CRIS - Earnings call 3 2023

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Operator

[Audio Gap]

[Operator Instructions] Please note that 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 Curis' Third Quarter 2023 Business Update Call.

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

see please our SEC details, filings. additional For

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

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

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

James Dentzer

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

to marked for removal clinical inflection point to a Leukemia for enrollment the in quarter our patients partial TakeAim the key the our were with return Lymphoma studies TakeAim focus and This hold. able clinical and of company as we

the unveiled, under pleased Annual from a morning, treatment ASH Meeting at which lymphoma, study, abstracts this our At TakeAim ASH, be of patients consideration. form have non-Hodgkin for for to extranodal provide we for first primary expect with Lymphoma will an Later proof-of-concept look our to rare CNS are are update XXth several options. there we including lymphoma and data abstracts limited

identify In enroll new have study, and reopened to we with the them and Leukemia are patients. TakeAim our clinical working sites

half study FLTX first relapsed from we targeting and XXXX. new As a at or have has of with reminder, Enrollment either the patients Leukemia to in our the mutation. patients patients TakeAim expect monotherapy refractory a first these data spliceosome of AML is or study with look a begun,

have study study combination minimal and azacitidine venetoclax with new is working venetoclax are intended on residual as safety emavusertib evaluate This venetoclax clinical with as in still emavusertib's are MRD. azacitidine of treatment, responding AML and to of or authorities in a by regulatory to effectiveness who AML. the and we studying but ability to Lastly, sites and well advancing enhance azacitidine patients triplet disease,

addition treatment to MRD-negative. from their Our is we MRD-positive that help with the patients hope can of convert status to these emavusertib regimen,

over We as the as combination providing therapy and We with to a expect making next of in of therapy, and X initial forward half quarters. all In short, in ibrutinib a see venetoclax, monotherapy, data doublet quarter potential in the with fourth a study and great the in combining second look azacitidine to of which should data initiate progress triplet coming the year. emavusertib as advancing this we're updates. those have

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

Diantha Duvall

you, Thank Jim.

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

We revenues to loss Curis were of both $X.XX and for period $XX.X million. for quarters September reported $XX.X of of per consist $X.X XXXX. periods XX, same the and XXXX share the for net share from as third sales million or $X.XX a Revenues Revenues Erivedge. million royalty ended of in both X of XXXX Roche's Genentech loss per the compared XXXX, a months or net for

third a costs September to due million in expenses and were to to lower ended Revenues for both compared million period same XXXX. reduction expenses primarily research the partially $XX.X development in the as of development the offset $X.X is by headcount, clinical employee-related in The $XX.X increased were quarter for costs. X attributable decrease and quarter million. and months for the Research XX, XXXX XXXX XXXX for

$X.X XXXX. were period XXXX. for X as for compared million expenses same XXXX, to third $XX.X period for same ended $XX.X expenses in were the for of million months in the $X.X XXXX Research as to million compared and XX, the and the development million September quarter administrative General

attributable period $X.X XXXX. same Other in of to and income months other the as the costs. to million as of XXXX, million for XXXX was legal quarter compared September to increase the XX, ended The $XX.X $XX.X higher the consulting administrative professional, primarily for in expense XXXX. for was net net services X expenses General were million for $X.X compared period million and third same

to XXXX, million primarily future $X.X million XXXX. Other compared Other of consists income same partially royalties. expense $X.X net the noncash net by of expense other related net for the to X ended interest for of September and income income, in XX, the offset expense was sale months period

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

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

Operator

from question Jen & your Yale Laidlaw first Instructions] Now from [Operator comes Company.

Yale Jen

questions the And congrats on here. Two progress.

The little You give of color? first could mentioned abstract in you a bit the you to more the there's is question X%, ASH that terms one. intend than

the I have a Then of general context follow-up. what's So that?

James Dentzer

Yes.

you, I Yale. thank appreciate So that.

we're So ASH of the going about defer abstract live. the comments until abstracts most to the go

and would we've I what that is leukemia lymphoma say ongoing. However, got

with got the or enrollment restarted really July study leukemia of The new patients. started in

to place at established the past the lymphoma for really We've XXXX combination that we've talked we've and looked a an and story. we story, before, about targeted to going indication at have are in And new coming ASH us really are is the CNS as Lymphoma therapy. data dose, of the primary go. our those monotherapy as be ASH. So data not ideal

CNS primary indication orphan you lymphoma. was, selected it's we within an recall, reason as first, The

of So that patients small would regulatory relatively number needed on a means path. be the

an what what ibrutinib in very to XX% I There increase Can patients an the lymphoma, we progressed get in BTK ibrutinib can establish to nice opportunity a by CNS is additive on be there CR rate. for be third, can a Second, a for adding looks clear resensitized? benefit, they we then whether have rate need. really also like but ibrutinib, it drug us is hope is treatment? going who to monotherapy, we And to established demonstrate our CRs primary be first, attained can benchmark CR in unmet

That has be IRAK-X inhibition. first This time that's hypothesis and data emavusertib possible. the for we will been always whether see the not or see to can

ASH So that data be a reviewing XXXX my for is is to story, the would ASH. going be story expectation lymphoma. at Leukemia the

Yale Jen

you second to set of is the And standard the helpful. that will of high-risk up you at current the mentioned that That's have development aspect? of what what's established, for Great. before so that? MDS pulley in And here that you on earlier question will see sort depend potentially be doing thoughts care your that Okay. terms

James Dentzer

right. No, that's exactly

as is azacitidine of standard in is is pending. azacitidine you of the know, the the by of AML still and care standard doublet. monotherapy, the Today, azacitidine-venetoclax in standard care the -- So venetoclax stand, MDS as care, That's we study. study VERONA

those results And imminent. are presumably

that would to MDS, monotherapy, doublet. negative the a waiting that of If of with positive then or is look proceed we standard we'll is study remains positive we're on is to course, other Is care that standard the is negative. if want study and of and to helpful? in If hand, So it's as with proceed care, azacitidine see, triplet. the doublet also the the

Yale Jen

sort this very That's And way line you maybe at to back ] of can any time point? [ helpful. very, Absolutely.

James Dentzer

don't We study. run that

no, XXXX. next unfortunately, it's is mean, the in I the ASH what So I that world expecting months, whether sometime broader early that's think is over sometime few or

but we you we do, don't than data. any those of outcome are more know course, Of the awaiting eagerly

Yale Jen

progress and Okay. Great. That's the very look on congrats at forward helpful. ASH. speaking to And again,

Operator

next comes Fitzgerald. Watsek Your Li from question from Cantor

Li Wang Watsek

the first next year, tell the half maybe particular us you us for the will a data in Jim, update in can AML of just expectations what bar bit little be? frame for and

James Dentzer

Yes.

with separate, VERONA in So we it's for of And relapsed to monotherapy awaiting setting be going to we and So the about, in and in path study refractory asked MDS, make FLTX patients. the right? the forward. news MDS, as understand we're really proceeding patients AML Yale spliceosome sure are

XX%. clear. CR pretty with and leader In benchmarks know, inhibitors, market gilteritinib is rate the FLTX and FLTX is for FLTX as gilteritinib, the spliceosome, you are

on XX.X%. would to rate. clear In that was getting want would a So there to not of it's improve capable are any CR CR patients, course, Their we that. spliceosome look of we rate course, that. on of improve And want to treatments

As I patients only spliceosome never published. as The is that anything worst-of-the-worst prognosis. far there's the literature know, the been data addressing have they in

demonstrated as poor. we understand that you from spliceosome So survival unfortunately range Median patients. the survival what end And refractory AML, as ever far the is lower is X we literature has X ranges quite months. is know, nobody in But studies to that from of as a the can in you get know, for relapsed response. the

upon emavusertib. And is, with what to would molecule, a anything improve FLTX, rate. in north that looking we're our class presumably in FLTX a inhibitors do So we Is XX% XX% of targeting would spliceosome in FLTX as greater a IRAKX can patients, would CR beating that it XX.X% rate very be be helpful? or be something that would setting. And CR/CRH than X, be exciting that

Li Wang Watsek

another [ you combination? the anticipate the any do you FLTX Do do And interaction regimen? or need triplet. more have ] think question for the for Yes. dose drug-drug And work I you to

James Dentzer

question. Excellent

the or say work overlapping there's see the do profile. drug-drug we done whether why we've see of That you work stays consistent. study answer I'd not in expect lab the the safety We DDI, said, we've an on one So second we date. done that and run of, to to that's clinical the based that don't don't to course, expect it any the interaction,

were In the our question me of terms the you first could in remind triplet? you with headed part expectation, that of where

Li Wang Watsek

do to more Do you work? need dose

James Dentzer

right. That's

to foray be triplet the and safety into that going the our mean, we're So answer efficacy. yes. first study, evaluating to I both is,

ibrutinib studied time the know certainly the will and dose. monotherapy. We So the have right and right we the we in ven the we in triplet dose We with of first clinic for but this think dose be think right we've aza ema. combination the venetoclax, know and

the to one Any think to want we're dosing questions, see determine Li? appropriate other of emavusertib those, that setting. in going results the I So of things regimen is, the we based can on for

Li Wang Watsek

No, you. that's Thank great.

Operator

Dane question Your James. from from He from Leone Raymond the line. disconnected comes next

A.J. Your Eagle. comes Rashid Columbia next from from question

A.J. Rashid

dispute. overland the On

James Dentzer

about the sorry in there up. that. last broke I'm any That queue? questions other Are one

Operator

It there questions. Okay. are appears no further

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

James Dentzer

you, Colin, you, today's thank and Thank everyone, call. joining for

always, and clinical updating help ongoing their in at and families commitment tireless at trials, our to Aurigene to forward our their thank NCI We to you support. and participating our for again for the partners team As Curis the to patients soon. and you Colin? look

Operator

concludes this gentlemen, conference call your for participating and ask and We Ladies you. today. you your please disconnect lines. that Thank for you thank

Curis (CRIS) 2 Nov 232023 Q3 Earnings call transcript