CRIS - Earnings call transcript Q2 2024

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Operator

Good morning, ladies and gentlemen, and welcome to the Curis provides second quarter 2024 business update conference call. [Operator Instructions] I would now like to turn the conference over to Diantha Duvall. Please go ahead.

Diantha Duvall

Thank you, and welcome to Curis' second quarter 2024 business update call.

Before we begin, I would like to encourage everyone to go to the Investor section of our website at www.curis.com to find our second 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.

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 second Diantha. morning, Curis' everyone, and welcome call.

study, patients Let's ibrutinib which have our start Lymphoma is with with PCNSL line. TakeAim in seen methotrexate treatment These in emavusertib after in chemo relapsed/refractory inhibitor. and by followed the patients that ibrutinib setting, generally evaluating failed second combination BTK radiation with a frontline in the have

where thesis and emavusertib The pathway driving we ibrutinib can regimen. As the this both pathway for their with add emavusertib the an to progress patients ibrutinib, study they're to scientific on is the TLR pathways eligible enable of achieve BCR that combination NHL, patients blocking to ibrutinib our enroll with into response this early over especially on need for objective patients the we rate after an X in data ASH These this first in the monotherapy. We encouraging, presented in data reported objective have at last population. ibrutinib December, they response conference but where unmet the very XX%. were study progressed given even high

well with a critical to regulatory development, initiated with as in saying I engagement the in our path CNSL. European noted by without discussions at path we for press to orphan that and authorization market we're protocol our is including in registrational communicating emavusertib CNS to with appropriate lymphoma continued has have and of the And time. Discussions recent Europe, marketing marketing that on central emavusertib's outcome discussions This these in primary morning, as report Agency. forward in primary granted a designation reduced drug FDA. several enroll benefits, Commission. with combination ibrutinib assistance with progressing also to have fees pleased of designation for step this XX most for years study. look the We applications, authorization in defining It for the provides are emavusertib Medicines I'm the pleased where goes next European registrational gain process been exclusivity, the as recently this patients and release alignment scientific application authorities

front the and While these are regulatory we number as to and have progress Europe, continue discussions to our by of expect U.S. data make operational and on initial for patients in to sites clinical ongoing, excellent target XX reach the well XX year-end. XX

We monotherapy earlier FLTX the EHA to refractory a X objective XX MLFSs. Also and In partial mutation, data Now FLTX X mutation. which patients factor is study this with AML. frontline patients, Leukemia demonstrate a AML. emavusertib relapsed in prior let's patients this when with mutation standard in the patients with venetoclax, failed and as venetoclax triple azacitidine a populations patient move X remember initiated of to AML. In study, provided inhibitor. objective At X study, splicing preclinical factor frontline objective azacitidine our data for year, in combination, these those setting, treatment had who evaluating able ASCO frontline splicing with response we potential were support evaluable emavusertib's treatment TakeAim with data patients inhibitor X All and updated X and these the an its care X -- a X the emavusertib. CR, remaining leukemia-free in response, or emavusertib X of patients is combination an is CRH complete novel to FLTX a with CRs, achieve of a FLTX and may that in XX with of response, the of emavusertib or and in patients patients note, achieved AML. In mechanism relapsed/refractory with that believe CRs this naive patients X were X of for and evaluable morphologic effect or population, state achieved of with the including a remission, hematologic and including X We combined an X synergistic of recently objective CRH achieved treatment with recovery you responses MLFS.

with expect the the TakeAim safety updates as and turn studies, financial that, this the I over progresses. With study update. and both year. our the very I'm later data initial from have Leukemia to progress TakeAim forward providing We year to Lymphoma this Overall, I'll call additional in look for to pleased Diantha

Diantha Duvall

$X to X.X and compared cash ended primarily Curis million employee-related cash, million same development quarter administrative for a there $XX.X $X.XX the ended and XX, as were XXXX Research as you, million of attributable X as XXXX, period XXXX. million and in $X.X for of million and June $X.X the compared same XXXX development in compared same a of outstanding. were to period share million per or compared as in June net administrative for of the Curis Research to XXXX. General expenses period XXXX in period higher The for million investments Jim. $XX.X and and second same were as administrative and share million same of $XX.X of compared $XX.X or XXXX, common for million loss costs. Curis' general research $XX XXXX. totaled net $X.X $XX.X X the $X.XX both quarter expenses $X.XX or million the for for X June the Thank shares reported approximately the million increases the in for a months to to compared for share in to per reported the loss second a are period share stock to $X.XX as XX, were period $XX loss and equivalents $XX.X for loss per net months million, were XXXX. net XXXX. General the same in ended for development and XXXX. or expenses of the $XX.X per XX, expenses expenses million months million

We cash, like and operations open expect maintain our existing of I'd equivalents quarter us enable XXXX. With to cash that, the planned call for into our investments the that to should first questions.

Operator

Instructions] Your of line [Operator Jen first comes from of the I-Eh question Laidlaw.

Yale Jen

Congrats on X progress. got here. all the I've

have the one first the words, you for consider in the of what The program what is were the the would advancing of I you follow-up. that for? looking forward? be towards In end of sort bar be that readout PCNSL guidepost terms the to year, a other Then

James Dentzer

as patients have who BTK a looking inhibitor. treat we're So to failed a reminder, just

which responses So put can failed really with of inhibitor. see If failed is the They we into this let's looking perspective. first-line choice them BTK They inhibitor, objective re-treated the if over again, we course, same that wouldn't get period. is to they respond. What treatment. BTK we're

Now looking lot of is I patients, a on it what a to we're been right, that we BTK has failed the realize really thesis think holds, in the number show you better data And of regimen. bar inhibitor, if of efficacy so adding of fundamentally course that the for course. even that emavusertib That's for. larger than patients changes a I far. can the But

Yale Jen

at you reported about anticipate at the you when patients -- XX time maybe and data? roughly XX a Absolutely, least at

James Dentzer

That's right.

Yale Jen

reported congrats all be earlier. that depending is data, data some positive I different the the have either question patients Okay. data or in How in on or here options of near as future. leukemia patients you the to option follow-up have of treatment on would could that terms only. maybe FFM, for the you the to XXXX. believe going the you would mentioned in And you obviously, the can And the you With consider experienced pursue this -- -- reported you have forward, as patients, different for obviously on heading all optionality take or want it terms experienced to of maybe the naive well the

James Dentzer

Sure.

-- [Technical consequence the the the So design hits as that's know right? you in and every nearly more is molecule, Difficulty] there's leukemia, fortunate of which a of IRAKX, Because expressed molecule in optionality,

Operator

inform would been the gentlemen, like speaker that and I you Ladies to disconnected. has

James Dentzer

in, call. what back sure the disconnected from got Not We're happened. Jonathan. We

me I got I can I-Eh So perhaps where answering I-Eh help was off. Jen's you cut questions. with

Yale Jen

problem. Sure. Not a

is experienced only as treatment for contemplate leukemia, treat in the of have for will you naive options as FLTX, the treatment that to whether different FFM The or you treat the well experience. terms that obviously, second -- would question the targeting either you treatment

So guess, X the X, or you I all. wanted among X whether options,

James Dentzer

Yes.

for thoughts, of out FLTX breaking let's about for FLTX, naive therapy, be a into couple so frontline experienced. then So monotherapy with and then which it groups of course, and separately within talk combination first separate and the a would

in also attractive where of So things patients in as IRAKX of know, and nearly is IRAKX the setting it expressed population. is roughly one FLTX, the FLTX more hits that know, the FLTX, AML with makes leukemia that and present the we then X/X in mutation being molecule all the you

has after as combines will with comers of azacitidine experienced of front to it leukemia all a with be appropriate we be exactly those be -- with you're opposed subpopulation, patients. it ibrutinib. In both and monotherapy, populations. venetoclax would it to it at where and because It we of in course, naive all in course, to resources look right, when patients targeting FLTX that the it could So application chase think we non-Hodgkins and for could as monotherapy unique in think have line available combination ideal, infinite

dataset going of the to a which of of moving the forward more aggressively. to most of have for we at full populations are one as year-end we're ASH, is we reading think going report course, discussions prioritize these I at

say in discussion, stay front are that us. all but of opportunities of would I So for those tuned

Yale Jen

And be helpful. upcoming in of one one highlights Okay. maybe what IRAKX That's the which make is terms NFX? symposium, might Great. just it for very more, the

James Dentzer

Yes.

symposium, be we're pleased to I that very IRAKX think year. the this again doing

utility in leukemia a gone know, every a at solid lymphoma also community experts really started IRAKX you publishing We've I involved has got, whole since the year, academic and great looking think, oncology. up first IRAKX's interest the year experts, we cross-section this tumors. level work as highlighting about in in people As in of of

got tumors, wealth that on because that's really now the studies of patients where well. in clinical solid lymphoma as are. pre-clinical also and them data ISTs public is in into we've interesting But ongoing data is clinical focused in Curis So of leukemia several has are forums today and a our there really been data X initiating our and

the going an part the expect interesting story. that's months, and I come, and in years increasingly So important of to quarters to become

Yale Jen

It's to details. the progress. forward very helpful great. Okay, ASH congrats look for more We and on

Operator

line from Wainwright. the Your Ed next question of of HC comes White

Edward White

with Lymphoma registrational discussing path. in recently TakeAim discuss to you Jim, that those your you mentioned met the FDA

would path regulatory Just what wanted be. thoughts know to ideal your on your

James Dentzer

we think how meeting like talk I expeditiously to about of path in Phase The the with then study FDA, I/II course. we and move do as development Well, can, an typical your would drug design and to pivotal you the study. is as end-of-phase conclude have

data because are grateful looked December think last out a I the that appropriate case, regulatory ahead need discussions. authorities this was very compelling. were having thought initiate think clear, the little is to of amenable that we in schedule, these it we put so to I discussions we obviously unmet those the And and

need to now discussions, forward So EMA most but patients to and would working expeditious to I the path sorely look get them FDA of on available the can't -- we're in both ongoing who course, and comment with on this middle of it. drug we

Operator

next question of the Roy. Our Soumit from comes line

Soumit Roy

first your or refractory spliceosome conversation ema Sorry, you prepared FDA minutes still delayed, the I path remarks. pursuing little monotherapy about? that the I few a going Are relapsed for missed and the was Is FLTX forward? of

James Dentzer

Yes, there from Jen similar so a was of Laidlaw. I-Eh question

in the and in you is because combination as So NHLX people's to foremost in of leukemia got know, course, opportunity both one farthest in minds opportunities of that's combination, and that NHL. appears we've The the along. monotherapy the be probably

design to say they we're authorities ought be. on what registrational that discussions already As in with regulatory

XX that could the in setting. year-end. data of be spliceosome mirror what which interesting. would by going and standard And it have data those in of to a look really roughly of combination, in we the to readout expect, lab, interesting current saw think then, FLTX care each group patients we set add we is expect this AML, that of if a to really frontline, I course, does with monotherapy, would We're

data, headache readout, it mature high-class that that for in think as of have when I just front see that prioritize in comes which we at to interested hold focus that going first as spliceosome, these it's And conversation are fastest, well. on but a and FLTX those we people thought. we'll a even course, We're readout, and of though out. of safety of the time there have lot a initial to ourselves studies

Soumit Roy

Okay.

expect be So would FDA first is meetings XX? maybe these fair of to it held quarter post-ASH

James Dentzer

process. discussions NHL? already Those are For in

For we what FDA. to would FLTX, out reach looked see data like the would wait to we before

I setting, in for kind as crowded are but think it's I in primary that AML, data third-line landscape CNS result of more drugs early, there showing the are that you isn't comparable a is know, the approved. in our the In no realize there setting patients. result these lymphoma,

get given to unmet data opportunity an think there's in the seen early given that patients think clear appears be treatment to and very that So date, need the I to these we've promising. we days, a to

I we're aggressively we on pick would that up normally that that move discussion grateful can. earlier to as said, do agreed authorities And to we than So as it. we want regulatory the as

Soumit Roy

initially Got but mean you PCNS? it, the

Edward White

Yes.

Soumit Roy

specific are other easy the pitch seeing any comments you any for physicians approaching it's -- these in reluctant, like options or they for enrollment, And use this you're for setting? patients, -- you is are no there specific to when or Ema an seeing are the

Edward White

for the fortunately but patients, for study. the unfortunately, No,

went bringing on this to population I of progress that, it's it say, promising, mention Once to you quite the and chemo in patients have after yourself. the of we're I whole is it careful very drugs Enthusiasm enthusiasm typically to looks days, very enroll, no has you several say But these what the to were it's go as that, we data. so among in to with know early solution know, think really radiation. be they I is when seeing. to investigators that, and days, methotrexate I the potential want early is have There this nothing. We ibrutinib. brain up treatment, unmet are community. we're be high-dose for frontline conference, part know, you that they to approved, horrible the we for catch though of then those to always as on patients. need a really we high. Early new there continue lot hope I really be as by excited a but able And frankly

very entertaining us. was, which the the a Our regulatory authorities physicians interested are of encouraging glad very little for we're were excited, ahead that and discussions schedule, in of course,

Soumit Roy

Right.

in As it's PCNSL, high with fairly we event. saw CAR-T also ICANS Gilead's

So it. certainly a molecule and small your safety profile allows

if solid Another question, maybe thoughts with do a and any Any little appreciated. bit aside from I the blood the trial we will cancer. In visibility is tumor, know run- emavusertib. this it Keytruda - investigator the cancer don't be recruiting. trial bladder the when would have start

James Dentzer

Sure.

those going as gastroesophageal on of melanoma, now urothelial that So got studies been cancer clinical the because are those colorectal you got we've ones well. in pancreatic know, We've ones the X study as in study in on we've trials company-sponsored tumors. bladder are where got are right solid investigator-sponsored focusing and we've going data. But the on and the NHL leukemia course in

those ISTs, preclinical nice at various at XX of the published point are we'll again, we're months. in some And the the conferences clinic exciting. I to that over have studies they're see They're not have into XXXX. XX All moving But hope where be trials. these they're these which last studies data really really from been now to position of company-sponsored. in results is a investigator-sponsored

course, the them from of But and study each collaboration of have these enrollment over course, great with data with very either appreciative the those studies. actually we So of sponsors. of we're of or the watching control don't reporting interest,

Operator

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

Li Wang Watsek

Jim, missed lymphoma you is competitive. to bit unmet earlier. just if lymphoma how question of need But the Sorry in AML, like maybe view the terms maybe opportunity less and I higher sounds in a it versus in little it there

make maybe So import regulatory lymphoma versus how for some a AML? about, thinking you're maybe decision? waiting to Are you prioritize

James Dentzer

Thanks Yes, you the for question. Lee. and in for thanks thank calling

a NHL to ways versus of answer there in AML, are that So couple question.

the data, as the agencies. And and it's most discussions, of NHL, where because think obviously with landscape interest was of course, the we're across larger that's well. that's partially I course, recent much the market one Of regulatory NHL in a in

So drugs space with a underway, indications. and of It's would hand would aggressively it's massive those XXXX billion. And $XX recent any those lymphoma. very inhibitors of in data just then enter all course CNS of hold, primary those we look other data processes -- into to BTK across years. we in go NHL to in move novel recent that had revenue a had hasn't it our if And in

think and be deliberately a more. In setting. focus really inhibitor, IRAKX leukemia, from unusual as more investors mean while excitement to IRAKX the for we designed an independent it really an as the really building I has is benefit deliberately that for that But hits molecule I you ability seems that's an patients and it the AML competitive it benefit, designed it as in space, know, on setting. fortuitously think obviously to you note, excitement designed and the FLTX, why oncology targets interest. is I and because of unique was key we targeted a offer

and on yes, -- certainly within state advanced the of progress. because of of data excitement AML is regulatory I the the radar screen. NHL the But the very the So also on partially our context unmet think high need very

Li Wang Watsek

combo And on maybe a appreciate And yes. AML the question I frontline strategy. then Okay. then, the color.

and long well to have all if as built for coverage. plan a there curious IRAKX is plan around maybe step as that a Just maybe stratify by session

Edward White

so Yes, thank you.

or -- strategy certainly leukemia, are for monotherapy separate I that as is you're there thinking as combination. a know think implying versus you we in

that that the on paper, of and an for but population know that this, don't as IRAKX. It's specifically inhibitors, for you given signaling path through the why I patients FLTX IRAKX in expect of others the that pointing inhibitor call, the escape FLTX FLTX best-in-class reason do on again, we're receptor with to the the I therapy a offers research targets offers is FLTX IRAKX. is additional the both drug better you toll-like target, showed Melgar the among originally inhibitor, FLTX the with potential ability, is which the X/X a think So might on know published AML. And benefit than path

IRAKX, FLTX disease â€“ So by And the FLTX are escape really, and even primary the blocking both why of though inhibitors. primary to its our data path. and blocking that driver looked path the the than a we're data other explains be better both early, in it view

And a it monotherapy exciting So out. that AML will expressed the is hit not the think, we every really are alternative. In current clear. know data But need it. started IRAKX so whether just all azacitidine see we preclinical care, comers. there, or venetoclax, is which is standard frontline, we patient in of I to and study, in with don't nearly pan

So added was there the emavusertib care, of when to standard efficacy. you that to increase when you doublet, aza-ven a in to added significant Ema preclinical the data showed

Now but helps. we hope to we've that see study, that in I started that hope patients just tuned. stay and

Operator

Please There further at back the turn Instructions] now time. to call to [Operator I'd Jim. questions this like are no ahead. go over

James Dentzer

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

Curis (CRIS) 1 Aug 242024 Q2 Earnings call transcript