximating them to up remission, form the think we're, into you them look long-term some put that's history really chance want itself for I people targeted not you'll therapies. agitated it's Like of Look show a about cure. these if monotherapy. see whether yes, whether how regard. just this as the But that's inhibitors, story, offer something think the get to nicely rolling chemo, remarkable hear ziftomenib at Menin best want keeps out. going repeating following with history. I really give stacks activity a at to patients KRAS And and they're very they in you that

Li Watsek

proportion enrolled to the guess quick guess study? on AIM a of far, you've just Maybe question agenda that just us you you monotherapy. great. I sense potentially, that Okay, so of Can enrolled TP, how many been a can what I patients patients those current give and

Troy Wilson

Yes.

of question. being challenge not a bit vague rare enrolled So specific, vast with Li. patients clear are we're in HRAS terms mutantions even a in of do trial. being we're is, to we're been the sick with what folks as, is, the we've majority as good And in It's And see population. it's little too The doing. a AIM-HN compelling study. We activity

we to that, either But also we're We've It's confidently significant significant enrollment. activity face trying drug. of it's years, patients, the hard of answer But we've value think can or that say the we questions. about we and shareholders, So fiduciaries good of could be next here the not of we're enrolled about to at got Kura. at ask terms challenges. in feasibility seeing we investments make number couple safety as enough I a look various activity. potentially And significant over maximizing for

the to And mutant potentially cell in if what We're world. anyone data neck what we've had we're a HN do to squamous forward strong probably a in run are patient from more do, data development because carcinoma perspective. there data, set. path going that harvest got we So to see can HRAS we regulatory to have going going than we're and

it's don't the set with much and want we'll our team But, path expectations when I and if too inappropriately. what say I it's, they And for don't to on knows because you come want the to focused have back forward when to monotherapy. is information more do. to appropriate,

and patient I resistance nicely, profiled point have a enrolling have is was logical significantly combination dysregulation drive overexpression place Li, that the is given a overlap, raised the the you we sure you U.S. can to between to important go XX% is enrollment, HN who mutations, surprisingly, patient that going want experiences and Current ATRAS you're at You HRAS step. these to about tell see make mutation. of PIKXCA there's an particularly the a that we pleased in with is, actually patients expand an very to population, triple not patients the to those mechanism HRAS were really meeting, next our and

Because in be as very they to a care. be if to So ATRAS these you we provide sure have can find the we're to a be and will way have appropriate for hope But to the they current potentially patients that put eligible first, study. our fiduciary. you patient’s ultimately, be it's win good way make who that trying responsible mutations HM we also overexpression, included for patients qualify

Li Watsek

so you Thank much. Great.

Operator

question. Credit Fauth has next with the Suisse Tiago

Tiago Fauth

from follow you a ziftomenib. Just on quick up

sounds potentially there's mix feasibility of the which would NPMX some NPMX So patients amount the like as the it you registration opportunity cohorts. skepticism healthy got the or be around bucket, mix, patients for at of you're KMTXA mutant the a that We've still relatively But like look actually commercial or building implications what on a bigger. the on are bit still between questions ranged some little seeing there. of

to would it get color. any So be good

seeing like patient a Sounds healthy of are there? amount you NPMX

Troy Wilson

Yes, good Tiago. a It's question.

in of denominator. gone on, seen has we've patients, to numerator the relative trial more the the as in So tilt balance the favor NPMX

driven most probably that by think activity. I notably clinical

in not let's to to it ahead in data. Just I as mutant too of feel to be and the of get confident far specific feasibility enrolling want the put there, But But NPMX out cohort. we numbers. don't

confident feel we're risk also a for We seeing benefit favorable patients. that the

it's get those this glimpse And equals Denominator get much comprehensive abstract the in definitely in more a a going It's at with encouraging, patients ASH. update you'll right XX you'll the of direction. N again,

Tiago Fauth

taking Got it. the thanks Also for question.

Operator

Moving on Cowen. with Nadeau to Phil

Phil Nadeau

morning. Good Congrats our the taking on Thanks progress. for questions.

off X necessary. Phase sign have seems and about is, then, always What you necessary? feel meeting a have a one do on meeting. follow-up and have then We're C two meeting zifto a first on And you on protocol the Type to been is on on wouldn't dose We like to expected curious the And Type C maybe zifto. one, Have AIM-HN. it second DS.

like than seen at that Sounds look to you're better in ASH maybe basically suggesting abstract. going DS what is we've the the

in your be And relative the DS patients, you is, different the reasons that why could more time? to is given, over and would you're NPMX think management I improving better contribution mix rates mind what one seeing two other there the be patient with

Troy Wilson

Phil. questions. Thanks for Yes, two the

adverse obviously. So effect, DS is event, non-mechanism on it’s an DS, the non-mechanism

in it system, they with think, And more of see be physicians to crannies tumor DS in their because relapsing the there's their in what is second gotten differentiation due syndrome. Our that's people the that detect cells nature to It ultimately, differentiation different One into able clinical with ability KMTXA the the I may is and joints. therapies. manage these nooks said, we And find comfortable disease. reason measures minds of at animal. the have all genotypes. we two have other The measures syndrome it reasons. really hold, The important of tissue, of off ziftomenib. came it our to more the really relapsing, inflammatory are a the bit as think the AML penetrant. patients the And in two as effective. the is in typical get would the patients if tissue. I targeted place -- often different I the The also, NPMX be terms between coming qualitatively is is has highly is ability a call characterize of our put those been to greatly hiding is is, lymphatic those experience of to residual we were may nature tissue in And And and markers. Ziftomenib looking improved the that in in it

has implications treatment. for that So

Phil, improving it's think it With FDA and about time. manage I detect frankly, respect question your the because ability improved our to meeting. it has to over

The with B Type that agency end meeting, X. for the discuss to Phase Xb B dose optimization. So we our the an meeting agency a considered one Type had Phase of meeting a

were was really going we reason going that to back if a get default, any that Type So timeframe a agency have be We requested meeting. a to request C Type for to there isn't to C don't, if the the by meeting, specifically us. meeting, we it

know, briefing is a you advance, very Type A people may posed. the choreographed agency meeting book, engagement agency provide typically that a meeting C it's questions the in the a as to -- a with schedule bounded responds you've you

ensure So it we Phase timely feel to both a dose would really questions the recommended X and in the that did we protocol get manner. on

maybe designation just last engage I'll elements the a the because yes, probably, to remind or not exception That's one is before with like forward. But RPXD, the important. moving something RPXD, important have on it's therapy more focus just breakthrough the this pre-NDA people, really of opportunity, the we our that's getting agency, for that. meeting of And people with

companion your the the to agency you want on We So sure to trial. of execution on with Because agree the agree make you've the a are and got that after go, sure all fully Does make you go, design diagnostics? you that, the with plan? they aligned ducks it's the on us with Do Phase in want X statistical agencies row. go.

from So purpose X on directorates we rolls on making and monotherapy really the and studies into this productive Project the forth. exercise that within is of closing so the and that design various Phase execution the of combination Optimus, have a FDA the the serving very then alignment forward sure dual out then study. And

for sponsors. So the help to that's C, the Type the wants and agency reason

development phase very much extremely get of were of program off hold. and So of the And in ziftomenib. they the two. moving forward clinical helpful throughout They have good on looking phase it into been us we're process helping to this very wrapping up partners

Phil Nadeau

And that follow given trials That's get Is power power, of date just the sufficient could supports then it endpoint? patients you very of filing? on think or sufficient that enrolled up last the patients meaningful result there's number positive the unblind enrolled, helpful. you've you and actually question possible on a number for a AIM-HN. Do we that

Troy Wilson

Yes.

kind much. mean, I regulatory curtain, be interactions that to there close a stay of have for to harvesting also So I as to phrased your it we development careful. the didn't short too enrollment the there of for Run, if wouldn't are of and say answer spending potentially forward. a obvious question, by we is, that Because of AIM the have feasibility. time data lack don't and want prior we to And did I to want was trial Phil path completion feel

challenging, but data. potentially So there's to I that would it's harvest a way say,

We need we work to have some do. more

with next information. Let us more you some come year likely back to

have to I AIM, a data goal. working Run, saw ultimately Our going internally. but for our harvest way that there's because of clinical to meaningful we've really be because activity, And the know one appreciate a unsatisfying, we this say, more bit may team number patients. potentially, I'll the of that's to in little strong And be signal is in seen

Phil Nadeau

That's again questions. our for helpful. Thanks taking

Operator

[Operator Instructions].

Reni move with JMP will to We Securities. now Benjamin

Reni Benjamin

look the any Hey, those design Troy, mean, I or largely confirmatory out? morning, the was Am study past, on that congrats guys. parameters the trial Thanks upon you'd questions changes I taking progress. you think more good I given right? has agreed the for the FDA in I been had there remembering thought less parameters originally to that around with confirmatory like. spelled And that could the what and

Troy Wilson

the Reni, about? are sorry, -- I'm study study, which talking we confirmatory for what

Reni Benjamin

For -- zifto? As remember... were I we

Troy Wilson

Yes.

no. no, So

that if So with that was impression, then my I left folks error.

with in dose that was gained exactly we've were endpoints consistent we would over I And a where what use endpoints and we Phase and that meeting a the CRH that's that's Reni, say, bar terms step we alignment is, of what kind upon done. optimization in study. optimization it what to why So the used saying so forth. further. agreed the be enabling again, of rate Xb discussed the registration in goes in success CR, that over Xb I and now, And keep from This Phase would

the always agree, we're If agency the to arises. the questions. agency There agency still selected? your protocol the some And it null to on to you respond again, manner should asked questions. on does the are can you question the syndrome? outstanding the XX that Those to obligated previously, -- does days. we've agree agency, can handling Phil in which is send Does agency sorts not So but you agree the they of hypothesis agree in but differentiation

go this most through you important is probably significant this the on program. want pushing if So to And make sure interaction, timelines, schedule it's really the you're formal that meeting. to process the and

also X decisions FDA, buy we've the future study, to for we're it we're set recommending the will sure handling for do how the what but and to make really future DS, foundational development dose, foundation the we FDAs package get every that not back we're agency the we the right. so want as look made And ziftomenib. on data Phase that the Because they only seeing, this

So sponsors do the it. good for you, time. practice to it's with and the take take FDA to If engage willing just is time

the in yourself may and this a month take while, you my considerable done having it pain might for heartache save will, down experience, you longer, road. or two a You but

So our team it's buy that's in doing. exactly and good get is FDAs to what the

Reni Benjamin

Got it.

-- with contribution you of color alpelisib? or Just additional relative have patient this switching on versus is gears Just to response? bit talk a more there the tipi evaluate a current to data? can a do little HN, evaluated you How any way durable

Troy Wilson

short good answer it's It Reni. is, And question no. a anecdotal. the Yes, is

safety the that it's overlapping over to We it's and tipifarnib toxicity. that. manageable able I or Thus seeing cumulative think is MAP question same far PAX reasons in MAP kinase alpelisib kinase have pretreated combine time a overlapping farnesyltransferase expected pathway population. are as of the target to foremost, found first we Hitting we pathway, inhibitors people shouldn't are kinase nearly our a big of events. because adverse we hitting toxicity. combine that We're encouraged, to was a in mark. experience. inhibitors heavily the they have with tried That the the of not and not Most because encouraged, skip of and combine been impossible pathway

that's So encouraging.

mitigating their alpelisib. It's well we known, Those that as number indication is patients, in seeing it's yet. scheduled evidence are And We of of changes the address of seen really labeled take done cancer. in induced the one right is midst in poster, activity, clinical haven't using sorts breast challenges we include potentially a rapid of sorts of we're other steps to the there hyperglycemia. can of by indicated optimization. clinical have the That of we that one in Those onset are dose anti-hypoglycemics. But benefit things.

forward, have shoots dose the To on green path we biologically if optimization. of to is, can think sort do we're activity, into good company in the we optimal our physicians I that work a registration active of says, an then combo. dose, news us gives see the gives that seeing response we're identify a just of as seeing us one of rate

think can study a individual really an we that big do on that of Reni, too I ask. the identifies the of contribution patient-by-patient two components, At it's then that proper but point, sort the basis,

Reni Benjamin

a still about evaluate and that ideal then, finally, that ideal evaluate. initially just guys we've And or the alone it. And combinations is XXXX, is just that to indications, guys in how go to Got I -- remember, about you let us talked selecting forward of moving the that. are Is [indiscernible] continue with for to either biomarker kind going there used? you with program, being the past

Troy Wilson

Yes.

apart questions answer So then two let both Reni peel them there, and me and slightly. them

of selected population So will in Project XXXX, Optimus. dose a biomarker in do with biologically active terms that for identifying the consistent optimal we

going any make of FDA that You'll look look every they're going and to look -- guidance at pharmacodynamics, sponsor to been at has look tolerability you'll their sure super we're safety expecting exposure, you'll you'll follow clinical and as we at about the and and evidence clear to at PK we're do. that that activity

combination we're And second positioning because can as just inhibitors potentially XXXX gets for it of and easier for you They PIX that are kinase right, ideal certain can good your look alpha news are take classes TXXXM mutants, we to therapies. now. two the The you look you EGFR let's inhibitors. mutant. actually an right Reni agent targeted For populations, those visible is, for know ExonXX question,

You can look for PIX kinase alpha mutant.

that the those If adaptive of poster, suggests have we same ability at resistance to data preclinical look markers the blunt with know Again, they you KRAS. INSERM and are. potentially the BRAF exists same synergy, what HLC, FTIs also with with

farnesyltransferase we're us selected hit that hard at with if to the Then And XXXX, allows you forward you of least determine as will, enough, Project Optimus. into consistent in roll program biomarker the it that beauty hard dose enough “air” soon as of So it what populations, able do monotherapy, easier. cohorts. and you trying makes can that better pretty targeted existing you're the combination multiple the then to goes a the into patient cohorts. aspect of biomarkers, already Using existing therapies that And imagine from are X is, rapid a doing. good than Phase to development

Reni Benjamin

the taking for Thanks Great. questions.

Operator

turn the your complete for question-and-answer will call closing And Wilson back ladies remarks. gentlemen, to Troy this and session. I'll

Troy Wilson

forward operator. We'll the there. conference Pete, feel Troy or you, you. questions, once any you seeing next today. meantime, we me. Have be many In for additional if have week joining look Credit please day all thank call of our to And in you free Great. Thank participating again Thank Suisse a everyone. and the contact you to good healthcare

Operator

you today. now for And may conclude for this conference gentlemen, thank ladies does your and and We do disconnect. you participation your

Kura Oncology (KURA) 3 Nov 222022 Q3 Earnings call transcript