KURA - Earnings call transcript Q3 2024

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Kura Oncology Third Quarter 2024 Financial Results Call. [Operator Instructions] Also, today's call is being recorded. [Operator Instructions] Now at this time, I'll turn things over to Mr. Pete De Spain, Head of Investor Relations. Please go ahead, sir.

Pete De Spain

Great. Bo. you, Thank welcome Call. and Oncology's Quarter Third Good to Conference XXXX afternoon, Kura

Joining Troy also Senior are and call of questions. Mollie me the on Vice Executive Dr. and Finance Accounting; Officer; President available Tom Leoni, answer our of Development, Chief and Wilson, us Doyle, President our is Vice Clinical and Dr. with Executive President our to

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

Troy Wilson

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

clinical to robust believe We inhibitor beginning ziftomenib the transform ziftomenib. generate we Society positioned to treatment ziftomenib development with well package our to is posted lives. Earlier may reporting is of what of longer KOMET-XXX program, on with the menin-dependent a of menin abstracts believe AML continue so of the that patients Hematology. week, support were American We this our the broad trial cancer of combination X lead data better, preliminary from website data

at robust safety ziftomenib including best-in-class the standards the in to June a continue as and and potential venetoclax combination activity profile of care, data with tolerability cutoff, for of durable abstracts As study, the in XX cytarabine well demonstrated combined as commonly as activity ziftomenib promising and of well Phase with relapsed/refractory KOMET-XXX the plus XX% with management. of X+X. In patients. observed daunorubicin, as dose was patients, ven/aza tolerated reported. On-target patients escalation QTc azacitidine patients and DS well will portion observed Updated XX activity Ia KMTXA as DLTs levels, dose KMTXA known support plus rearranged reported XXX-milligram from cohorts XXX-milligram clinical differentiation at all activity NPMX including prolongation patients. and mutant venetoclax-exposed results, appropriate ziftomenib-induced syndrome ASH. was and in including of the Encouraging both were of be or X previously data XXX- in rearranged was No resolution including had

AML were or negativity. with and particularly of of population, the that rates remained the rates rearranged by X induction we by XXX very in XXX patients combined safety and complete of events of X+X the fact ziftomenib risk start. AML study frontline adverse including reported are AML on Notably, risk at encouraged patients the among suggesting XX% very patient milligrams, MRD encouraged year the the tolerability rearranged XX of and after be response syndrome differentiation challenging KMTXA the no NPMX-mutant In chemotherapy. We're cohorts, of context cutoff, safely as KMTXA profile, XX can data patients, of XXX% adverse the study

cleared to high-risk removing diagnosed patients plus the notably, plus Phase KMTXA XX in have rearranged We combination Ib The milligrams. at ziftomenib in and study NPMX as AML lay the Ia study at AML the We at be presented combination advanced continue or the disease. Each current cohorts, in Phase the KMTXA KMTXA rearranged expansion believe cohorts will is sharing dose AML, per ASH. Ib mutant data with to rearranged or expansion the XXX portion study into the in cohort groundwork Here, NPMX enroll anticipate to Ib mature a expansion again, sharing at and highest meeting leukemia from NPMX the X with for patients patients will more expect than newly and to to fit care rearranged diagnosed standards or least newly have we Phase next data data cohorts for acute I'm to that from both the NPMX including ven/aza mutant mutant redefine diagnosed ziftomenib or dose Phase independently, newly medical the look helping most Phase data from updated myeloid unfit We including cohort. more expansion XXX-milligram report month. In pleased enrolling escalation includes us the patients populations. in KMTXA X+X a all of KOMET-XXX mutant results, forward Ib set, well preliminary study of requirement multiple as meantime, XXXX. XXX for

for in In including and continue poor. with these KOMET-XXX care, ongoing combination as KOMET-XXX, with FLTX low-dose of Roughly well study FLAG-IDA patients we relapsed/refractory addition NPMX-mutant ziftomenib of standards additional the is the our half as and inhibitor prognosis dosing to of FLTX have patients gilteritinib patients mutations, in co-occurring all cytarabine. AML

continuum FLTX-mutant with populations, effects When in frontline inhibitor the establishing strong to driven pharmaceutical properties optimal to and step a all toward for menin first fit, profile to Preclinical become and believe pathway. alone. mission whose with leukemias of combination look efficacy compared agent unfit and by the for safety inhibitors best-in-class ziftomenib our mission patients refractory as leukemias. Ultimately, menin cornerstone we for the ziftomenib ziftomenib ziftomenib AML. single acute acute critical across patients NPMX-mutant and care AML A eligible with FLTX either relapsed shown data the is synergistic of has a develop with therapy could we that is disease for patients across is enable best-in-class

therapy and is approximately a annually refractory granted NPMX-mutant no AML. for approved there is therapy. be for NPMX-mutant is therapy to investigational designation XX% treatment AML significant of first targeted unmet which ziftomenib breakthrough AML new of represents the and a cases relapsed only need disease As of reminder, and

KOMET-XXX the with in featured for clinical Supporting a devastating awarded medicine from FDA based The KOMET-XXX as on were Oncology. Lancet trial, of disease. oncology our recently patients BTD this leading data data potential an portion I journal, from ziftomenib's innovative recognizing Phase

NPMX more expedite in line patients XX next study completed pivotal enrollment from in mutant we of fewer and review We results the this a top development XX year closely year, monotherapy. KOMET-XXX work forward FDA with earlier ziftomenib continue We registration-directed to sharing than look as this portion to than to months. enrolling of as

the and we reported solid of treatment imatinib we've EORTC-NCI-AACR for tumors Barcelona, unexpectedly both at durable was of And imatinib-resistant Molecular GIST on Meanwhile, menin combination to imatinib-sensitive for combination patient-derived imatinib data ziftomenib antitumor GIST. The showed gastrointestinal of stromal and the or robust models. the all activity cases, xenograft in leukemias, of significantly superior combination monotherapy. Mechanistically, the Last in Therapeutics Symposium and signaling preclinical activity, for a and including expression the Cancer AKT/mTOR revealed the mechanism Targets KIT-dependent the data ziftomenib body robust supporting silencing in preclinical beyond treatment and ERK growing and reduce ziftomenib advanced sharply the cell-cycle with and that a generated and/or effectively acute imatinib apoptosis. supports opportunities arrest certain data month, potential KIT inhibitors both driving and combining tumors. pathways in to

patients year, a promising GIST available, clearance application new and FDA frontline as GIST. We're proof-of-concept imatinib ziftomenib advanced we well in evaluating advanced in our believe represents this combination utility ziftomenib. the of treatment frontline that ziftomenib with a standard of for suggesting combination in in reported partner with patients half supporting Given of care mutational GIST, is to drug study all to August, agnostic after for data status generic XXXX. are now potential for failure explore in of In investigational successful, patients, KIT in GIST the for and of opportunity the If including the we imatinib appears initiate of versions established nearly setting. Earlier the imatinib received potential prepared imatinib to GIST an in inhibitors the we first of the to be treatment those opportunity preclinical menin the therapeutic diabetes.

inhibitor drug first and We are multiple metabolic of we and of half XXXX. other first targeting diseases, in these nominate candidates development next-generation advancing the expect diabetes to next-generation the candidates menin

need success potency, chemical a of improve the targeted to drug augment potential this KO-XXXX antitumor our for to earlier to a the candidates. while therapies, body inhibitors, pan-RAS therapies, We've need. let's to programs. innate to transferase and remains of turn the attention was of inhibitor, XXXX and the the growing inhibitors. KO-XXXX, enhanced generated FTI drive farnesyl properties quickly farnesyl Now as that therapeutic kinase effects including demonstrate KRAS Despite upon companion and designed targeted developing resistance. We're pharmacokinetic data physical activity, adaptive preclinical our a inhibitors transferase of activities tyrosine our and address considerable next-generation of inhibitor blunting antitumor clinical

to we concurrently us cancer. first very KRAS in call a dose Late that the the KO-XXXX clear escalation with cell last monotherapy escalating patient mutated combination in patients uses trial we study combination an design enabled innovative cohorts as we adagrasib carcinoma. a agent. Earlier dose And KO-XXXX with the in began in in to of dose in renal a escalation with this I Phase continuing in cell cell August, dosed in cabozantinib we combination as year, GXXC dosed while with year, FIT-XXX first single FIT-XXX. non-small lung that dosing patient KO-XXXX early begin

of now and collaboration study agreement KO-XXXX is Bristol-Myers supply the reminder, a Squibb adagrasib Mirati, As clinical Company. by and a with a supported

to combination FTI in squamous opportunity call tumor the financial combine a to from believe believe multiple forward indications. Meanwhile, may at that, continue combination drive presenting half neck and solid study preliminary in and KO-XXXX could medical now evaluate KURRENT-HN. cell there We meaningful an a partner the over enhanced be the look a alpha in a the head of the turn for antitumor a to of our we and alpelisib therapy tipifarnib XXXX. With call I'll carcinoma of PIX-kinase with targeted in trial KURRENT-HN successful, with we meeting results. activity discussion clinical to to If first become therapies inhibitor a targeted Tom data large PIKXCA-dependent we

Thomas Doyle

for quarter XXXX. was third of and third administrative for Troy, of of our third financial $XX.X quarter to provide of the XXXX loss everyone. for the $XX.X expenses quarter quarter overview The $XX.X third increases expenses for XXXX you, quarter development and brief million the of million million, Net R&D afternoon, Research XXXX third compared of to were and were to clinical good for $XX.X in expenses the programs. General compared ziftomenib results compared happy of expense to for $X.X XXXX. KO-XXXX to trial our to million, to a net $XX.X in of the period the same compared the quarter increase XXXX. I'm Thank for was noncash million, share-based costs and $XX.X of the included of in the million for due XXXX. compensation related primarily quarter third million third $X.X loss XXXX. million, a This

XX, December XX, turn equivalents million, of $XXX.X and our the cash, we September equivalents XXXX. of compared current I will believe to of back to Troy. XXXX, that had We to cash investments XXXX. With investments that, our plan cash call short-term As over be million operating $XXX now cash, sufficient short-term fund and into as

Troy Wilson

Thanks, Tom.

Before experience as in invaluable are across our with affairs, like and leadership more with and Directors. than patients to companies years take inhibitor closing, large regulatory industry I'd opportunity his accomplished combined for extensive create shareholders. and both and an development Vasconcelles welcome while Dr. value to executive Michael programs drug leadership. continuing to menin Mike we experience is to R&D to market oncology advance Board of FTI biopharmaceutical XX of our this and His emerging

preliminary GIST first from the candidate diabetes imatinib initiate in nominate meeting a with present the data relapsed/refractory our trial question-and-answer ziftomenib Now menin-inhibitor at XXXX; report menin targeting half advanced out KOMET-XXX in first for the XXXX; the combination AML patients registration-directed a into data X+X ven/aza Ib proof-of-concept evaluating early the session, lay of from in and KOMET-XXX ziftomenib top of from me portion before the XXXX. XXXX; in let trial in updated of with in milestones line a and ziftomenib study ASH next-generation at results of of expansion we development NPMX-mutant XXXX; KOMET-XXX anticipated Phase December medical our program: in Present jump inhibitor upcoming and in half

transferase in in maximum in expansion renal of carcinoma head with year; end tolerated and by in cabozantinib half KO-XXXX monotherapy first XXXX; cell cell present squamous tipifarnib XXXX. alpelisib our cohorts For Identify the the data as a neck inhibitor in the dose half programs: farnesyl KURRENT-HN of one or for for initiate of first of of combination the and carcinoma trial combination this the more the PIKXCA-dependent and KO-XXXX from

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

Operator

[Operator we Li this Instructions] to first Cantor. Watsek go afternoon at

Li Wang Watsek

endpoints? MRD difference thinking on negativity Troy, Congrats your the was you of used ASH in the how the And methodology data part the is -- data using abstract, frontline peers? presented in potential of guess, just there your are any then by that for progress. negativity MRD I you versus as about the

Troy Wilson

my ask Yes. then answer, Li. if Great question, comment I'll give and can. you I'll Mollie she to

for the accelerated the endpoint. base case So benefit opportunity I design, mean, these There consider as be that using -- frontline scenario MRD survival endpoint an is but to a use that negativity an everybody's as base studies the wouldn't in for case. you're I surrogate may

evidence I think although them here something not a It relatively green yet in authorities. of is to there's path it, discussing health that that light the on intend good support we been near given with sort has that's by the future. the

year an the design next to you certainly we'll try for be able So call don't if come successful. we'll back the I think, know strategy, regulatory others and that. going I this to on and early on endpoints. We're to update trial to probably Li, with reach be

can think comment could also but a case our maybe the if thoughts may case. I'll question MRD differ from Li's excuse others. make using let add survival to you the we her we're I methodology to that. case, me, how on upside Mollie, strong And base and Mollie negativity, as as

Mollie Leoni

Sure.

So is Troy exactly right.

MRD to out we'll be be patients. studies and know we indications the be in turn frontline pursuing to indications that benefit their for the surrogate. they're wish seen survival While in negativity looking endpoint of obvious a other these pursue, We've to excellent able to an way we as new clear a it at is use each

are those much with or and to used the in fact this and setting, it endpoint discussion part as would do we and it our it's notice much to about be be think to regards methodology point health as to a used for an able that samples we they're authorities but the allowed confirm to what discussions. With the you because as we there's of study, data be good in very setting made So to how we at nothing we have quiet varied be able the more use yet imagine. might get them, relapsed/refractory more of to were use you'll to abstracts, deny argument to MRD is in of type to have we extent it due that it less a up our can -- assess

those the more to in do do transplant, can provide decisions regards these care So negativity local a we particular et central so actually what to are to samples uniform cetera. our standard make setting, of results. they're test with that patients. Frontline because give looks They we plan like consistently actually to MRD analysis answer is of a did done what to our used

also give result the tests, centrally So we but plan on uniform so we did on site-based we MRD can running that those do much more negativity. provide those a

Li Wang Watsek

if what a see? sense I that you data number follow-up patients, present wonder just and of then And types mg give might the we of ASH, of can data Okay. you'll that for X at us

Troy Wilson

Yes. data can we've anticipating XXX -- on we're Li, I there. of see we're kind showing the this think so abstract, than more point. at That halfway patients by said you will

any You'll see every additional response as of with as on status on duration different levels. respect of at the We're clinical really well dose as patient patients the their to planning study updating benefit.

and with that's milligrams dose activity. that the across what support, expects these a in see Not tolerability, the response interestingly robust lot, go It's of to a component a now at high actually we by but milligrams, moved dose response actually and which activity something that might you XXX we've i.e., see the clear driven We to all respect asked higher see improves, as given also and sort of and tolerability at XXX pretty do is you'll safety helps cohorts expecting activity. dose, expect, activity. But you know, if get consistent dose a into with do the tolerability. significant of terms levels XXX In to response? safety cohorts, and as counterintuitive, we that pretty safety expect forward one expansion partly we're of is a to seem

think, So in will what update I you actually you'll see be, abstracts. sort even of the that a to it see -- relative meaningful

Operator

Jonathan now We Chang at go next to Leerink Partners.

Jonathan Chang

see what to as see zifto do be data how factors treatment benefit? how starting menin determining and your and the for the thinking we're stay longer-term key in the other on As space, on the And that what impacted class? could for patients can inhibitors long you has opportunity

Troy Wilson

of the number you're frontline from I what's messages one the folks I big -- Jonathan, to take-home appreciate sort data one want the there another, is significant abstract setting. that alluding of is are of relapsed/refractory into while to actually -- something think Yes, emerge which of that to, against comparing that's set get scrum the our a beginning in

KMTXA of XX at been So just June, had data on and on point notice the if of cutoff. for data frontline go you patients of out benefit, patients, for read some patients as therapy the abstract in mutant of study -- the you'll that as and a XX out study X+X, NPMX And XX year. of going cutoff rearranged everybody's those that the XX for remained for you

we're need clinical response, dire about need thinks as continuation is in their ziftomenib, said what to So they on the alternative, whether think, to a zifto and seeing, patients are a we've what to beginning we of back early transplant they emerge in post-transplant in there they clearly, then don't go and a go intercept i.e., transplant of is the in on go necessarily or get get in response, can maintenance. That's they frontline X+X treatment stay benefit, we The the provide they on therapy, data that is relapsed/refractory That's of if journey patients adverse again, unmet consistently, on in study. the commercial significant. you one population. But that's as a even not options. Those right? survival, cutoff, patients, percent the that have risk Jonathan, population. the That's clearly of the staying significant opportunity, in form XX-plus fact study,

I've that the it year, now in potentially X+X we're think in it where even is I really frontline well we expansion disease. adverse our hopeful is months, and relative excited significantly XX adverse what, as to thought you thinking response And We're I them share a to that's both that commercial update think cohorts ven/aza. If And as really the hard that we're frontline looks that, pretty helps inflecting way for the picture for the about think continues as about in as always to trend beginning attractive therapy longer, and risk our the models, frontline but begin case. keep focus. setting. the take the the for frontline that's drive the comers frontline, into with And keep the -- relapsed/refractory all and them you patients, these risk, in on a the without X+X i.e., on competition. frontline can to I is that come it see gets

Operator

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

Jason Zemansky

the Congratulations on progress.

efficacy? safety at ASH, follow-up. thinking do combination that be the to focus? Or key in a enough insights benchmarking at mature here? win Is the And terms of be expect what still data you updates gain then into to a point Regarding we the should

Troy Wilson

Yes.

want think we be. Jason. in relapsed/refractory And benchmarking. you of what that, then can bit a with Jason's benchmarks start start and about we about sort maybe how we take talk frontline would little Maybe with terms let's the the of Mollie, to and the can So question

Mollie Leoni

doing most prognostic these the that's any failed venetoclax. in for the setting, extremely part, on Sure. know, as Realistically, well have, And factor therapy. for relapsed/refractory an poor we patients

only less probably KMTXA, or For the months patients. than response higher, XX%. suggest overall, of at NPMX should survival particular be data subsets for so Potential rate would you tends is that in the X.X to slightly bar these set but the

how that is. situation the bleak helps see So

as add? been dose referred, is the through ability think a there tolerability increase extremely we fact able see very that improvement, in significant. But out, doses. and we safety DLTs, strong not escalate so point the would activity improved as dose as getting you I Troy as only escalation. And anything escalate escalate goal without is over to And an the Troy, we're see we to is Phase that safety but any the with to be really, safely we've that good obviously, you XXX-milligram to safely, sign would and

Troy Wilson

frontline not that, think No, population. could maybe we you about Mollie. risk in that for to But and help how expectations adverse the set

Mollie Leoni

Absolutely.

the at rate response best about So for rate response put control about which is our -- arm, comparison at frontline Vyxeos the XX%. a the composite

hematologic complete So CR, your incomplete recovery that your would be response with recovery. your response complete and with complete response, partial your hematologic

survival So overall there about X XX% and an about of months.

patients, a risk dose not setting on escalate adverse staying very again, these for able But these to excellent in again, significant time. seeing to we're patients good to So the be of ability see. are periods

to, even come which a in XXX-milligram Troy As well off going alluded few on year. for our has study cohort, very been over have

we're think encouraged far, forward. seeing I us signs to keep moving that so make So,

Jason Zemansky

it. Got a and on is especially rate, which think is X+X well? back there here helpful. both maybe And has tolerability And ceiling The sense. circle on in safety. and as that a be guiding X% the away would team level a curious, makes DS But comments you there settings? I'm encouraging from ven/aza to been your That's

Troy Wilson

Go ahead, Mollie.

take You that?

Mollie Leoni

urgent need X they're a patients, in and time. of hospitalized that What Yes, always DS symptoms all tend of Sure. tolerable. event. And grading for like syndrome, intervention, easily long traditionally and for fevers other significance, these as or is the it fragile the controllable, extremely that was as means I they're is rate patient thought unknown we simply Grade people to to have extremely easily that hospitalized less addressed, the remind XX% was differentiation that might

easily it DS do we appear controlled. And different And to the drug X to we're that control Grade symptoms. Steroids need grades be with able necessarily is to seeing sufficient. are very seem extremely care them. supportive X interrupt a is monotherapy to associated be severe doesn't is and what's So not and from X even what that DS

get level, summarize, treat patients to reasonable with probably easily would and severity XX%, the and just quickly the bar. these therapy on we about So is where a continued ability to set

Troy Wilson

Jason, add that. I'll Yes, just just I'll add to to that.

single-digit we to give the full expect data, You'll DS percentages. to see, the when drop rate

encouraged. in as think relapsed/refractory it KMTX with in Mollie We've we're seen managed indicated setting, the primarily, be I So well rearranged combinations. the to these seems

Operator

We'll go next to Jefferies. now with Roger Song

Jiale Song

the all right plan, -- one for the Congrats Maybe pivotal you're to to understanding progress. again, potential back related the question FDA discussing with now. the

curious initiation more the timing or XXX your at RPXD move you Just finalize dose design? pivotal into the once dose Do about package for release. Or for sufficient to to the exposure pivotal need others? versus you efficacy the the data versus total the current the expansion the study you dose-dependent dose, milligram see higher or

Troy Wilson

Yes, we already preparing and are authorities have trials to Roger, those designed health discussion. engage the in

off dose ziftomenib the addition So a combine XXX tolerability critical health to the recommend one -- want of that is we believe there's of going really to we'll combination. The both activity in selection, to safety discussion authorities clinical currently in and thinking in in global the year. both questions, studies dose a and support an represent and robust are if other an answer middle the We address indicated, The Mollie as as indicated health I the dose your question, about helps endpoints. kick those opportunity the Mollie and endpoints up milligrams as design, us, to talk previous the that ven/aza. next to that to to X+X that and we'll but mean, the question, we'll have powering, that's there. We're FDA

those for we've trials settings. each of so designed X And

necessarily interesting is, appreciated an enter And Something had We to it we a or then go the in commercial we're we sort That's that are might go X don't staying Mollie cohort. patient, -- abstract, has the might don't it but They in what set. you therapy I before really them X see really patients fulsome been naively that would see think seeing. or would dosed in and indicated, cycles, of more X+X. the transplant, through not I you'll not we data on back. frontline us opportunity to assumed they're as think surprise get an the Patients And for are is to But what to understand and of opportunity, also see terms and of was the that. But is emerge. can that's may zifto not benefit of plus larger led it be in that data thought the venetoclax we We periods enrollment. to us meaningful. we'll have just And question, azacitidine them to appreciation There's transplant. the -- see that that appears important. no beginning whereas we'll that's you see equally prolonged to X+X can nearly we terms pursue going in time. Many need of obviously, much that clinical this. to profile

of or towards studies that next combination discussions the in a goal starting year study your question. of of year. next regulatory Hopefully, in, we're middle answer with all about helps rolling early part So think that a

Jiale Song

think regarding NPMX, time about for Excellent. terms monotherapy? of line the in That's we the similar monotherapy very XXXX. how your early to data filing the continue helpful. that be NDA should the And And --

Troy Wilson

Yes.

question. -- Another for that you thank

So be has in we'll NDA we'll about that next and position for position, to the closer, a and ideally, the a cleaned submit a a submission think year. that period it. to well year better for of you to some looking in yes, rough would on time, data few agency. We little timing approval goes but by half once locked, in been give top to the if be We'll should the idea measured to be specific be that collected review, and of more bit all Roger, how guide Within line ready provide with when the months, second next results. of an we're a

Operator

Capital. at go to LifeSci We'll next Zhu Charles now

Yue-Wen Zhu

progress. Congrats couple A on the us. from

of what there? 'adverse enrollment proportion we how patients are this thinking remind Ib your expansion in could risk?' if you're cohorts, population First, be including you broader should And us a Phase about adverse speed risk beyond

Troy Wilson

think we what, if you Sure, we Charles. what, enrollment? adverse to don't population? anything can can say then sort how about the Mollie, about anything, broader I -- know, of speak risk if And versus that,

Mollie Leoni

Sure.

So a treatment-related complex that risk patients the or way AML. is we've defined cytogenetic be may adverse also older have

how to the where about numbers, we affects is it how don't fair that can of brisk. XX%. And you we tell amount it a So define up, know patients. the risk, but would And estimate extraordinarily that enrollment I Ia, have adverse be enrollment risk. did in able being does that regards with realistically, to our exact I my was open comprise adverse

that the you we're brisk, if into just with move worth of fact year. It a the can so, share as able XXX is Ib. just not more to see patients As we after Phase over as now data now

excitement of the So trials. participate our we are investigators very of the and patients encouraged in to by the the desire

Yue-Wen Zhu

response combination? the are and a Great. longer it. at effect be one appears XXX regarding here. but clarifying very dose numerically question XXX-milligram about milligrams? be dose XXX your we it deepening response XXX the be what follow-up seeing Is versus Got lower there abstract, a And inverse should granted, milligrams between thinking these ASH small And has in that we given how that to could end,

Troy Wilson

you do to want take Mollie, that?

Mollie Leoni

Sure.

combination reasons. think I a there's of

the as small complicate is, out, point demographic numbers. those one the characteristics there's varying that I as think within biggest numbers, at the interpretation. can look small when exactly I And details, baseline you well

different different for you'll levels. for priors levels, different have dose different So dose of ECOG numbers medians

study, data count totality the patients. And those for both totality clarify us what response, the the the of upon these data really should if monitoring the to the expansion the taken the based and right ultimately, XXX response to into should that different taking tolerability, safety the agreed pieces. be into also us is independent especially not forward account baseline should tells of I that involved the decide milligrams evidence to improvements, what dose it about helping have it but both have helps the dose characteristics, dose that should myriad decide and to a committees escalate, rates, cohort not committee safety just does speed of been carry of committee become helping that that And consistently throughout be. in determine and ultimately, data monitoring the correct So when we an we only

an -- of particular while think could response, be is actually dose inverse don't study. appear reality the it that to we So we this

Yue-Wen Zhu

Makes Great. sense. Perfect.

If one humor, one just last could me. you from maybe

you parties Regarding your third from on-target you a their on menin sensitivities used when things relative of the those resistance they with there, the heard but reported menin that assays the of XX.X% the emergent to one of few or are clarify of some mutations, mutations could assay what how assays? that mean different similar does zifto? out we've resistance And rate peers/competitors rate and

Mollie Leoni

to you're PCR difference I that RT-PCR between referring So we Digital used. Droplet think and the

sources, We for DNA RNA, versus data. also different use examining that

sensitive However, the patients would we that for at have been mutations less looked a assay. even detectable at

need didn't order Digital were Droplet if mutations in we there. PCR So determine to these

developed over is highly think things than do that Droplet to able the to data reliable we're And baseline our at determine Digital rather we and data. were if So were that time. PCR using that present these other remember, to compare these they

we extraordinarily we our continued addition, on more and consistent confirm analyses are work sensitive obviously In to what we've presented that this through do topic, EHA. our findings continued with at more and to have

Operator

We Nadeau Cowen. go TD Phil now next at to

Philip Nadeau

We Is a the were intrigued there increase. increased safety by to safety doses improve about improving why as zifto should exposure? with mechanistic for your as rationale comments

Troy Wilson

I'll is give Yes, let you Phil, color. there Mollie actually. And more

Mollie Leoni

bit even actually think. more It's you'd a than obvious little Yes.

to be less for susceptible count bleeds, seeing have have have Obviously, faster less increased faster are dose. count infections, patients recoveries need with to these We transfusions. susceptible be time less time mean recoveries to to

the So we increased seeing at very be there dose. to safety are why good basis does a improved seem for

Philip Nadeau

helpful. on the question very inhibitors. menin then second is next-generation And That

candidate to I underway mentioned will menin first next-generation identify Are in to malignancies that the efforts diabetes of half you for XXXX. there well? nominate inhibitors advance a specifically think you heme in as

Troy Wilson

molecule Yes. that zifto. active could thing we against I we was you Phil, all to there always imagine could right? have improving one a on baby It's your the is, molecules. gatekeeper actually you the beautiful, most be. say hard -- develop known It's is mutations. mean think The might

combinations. that's molecules. to very, we Mollie low of have mutations gatekeeper said, now of that induction not we're We in an continue that, to And such advantage. It's obvious us see rates as very

front have the inhibitors. with really the say at bets the them combinations I line and FLTX we molecules. holding moment, the initially well putting going So as in We're zifto into for on the work, example, would as doing

inhibitor tumors. nice at think out very I combining optionality work for applications? And for we having there GIST. are data if looking there to want are, those applications. ziftomenib potentially solid inhibitors solid what menin of solid determine, preclinical however, We're We tumor some tumor menin is other And put next-generation in is example? that Or imatinib with are, a the doing distinct an isolated the other you

work, that picture begin to continue year. we'll next probably do more in we Phil, to As fill

Operator

to We Peter Barclays. next now go at Lawson

Peter Lawson

patients Just versus think that saw I study, expectations as then kind how pivotal of we -- we in data that think for we treated about published? Phase in the what prior the should was about

Troy Wilson

want you do to Mollie, Peter's Yes. speak question? to

Mollie Leoni

that published post set between we'll can All synergistic too is to exactly We what and data monotherapy on a II data. these put but effect more to better It's analyze analyze the to the as look it post on back, Phase that like Is to patients respond small venetoclax? and X ASH. I presenting Sure. a get as data these ability be was continue resensitize encouraged. continue these patients data think we continue get and picture probably don't resensitize good we're respond the we combination molecules? potential to the as gain patients to will is venetoclax as failure to know. Obviously, is our the setting, do very Again, to to set, out we be early, due able able data patients data to to that a therapies. In failure. there say to the for we'll We still if and our well venetoclax we

Peter Lawson

Perfect. Really interesting.

the X+X the differ the you response? On could between, that versus the duration risk what do KMTXA adverse would How think, patients? NPMX patients, of

Troy Wilson

to want as you take that question do well? Mollie, Yes.

Mollie Leoni

know the realistically because are these this don't of question patients What's is, all nice is yet, we to answer that still ongoing therapy.

our So we it these that duration median of on thankfully, way. hope we groups. response for that haven't And reached continues

so this continues to be answer. And question difficult to that

Peter Lawson

KMTXA kind patients? and you fundamental no think, NPMX of do between the There's difference,

Mollie Leoni

do. I

I ziftomenib and is control. able been of able disease where the that tissues becomes monocytic more have already is in front KMTXA the because these even much of to well harder line. rearranged to think so actually They some cells find think permanently our accumulate that's at as areas time in invade much to I diagnosis where aggressive drug a so just are like KMTXA a invasive. have molecule important But the

a the aggression the fundamental for difference great become of So inhibitors hope at yes, between in level menin the equalizer that we but definitely X, least them.

Operator

We Justin BTIG. go next of now to Zelin

Justin Zelin

line Maybe earlier progress. up the those combination earlier do your Would that mutations. question analysis resistance differ on and an if might think And you there in just expectations look Congrats on you to in about following that settings? studies? it

Troy Wilson

Mollie, that? do you want take to

Mollie Leoni

frontline types these well to the fast grow your develop these differential Yes. resistant settings, because a are hitting regards Obviously, see you're of baseline to bacteria, time, mutations, after of you mutations, menin could in relapsed/refractory it you're risks really mutations and least these ability to giving your monotherapy it enough, combination, be like It's hard other not decrease a although big exposure just the into risk to they out for setting don't to get developing existence enough, just that's going colonies. enormously. expect with to at we with resistance very once inhibitors. But in

to able decrease are in outcomes So see the for think have on patients I these an you're that overall to issue that a mutations combinations. successful becoming just going

Operator

we'll next to Canino go at now Brad And Stifel.

Bradley Canino

initiate one with trial we've one in of seen European Just the given frontline groups. the of for Wondering, collaboration one peer companies menin a me. cooperative

pros Just say, employing company-sponsored one? collaboration do you what's using similar a and such versus, doing your strategy? cons full How a of current a thinking the about think about

Troy Wilson

Brad. Yes.

a across So in work. LDAC, cooperative They we for But really our the X+X ecosystem. in plan, the run-up important about different FLAG-IDA. XXX, see the activity of establishing is ASH, next to tolerability, a In is more and of clinical hopefully, ven/aza. which in and around view, are talk this safety, combinations. Much do year, combinability, range we'll terrific gilteritinib, packages can groups reflected obviously, you focus, play role development some the data

very either you is, unmet find it's be value And groups. And XX, think get-go them it take that at but patients you that And so release. see more studies of full with context, using their most identify really unquestionably study it's difficult study pedal commercial smaller pediatric of things are opportunities are that opportunity, we this. The populations perhaps LLS. The you either data need, do. to where for huge or the I group to because a a get important I honest, collaboration all their the for to ideal on to to money here the the on patients. a know happy want they're It's these right interpret patients have line. huge you how advantage. us months. don't LLS' probably extent treatment, big and with those study. data, that's the ven/aza even And or those in XX% can dictate indications ideally XX, for is, where these think for of trials going know keep some perhaps difficult to X+X one because our we cooperative collaborating downside group you're not is time be to to it's We right? XX amendments the They make to cooperative you design, cooperative is They dictate any in

you're indications of both. see Brad, cooperative continue studies, do to us, and may mix appropriate. groups So studies a Kura-sponsored we'll smaller be going to planned We'll do those have but where for work

Operator

We'll go next at to Dai now UBS. David

Xiaochuan Dai

on on quarter. for Xiaochuan the David. Congrats This is

kind pivotal AML is in question first refractory in like our early the guess data, I relapsed or for XXXX. of data, pivotal NPMX-mutated ziftomenib So

think well inhibitor. So saw so efficacy duration bar. And were cohort, there like just on curious the we your clinical who aza actually I the if ziftomenib for for abstract have as meaningful prior around as ASH could some you expectations patients XX% menin second one, plus the set

to the like think resistance activity higher So just curious are like mutation against we at patients. of if to to presentation? profile the these the just from going it's efficacy patients some Yes, see related potentially set I

Troy Wilson

Xiaochuan. Sure.

nothing So is think we always data, ever which our with same in don't response. Certainly, the the ever to patient, duration before of bar months varied and XX% regulatory point, to I've been changed. CR/CRh XX% to view, is, to the pivotal bar I've even to the that a think when given respect I I this asked monotherapy X has dosed question. X median we've approval from guidance,

the the to agency that approvability. uses Now bar is that consider

there by a lot you, those factors, Mollie of spoken of have are competitors to already As indicated of ours. and has been to some other

we're So think safety and CRC how as rate, about overall that monotherapy well as response the rate, in. all tolerability, it data. to that's factors such continuing things But as

As as menin learning relapsed/refractory materials we we prior some far yet story. Because patients if story. prior to additional in can experienced will activity therapy, are kind of inhibitors, when that Mollie that still It data population yes, do of seen what, there that see it's data is, an setting, in with on of progressed rules have the we don't anything, -- they've patients what have previously; who of in lines the status, on evolving is part ECOG at inhibitors be the have who menin treat presented but i.e., as them heterogeneous, the the the increase part indicated, are in the of think patient ziftomenib. activity road, so to I fully encouraged we ASH and

Operator

Farmer Scotiabank. go at George next we'll now And to

Unknown Analyst

George. is okay? me Can [indiscernible] This you on hear for

Troy Wilson

can. We

Unknown Analyst

that what eventually data see program about II be setting benchmark need in year, and from this other your more going guess going down from ziftomenib Great. own which how the we diabetes menin inhibitor, by the potential is to Curious for you'll next-gen expect your program to information competitor Phase from next menin inhibition critical this I be get diabetes different year-end? And road. and some Okay. and we're from they'll the molecule to on of

that follow-up. similar to differentiate program? then And other have So I be from in or what are hoping ways you a

Troy Wilson

Yes.

Okay.

competitor away only So ziftomenib, compounds we next-generation we evaluate whether experiments in diabetes, as not our should AML, portfolio. compounds it's whether our as these hands, when but understand GIST, well in do and from folks it's

diabetes, extremely also don't in part So to picture. And we is we zifto for in as uniquely is is Francis GIST, its can try example, of And on hit President a active. Research, GIST. tissue due he to you're to In hard holistic that hits which actually seems zifto other it in penetrance. provides is think I be get probably very us Vice Burrows, who all. We're have menin potent the can knockdown. as some It It's Translational property Senior to say, we -- our a a of degrader, the we is by menin quite shared of menin hit sort not in think compounds, as not the drive hard as the to pharmacology in in seeing ADA it. who showed with we one that at it it meeting the you with call, leukemia as not active characterizes hits diabetes order June. models that

honestly, for most the We're setting, anything and talking patients. are leukemia That's these higher. is are X to As not away, diabetic properties about we're much next-gen hurdle but tolerability safety right? about tolerability. In not They -- important a safety. patients that the of talking patients. type the compound, we take safety and not sick, is about think

the activity models, only as to create trying really not going a we put large emphasis in therapeutic animal can. but you're see appropriate So to on us real a window as

that zifto, compounds, takes weeks Does it The sense? see to be you it compounds remove in. the does zifto other when that. and add make When do is this that aware other decay. for other kick epigenetic for it to is Yes, benchmarked several not may mechanism. With you What you an competitor we've activity of. certain because this weeks the zifto, interesting thing, several against see activity with you we takes

As you that's almost away goes soon suggesting competitor maybe via entirely pharmacology menin. immediately, as the that remove acting compounds, not the

allow this I'll to as you not we're and that data know on going to and ultimately of out say sure we as are we would there space, make about parties study. want thing want diabetes they the right clinical to do what preclinical see consulting would understand very sophisticated so And them to are well. The there final far sort is that that as shy

that. follow-up. looking happy said couple, a of we'll that Again, the people talk And had So much about to of first probably year, continues you it maybe and diabetes nominating more evolve. to to you first a through as walk then in compound, half have next to forward data

Unknown Analyst

Does helpful diabetes very -- clinic? current clinical color runway include work I as the you early estimate Very, Yes. this early in your Phase enter there. cash work

Troy Wilson

Yes.

Let speak can me ask that if Tom question. to actually he

Thomas Doyle

It Thank does. you.

work does runway diabetes. in the Our include cash next-generation menin

Operator

for back Wilson, Dr. appears have the further I'd any comments. sir, you, like questions closing turn no it conference today. we to And to

Troy Wilson

once contact of many Pete, the you London again have have good Thank me. We'll seeing in all be call you, meantime, Healthcare the for pond there. look thank and all Conference our Bo, Tom at forward a if of the across please you or Thank questions, joining participating additional a today. Jefferies and you again, weeks, In feel and to you free evening, to everyone. couple any

Operator

Wilson. all Dr. you, you a and great Financial Again, will conclude Oncology so Thank Quarter Kura us, joining Results wish Call. evening. ladies for much and Goodbye. thanks gentlemen, that the Again, we Third

Kura Oncology (KURA) 7 Nov 242024 Q3 Earnings call transcript