CRIS - Earnings call transcript Q1 2024

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Operator

Good morning, ladies and gentlemen, and welcome to the Curis First Quarter 2024 Business Update. [Operator Instructions] This call is being recorded on Tuesday, May 7, 2024. I would now like to turn the conference over to Diantha Duvall. Please go ahead.

Diantha Duvall

Thank you, and welcome to Curis' First Quarter 2024 Business Update Call.

Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our first quarter 2024 business update press release and related financial tables. I would also like to remind everyone that during the call, we will be making forward-looking statements, which are based on our current expectations and beliefs. to materially. and subject results and are differ may statements certain uncertainties, risks actual These

details, see additional For please our SEC filings.

on Officer; Scientific Joining and Chief today today's Jim are me Dentzer, Development Chief Officer. Executive and Bob Officer; Chief Martell, Jonathan Zung, call President

call. I'd be to the Jim. like will end also period the the for available We to question-and-answer turn a at of now over call

James Dentzer

morning, business Diantha. Good everyone, update you, to QX and Thank Curis' call. welcome

and key advancing quarter, AML focus: therapy relapsed/refractory areas combines therapy emavusertib as CNS made splicing X triplet ibrutinib all third, in progress for frontline our in This second, combining AML in with study; azacitidine relapsed/refractory Leukemia doublet in TakeAim regardless with lymphoma, or that as primary status, with of of in as mutation with emavusertib for a monotherapy in patients venetoclax. we with FLTX a factor first, and mutation comers, emavusertib a study; our significant Lymphoma our patients TakeAim a

a X and mutation with factor patients patients: both mutation, in patients Tuesday, of had to accepted populations. EHA line splicing X TakeAim patient abstracts, including who X and Conference's data factor from X mutation, with with a both Leukemia a we in FLTX disclosed publication FLTX study. update our splicing for expect a a top Previously, provide the we connection Next was clinical of data with included

the released, patients splicing FLTX XX emavusertib XX status patients a a including a data mutation will the relapsed/refractory FLTX AML FDA with next monotherapy. mutation, therapies update We mutation CR/CRh with which benchmarks new our genetically is can benchmark. and patients a IRAKX, is bringing with frontline single for patients these total possible, therapy. escape report week targeted factor of XX who and in gilteritinib, failed for as hypothesis patients failed for relapsed/refractory in FLTX X central targets included Our its patients, more in conferences the in have patients with both agent, the path the molecules rate goal our emavusertib treated and for existing FLTX is XX XX% to a a to patients data. these population, are achieve benchmark The designed of data and discussing fully have inhibition when factor by emavusertib's FLTX potential FLTX treatment label top beat because to at With is think the with the EHA on the mutation, forward AML medical more that line outperform is emavusertib, and as to ASCO this the demonstrates, prior presentations patients an though the for preclinical populations. In data unlike are followed the call existing for This detailed even a in study is inhibitor both a demonstrated treatments, majority investor both FLTX. look the who that populations. We explore splicing

establish the further that showing a has the FLTX AML new EHA, that population. support XX we'll at and to patients best-in-class hypothesis, ASCO the namely to potential we With for emavusertib and benchmark be hope

treated hope are survival a was with only only the for Anything show As frontline by splicing this X no clear AML activity standard we benchmark novel aza-ven is patients for challenging especially is relapsed/refractory induction. We study the population. intensive in for single-agent very a is far ineffective. This of can X. aza-ven emavusertib's mutation in ineligible notable the mechanism patients, treatments as very lower. small that find drugs study care shows of set relapsed/refractory neutrophil move doublet. aza-ven unfortunately for extended and rate months, benchmark is, we'll There It to ultimately, factor few beat our population, approved. can platelet the responses The survival. we existing count splicing be for increases, patients, and these blast with that response are was positive. would Expected patients factor published reductions, objective data was X% In course, with and a looking increases, AML patients be emavusertib set, only for expanded the

data turn TakeAim relapsed/refractory see to prior failed patients with recent our we a we conference, progress Lymphoma there we with well. most who ASH lymphoma, had At CNS BTK primary inhibitor. As study, as significant the X treatment presented for

high to an later data likely provide we report patients. are this XX December. Previously, to most have on pleased lymphoma data to XX CNS with expect XX patients, treatment to report expected ASH year, as inhibitor. prior update failed who in expect data BTK to now We additional estimate we conference a refine to at the approximately range primary have Today, relapsed/refractory we with the that end we the of said for

to the also in pleased advancement of in announce We study are frontline AML. all our triplet comers

preliminary we our the again, have in clear at this of that data likely neither from enrollment this and AML year, conference safety monotherapy anticancer around begun excitement study have upon important We nor azacitidine an know in ASH We builds IRAKX addresses and are in novel seeing frontline later most expect targeting is studies. to venetoclax target activity it. December. The the stems and IRAKX the

Diantha? updated the data the we lymphoma, forward benchmark step and to in our a and AML. In comers results in new all back is reporting logical for across Diantha its we're turn therapy I'll next that, by the to triplet over board in explore call leukemia potential the week. ema-aza-ven review leukemia progress and With to our to our to frontline summary, establish So for the next encouraged quarter. look financial

Diantha Duvall

Jim. you, Thank

as period $X.XX first $XX.X reported same $X.X The of costs. General to million administrative higher $XX.X Research were $X.XX quarter the quarter expenses development share of XXXX. same expenses in XXXX increase in for net million in as million were compared the quarter same Curis $X.X $X.X per compared first million million XXXX of loss in or and net primarily XXXX. $X.X period the to of were XXXX, per to For the loss period expenses research for as and a employee-related a compared to first development the million share and for XXXX. of the or attributable for for

As million, totaled approximately XX, and there cash, XXXX, March of investments of and million $XX.X stock are equivalents Curis' shares X.X cash common outstanding.

I'd We planned continue expect our be cash that Operator? solid position into and existing open like questions. equivalents a cash to XXXX. With and to to us in investments the enable cash, call maintain should for operations that, our

Operator

first comes [Operator from Roy question Your with Research. Jones Instructions] Soumit

Soumit Roy

next could -- multiple for are presented. I on clearly I really, FLTX Congratulations couple on expected of know if it, week. going don't to the both really data on present reduction of rate, kind give recovery, A and questions you the relapsed/refractory missed et spliceosome much progress and going the fronts, data us mutants neutrophil mutant data cetera? around baseline details how to we And you Are setting? response levels, expect? in percent blast fair what details count

James Dentzer

Thanks for joining.

to detailed to the talk be to the data. both need factor top So FLTX are going the splicing but It to is populations. We the going course, discussion. little come we wait sensitive poster line review can presenting more and abstract, a data to for the for absolutely yes, of we're to mutation to we be need to conference. up to Obviously, the going be of have a

forward having look think talking to So there's We're granular EHA week. some to and forward And conversations ASCO more at next news we looking it. in detailed about we the a and exciting both level.

Soumit Roy

Totally path in last forward of the population relapsed/refractory mutant setting. understandable. question patient is My around splices for these

think registration I population, clearer. the FLTX the So is path much

going you included On give mutation? color. are forward? the diagnostic? develop and you is companion screened splices mutation, of to Are Or to routinely for how that us go any fairly you can any planning If it

James Dentzer

Sure.

have of to course, FDA. a we with need, discussion So

level, here goes. single-agent about So we the nothing giving put need approved But I context careful when our because shown the it's depend nothing say, drug we conversation is going complicating into design that's This activity at the The highest to in I works. with first here, would you is is this how that really want factor population. think thoughts. to the of FDA be study, on the to we're

looks whether whether survival, be like some not would whether all to going single-arm a thoughts look these really got but questions or on study else, upon depend with they those, and or it response whether comparing FDA rate, something a for the conversation want of for something we've are it's FDA. questions, objective they So an great to

I'd say forward to how conversation to assume study, off we companion and is tuned. will think with new incorporated that timing to into I'm go So population, think a diagnostic. on little but pivotal on what the bit. If we're have any about that for depend genetically that FDA going need I the fair going it's a we and Again, that gets driven to a one that stay hold of

Soumit Roy

it. last of percent. And is the FLTX, CR gilteritinib may -- with But bar to rate Got mentioned relapsed/refractory if beat weren't for question those you the patients. XX-ish one in I FLTX-experienced sneak around

beat fair? So are to XX% Is like rate. yourself? more the to Or bar a bar up was XX% mind, in setting our that response you high for

James Dentzer

Bob, maybe jumping would Bob's to talk in? Actually, the person mind Yes. to you that. best

Robert Martell

Soumit, be key. emavusertib The is targeting XX% from that's expect obviously, so resistance agree, pathway, TLR new as the inhibition. demonstrated much terms in would is have upregulated you And is a than critical I Jim. Thanks, this patients because lower strongly in these to in Yes. might area following what where bar we drug IRAKX FLTX FLTX FLTX because of know, targeting inhibition. exactly

precedent be that will the earlier It lower mechanism. a can gilteritinib resistance they lines combination. The had know with is We this. has the as And of though than In fact, that think, this for IRAKX hurdle patient XX%, a of that. why FDA approval inhibition, resistance TLR therapy. may as for prior signaling don't what to the we a would rescue in presented even accept that FLTX through that's we require we

with And will them. so really, Jim as mentioned, require discussions some that

Operator

question next from Watsek Cantor Your with the of comes Li Fitzgerald. line

Li Wang Watsek

Congrats the progress. on

we of questions we're maybe to see be on expect EHA MRD follow-up. of additional and the relative And data abstract going at to sort whether what data Conference medium couple Should the some cuts? a data will then comment Just here.

James Dentzer

you, Thank appreciate question. Li, the and I

So the will abstract. compared in detail at to yes, there conferences what's additional certainly both be

are really the comes it's top my week, looking can that we're data -- in that to to to much next Soumit's answer There as limited question, going going ASCO imagine, about definition, more similar be there's forward So that, presentations and EHA. abstract. have is at be you to at and and going to posters to but the detail detail a in to discussion line we're by the

Li Wang Watsek

follow-up? And Okay. medium the

James Dentzer

and that's if have released, discussion data are right. wait the data all when a Let's about the

Li Wang Watsek

Maybe on just then on have And a less think study. patients fair. the That's both X Okay. and for little And lines how correctly, therapy. bit expand are recall of patients the treatments should FLTX prior these the if lines therapy? of these impact we to than in response prior what spliceosome about enrolled I

James Dentzer

you. Yes. Yes. Thank

lines So prior it's than the actually coming study. less X into

the So you're AML the talk you happen know yes, in that better actually, these -- of maybe AML. person what, therapy typically to typically, in patients Bob, well, lines in about

Robert Martell

Yes.

So -- right.

FLTX are may really But with fit, who patients lesser therapy, generally, very are ineligible a and or they just discussing fail, go aza-ven. that a therapy. eligible like get will we intensive have oftentimes, will then for oftentimes So induction would upfront intensive. aza-ven some get once prior induction ago. bit patients, to they not all who for the chemotherapy of a mutation Patients FLTX But on inhibitor had will cytotoxic were intensive get patients intensive those

about X poor couple or a There's resistant fail aza-ven may on you looked outcomes. aza-ven, board progress months the that know, at across patients of following as survival extremely to to have in studies failure of are patients. is those studies of and have the that those been both So on who or outcomes X

treat. about. So really, well, excited viewed a in population we're data be difficult our that And which really to as should perspective

Operator

of Yale Jen Laidlaw. comes line next the Your question with from

Yale Jen

standard aza-ven is I asked, to just that I question guess, you the line on patients. the, [indiscernible] for which FLTX inhibitor just last want mentioned

well. survival. mentioned I be the about about a benchmark the What Because So you that as actually might probably you think to have will ORR? compared

James Dentzer

again, Actually, probably you're one. to better Yes. that take Bob,

Robert Martell

an data post There the factor study factor at sort looking So splicing response one rate that rate. have interesting of extremely is not with -- AML demonstrates response treatment lot first-line a mutation there's aza-ven. low really splicing mutations of on

achieve splicing So splicing a dramatically unable mutation CR response achieve factor patients the have XX% approximately maybe XX% are line. to whereas mutation who almost with first and a factor rates don't have patients It's who only in XX% a of that, reduced. can the

population, aren't although is that Does roughly of detailed similar, of your there answer on In that that. as question? data subset terms a FLTX

James Dentzer

Yes. that Yale. was way, the And frontline, by

we're in course, So The about the hurdle our it's we're though the populations settings, going so And population. underserved. to right? even drop-off why it case, gets is agent that of across So board, about seeing excited that therapies. existing in far in excited lower. for that to is of worse after dramatic relapsed/refractory, we're both the that performance they're something relapsed/refractory in show the in Again, we're there's it's frontline, activity a one not reasons talk

Yale Jen

I accelerated this population, And be just growth will Right. to you was if think data hypothesis mean, in -- pathway the whether a these potentially anticipate patients patient would robust?

James Dentzer

gilteritinib, at In for for cases, FDA trials not the that accelerated We approval, that. say based it's approved the those on specifically X precedents all were studies, and that CRh that So a in endpoint, AML, drugs led and IDHX. even for single-arm full IDHX to you for interesting look approval.

and can't, at need the therapies. believe we precedents are to by understanding diseases new these that really an that course, have in existing patients FDA But need the We therapies, mouth. with FDA. are those put discussion the in we So underserved FDA's of of reflect words these

if can can that but bring a see that set in drugs a it early So the be that indications to possible. in agree as FDA pair and with activity patients we our that get of hands path to registration and would FDA still, physicians can these we can the single-agent hope of that to survival, as be data quickly position hopefully will show a

Yale Jen

would is the move forward-looking Maybe to type refractory words, bit -- terms last thoughts, of the robust, up consider question that of patients line here, I this to at you data FLTX is the which you of in development? again, if instead combination, in a little mean, the patients, in a stage first would of other

James Dentzer

Yes.

it's in fact, answer drug, is it's for CLKs, right? in but of AML. a mutation not we've all whether course, or the also CLKX, X. target and a IRAKX. I DYRK. our context it And And emavusertib, drug a the of comers, FLTX, for number that that, FLTX, not. does is reason targets for this the X of hit So mean It of targets started already is that, It you have FLTX targets interest the multi-targeted targets that just

that study, ema -- the precisely we've So and why with is started combination already in frontline of the triplet aza-ven. study

patients, frontline nondilutive obviously, a we with access aza-ven clinical authorities setting with the get safe. And have can that in a of what in adding to the the conversation those that we'll we do is to commercial I and this that, the have accelerate And to we data mature So be infrastructure to, setting I so that monotherapy, by financing, simultaneously set hand, ability frontline development time splicing time FLTX to to of go in I the partner the a maximize our We'll doublet and factor be, get partners have be by clinical a broader patients and to hope handful are case safety. to patients it's can access we'll we think pace we a and to a and with call, prepared the will make in be as just though a we to think can launch. a increase position our but hopefully, shown, we initial year-end, have in even study with in ASH, we the And relapsed/refractory ema drug in show regulatory as get position monotherapy combination. in ready. the data would would that safety if can

thinking So those of time. all of point our things in this are part at

Operator

Your next of Jahangiri the Bill with line question comes from Truist.

Billal Jahangiri

progress. Congratulations on your couple here. a of I have questions

be pick subgroup representative that triplet I to on then the inside derisk over to also, spliceosome those And study. a split as move ] And FLTX safety study, BTK-naive and to world? question. know, is and can and we going of real enrolling to, Your I'm on patients maybe this since there seeing time the a triplet? that Is for guys patients the the later don't year? guess X we'll is patients way for then data this still first contrast [ I the of And are PCNSL, this well compare the you sets experienced between that's naive

James Dentzer

Yes. Bill, Thank it, for Appreciate and joining thanks you. us.

let off a those in try X So me questions and row. knock

FLTX split on versus spliceosome patients. patients So first, the

the And Both recruiting So AML. I reflects are interesting. it studies need think quickly. this one really really, in these unmet of is

you rates target. In year, seeing sites in got partial real off clinical enrollment may our spliceosome and really our up board running. of has as recall, novel sites. As AML strong at particular, a hold been interesting. we the the are note, across our came you pace demand midyear a for really we And last There's pent-up

constitutes X/X have we This make roughly is is activity drugs of that splicing nothing patients activity. FLTX. no a are XX% outpaced available. AML only have much And is compelling. precisely agent X/X time Patients mutation of portion FLTX a yet, There factor said. FLTX people these And nothing a factor of think kind a I up AML see Not really it's And patients. are smaller the works of with approved, that to that seeing what first single for a has AML. community. mutation. So in enrollment patients of splicing with mutation. Maybe

these well. the We're and take another begin having So and and with FDA we the week we our those in to XX X data spliceosome. you those and as our the to results look to got that. discussions to in discussions in data couple looking And look with next in design, follow sharing going add We've to registrational on with FLTX set patients forward forward FDA we're patients forward populations.

The second question triplet about was safety.

design that of all study, you it's about, this to our program the and mentioned partner Yale, as may ensuring is I think, interesting, So as is ready. really remember, I leukemia

mutation. data triplet study driven we have, splicing started are and patients who distinct a FLTX in will enrolls take by to We're genetically year-end, we study positive. still in factor doublet just on aza-ven that CR in study in X is So populations mature achieved sets currently triplet. the and turning therapy, their but frontline emavusertib the setting into then a have add the who patients The MRD to going into are those

course, and discussion of this of IRAKX, would that we in care then current standard hope a novel Of board, that therapy course, in BTK-naive But that the we patients efficacy. is of see get we're to obviously, a saw emavusertib new we not. Then to establish care, single-agent doublet, hope, have -- in in AML of of in preclinical add or in we novel be comers, those the the really to and current want hit say we key the the care of to we target year-end, the it. study drug, clearly existing of is new that's see been we so to emavusertib, effect see year-end got what to to by frontline can mutation We data, question a the have on address of FLTX setting, in and we've aza-ven then novel to because potential we're will all efficacy your activity. that is always that allows establish doesn't third MRD that negativity. we the matters we of we're was we isolate care to hoping that add what standard the a That able to across the would standard target standard hoping new benchmark and drug know patients And lymphoma. target able by to what adding that get safety that signs a clinic, is which the doublet to seeing But to IRAKX. hitting aza-ven can the time

downregulate NHL combination of CNS emavusertib within is are and on indications of So pathways pathway. There are just There's it as overactivity the we with ibrutinib NHL, blocking underlying in drug driving in one are in it of as ibrutinib logic that's reminder, are a a second tested precisely that to today. over patients The NF-kappaB patients. with these NF-kappaB activity the as patients. overactivity, and lot BCR that pathway, by on because blocks BTK-naive have on allows BTK-experienced patients primary X that NF-kappaB There patients driving that pathway who inhibitors multiple only are emavusertib. ibrutinib who TLR or drug lymphoma are them BTK specifically the well

both going NHL, view which pathways is better blocking that blocking be of driving both than disease would blocking Our are alone. one to pathways in those is either be driving NF-kappaB, always

BTK setting the were rechallenge we So compare rate if are X. and is relapsed someone hypothesis and expect see had it's we a BTK-naive think response into patients both have. But being already the we mechanistic with inhibitor. we then BTK on as say, we probably into yet and and able is whether or go going powerful But logic that wonder from either course, that patients, would, done, good, ibrutinib take of know the refractory, because BTK-experienced immediately the fail, show preclinical already to efficacy was coming -- clinic and again, more can if these then contrast, might the BTK-naive to and you now even them and as to be which the all we've patients, supported, you

emavusertib of or that that. we So is and those show with get can BTK to even resensitize to synergistic patients that failed alone in BTK, activity its ability they've combination patients, either the though can it's we just then obviously driving emavusertib's if performance BTK

question was you think we that thing question. to thoroughly. it really that's I long. powerful answered Thank asking your That so And do. a for pretty hope

Billal Jahangiri

did. It did. It

be would the for triplet. this guess, give So not right? comparison, meant patients just -- Just our one those but that it are to have front, of more when then in we how back to right? it's compare of positivity safety, comparison job, have I we know fare be there of is to how on to unethical would -- us I can you MRD but the off, that to who time to point get So for sake and you comes? of some benchmarks they historical and something any so patients these aza-ven that just emavusertib for

James Dentzer

the within person Bob, Actually, that. Yes. setting, the to leukemia to talk you're better maybe

Robert Martell

Yes. in AML that I have a major patient to that front right has for care details don't the disease, been of continues the me, but problem molecular if taken clearly, of because, implies of. have a evidence it's induction not disease

but maybe are with that, significant it CR able a but we of who that strongly do they relapse. portion to significant of patients a molecular is there's can't CRh, also, very negative, a So achieve a MRD achieve negative, MRD when majority to not get correlates and who say, a I'd patients or analysis,

Jim we're ultimately would like so we're that's early said, achieve. In looking what mainly be for to looking And this study, safety.

And as combination with that for goal the in the situation of be so ultimately, aza-ven don't but start would beginning. study, would the out long-term study ultimately that from where a upfront goal this earlier we we sort particular in have

Operator

the comes question next line James. McCutcheon of from of Your Sean Raymond

Sean McCutcheon

study probably to a or into going to if next said in after pivotal up Correct potential same the having I'm end FLTX setting, the to top single you're spliceosome week. me with wrong, bucket. the the previously relapsed/refractory forward you that either line look the cohort AML co-mutations going maybe but go Definitely in

a current established in you're between of well is spliceosome consistent you in So your and of terms this us current understanding FLTX, or that what FLTX plan? you'll considering? and scope that Can first, set the context, walk your need. more data decision factors scale with Obviously, bit the through the

James Dentzer

Yes. for you, and the Sean, question. thank thanks No,

thing we In issue. on this caveat said we say FDA the same would certainly with need from right. significant very that, I and you're today, that the yes, So past, guidance the have

their population splicing a patients we've And or roughly in a mutation. There factor it's it's only, go X/X that we've have splicing very X. our In talked seen going has factor mutation XX as AML is XX% for number FLTX a Our that studies. a of only about, into expectation they're mutation patients, and clear of the patients, have to it. a FLTX population are we've and roughly got small respective

So for make who of conversation mutation need that's with but would of that in, again, had But you go studies. have to decide subject eligible and both ask they in there that's which that going with small they'd to conversation we to to be we them that's a again, that to patients both what one I qualify one FDA. discussion with not sure populations. like And studies. suspect, going see. patients be we How -- FDA, put they're suspect those a would presumably is I are that both dual going But with study be for in haven't to number patients what

Sean McCutcheon

of the quick just ASCO Yes. sorry but And be missed cut? data same will sets a clarification, this, the I the EHA point and if data

James Dentzer

more to out. answer next at talk are data come short week both data that going different But the to that the the We'll populations. is both for about conferences. cut There question. be when same presenters absolutely. Yes It's

of the your a data. of Sort sides you story and at a the high-class target present to lot you biotech behind-the-scenes both a headache, of working is on that that pond physicians of company managing want get -- novel

is people the cutoff the so data going have set, And we're same. to But data the conferences. different at different

Operator

Jim time. call the questions I'll at to this no continue. over further are turn Dentzer. Please There

James Dentzer

to trials, for Aurigene thank team their at support. commitment and ongoing Operator? our Thank operator. help their look always, to our We as NCI Curis soon. forward for the you updating families to you, and you and in And to the again our patients participating hard work partners clinical at and and

Operator

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

disconnect. now You may

Curis (CRIS) 7 May 242024 Q1 Earnings call transcript