Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, and welcome to the Curis First Quarter 2023 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. Ms. Diantha, please go ahead.

Diantha Duvall

to first welcome Update XXXX and Call. you, the quarter Curis Business Thank

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

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

details, please additional see For our SEC filings.

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

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

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

James Dentzer

Good to with Thank Update we afternoon, Quarter Business past welcome emavusertib. . progress made important everyone, candidate, First and Call. clinical Curis' This quarter, lead you, our Diantha.

update, FDA we additional our excitement the we among and in enrolling mentioned the indicative is the need believe of we ahead clear in of both leukemia community agent. this March As novel unmet completed for the by schedule, clinical requested patients which

We these quarter expect the patients discuss data analyzing and with are third FDA these this data quarter. the and to in collecting from

move We and us into these the study. the to our are for phase aim Phase data allow leukemia Dose optimistic expansion that FDA proceed Recommended to will sufficient be X with take a of

important orphan emavusertib is in the of with them TakeAim inhibitor with therapy has our Primary in which Emavusertib ibrutinib need. high patients enrolling System believe population with unmet PCNSL, an be potential or to ibrutinib study. and also patients Nervous BTK We combination Leukemia with an the with We're new Lymphoma PCNSL, in combination Central treating in

Curis' with of a well-respected pharma. team Development experience our drug to strengthens team in also both addition expansion leader Dr. Jonathan Dr. large with as wealth biotech Officer. industry the executive as executive the a Chief of Zung and of the Zung I'm pleased announce our development

progress In forward in the single short, the of and look the significant quarter candidate, clinical lead in agent make ahead. we showing sharing cornerstone combination our clear broad discussions therapy potential our Emavusertib, establishing And malignancies. and to hematological potential activity results with FDA CURES team continues as a treatment to both in

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

Diantha Duvall

Jim. you, Thank

share period For loss a per quarter $X.XX first to first a in loss XXXX, as compared share, million $XX.X million $X.X XXXX the of in of Revenues reported million net same Curis XXXX. for for to of same compared net period for as the $X.X $X.XX per the $XX.X the XXXX. of or or million were quarter

expenses $XX.X headcount. employee the development the primarily quarter XXXX period manufacturing decrease of XXXX. and for the lower were costs research The in related timing the a quarter in $X.X million to compared is first attributable of costs million Research to due development as for and and reduction same in expenses for to

in to The related $X.X due expenses for administrative for to costs same in quarter primarily of XXXX. million $X.X in expenses the as compared employee reduction General and lower general first driven the million by decrease were headcount. period XXXX was administrative

XXXX. net For interest consists for million was other as primarily same net of X income the of offset other the partially related expense future by royalty XXXX, quarter income Other payments. expense to of income first in net $X.X compared expense to million period

investments cash cash, common March equivalent million outstanding. As there stock approximately of Curis' XXth, as and XXXX. were and of $XX.X $XX.X million totaled of shares

and existing operations investments cash our us into position cash equivalents expect We cash, our and planned continue 'XX. to to be in enable a should strong that maintain

call I'd for the turn to like the open call operator, that, With questions

Operator

Li Fitzgerald. from come [Operator Please instructions]. ahead. go with Cantor question And first will Watsek our

Li Watsek

good you the additional do compares how nine have maybe in data a patients Hey, taking of do in XXX you the QX, sense that Thanks with higher Jim, QX? for to dose And enroll the FDA far seen questions. your have to so for you meg? prior out curious, share activity plan just meeting afternoon. the that you've to

James Dentzer

you the very So thank question. much for

So we're more we'll the first discussion and the having planning then on data discuss later. FDA with publicly

FDA that's best think the the it. that's time. this for at the prefer answer course, us way I And Of would

XXX the doses, milligrams, you which which we've And is, those the the questions was, tell both BID, two of FDA's answered is FDA in we better got I of year two and the that doses? open we've with think last question with what the responses. of that milligrams, all past we exception, which BID, and can said look of safe, both XXX have shown is, one

seemed XXX. would for our at both were last that to to slight a to anticipate both So were lead view time, be seemed we There data responses, both had preference the be year this could safe. good,

added have We at XXX a two. analysis the fulsome have between since more to more patients

the come better to Either means so the data is are. the XXX, what XXX, forward look that these far. to assumption where, to, my walking FDA, look conversation FDA. at there's that were through for take out outcomes when that did be the data consistent And I If look completely they those with and look after we of going good, we there's what like even If have a preference is preference And XXX last is seen doses for that you than we'd data a at time. with effective. safe, going to doses they're the means we are are both data to these both dataset and

Li Watsek

a follow… Maybe Okay.

James Dentzer

helpful. answer Hope the Pretty long to that's question.

Li Watsek

you well? three, as meeting, the discuss the the I with be be Maybe Yeah, guess when you for meeting to to might after question, and to you up a this follow do think path QX sure. respect the able clinical hold would able communicate registrational with FDA to

James Dentzer

of that hope is we at the now right to QX. have plan the with discussion our think I I, this Yeah, end FDA

would out with of we forward. the it come as with that as that we moving have answers we're soon So course, we, as,

clear been in design, design steps, pretty In precedent think of straightforward. the I the in, terms fairly for is the we've AML next the

IDHX at is studies these primary in with we And flip be assume consistent and going practice done a three, have CRH and design we're arm FDA a that look their studies, the CR with similar going -- MDs. secondary one, all duration design with is of pivotal past endpoints. We endpoint single a is IDHX, to of survival response would forward,

refractory and reason there that's discussion. because for is drugs are longer approved. a precisely of both It's in good why It's there longer treatment no and MDS, it's because thing. no discussion precedent The relapsed bad a a is

that the course, it's So the open a that good of news space. is in wide

course, a The is wide because more open FDA. approved, because going take to with nothing news know, and of space you with, uncertain some it's it's is dialogue

FDA. to clinical the will discussions As I discuss with of eager with And look forward we hold, having minute can, we you. those off with getting course, be very to

Operator

next come Jen with & go instructions].our will Yale ahead. Please Laidlaw Company. [Operator from question

Yale Jen

of there my and afternoon, with My these patient taking night you. about the characteristics Good of, question enrolled, is, for general already talk thanks you the the you patients? first can anything is Thank first that is question. question

James Dentzer

can FDA. that you're and you else about or population, So refractory MDS, this run know prognosis. a baseline discussions. and looking FDA all yeah, have these relapse what what relapse We're we're is at we've going the we're withhold characteristics seeing But to, front that try to talking we're already not we AML anything in going say discussion refractory after had until poor going patients to with the whether very

to six a, Median just survival in a X.X months. from the It, anywhere bleak prognosis. literature very is it's

So between to it's are now far we're any going and into that see be tough that fair shape. unfortunately have so likely and in to NDA submission, patients the any to say patients patients come pretty are that study those

Yale Jen

well. as and appreciate I Understood. that, respect that

you You test anticipate may was about is CCN my where a How us here background? follow-up also, and and rationale would things this XXX that start in you the it thanks. what give behind And could this little to and at question moment you months? are what bit and mentioned

James Dentzer

Yeah.

So the, to primary I'll in. Bob so going start join and CNS I then into the lymphoma, can rationale for ask I, to,

we're activity. where ibrutinib. logic really pathways, is is in lymphoma The the down-regulate there where B-cell today receptor BCR lymphoma, general, remember pathway And treated NF-κB with pathway two treating and NF-κB lives biologic turn driven in toll-like in So in to combination lymphoma by Btk IRAKX you is the lives.

down one the the you best want both. to we, scientific we is to thing course shut to in our patients, in then shut the and that these to in What in lab down-regulate the, of then later was down other. It's or NF-κB clinic, if discovered activity the isn't that pathway early in corroborated do work what

lymphoma logic So is toll-like lymphoma that's to primary orphan side, as in in and down receptor this the and the opposed it's the to where a of in an type indication. BCR cancer going particular, side particularly general drug it's behind sensitive CNS

should our to to I want in colors quickly if add favor. mean Bob, know it get works more can that an So hopefully to answer that we that. you fairly don't any

Robert Martell

patients ultimately Yeah, no, primary have I said, key driver think expand what of just and of, CNS who explanation. MYDXX And Jim good lymphoma this IRAKX the good, you activity. have a mutations. is to majority sort The, is on a of that was know, NF-κB

the TLR the PCNSL be pathway to actual terms driving of disease the, towards so the And disease, in the more seems disease. weighted the, what's

Now the lymphoma. and particular we interesting data some have with published nice literature in some in data there's CNS really

the as models well. in exposure For preclinical know crossing example, that emavusertib and we of barrier we excellent blood-brain in these and, tumors get

of therapeutic these this levels fact, that preclinical therapeutic ranges. So feature are getting is models nice a in in emavusertib at

aside You for for just demonstrated lymphoma, know, but actually only well. CNS as been as not that's melanoma an

So capture of it's we a where think great or, we area you early potential drugs a not think indication. lot approved other great us to is a, as there's or a opportunity used, a a, know, for and that this

Yale Jen

to with be meetings something the sort, And the what of next in the of endings? nine and expectation after months, type to that FDA be six occur happy should terms

James Dentzer

talk data in the we get the identify timing of sites on with to of yet. just we're I'd all and when to Yeah, going too follow premature drug, patients, this working have I our we'll them think are those point phase say to then it's the, the them. at about the,

investors long, be is outcomes most little they've of than sets broadly, worse survive disease have prognosis. why that a versus following frankly you know, reasons been bit know, for lymphoma, their the You one the tend patients in more very that, to bad news been better. don't much just leukemia lymphoma the are a following is leukemia the patients The

moving are things than the on leukemia in that data but in sets have all fast lymphoma our fronts equal, furious side, sooner would So and sets view simultaneously. side likely have data we being to be we're we'll the both

Robert Martell

to patient continued to we quickly This if added continued don't remember We response. I'll know data you ibrutinib, had one our patient with a ibrutinib. was and is add complete a and who I into that year. last presented went CNS ibrutinib primary and, quickly lymphoma. They emavusertib resistant who

about know, So, that. we're you really excited

I think proof of patients. that's in a concept nice

Yale Jen

obviously patient amenable Underscores to might that the be MYDXX be idea driving in but with really NF-κB that which combination. what's in that you we consistent express. it's to one it's patient, exciting disease being these side, more said Yeah. NF-κB only going is to added the one was Bob's And, our should through receptor and drug appears what turn point as in toll-like means and very the they driving patients

Robert Martell

Yeah. And a concept of resistance. we can ibrutinib that overcome proof nice

Yale Jen

Exactly.

That's and for encouraging a the best agency. with lot and again, luck thanks very the Okay, great. meetings

Operator

Raymond The with Leon come Dane Please question will James. ahead. next go from

Laura Hillman

Dane. have for questions. Hey guys, on this I Laura two is

guys point [indiscernible] is follow-up the or up then long going FDA? XXX that expansion this how last are seeing data you taken rep robust to any combination cohort to package looking at for First Venetoclax back we year the at year? duration the more to milligram be also Thanks. characteristics be follow the And any at disclosed patient

James Dentzer

Sure.

address question first. the me the, So let first

we that from in follow you terms glean guidance think that you of gave time, the the on can, timing. I So up can

then QX. patients the and we're recruited So FDA QX. we're them the in filing and them up with QX, the, we getting And in following data data We getting the back discussing QX. sites opened in in

nutshell. really of that's in So the a timeline short

remember that were we to FDA milligrams. put monotherapy the partial XXX the asked us On Venetoclax, only may at enroll hold on you when

in about really So to have patients. we don't further talk information those combination

having therapy those course, we can we path. of forward look we to And forward as look soon combination Although to forward, as with monotherapy, but discussions forward of to not lifting you partial imagine, look the moving as the just as with with hold, you can.

Robert Martell

that Venetoclax activity things maybe data the the of is, to exciting and, was know, like you you some about I looked Yeah, there. recall there and it really as anti-cancer and add one nice can

ways been you shown of be One to other regulated up-regulation anti develop key know, Venetoclax why actual able And apop of exact MCLX, BCLXL. of resistance the as leukemia these have this such that may factors you to be think to, this know, well. through overcome emavusertib you we resistance know, pathway. drug as And is venetoclax that's

Operator

President This question I Please for Mr. the Chief over back Executive go concludes and the turn ahead. answer Officer, session. and James our like Company's to would closing conference Dentzer to remarks.

James Dentzer

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

Operator

concluded. The for now conference participation. Thank your is again you

now You may disconnect.

Curis (CRIS) 4 May 232023 Q1 Earnings call transcript