Earnings call transcript Q4 2022

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Operator

Good morning, and welcome to the Curis Fourth Quarter 2022 Business Update Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.

Diantha Duvall

Thank you, and welcome to the Curis Fourth Quarter 2022 Business Update Call.

business would section encourage www.curis.com of our quarter I to to to begin, related fourth Investors and the our XXXX we like everyone to go find financial Before tables. release update website at

and that may These like be we to statements statements, are are everyone forward-looking differ current our risks the based call, subject I would on remind uncertainties expectations during results also which to materially. and will actual making and certain beliefs.

filings. SEC our see please details, additional For

me are Martell, Chief of Joining call Executive Officer; R&D. and today's Dentzer, President on Jim and Head Bob

question-and-answer We at will also be available end for call. a the period of the

now to like Jim. over to I'd the turn call

James Dentzer

progress combination Diantha. leukemia ibrutinib Update TakeAim Lymphoma and and Phase malignancies. clinical with candidate, with monotherapy with the Fourth hematologic Thank morning, arms being TakeAim welcome combination and emavusertib, Quarter or study, with and relapsed refractory which Good is or relapsed Call. to in or The quarter, patients Business past X/X and other syndromes with studies: study currently two clinical Curis' Phase AML both myelodysplastic study important X/X or our you, This evaluated Leukemia lead everyone, acute MDS; made patients myeloid for a study, a for NHL refractory high-risk we

of earlier alternative an to marrow achieving emavusertib's reaffirmed of AML XX% doubled with an data all MDS. were spliceosome pleased with update and set for AML rate of FLTX patients patients AML with be responses which TakeAim a an of our CR rate and to study, update size This Remission. present Leukemia had of XX%, had or with with We therapeutic mutation a MDS a in the Complete especially patients mutation important CR/CRh XX%. a overall had the clinical response data a potential five from mutation rate spliceosome patients a

of and leukemia our dose enroll the had to facilitate made the discussions or on We're of the clinical the need completed today to sites, by X to call, partial the nine FDA we in announced that our Phase announce patient of resolution the quarter's the schedule, on have sites unmet we We've this that clinical XXX-milligram Recommended RPXD enrollment the therapeutic partial requested hold. novel of our we additional at hold study. we nine so in important the also pleased In of critical the level excitement have work the clinical that progress FDA FDA. reopening believe resolve completed Dose the surrounding and our patients last and sorely patients also reflects underserved is This and with ahead reopening additional this approved could population.

in meet FDA QX to QX these review collect patients data. in for expect and with We to those data

the in to forward is working We short, Lymphoma Leukemia FDA end on in TakeAim XXXX and gain RPXD into and enroll resolution our the which forward primary XXXX. and TakeAim with In on look with ahead had the productive also months momentum in ibrutinib. to carried We our combination CNS lymphoma the hold. clinical of to partial that of study treating emavusertib and continue in of very focusing we a we are patients alignment study

I'll results financial over that, the review back for With the our turn to Diantha to call Diantha? quarter.

Diantha Duvall

Jim. you, Thank

XXXX share million in for XX, the were same ended for months a per million $X.X for in Curis December XXXX and XXXX, $XX.X compared million share share loss period $X.XX or XX as of the $X.X months per XXXX, $X.XX of XX Curis $XX.X Revenues were $X.XX a XXXX. million or net to of quarters the of and net a the XX, ended quarter and or same fourth reported XXXX, for period $X.XX December loss XXXX. a and $XX.X December loss net share loss respectively. the or reported per XX, for as of XXXX, million million For net $XX.X per $XX.X million, Revenues respectively. compared of to the $XX.X fourth million,

quarter Operating royalty period the the following: $XX.X to for for compared million the primarily the in research expenses XXXX, manufacturing ended for same $X.X licensors December XXXX, decreased to Research compared million million $XX.X of XXXX development to third-party the same fourth million XXXX; same were period in were expense cost in development for fourth and quarter XX as fourth and the the million XXXX. patent to $XX.X development Erivedge for million XXXX the of royalty million the for XXXX; for to revenues, million the same expenses amounts the of in were were months as same compared million And with XX XXXX. 'XX. period and university $X.X consisted to clinical $XX.X due in for months for Genentech $X.X compared XXXX, expenses of as for to December costs. for attributable and for XXXX months The which the the XX, to is quarter $X.X ended personnel, in as ended revenues development $XX.X of and XX period connection the period Operating expenses XXXX. as were $X.X $XX.X sales December compared XX, as $XX.X XX, period quarter million comprised Roche same for net the compared research in million million in decrease were

a administrative driven XXXX, ended for same expenses same decrease months XXXX period in million primarily for XX in XXXX. million was $XX.X The in in million expenses period General were for costs. the and general December to decrease expenses the and administrative and 'XX. $X.X quarter General administrative million XX, the compared were as to fourth as compared December personnel for $XX.X by XX, ended the $X.X

year XX other total expense by was and for interest months to $X.X expense December royalty ended 'XX, compared Other period 'XX the respectively. for million future ended XXXX. in XXXX, was as December of XX, XXXX, income. the quarters $X.X payments, consisted XX, million related of primarily fourth Other the offset expense same to partially expense for million, the For net $X.X

Other imputed consisted upon to of forgiveness for PPP interest expense ended the net loan. partially primarily expense the recognized XXXX, royalty of by related XX, gain year payments, future December offset a a

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

have our to cash, continue and planned operations position a investments to our equivalents maintain XXXX. and cash existing We us cash should into enable strong expect

questions. like open I'd that, Operator? call to With up for the

Operator

will from Ed of H.C. first question [Operator Wainwright. White our come Instructions] And

Ed White

said Jim, had had TakeAim you in that data previously, Lymphoma, expected you XXXX.

should to Now you as in see little XXXX, data a can us that expect that year? this we're of guidance when give we to in bit

James Dentzer

things Ed. update for to If Thanks, by stand hoping with year-end. But we're and course, provide very I studies. between on calling know. then, in. think Thanks both we're expectation Yes, an you we we'll of where that now same, our the change pleased remains let

Ed White

more program there? halted. you further? And get I in there on the thoughts all. being perhaps given restarting is Great. this just anything been mention to is thoughts didn't -- your VISTA there out XXXX? Or I any that Is changing at know to wanted program it's

James Dentzer

the I I with the a nothing paused It's really our to yet. for We about reason It's think it program. we a it's terrific program. do premature nice yes, us think excitement about to terrific were restarting Well, progress had Remember, making target. it just thought.

we're to a in cut get think order And needed our to we it was more to the -- back cash point given I went need in cash about the ensure where market IRAKX. we to is burn any to XXXX. go all to financial climate, confident that until put on ability got doesn't cash we different or the access that that on IRAKX, to impact compromising that we've

right we're for as So we are where I said, excited now. really

add to in course we'll year. think financial a program eye markets the keeping as the through broadly IRAKX this I XXXX. we be And we're go the of value to great on our more position

Ed White

year regarding expense? emavusertib maybe just R&D as track, back ramp Diantha, up ramp on Okay. we Since question R&D the or brought the of development a the flattening not -- how a your for the gets about thinking you expense or thoughts financials, just of be throughout should the on perhaps

Diantha Duvall

you in said, I are And November. QX, costs as Ed, think we if the we reprioritization recall, announced our coming So down.

likely So just did come could I think of be sit reprioritization. ourselves rate, will sort sort avail not of the fact it sort further we although of the of run post ongoing QX full quarter with little in where bit by virtue say we will down I a a

Operator

Soumit comes The of from Roy next JonesTrading. question

Soumit Roy

late-line you you all some patients, can Are nine AML the you us enrolled. to any you got patients additional provide give if you late MDS, AML as hold whole also, the can patients today, enrollment new patients you seen And do have if think on idea? getting very patients? and The if are these prior they more line or color they are mentioned, are

Robert Martell

This Soumit. is to at in lower the dose really around we're FDA's the address XXX Martell. currently of particular, Bob Hey, trying Yes, the dosing question milligrams.

as treat. patients enrolled study regular AML patients have the on prior is And protocol, had of of we've to noticed so -- We and that we've challenging the of of obviously lines And patients that's many these part therapy. which X population open that a nine the both Phase MDS. to lots enrolled

lines who’re little So But therapy. of bit for guidelines. nine always while perhaps in made patients we we're patients, not we restricting haven't earlier per their se, specific seek a these

Soumit Roy

four And you Totally question is, confirm with one and combination patients being had really emavusertib you still rate. patients treated? Can understandable. are previously venetoclax these That's last XX% if helpful. response on

Robert Martell

Yes.

of two in saw data any pretty blast as provide impressive that -- on And AML, the detail had responses in given since with really to had this getting available them on patients presentation, we haven't back their the the dramatic not normal. than deep We we further count counts. quite who the out fact other that the call reductions of we're updates or you -- mentioned, had MDS, where patient's prepared blast to any was ASH Three assessments four responses their

the So in hits as apoptosis reduces MCLX. these patients, BCLX. anti-apoptotic is that's little in you MCLX. fact, major factor the bit know, from Well, a just undergoing to to the venetoclax talk other hitting cancer mechanism, IRAKX And

on a and ultimately standpoint, a really mechanistic is to combination. great this from think combination we potential data we're So get more that excited,

Operator

Laidlaw. of question comes Jen The Yale from next

Yale Jen

they for completed, -- to Or patients very enrolled the before? are similar they of prior the nine compared you difference have ones any sort the to you much Just patients? are have recently

Robert Martell

would intents to Phase available In we're who've patients I under general, all Jen. all there's therapies. enrolling had line Yale for patients Hey, basically last the Yes. patients, essentially prior X. similar say and purposes

pretty And been striking amazing, honestly. are fact -- the before, a patients said we've we've efficacy these again, is so such earlier And in that the in efficacy like difficult very patients situation. seeing

that recommended So enroll we're Phase we dose, more once selecting likely targeted we'll X who much respond. be, just continuing identify to mentioned, a population. same to are patients we've Eventually, as

UXAFX, So be another that's future Similarly, selective get the population mutations, splicing we’ll as to only factor those get we in the the as we FLTX patients two forward SFXBX be our mutation once with patients we'll as well, and recommended recommended dose. dose. investigating patient that going our soon selecting

Yale Jen

in long Okay. more of what -- bit too any Great. read-through should we And presented maybe is you that which the previous ASH data not just the And what to from meetings, the question, just thanks. elaborate see little a ago? as terms

Robert Martell

had, early as the the ASH prior. the data had we fact Well, the was year perspective that, in read-through I towards biggest from XXXX, striking pretty you year my and the of in remember, back think

including Well, about patient the this had said expand case, they patient see it all and responses in for we we continued -- first that the having responses. patients continue exciting never of we've it's X.X as fact as population signal and database. new also very which couple ASH about The Oftentimes, months. to durable patients to almost our of in population these months. of One activity, continuing patients And had, then HMA, you before, the you this prior out know, survival, end. in as multiple was get difficult to dramatic six really patients very see can year a get the pans last median things doubled treat. the essentially the And are is, these a in a when that over is response AML

we continue that we've far. that the read-through it data the And doubling as the was been we've to excited big gotten patient So that get population. see essentially like really so is really to we're,

Operator

And Instructions] from question [Operator come Cantor next of Li our Fitzgerald. will Watsek

Unidentified Analyst

This Li. is Rosemarie on for

what might after types talking them. you XQ would and to you about when the you The with us anticipate tell FDA, do So you data and regarding your be of the communicate the Street discussion meeting? nine collecting be with And patients feedback with potentially able the would

Robert Martell

talk data Well, the the then let about start me with can communication. Jim and maybe

may FDA So Project be the is -- so with you familiar Optimus.

is start essentially Phase more undertaken let in there. me to oncology so X FDA going recommended through or of has to an from So effort the drugs year try This in participate for determination last X. the that are dose the much that the Phase

And so safety. of around this, exploring which where they've some is efficacy guidelines kind some multiple of and set doses and one is there

in toxicities actually our have they doses safety that but three So were of of three met also safe. high the criteria, They we didn't all doses had felt efficacy. that example we've had emavusertib, rate dose-limiting a some meaning that

comparable and that to twice that. XXX. at we Well, dose XXX a the the three XXX evaluated the and only we patients when XXX evaluated the offered the explored had efficacy had daily XXX We felt originally

FDA bit goal the that to patients explore a and So get to that's wanted more, is the up for us to nine just XX that patients. little total the

we they're why don't they've early emavusertib, better to are that understand did as really efficacy well. or development. some us for that is X driving we this since who wanted their around level, dose for that think that's all doing unique Phase ultimately, asked they at the this. have force companies Curis to I in that And And think this So

James Dentzer

Yes.

add me that, Li. Let to

trying levels, the find Project dose lowest about the level. So to that about know can that is dose Optimus lead as first, when we to we efficacy optimal said, Bob talk different

of we're data tested question one think interested XXX have it we're you're anticipating news. the Project of that efficacy. you XXX, is the about gets and have The still make so the good fully if the things end both excited data I that news we in That's want going doses means we year. because, in that end sure also It's the the XXX to have the of by us at you that Optimus all that and explore year, leukemia would course, by lymphoma to those. the of of good

My both patients able are the or that ahead be and patients get that as that we're we're patients. just or going among Right this enrolled investigators Whether schedule. as these the FDA dire of output well to doing talk to in at I FDA from end and situation we my get now, some were critical remains we is open seen, think, and to our therapy in, to XXX XXX said everything has the treating And have sites to new and unmet I the we course. not comments, hope thrilled up about. of in it asked, the need that reflects are excitement

Robert Martell

I'm response and analysis. that more an one Li, they analysis the And a what to really likes -- is bit call thing just efficacy specific exposure sorry, data, little the give detail on response FDA

in they patient. closely actual is what emavusertib at exposure the of each look So

you all pharmacokinetic these detailed on of doing know, patients. we're So analyses as

that. So and give at to safety. they'll compare They'll dose. us the understanding of They'll very will efficacy it granular and to that look help optimal a that them compare

And so for. that's to aspect what the fundamental we're be of really going looking

Unidentified Analyst

Got it.

maybe And one just quick sorry, follow-up.

or you your do in If think you XQ could have you hold potentially XQ, restart? how quickly lifted

Robert Martell

the going. open are studies -- and already Well, we're actually already

agreement, and So we with it the we dose have level. open, studies once that continue would that essentially are already

don't delay that happens. significant anticipate So I once any

James Dentzer

me Yes, that. to Rosemarie, let add

at end resume the kind allowed So they that comments. sites went shut to you of the hold, we year last have But we had when The your said quickly course, effectively was it of big us that enrollment. was change down. to when of in on I

already sites So went our in then open through we and recruiting of the process QX getting patients. all new

the process now point, as concerned, give for is and nine recruit to XXX? dose Bob's And but way, prefer. open. which they needed Do the races. done. they prefer our that's it to or off in and open So we FDA sites to the to we're We not see data, we're the FDA XXX as those are the far wait patients, of are Either

Unidentified Analyst

get you can the as dose, soon you go? As

Robert Martell

continue plan. can enrollment think let's we overall feel back we at like our step We're can accumulate We potential ultimately, interested data which in and that about there. dose, registrational

with of AML. a So AML; that for couple and would with there's we've secondly, FLTX rapid that in splicing opportunities mutated studies mutated single-arm mentioned patients very patients, in mutated and registration be factor FLTX

studies. those are so single-arm And

we greater we what dose, our as be. our expanding really much registrational at having soon can that. on point, As plan that start clarity have will And

Operator

turn question-and-answer our Executive the like to Chief James closing I any session. and to concludes Officer, conference President Dentzer, remarks. over would for the company's This back

James Dentzer

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

Operator

now your you you The participation. And now again disconnect. Thank conference for concluded. has may

Curis (CRIS) 13 Mar 232022 Q4 Earnings call transcript