CRIS - Earnings call transcript Q3 2024

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Operator

Good morning, ladies and gentlemen, and welcome to the Curis Third Quarter 2024 Business Update Call. [Operator Instructions] This call is being recorded on Thursday, November 14, 2024. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Please go ahead.

Diantha Duvall

Thank you, and welcome to Curis' Third 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 third 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 upon 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.

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

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

James Dentzer

to Business Update Quarter you, Good Thank Third Diantha. morning, Curis' everyone, and welcome Call.

this study, was progresses. CR than cell early of salvage Let's response which data when X of update emavusertib ibrutinib driving partial which by also in that annual receive our IRAKX even Symposium eligible clinical complete with X blocking achieve start both CRu; It's data patients Lymphoma NHL, are an is with our in become September, encouraging, treatment PCNSL of the These third followed high the after TakeAim data X duration population. in generally emavusertib unmet fails treated months. treatment after thesis or ibrutinib. In CRs; of at greater inhibitor. in emavusertib data is especially and patients failed or an regimen, line responses and with PCNSL evaluable that relapsed/refractory BTK combination TLR patients. a radiation These PRs. or by our frontline is ibrutinib. The enroll objective These they've enable with in patients patients the blocking unconfirmed responses, with we blocking in that pathways need for The given the chemo pathway disease in X response X are evaluating had can CRu study response, the with setting, BCR to the complete combination with BTK this pathway this a showed a ibrutinib but very in to X supported progressed a methotrexate-based a our and preclinical data when with with the XX includes setting, patient's both the released for and early which on patients Cancer, inhibitor combination

are in to gain the continue enroll study patients path. regulatory and to this engaging registrational alignment authorities with actively on We

As and the Israel. we're run is registrational reminder, goes a this being making. step the is in next I'm Europe study the approval with a to that pleased saying progress emavusertib's U.S., critical development, defining path in and without It

Winer data a patients patients of Dr. in expanded patients XX XX an EHA evaluating X showed set CRs, FLTX At on with FLTX These inhibitor. Now monotherapy the failed objective let's objective a year, inhibitor in CRh of for is relapsed/refractory by response, ASH updated we will Leukemia an data month, these response. note, a as the which response. At X patients move patients with ASCO AML. with to to were study, of be with X. had the FLTX emavusertib objective from Also presentation next oral our achieved XX X and achieved naive data TakeAim earlier mutation. of presented this including treatment and Eric patients achieved December of X X MLFSs. Monday, prior who X X evaluable of provided remaining meeting And patients, those treatment response-evaluable All an on an Dana-Farber X an

by MDS Diantha? with Garcia-Manero MD updated be to study I and Dr. We With I'm data Anderson Leukemia a being with over the patients financial from Guillermo Diantha providing pleased that, December I'll the both year poster TakeAim author, in look will update. Lymphoma lead X. Overall, to presented and turn progress on in progresses. as also call studies, forward in additional for for our the providing Sunday, high-risk TakeAim very the our updates

Diantha Duvall

were same to of $X.XX will impact development was per Curis outstanding. million million for and equivalents I'd of questions. same warrants and Operator? $X.XX cash you, net XXXX months to or stock $X.X the The million million million XXXX. share totaled of The to in and million primarily equivalents loss same $XX.X expects of turn $X.XX per period $XX.X the to net quarter the for loss to approximately per compared operations XXXX, third were per XXXX. General Curis' third the XXXX. X $XX.X period XXXX. Research net in administrative employee-related decrease that, September or same expenses for over $XX.X were the compared $XX.X and share cash of for in the October $X.X attributable lower XXXX quarter $XX.X legal net we XXXX, reported Curis for $XX.X for common period a months XX, a were to Curis direct million, call the Jim. third or its lower of XXXX, company for costs. cash to the $XX.X the $XX.X was million compared reported a a expenses compared unregistered $XX.X X.X of the September million of had share XX, for completed September months decrease XXXX. primarily Thank expenses X the G&A the same in registered existing million of period attributable for the its loss or Including to planned same proceeds offering of concurrent quarter employee-related net $X.XX loss and period for compared million to enable mid-'XX. With placement cash in X ended like private shares the of with million and a into for ended XX, million. XXXX. In in October, XXXX expenses ended approximately offerings, the million R&D period $XX.X for the costs. XXXX $X.X and share consulting compared for million

Operator

H.C. from White [Operator of question Wainwright. Instructions] comes Your first the from Ed line

Edward White

working in mentioned the that FDA gain of to implies with alignment you're so So you that sort that PCNSL, alignment. of you're out had

alignment get what ideal your done into So to now what the needs in and to approval mind? be to is right pathway

James Dentzer

Sure.

of So say the we're we're I out any just alignment I'd say by discussions. in engaging stretch. wouldn't No,

have I on we get think data first the we expected seeing second drug. we the of therapy patients, FDA the days, past and as this directly calls, what accelerated path for in the small to out results in we've frankly, to we though better to couldn't wanted on see earlier patients, if this that was were, these said line. And it were line than to reach even started in early number and see, saw a that better this than we year, we an salvage in we

thought need, that you We a the frankly, critical Phase what complete registrational reports, getting, faster I/II You given terrific there's normal study, FDA talk you that all we an the meeting And end-of-phase approved then the the approval looked, a like. run looks salvage design have are path line might you no about know and is that such with data drugs this. we're with unmet the for have a of path. FDA

what clarity discussion we're in have to does accelerated with a remain are an now. be in having -- So so, but path? that's my have if those be that And approval hopefully the position is My where some Can QX going in discussions we'll hope view, that will we look seen. like? to right

at faster with think the and point, by path. least this engaged accelerated excited I we're that data, we're on identifying FDA the a an just pleased is at us or

Edward White

$X.X and you. administrative for Great. General maybe and quarter-over-quarter million. $X million costs down a And about question was Diantha, down about were R&D

you initial wanted the FDA continue in cadence the thinking it As but know clinic, of be I the on advance forward, thinking how to get should quarter, we how as going but only expenses for in of guidance, your might waiting it. difficult of should we you're thoughts to be for expenses be not just XXXX? fourth

Diantha Duvall

Yes. for the Thanks, Ed, question.

due our that down. burn million the that did for million should really We call So assume modulation million burn part, to $XX I sort earlier in that -- burn of for brought number. Curis the $XX But probably It that manufacturing. in mark. XXXX $XX some range. $XX cost that of has will the million But been sort would in I has normal most some to $XX stay that year of would vary expect around million historical the, timing it,

Operator

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

Billal Jahangiri

question point, you given impacts ema VERONA that what surprising was for We want which had population? doublet that the that? in know the enough at shown. patient a But all the on given is responses hasn't about in isn't XX%, this mutants, in pursuing that we potential sense? hrMDS XX% data and is impressive broader or abstract in given seen? representative out, the [indiscernible] potential specific makes MDS at gene ema And the There's signatures to ASH. without have spliceosome are Are more? additive given are mutations you've Is it HMA read ven hrMDS a How the posted

James Dentzer

thanks Great Bill, in. for calling question.

exciting, first, forward these enough people it. really are of not to things paying is that It's we're to. So MDS and yes, one attention really looking

go of As aza But patients until those patients. is through once And that, really you know, out, standard there's it's a for care. nothing VERONA population. reads challenging

So really is the opportunity terrific.

of this mutation, different seen So mutations. CRs. more emavusertib patients activity point, in as combining than of a we've We're seeing know, exploring regimens dosing marrow splicing FLTX and agents. the perhaps CRs with we're lot At possibilities with responses, you patients other also with

what many And going readout you But a update to As going to people to matter as that discussion. provide would is exciting is Garcia-Manero not like. yes, I looking the really of be MDS, discussion the looks evolving attention see to is that data do. it paying an you hopefully, for forward lot But that really XXXX. thank say, going a at say should we into as We're VERONA this combination Dr. ASH.

Operator

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

Unknown Analyst

Daniel This on ] is Bronder Li. [

PCNSL do question? answer you also, BTK question that any of regarding on might the contribution raise We have And ] you question? a help trial parts, as historical and that the think could FDA that that data do have the responses [ a you

James Dentzer

Sure. Thanks go Yes, call. the question. address then I'll Thank to let the second the me first, for question and you one. first the for

So answer FDA with the evolving. discussions short are is

they the But have of that. to to question to really that meant address implicitly. study see we'll how is respond design So this

have a progressed after in patients on taking they BTK. we're immediately So

So with X should just would a progressed. be, if retreating response, have no you that progressed on BTK just right? a should same You the inhibitor logic have effect, inhibitor,

by you we thesis much believe suggests due effect, the of is or is capacity definition be addition that design, synergistic more which emavusertib, a monotherapy by benefit to or powerful accurately, its the BTK inhibitor. more So with least either in likely to the maybe at receive is the

you and ibrutinib of in CR that have that a And a to part the the PCNSL. first from -- So that the or published a and second is, was and question, efficacy. were question of about FDA, we [indiscernible] question that's rate able know study or a likely definition by may registrational clinical we're BTK remember the does design, their in there, study see of same date the to out naive effect the the plays them At ORR. how of largest and the you in second benefiting to line, of lot with the comparative we'll yes, into design have that study X second get is BTK patients asked was progress, time, the study There's which XX% to in conversation agents. And literature question by currently highlight design. was XX% the that

would I about days I earlier, a expected we early drug this it's setting be that have why the they So in of not clinicians regimen. And second disease, salvage we're fair. to that But our encouraged outperforming why salvage data that's the line. are that. our very line we are, so in are said But any excited and would studied say being possibility outperform line would

Unknown Analyst

the about AML how I different you if PCNSL between ask question. moving the your follow-up a your to going wondering, just and were go MDS program Okay. are forward? programs And programs, prioritization We may versus or another

James Dentzer

Yes, question. a that's fantastic

really you areas. headaches high-class would at works the in number the that So all we of am I to position where in about have a tell drug therapeutic it Curis, that grateful we expect I are if we the

that primary in We're in also studying are it studying As going you studying tumors in CNS months. the we're in XX AML. got it out lymphoma. ISTs over We're MDS. next X on We've it reading solid know,

to is and and looks at prioritize We in those. I out have Curis of in FDA job opportunities, an embarrassment trying discussions part primary of management team on this registrational of what at hardest that with investment for embarrassment CNS this the maybe lymphoma figure riches because would to how like. point the the we're time, say, path

that a I think us. given priority seeing, it's unmet attractive and we're the market very got clear need by for high a that's well. the data commercial definition, Coincidently, very to be as

other that's read used, types Beyond X the NHL a to and us. AML opportunity out for really BTKs of compelling ASH. to the expanding that, about get are at where data MDS,

all great is we're these primary shortly tumors. It's thereafter, absolutely with we're solid then authorities we to have lymphoma, in And us, having to high-class same So how hand, data start for the that let's prioritize going to opportunities. question. engage Today, a a those in I'd headache what and getting we're best data path regulatory say the about that discussion. it that approval NHL, discussion but in do of is prioritizing CNS how

Operator

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

Sean McCutcheon

from me. couple A

First, kind need as the XXX the or of data database dose with some secondly, think CNS ema? rough of of in for through the how the AML number -- the many patients and package general, triplet have of kind patients positive with disposition of assessment in the just threshold think sufficient in aza, particular, CR study, speak you at enrolling seen in treated what far those be as challenges on current the lymphoma, of above you the patients you you've of primary And combination issues as us or go-forward and ibrutinib treatment ven walk Do then that your can patients precedent. And ema? that will you can MRD the be timing currently with safety what of whether is a you do of patients to based agents? you'll

James Dentzer

All Sean. right. Thank you,

great -- questions. So

study. primary the then with question, go to start I'll triplet me lymphoma Let and CNS the

CNS that's with FDA. having lymphoma to whole be study the So point of honest, primary we're discussion the the

data for process you through know, you is meeting, When to go studies those dose the As into follow end-of-phase patients, FDA, an do you the the database, back, Phase all reports, registrational talk escalation. then going normal a run go any the the produce pivotal. get design drug have about I/II, lock the you and

conversation I a faster data if with we should in think be FDA it thought to see given having have, the be -- it they'd we the worth interested running was a process.

primary they take that with a now call. are We right now lymphoma, lot are that do CNS but grateful discussions. In there's inhibitor. of X not We're a studies agreed there in we to precedent, ongoing BTK know that

study approved the So care inhibitors. But know, Japan BTK CNS lymphoma the which is ibrutinib is BTK in is has for inhibitor, that Pharmaceuticals primary a Ono all and today is in now tirabrutinib, for X with in its know regimens. they standard methotrexate-based to ibrutinib. using obviously, that that get And approval salvage, U.S. displace line, in We it's for combination they're a study, the tirabrutinib study that frontline trying also second to not have they're of

is the of In of was n or XX. study, frontline XX n study their

study salvage setting of XX. second need Presumably line n line is XX. wouldn't The

course, the make an but from in question Now need given is, there our larger might has sense, efficacy recognize safety database because to a we of perspective simply tirabrutinib it's that already Japan. approved data that

with okay, but trial. So and to where study, reasonable a we survival-based know would in is with I suggest end a that approval a that, we study if going smaller accelerated exactly granting the to out, a come think then point perhaps have they're that's it's confirmatory larger don't FDA that us

about course, has discussions their this in FDA of precedent of this how be these point. makes see chose study ultra-rare CNS it a the feels X indication, given in primarily need study and I that sense lymphoma. Ono the to of But small that. at that It's think sizes, the that's We All conjecture that we appropriate. finish would reasons,

the to triplet you asked the Now looking study, were design. on have the about had about question you What specifically design...

Sean McCutcheon

front it in of of on patients? enrollment insight CR more docs patients aza, reticence your terms on the in MRD patients some adding -- challenges of of the the boost that's Some receiving of setting, it's yes, and and just received any line setting maintenance are AML Or to progressed who getting that -- issue there? enrollment whether to agent kind of in terms positive disposition you've in an ven from seen are that the receiving getting study, the seen you've forward aza-ven and strategy moving additional of the kind just in

James Dentzer

Yes. what No, you the who aza-ven CR At a is can finding want your this X and they're from you is, who study, not all patients time, try and still we how a enough cycle MRD do long-term the in really are I positive, diagnosed or our all stable to of into they safety issue think lot safety. and It's at point the to finger into get to reticence are find the patients go accentuate all. and on minute triplet. do put at of X, day just It's on it. go to -- sites. course, in We the the patients go solution that

sites. make a safe number at simply and is looking and be very ven to sure tolerable. that combination are going of of to We aza ema, small this We're

to tolerable little that just Anecdotally, who half tricky. you to aza same No efficacy. come some of for want off We not As are at the know, combination on is aza-ven and have sure dose patients X the ema-aza-ven all first. them go tolerability, ven a sites way. point make

So going these we're after patients. that's why

we to frankly at follow sites. shown and turbocharge tolerable, want that We do, X take increase patients, it you'll it. X, them we safe point, we of expand physician -- will study. I the is think a to just We eager find cycle won't find to very the need day to no, long. of we it's once we go aza-ven sure that number make regimen. And Once just understand the to and something been So then the the of that handful be community potency

Operator

We do this not time. further Please have questions continue. Dentzer. at Jim

James Dentzer

the Thank clinical for you our the and you, Curis and joining us and in as a forward today's and community at soon. and thank hard We our academic again and participating patients special and team at you on updating to our you, to their look partners, for to Operator? thank work always, their . support. and ongoing everyone, trials call. commitment the Aurigene especially collaboration NCI families to for

Operator

concludes conference call. for Thank participation. you. This you your today's Thank

You may now disconnect.

Curis (CRIS) 14 Nov 242024 Q3 Earnings call transcript